Podcasts about opdivo

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world.Jefferies predicts an increase in small tuck-in deals in the biotech industry as companies face challenges accessing capital. Companies and industry groups are offering solutions to mitigate the impact of Trump tariffs on rare disease, cell, and gene therapy. Pitchbook suggests a shift towards more sustainable investing in biotech VC firms. Gilead is gearing up to challenge J&J in the $20 billion multiple myeloma CAR-T market. PTP's generative AI is revolutionizing data summaries for biotech QC workflows. Sanofi recently acquired Blueprint for $9.5 billion, while BMS has committed up to $11 billion with Biontech. Lilly has signed a deal worth up to $870 million, and Regeneron is investing nearly $2 billion in a Chinese obesity drug. Merck's CEO is emphasizing diversity in operations following the defeat of an anti-DEI measure. Immuno-oncology drugs Keytruda and Opdivo may face scrutiny in the near future.In other news, Vigil Neuroscience's Trem2 antibody for a rare brain disease failed in a Phase II trial shortly after Sanofi's acquisition of the company. Analysts believe the results were not surprising and should not impact the deal. Lilly has signed a deal worth up to $870 million to develop a long-acting GLP-1 obesity drug, while the FDA is committed to making rare disease drugs available at the first sign of promise. Pharma tuck-in deals are increasing after a slow first quarter for small biotechs. BioAgc Biologics will be attending Bio International in Boston to discuss their global drug production capabilities.Stay tuned for more updates on investing in research, welcoming global talent, the biotech VC cycle, Gilead's challenge to J&J in the multiple myeloma CAR-T market, and much more. Upcoming events and job listings in the pharmaceutical industry are also featured in our newsletter.Thank you for tuning in to Pharma and Biotech daily.

Ahead of the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, CancerNetwork® spoke with a variety of oncology experts about the late-breaking abstracts, plenary sessions, and other key presentations that may shift the paradigm across different cancer care fields. They highlighted anticipated clinical trial results that may transform the standard of care for gynecologic malignancies, lung cancer, and other disease types. Rachel N. Grisham, MD, section head of Ovarian Cancer and director of Gynecologic Medical Oncology at MSK Westchester of Memorial Sloan Kettering Cancer Center, shared her anticipation of findings from the phase 3 ROSELLA trial (NCT05257408) assessing relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer. She stated she was excited to see if the data may represent a new opportunity for this patient population. Next, MinhTri Nguyen, MD, a medical oncologist and hematologist at Stanford Health Care, highlighted a few breast cancer presentations to look out for. These topics included a plenary session on data from the phase 3 SERENA-6 study (NCT04964934) evaluating camizestrant in combination with CDK4/6 inhibitors for those with hormone receptor–positive, HER2-negative advanced breast cancer harboring emergent ESR1 mutations. Additionally, Eric K. Singhi, MD, assistant professor in the Department of General Oncology in the Division of Cancer Medicine, and assistant professor in the Department of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, spoke about a range of potentially practice-changing results in the lung cancer field. For example, he described a session focused on primary results of the phase 3 IMforte trial (NCT05091567) assessing lurbinectedin (Zepzelca) plus atezolizumab (Tecentriq) for those with extensive-stage small cell lung cancer (ES-SCLC). According to Singhi, data from IMforte may shift the paradigm of maintenance therapy for this SCLC population. In the world of head and neck cancer, Douglas R. Adkins, MD, associate professor of Internal Medicine, Division of Oncology, Section of Medical Oncology at Washington University School of Medicine in St. Louis, Missouri, highlighted the session on the phase 3 NIVOPOSTOP GORTEC 2018-01 trial (NCT03576417). Investigators of this study evaluated nivolumab (Opdivo) in combination with chemoradiotherapy for those with resected head and neck squamous cell carcinoma. Adkins noted his excitement to see how these data may impact the standard of care, particularly for patients in Europe, where investigators conducted the study. As part of an Oncology Decoded discussion, Benjamin Garmezy, MD, the associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers, discussed key abstracts in bladder cancer. One specific presentation included additional findings from the phase 3 NIAGARA trial (NCT03732677), which may show how circulating tumor DNA can influence treatment decision-making regarding perioperative durvalumab (Imfinzi) for patients with muscle-invasive bladder cancer.

In today's episode, supported by Replimune, we had the pleasure of speaking with Anna C. Pavlick, BSN, MSc, DO, MBA, about the use of RP1 plus nivolumab (Opdivo) for the treatment of patients with advanced melanoma. Dr Pavlick is a professor of medicine in the Division of Hematology & Medical Oncology at Weill Cornell Medicine in New York, New York; as well as the founding director of the Cutaneous Oncology Program at Weill Cornell Medicine and NewYork-Presbyterian. In our exclusive interview, Dr Pavlick discussed the rationale for investigating this combination in patients with advanced melanoma who have received prior immune checkpoint inhibition, key efficacy and safety findings from the phase 1/2 IGNYTE trial (NCT03767348), and where the future may be headed regarding the use of oncolytic viruses in melanoma.

Pushback against the Trump administration's massive government cuts exploded this weekend across America—and biopharma is no exception. Taking a deep dive into the leadership cuts, we found that more than half of the senior FDA leaders from six months ago are no longer there, and that's just the leadership. Across the Department of Health and Human Services, some 20,000 people will be leaving—of their own accord or otherwise—amounting to a 25% reduction in headcount that would leave HHS with around 62,000 employees. With many of these people likely destined for biopharma, does this pose an ethical problem?   Meanwhile, the escalating tariff war is beginning to ring alarm bells for the economy, with Goldman Sachs now predicting a 45% chance of a recession happening in the next 12 months. While pharma has historically been considered resistant to the challenges of a recession—people always need medicines—this time around could be different, in part because of the consumer-led obesity market. Thanks to the Trump administration's decision to nix a Biden era proposal to cover GLP-1s under Medicare Part D—at least for now—these drugs will continue to cost consumers a pretty penny.   Even without a recession being declared, Eli Lilly's and Novo Nordisk's stocks are falling significantly with the rest of the market. Lilly has lost more than $95 billion in market value in one month. Novo's value has declined $72 billion.   The drugmakers are also still battling makers of knockoff versions of their drugs. Most recently, Lilly filed a lawsuit against a med spa in Indianapolis for allegedly taking vials of tirzepatide and splitting them up into single doses that are sold to patients without the packaging inserts.  Of course, Lilly and Novo aren't the only pharma drug rivalry out there. There's also Keytruda vs. Opdivo, Leqembi vs. Kisunla and more.   Finally, we take a look at seven late-stage MASH candidates that could hit the market in the next few years, following the FDA's 2024 approval of Madrigal's Rezdiffra, the first treatment for the metabolic disorder. 

A patient with Duchenne muscular dystrophy taking Sarepta's gene therapy Elevidys has died of acute liver failure, possibly related to a recent viral infection. Sarepta, which said it will update Elevidys' label to reflect the new safety signal, saw its shares drop 22% on the news but analysts still seem positive on the drug, as treatment options for Duchenne remain limited.Meanwhile, both AstraZeneca and Taiho Pharmaceuticals announced acquisitions worth up to $1 billion or more in two sizzling therapeutic spaces, cell therapy and antibody-drug conjugates, respectively.Despite canceling a vaccine advisory committee late last month, the FDA on Thursday selected flu strains to be targeted in the upcoming 2025-2026 flu season. And at another federal agency, the Centers for Disease Control and Prevention, employees will have to wait a bit longer to see who will take the helm under Donald Trump, as the president's nominee, Dave Weldon, was pulled hours before he was set to appear before a Senate committee on Thursday. Like HHS Secretary Robert F. Kennedy Jr., Weldon has expressed anti-vaccine views in the past, particularly his continued suggestion of the link between vaccines and autism. Guggenheim Partners called the move to revoke Weldon's nomination “a positive sign for reigning in vaccine criticism.”In the weight loss arena, BioSpace takes deep dives into the tendency for biopharma to develop fast-followers, or me-too drugs—following a pattern seen with PD-1 checkpoint inhibitors after the approvals of Merck's Keytruda and Bristol Myers Squibb's Opdivo. One key difference between these two markets, however, is that when it comes to GLP-1s for weight loss, patients are not staying on these medicines. Drug developers are trying several approaches to improve treatment persistence, including titration, combinations and even secondary drugs that address side effects. They're also making other moves to differentiate themselves, including focusing on overall health outcomes—in areas like cardiovascular, sleep apnea and kidney disease.Following on BioSpace's coverage of the major patent cliffs that many Big Pharma companies are facing in coming years, we also take a look back at some of the companies that have already weathered such loss of exclusivity. It's rarely a straightforward story of sales crashing off patent, as companies take various tacks to extend their blockbuster sales.Finally, the cardiovascular space is expecting some movement this week. First, Alnylam is anticipating a decision on its RNAi silencer Amvuttra in ATTR-CM. An approval—which is widely expected—would make three companies on the market in this rapidly expanding space after Pfizer's tafamidis was approved in May of 2019, and BridgeBio's Attruby got the greenlight in November last year. And second, Milestone Pharmaceutical has a PDUFA coming up for etripamil in paroxysmal supraventricular tachycardia.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Moderna reported higher-than-expected losses in its fourth-quarter earnings report and is anticipating layoffs. The company's revenue was down substantially from the previous year. Meanwhile, controversial figure RFK Jr. was confirmed as the Health and Human Services Secretary, despite his history of anti-vaccine rhetoric. In other news, BMS' phase III Opdivo and Yervoy combination therapy failed in adjuvant melanoma, potentially limiting market opportunities. Amgen and Ideaya have ended their collaboration on a cancer combo therapy, with Amgen continuing to advance one component in a mid-stage trial for lung cancer. Pliant has brought in outside experts to review a study pause in idiopathic pulmonary fibrosis research. Stay tuned for more updates on various biopharma companies and their developments.

In collaboration with KidneyCAN, CancerNetwork® spoke with Eric Jonasch, MD, a professor in the Department of Genitourinary Medical Oncology of the Division of Cancer Medicine, and the director of the von Hippel Lindau Center at the University of Texas MD Anderson Cancer Center in Houston, Texas, about the missions and goals of the Kidney Cancer Research Consortium. Jonasch is the principal investigator of an effort, supported by a Department of Defense (DoD)–funded grant, that aims to improve the treatment of patients with renal cell carcinoma (RCC) by developing a network of clinical trial centers that have expertise in both developing and executing new research efforts.  “We want to do the clinical trials that the industry wouldn't do otherwise and do the trials that are going to allow us to gain knowledge faster,” Jonasch said. “We do this by, number one, using novel agents; number 2, using more efficient and innovative clinical trial designs; and, number 3, incorporating correlative studies, including biopsies and various other circulating biomarkers analyses that allow us to get smarter faster.” Many of the ongoing and recently completed trials in the kidney cancer space focused heavily on immune therapy, utilizing checkpoint-blocking antibodies like nivolumab (Opdivo) and pembrolizumab (Keytruda) or CTLA-4–blocking agents like ipilimumab (Yervoy). Of the studies moving the space forward, Jonasch highlighted an ongoing phase 1b/2 trial (NCT05501054) evaluating ipilimumab, nivolumab, and ciforadenant (CPI-444), an A2A inhibitor, in RCC along with other trials. During the discussion, Jonasch mentioned the initiative to incorporate biopsies in treatment more frequently, particularly through giving a pre- and post-biopsy to see how the results change during therapy. This approach gives investigators an opportunity to see how cancer cells interact with immune cells.  Additionally, Jonasch stated that they wish to expand their efforts to the broader kidney cancer community, as currently, work in the consortium only takes place in 7 “ivory tower” institutions that may be difficult to access for some patients. One of the ways they're combatting this barrier is through working with the Veterans Affairs hospital system. Once that effort is complete, Jonasch hopes the consortium will be able to start helping more patient groups.  KidneyCAN is a nonprofit organization with a mission to accelerate cures for kidney cancer through education, advocacy, and research funding. You can learn more about KidneyCAN's work here: https://kidneycan.org/ Reference Beckermann K, Rini B, Haas N, George D, Jonasch E. Phase 1b/2 trial of ipilimumab, nivolumab, and ciforadenant (INC) (adenosine A2a receptor antagonist) in first-line advanced renal cell carcinoma. Oncologist. 2023;28(suppl 1):S13–4. doi:10.1093/oncolo/oyad216.022.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Johnson & Johnson has made a significant move in the neurology field by acquiring Intra-Cellular for $14.6 billion, gaining access to assets such as Caplyta for schizophrenia and bipolar depression. Biogen has submitted an offer to acquire Sage Therapeutics after facing regulatory and clinical challenges. Gilead is diversifying with a potential $1.7 billion inflammation pact with Leo, focusing on targeting stat6. The FDA's evolving biomarker focus was highlighted by a committee's decision to limit the use of Keytruda and Opdivo in certain cancers based on PD-L1 expression levels. AGC Biologics is offering representative scale-down data for gene of interest candidates before committing to a GMP contract, potentially accelerating timelines by up to 6 months. Other news includes GSK's acquisition of Idorsia targeting rare cancer, AbbVie absorbing the cost of a schizophrenia failure, and collaborations between Merus and Biohaven. Additionally, five novel FDA approvals have been achieved in 2024, while Passage Bio is cutting staff to extend cash runway.The FDA's evolving focus on biomarkers is reflected in the scrutiny of Keytruda and Opdivo for stomach and esophageal cancers based on PD-L1 expression levels. This trend leverages ever-maturing datasets to make more informed decisions about drug approvals. In addition, five novel FDA approvals in 2024 included new mechanisms of action in oncology and neurosciences. Gene therapies for cardiovascular diseases like congestive heart failure and cardiomyopathy are advancing in the clinic, benefiting from technological advancements and positive early data. The NextGen Class of 2025 startups are focusing on ADCs, radiopharmaceuticals, and cell and gene therapies. Pfizer's subcutaneous PD-1 blocker showed positive results in bladder cancer trials, while Denali and AbbVie/Calico faced setbacks in ALS trials. The FDA is proposing setting a bar for weight-loss therapies as the obesity space heats up, with Metsera touting powerful weight loss results.

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:   The good — FDA approves Opdivo subcutaneous version The bad — Marinus Pharmaceuticals sells operations The ugly — Novo Nordisk pushes back against compounding pharmacies   

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world.Roche has recently finalized a new deal in China valued at up to $1 billion for an antibody-drug conjugate. However, Neumora's depression drug trial has unfortunately not yielded successful results. Additionally, Sangamo has experienced a setback by losing a partnership with Pfizer in hemophilia gene therapy. On a more positive note, Axsome has released mixed data from Alzheimer's trials but still plans to move forward with filing for FDA approval.In other recent developments, Merck's PAH drug and BMS' Opdivo injection have received regulatory greenlights. It's important to note that there are currently job opportunities available in various pharmaceutical companies for those looking to make a career move in the industry.Looking ahead to 2024, the neurobiopharma industry has been characterized as a rollercoaster of ups and downs.

In today's episode, we had the pleasure of speaking with Alex F. Herrera, MD, about key safety and efficacy findings from the phase 3 SWOG S1826 trial (NCT03907488) evaluating nivolumab (Opdivo) plus doxorubicin, vinblastine, and dacarbazine (N+AVD) vs brentuximab vedotin (BV) plus AVD (BV+AVD) in adolescent and adult patients with stage III or IV advanced-stage classic Hodgkin lymphoma. Herrera is chief of the Division of Lymphoma in the Department of Hematology & Hematopoietic Cell Transplantation, as well as the associate medical director of the Briskin Center for Clinical Research and an associate professor in the Division of Lymphoma in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope in Duarte, California. After 2.1 years of follow-up (range, 0-4.2), N+AVD prolonged median progression-free survival (PFS) and had a more tolerable safety profile compared with BV+AVD. The 2-year PFS rate with N+AVD was 92% (95% CI, 89%-94%) vs 83% (95% CI, 79%-86%) with BV+AVD (HR, 0.45; 95% CI, 0.30-0.65). Notably, the benefit with N+AVD was consistent across diverse patient subgroups enrolled in the study. In our exclusive interview, Dr Herrera expanded on the rationale for conducting SWOG S1826, detailed key data showing sustained benefit and safety with N+AVD, and explained how these results support the use of N+AVD as a strong candidate for primary treatment in adolescent and adult patients with stage III or IV Hodgkin lymphoma.

As part of Oncology On the Go, CancerNetwork® spoke with Andrew M. Evens, DO, MBA, MSc, about developments in the treatment landscape for adolescents and young adults (AYA) with lymphoma. He highlighted collaboration between adult and pediatric oncologists that may better standardize treatment for this population.  Evens is the deputy director for clinical services at the Rutgers Cancer Institute and system director of medical oncology and oncology lead at RWJBarnabas Health Medical Group. Of note, Evens discussed an effort to “harmonize” efforts between adult and pediatric oncologists in treating AYA patients who may receive different treatment regimens, despite being similar in age. Furthermore, he highlighted 2 prominent trials that illustrated collaborative efforts from both adult and pediatric oncologists: the phase 3 SWOG S1826 trial (NCT03907488) and the phase 3 AHOD2131 trial (NCT05675410). Regarding the SWOG trial, Evens highlighted the greater efficacy and tolerability of nivolumab (Opdivo) with doxorubicin hydrochloride (Adriamycin), vinblastine sulfate, and dacarbazine (AVD) vs the standard of care brentuximab vedotin (Adcetris) plus AVD.  “You could say it was, generally speaking, a double winner. [The nivolumab combination] was more effective at 2 years; the progression-free survival [PFS] was greater than 90%, [which was] a remarkable output. When I say a double winner, it was also largely better tolerated. There was less neuropathy, [fewer] infections, and less sepsis [vs brentuximab vedotin plus AVD]. Surprisingly, to a certain extent, [there were] not many immune-related adverse events outside of thyroid [events],” Evens said. Furthermore, Evens discussed how collaboration between adult and pediatric oncology has impacted developments in the AYA lymphoma sphere. He placed a particular emphasis on the efforts of the Lymphoma Research Foundation, which convened multiple AYA lymphoma symposiums and established an AYA consortium. He then outlined unmet needs for this patient population, which included mitigating late toxicities following treatment and addressing inconsistencies in guidelines for lymphoma treatment in the AYA group. Evens then discussed mitigating disparities and addressing barriers to care, underscoring a need to navigate the complexities of treatment for a patient population with a myriad of stressors. He concluded by highlighting resources available to AYA lymphoma groups, which include educational, medical, and psychosocial resources to best educate patients and express to them that they are not alone.  “At the end of the day, be an advocate. Be an advocate for yourself. Be an advocate for others and know that there are [many] resources and people out there to help. We want to make sure nobody has to go through this alone, and that they have the medical and other psychosocial resources available to them,” Evens concluded.

In today's episode, we had the pleasure of speaking with Samuel A. Kareff, MD, MPH, about the intersections between early-phase clinical research and meaningful mentorship experiences during oncology/hematology fellowship. Dr Kareff is a medical oncologist and hematologist at the Eugene M. and Christine E. Lynn Cancer Institute, part of Baptist Health, in Boca Raton, Florida. He formerly served as chief fellow during his hematology/medical oncology fellowship at the University of Miami Sylvester Comprehensive Cancer Center in Florida. In our exclusive interview, Dr Kareff discussed the rationale for and design of a proposed phase 1 clinical trial investigating the oncolytic virus SVV-001 in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) in patients with neuroendocrine carcinoma or neuroendocrine tumors. He also shared advice from his fellowship experience and emphasized how seeking out effective mentors can prepare fellows for the next steps in their careers. 

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Sanofi has signed a $326 million deal with Orano Med for radiopharma, following a similar deal made in September. Sage Therapeutics is laying off 33% of employees to support the launch of its postpartum depression drug. Bristol-Myers Squibb's Opdivo showed a progression-free survival advantage over Pfizer's Adcetris in a late-stage study for Hodgkin's lymphoma. Kezar Life Sciences has cut its lupus program after patient deaths and is now focusing on autoimmune hepatitis. The Institute for Clinical Research is researching ways to extend healthy lifespan. Other news includes GSK and Viiv touting the effectiveness of a long-acting HIV prep, Bavarian Nordic's Jynneos eliciting a robust antibody response in adolescents, and AbbVie winning approval for an advanced Parkinson's treatment. Takeda has walked away from a partnership for Huntington's disease after investing $260 million.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.CVS is laying off 2,900 employees as part of a cost-cutting plan and potential business breakup. Humana's Medicare Advantage star ratings have dropped significantly, impacting profits. Healthcare workers face burnout, while the payer-provider relationship is evolving. Mission Hospital in North Carolina is struggling after Hurricane Helene, and Steward CEO Ralph de la Torre is being sued by senators. Healthcare companies are urged to prioritize patient-centric experiences. The text also highlights upcoming healthcare conferences, telehealth trends, and insights into the relationship between providers and payers.The FDA has officially declared the end of the shortage of Zepbound and Mounjaro, putting pressure on companies selling compounded alternatives. Biopharma conferences in 2025 are important for showcasing clinical trial results. The FDA is set to make several key decisions in the fourth quarter, including approving a rival to a popular Pfizer heart drug. Roche plans to address an $8 billion sales gap due to biosimilar competition. Lilly is investing $4.5 billion in a "foundry" for advanced drug manufacturing. Additionally, there are resources available on topics such as AI in clinical research, genetic screening, gene therapy, and biosimilars. Other industry news includes potential sales of pharma units by Chinese company Wuxi, and the US's commitment to African manufacturing in HIV programs.Sanofi has sold the global rights to a rare autoimmune drug for cold agglutinin disease to Recordati in a potential $1 billion deal. Recordati will make an upfront payment of $825 million to Sanofi, with milestone payments of up to $250 million. Meanwhile, Novo's lowest dose of Wegovy remains on the FDA's drug shortage list. AbbVie has trimmed its full-year earnings guidance due to R&D milestone costs, following the success of its Parkinson's disease candidate Tavapadon. Relay Therapeutics is laying off 10% of its workforce to streamline its research organization. The pharma industry is prioritizing scaling GLP-1 manufacturing capacity to meet the demand for weight loss drugs. Lilly has ended its obesity drug shortage, while Novo continues to face shortages. WBL's proprietary library prep for cfDNA whole genome sequencing aims to enhance specificity, sensitivity, and data quality at low concentrations. In other news, BMS has received FDA approval for an Opdivo regimen in NSCLC and Bavarian Nordic's MPox shot shows antibody responses wane after 6 to 12 months.Dr. Matthew Schrag, a vascular neurologist at Vanderbilt University, is not prescribing the new Alzheimer's disease treatments, Kisunla and Leqembi, due to concerns over risks and costs. Schrag has a history of challenging prevailing science in Alzheimer's and has exposed instances of potential misconduct by researchers. In 2021, he raised allegations of data manipulation against Cassava Sciences, leading to ongoing scrutiny and calls for their phase 3 trials to be stopped. Despite distancing himself from the controversy, Schrag's findings have had a significant impact on the company. The article also discusses Roivant's unique approach to drug development, the latest advances in oncology research, and the challenges in navigating the path from preclinical studies to regulatory approval for gene therapies. The text highlights the importance of efficient therapeutic development processes and increasing diversity in clinical trials. Additionally, it provides links to resources on selecting clinical trial sites, unlocking partnerships for small biotech firms, and optimizing AAV manufacturing processes. The newsletter also includes updates on Medicare drug price talks, a groundbreaking trial for lung cancer treatment, and a map of a fruit fly's brain that has impressed neuroscientists.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Bristol Myers has received approval for a first-of-its-kind schizophrenia drug, Cobenfy, and plans to sell it despite potential insurance barriers for patients. Biogen and UCB are planning a large study for their lupus medicine, Biohaven is seeking approval for a neurological disorder drug, and Amgen claims success for immune drugs. Scientist.com discusses streamlining IND applications for cell and gene therapy innovations, while Arch raises $3 billion for a biotech fund. The article also covers strategies to keep clinical trials on schedule and provides insights into the market strategies of drugmakers. Additionally, upcoming events and trending news in the biopharma industry are highlighted. Biopharma Dive offers in-depth journalism and insights into the biotech and pharma industries, covering topics such as clinical readouts, FDA approvals, gene therapy, drug pricing, and research partnerships.Bristol Myers Squibb (BMS) has received FDA approval for KarXT, the first new schizophrenia therapy in 35 years. The drug targets muscarinic receptors and is considered ahead of competition from AbbVie and Neurocrine Biosciences. Pfizer's withdrawal of Oxbryta has left the sickle cell community scrambling, as the therapy was predicted to reach $750 million in sales. Sanofi and Regeneron's Dupixent has received approval for use in chronic obstructive pulmonary disease. The FDA's oncology drugs advisory committee has recommended limiting the use of Keytruda and Opdivo in stomach and esophageal cancer patients with low PD-L1 expression. Additionally, AbbVie's acquisition of Cerevel is showing promise with a phase III win in Parkinson's disease. Cassava has agreed to pay a $40 million fine to resolve an SEC probe, while Roche is looking to push Gazyva into lupus nephritis with positive late-stage data. Lilly is facing scrutiny over drug pricing compared to Novo Nordisk. The BACE credential is highlighted as a way to advance a career in the biotech industry.Senators have introduced a bill to establish cybersecurity standards for healthcare providers, health plans, and business associates. A study found that hospital acquisitions provide a one-time efficiency boost to margins but do not continue to improve operating metrics in the long term. Canopy CEO Shan Sinha discusses healthcare workplace violence and technology's role in protecting workers. The unexpected consequences of hospital quality scores are explored, suggesting a reexamination of the federal hospital-acquired condition reduction program. AI is being integrated into healthcare to give back time and prioritize people in day-to-day tasks. In other news, hospitals in Florida are preparing for Hurricane Helene, a major U.S. prison is criticized for substandard healthcare, and families in states banning health care for transgender teens may have to travel for care. Healthcare Dive provides in-depth journalism on topics such as health IT, policy, insurance, and more for decision-makers in the industry.The FDA recently approved Bristol Myers Squibb and Karuna Therapeutics' new drug, KarXT, now known as Cobenfy, for schizophrenia. This marks the first new mode of action approved for the condition in decades. The drug showed promising results in clinical trials, with patients on Cobenfy actually losing weight compared to gaining weight on other medications. However, there is still room for improvement as over 50% of patients discontinued treatment. The approval of Cobenfy highlights Bristol Myers Squibb's deal-making skills and sets the stage for a new generation of treatments for schizophrenia. Other upcoming drugs in the field may further shake up the market. Pharmaceutical companies are continuously working on market strategies to successfully launch new drugs post-FDA approval, as turning a new drug into a successful asset remains a challenge in the

Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS' Opdivo along with AstraZeneca's Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14). More On These Topics From The Pink Sheet Dozen Novel Agents Dream Of August US FDA Approval: https://pink.citeline.com/PS155070/Dozen-Novel-Agents-Dream-Of-August-US-FDA-Approval BMS's Opdivo May Be Next Casualty Of US FDA's Perioperative Trial Redesign Push: https://pink.citeline.com/PS155056/BMSs-Opdivo-May-Be-Next-Casualty-Of-US-FDAs-Perioperative-Trial-Redesign-Push EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation: https://pink.citeline.com/PS155059/EU-Pilot-On-Raw-Data-Analysis-Shows-Benefits-For-Streamlining-Medicines-Evaluation

Conference season kicked into high gear this week with the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and the BIO International Convention in San Diego. Check out BioSpace's ASCO24 Tracker with all the biggest data and other news from the cancer meeting, which wrapped up on Tuesday. Among the trial results highlighted at ASCO24 were BMS' Phase III study results in liver cancer. There was also a lot of news on non-small cell lung cancer (NSCLC): Pfizer presented results from a Phase III trial evaluating its ALK inhibitor Lorbrena, BMS provided three updates on its immunotherapy Opdivo and Opdivo-based combinations, while Gilead unveiled additional details on a failed Phase III trial for its antibody-drug conjugate (ADC) Trodelvy. Currently, there is one ADC approved to treat NSCLC, AstraZeneca and Daiichi Sankyo's Enhertu, for patients with HER2-mutated metastatic disease. While the companies' investigational ADC Dato-DXd is making some headway against NSCLC, experts recently told BioSpace that more compelling surface targets for lung cancer are needed in order for ADCs to really make a difference. When it comes to M&A, Big Pharma continues to show strong interest in oncology, particularly ADCs and radiopharmaceuticals. However, last week's biggest deal was Merck's $3 billion acquisition of EyeBio and its first-in-class trispecific antibody Restoret, marking the company's return to the ophthalmology space after nearly a decade. For now, it appears Big Pharma favors smaller M&A over megabillion-dollar deals. Recent buying activity also indicates a potential resurgence in the appetites of larger companies for psychiatric drug development.

The Daily Business and Finance Show - Saturday, 11 May 2024 We get our business and finance news from Seeking Alpha and you should too! Subscribe to Seeking Alpha Premium for more in-depth market news and help support this podcast. Free for 14-days! Please click here for more info: Subscribe to Seeking Alpha Premium News Today's headlines: Biden set to announce 100% tariffs on Chinese EVs AI-discovered drugs have an 80%–90% success rate: study Global renewable energy grew by 30%, but demand is still too high for supply - Ember Marijuana THC potency at all-time high - DEA Bitcoin stands to gain from U.S. fiscal dominance, Trump victory: StanChart Nasdaq, S&P, Dow end solidly higher for the week as investors eye CPI data Cannabis rescheduling unlikely to happen by end of year -- Seeking Alpha survey Bristol Myers' Opdivo fails in Phase 3 lung cancer study Explanations from OpenAI ChatGPT API with proprietary prompts. This podcast provides information only and should not be construed as financial or business advice. This podcast is produced by Klassic Studios Learn more about your ad choices. Visit megaphone.fm/adchoices

Led by CBER Director Peter Marks, FDA is moving forward with policies that aim to improve access to gene therapies for patients with rare diseases. On the latest BioCentury This Week podcast, BioCentury's editors discuss how FDA plans to use regulatory policies to overcome barriers that are slowing gene therapy, as well as how Pfizer hopes to ensure access to its newly approved hemophilia gene therapy. The editors also assess the $2.4 billion acquisition of Massachusetts oncology company Deciphera by Japan's Ono as it seeks to diversify its pipeline beyond Opdivo and expand its global footprint. They also discuss the $1 billion launch of AI-guided therapeutics developer Xaira. Finally, BioCentury's Joshua Berlin joins the podcast to preview BioCentury's upcoming conference Bio€quity Europe, which kicks off May 12 in San Sebastián. This week's podcast is sponsored by Jeito Capital. 

Bristol-Myers Squibb started the year on a strong note, demonstrating their presence in the pharmaceutical industry. Their top-line growth in the first quarter was in line with internal forecasts, with products such as Eliquis, Opdivo, Reblozyl, Yervoy, and Breyanzi contributing to performance. The ability to sustain this momentum was a point of emphasis on the call.Alongside sound financials, Bristol-Myers Squibb has seen sales growth for its major brands. They have recorded key wins in their pipeline development, including cell therapy approvals and the launch of new trials. The acquisitions of Mirati Therapeutics, Karuna Therapeutics, RayzeBio, and SystImmune have enlarged the company's scope for growth, indicating planning beyond financial fortitude.Consumer trend analysis from the earnings call points towards an increased demand for products like Opdivo, Camzyos, and Sotyktu. Despite inventorial and gross-to-net impacts, products such as Eliquis, Opdivo, Reblozyl, and Breyanzi witnessed sales growth. The company plans to increase Sotyktu's commercial volume this year, in response to demonstrated consumer demand.Bristol-Myers Squibb's future strategy focuses on optimizing decision-making processes, refining its portfolio, and directing attention to high return on investment initiatives. The company projects significant cost savings by 2025, planning to reallocate these savings into growth brands and research and development. This signals an investment in fostering innovation and driving pragmatic growth. Future plans include the launch of KarXT for schizophrenia, and ramping up clinical programs for Krazati, RayzeBio's radioligand platform, and SystImmune's bispecific ADC.As the CEO mentioned in the earnings call, Bristol-Myers Squibb is relying on Opdivo as an important cog in the growth wheel of the company's future. This reliance on Opdivo is part of the larger growth strategy, indicating Bristol-Myers Squibb's focus on introducing innovative treatments in the field of life sciences. However, as with all business strategies, the outcomes will depend heavily on execution and market response. This brings forth the uncertainty associated with the future in spite of clear strategic direction and strong past performances. As much as Bristol-Myers Squibb has set its compass for a promising future, the path remains fraught with the challenges typical to the pharmaceutical industry. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.theprompt.email

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The FDA has delayed its decision on Eli Lilly's Alzheimer's drug, Donanemab, and will convene a committee to discuss the application. President Biden addressed drug prices in the State of the Union, calling for lower prescription drug prices. Additionally, Beigene's Brukinsa was approved for follicular lymphoma, and Amylyx's ALS drug faced uncertainty after a Phase III trial failure. Other news included BMS gaining FDA approval for Opdivo in first-line bladder cancer and Merck KGaA discontinuing a BTK inhibitor after a Phase III trial failure. The biopharma industry is experiencing layoffs, with companies like Sumitomo and Evonik cutting staff.

Last week we saw some FDA approvals come through, as well as research that explored the psychosocial outcomes of individuals who survived pediatric rhabdosarcoma. And finally, we'll discuss another cancer vaccine clinical trial that got the green light from the Food and Drug Administration.  FDA Approved Besponsa for Children With Acute Lymphoblastic Leukemia The first FDA approval of last week was one in the pediatric cancer space. The agency approved Besponsa for children who are at least 1 year old and have relapsed or refractory CD22-positive precursor acute lymphoblastic leukemia., also known as ALL.  The approval is coming after findings from a single-arm study involving 53 children. Of which, 22 — that's 42% — achieved a complete response from the therapy, with the median duration of complete response being 8.2 months. Additionally, the majority of patients who achieved a complete response also had minimal residual disease negativity, which indicates that there were 5% or less blasts found in the bone marrow and no cancer cells detected in the blood.  Having a new treatment option for children with ALL is particularly exciting, as ALL is one of the most common pediatric cancers, according to the American Cancer Society.  FDA Approves Opdivo Plus Chemo for Unresectable or Metastatic Bladder Cancer Last week, the FDA also approved an immunotherapy/chemotherapy regimen for certain patients with bladder cancer. Specifically, the agency OKed Opdivo plus cisplatin and gemcitabine for the frontline treatment of adults with unresectable or metastatic urothelial carcinoma.  This approval was backed by findings from the CheckMate-901 trial, which showed that the Opdivo-chemotherapy regimen improved overall survival (which is the time patients live before death of any cause) and progression-free survival (which is the time patients live without their disease worsening) compared to those who did not receive Opdivo. The median overall survival was 21.7 months for those who received Opdivo compared to 18.9 months for those who did not, while progression-free survival was 7.9 and 7.6 months, respectively.  FDA Approves Brukinsa, Gazyva Combo for Relapsed, Refractory Follicular Lymphoma Last week, the Food and Drug Administration also approved Brukinsa plus Gazyva for patients with relapsed or refractory follicular lymphoma after findings from the ROSEWOOD trial showed that not only did more patients respond to the two-drug treatment compared to Gazyva alone, but also at a median follow-up of 19 months, more patients were still responding compared to the Gazvya arm as well.  Rhabdomyosarcoma Survivors May Have Poor Psychological Outcomes A study published in the journal, Cancer, found that survivors of rhabdomyosarcoma — which is a rare cancer affecting soft tissues — may face increased risk of psychological challenges, especially if they were exposed to previous radiation therapy or have a history of smoking. Researchers examined neurocognitive impairment, emotional distress and health-related quality of life in survivors compared to their siblings. Results showed higher rates of issues like memory impairment and emotional distress among survivors, with smoking linked to poorer outcomes. The CURE® team spoke with study author, Ellen van der Plas on the findings. Here is what she had to say.  Ovarian Cancer Vaccine Trial Gets FDA Clearance to Proceed The FDA has given the green light for a clinical trial of a vaccine designed to treat advanced ovarian cancer. Known as Innocell, this personalized therapy utilizes cells from the patient's own tumor which is inactivated via riboflavin and UV light. The drug is being manufactured at City of Hope in Los Angeles, and the trial aims to assess the vaccine's safety and effectiveness in stimulating immune response. This is one of the many cancer vaccines being explored and developed in the oncology space. Check back on prior CURE® coverage for updates on vaccines to treat breast, lung, skin and other cancers.   For more news on cancer updates, research and education, don't forget to subscribe to CURE®'s newsletters here.

After the 2024 Gastrointestinal Cancers Symposium, Jun Gong, MD, and Daneng Li, MD, sat down to discuss the most relevant trial data to have come from the conference. They convened for a live X Space hosted by CancerNetwork®. During the discussion, they covered different trials across the gastrointestinal space, which included those evaluating different disease states from hepatocellular carcinoma (HCC) to colorectal cancer (CRC), and those assessing circulating tumor DNA (ctDNA) dynamics. Gong, a hematologic oncologist focusing on gastrointestinal and genitourinary cancers at Cedars-Sinai Medical Center, and Li, an associate professor in the Department of Medical Oncology and Therapeutics Research at City of Hope, each gave their perspective on the clinical trial data and discussed if they had implemented any of these study treatments into clinical practice.  The studies they covered included:  1.        Phase 3 NETTER-2 Trial (NCT03972488)1: - Investigated lutetium Lu 177 dotatate (Lutathera) plus octreotide vs octreotide alone for advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). - Lutetium Lu 177 significantly improved progression-free survival (PFS) and overall response rate (ORR) compared with octreotide alone. - The agent may be considered for patients with high-grade GEP-NETs who desire significant tumor shrinkage. 2.        Phase 3 EMERALD-1 Trial (NCT03778957)2: - Studied transarterial chemoembolization (TACE) plus durvalumab (Imfinzi) with or without bevacizumab (Avastin) for unresectable HCC. - Durvalumab/bevacizumab plus TACE improved PFS compared with placebo plus TACE. - TACE may be preferred over transarterial radioembolization (TARE) due to faster patient recovery. 3.        Phase 3 CheckMate-8HW Trial3: - Evaluated nivolumab (Opdivo) plus ipilimumab (Yervoy) vs chemotherapy for first-line treatment of microsatellite instability-high/mismatch repair deficient metastatic CRC. - Nivolumab/ipilimumab demonstrated superior PFS compared with chemotherapy. - Chemotherapy may no longer be the standard first-line treatment for this patient population. 4.        BESPOKE Study (NCT04264702)4: - Assessed the impact of minimal residual disease (MRD) detected by ctDNA on disease recurrence in patients with stage II and III CRC receiving adjuvant chemotherapy. - MRD positivity was associated with worse disease-free survival (DFS). - ctDNA clearance at 12 weeks indicated improved DFS.  5.        GALAXY Trial5: - ctDNA is a promising biomarker that can be used to predict recurrence in patients with CRC. - Patients with ctDNA-positive disease had a worse DFS than patients with ctDNA-negative disease. - This suggests that ctDNA may be useful for making treatment decisions, but more research is needed before it can be used in clinical practice. 6.        Phase 3 FRESCO-2 Trial (NCT04322539)6: - Fruquintinib (Fruzaqla) improved the quality of life in patients with metastatic CRC when combined with best supportive care and significantly improved quality-adjusted time without symptoms of disease or toxicity compared with placebo and best supportive care. - The study showed positive effects on PFS, response rate, disease control, and duration of response with the fruquintinib combination. - The findings from this trial supported the FDA approval of fruquintinib for metastatic CRC in November 2023.7 References 1.        Singh S, Halperin D, Myrehaug S, et al. [177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: primary analysis of the phase 3 randomized NETTER-2 study. J Clin Oncol. 2024(suppl 3):LBA588. doi:10.1200/JCO.2024.42.3_suppl.LBA588 2.        Lencioni R, Kudo M, Erinjeri J, et al. EMERALD-1: a phase 3, randomized, placebo-controlled study of transarterial chemoembolization combined with durvalumab with or without bevacizumab in participants with unresectable hepatocellular carcinoma eligible for embolization. J Clin Oncol. 2024;42(suppl 3):LBA432. doi.10.1200/JCO.2024.42.3_suppl.LBA432 3.        Andre T, Elez E, Van Cutsem E, et al. Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): First results of the CheckMate 8HW study. J Clin Oncol. 2024;42(suppl_3):LBA768. doi.10.1200/JCO.2024.42.3_suppl.LBA768 4.        Kasi P, Aushev V, Ensor J, et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): interim analysis of BESPOKE CRC study. J Clin Oncol. 2024;42 (suppl _3):9. doi:10.1200/JCO.2024.42.3_suppl.9 5.        Yukami H, Nakamura Y, Mishima S, et al. Circulating tumor DNA (ctDNA) dynamics in patients with colorectal cancer (CRC) with molecular residual disease: Updated analysis from GALAXY study in the CIRCULATE-JAPAN. J Clin Oncol. 2024;42(suppl_3):6. doi:10.1200/JCO.2024.42.3_suppl.6 6.        Stintzing S, Tabernero J, Satoh T, et al. Quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) analysis of fruquintinib + best supportive care (BSC) compared with placebo + BSC in metastatic colorectal cancer (mCRC): results from the FRESCO-2 trial. J Clin Oncol. 2024;42(suppl 3):116. doi:10.1200/JCO.2024.42.3_suppl.116 7.        FDA approves fruquintinib in refractory metastatic colorectal cancer. FDA. News release. November 8, 2023. Accessed February 7, 2024. https://shorturl.at/isJW2

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. In our first news, Walgreens has appointed Mary Langowski as the new president of its U.S. healthcare segment, replacing John Driscoll. Molina Healthcare has reported a loss of 500,000 members due to redeterminations, but expects proposed 2025 rates to boost its benchmark rate. UnitedHealth's COO, Dirk McMahon, is retiring after two decades at the company. The American Hospital Association (AHA) has called for more payer oversight in resolving disputes over surprise medical bills.Moving on to the next news, Amgen, Roche, and Pfizer are looking to enter the GLP-1 weight loss market, challenging Novo Nordisk and Eli Lilly. These companies are developing their own versions of diabetes and weight loss drugs. Smaller biotech companies have also shown promising results in clinical trials with their own GLP-1 agonists. Amgen, Roche, and Pfizer are currently in the clinical stages of developing their GLP-1 receptor agonists and could soon enter the weight loss and obesity markets.In financial news, Eli Lilly has reported revenue of over $9.3 billion in Q4 2023, surpassing expectations. The company credits the strong performance to the demand for their weight-loss drug Zepbound and the diabetes treatment Mounjaro. Vertex Pharmaceuticals announced positive results for its cystic fibrosis triple combination therapy in two randomized controlled trials. GlaxoSmithKline's Blenrep combination therapy also achieved a phase III win in multiple myeloma. Novartis has acquired German biotech company MorphoSys to strengthen its oncology portfolio. Bristol Myers Squibb highlighted their comprehensive approach to cancer research.Shifting gears to regulatory news, the FDA panel has recommended new standards for pulse oximeters due to concerns of bias. Cardinal Health has expanded its recall of Monoject syringes due to compatibility problems. The FDA is planning to reclassify most high-risk in vitro diagnostic devices (IVDs) to ease the path for clearance. Edwards has received FDA approval for the first transcatheter tricuspid valve replacement treatment. ECRI has identified usability challenges for at-home devices and inadequate device cleaning instructions as top health technology hazards.Finally, several biopharmaceutical companies are focusing on neuroinflammation as a potential target for treating Alzheimer's disease. Vertex Pharmaceuticals' non-opioid pain drug, VX-548, recently failed in a Phase III trial. Bristol Myers Squibb takes a comprehensive approach to cancer research. Takeda's immunoglobulin therapy for Clostridium difficile infection (CDI) has been approved by the FDA. Novartis has dropped a blood cancer asset after disappointing Phase III results. Merck's Keytruda has achieved Phase III wins in kidney and bladder cancer. BMS's Opdivo has failed in a late-stage kidney cancer trial.These developments indicate positive progress in the pharmaceutical industry, particularly in the areas of cancer treatment and rare diseases like cystic fibrosis. Companies continue to innovate and strive for breakthrough therapies that can improve patient outcomes.Thank you for listening to Pharma and Biotech Daily. Stay tuned for more updates in the world of Pharma and Biotech.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Sarepta Therapeutics has released data on its new drug for Duchenne muscular dystrophy, showing potent boosting of dystrophin protein production. However, some side effects, including electrolyte imbalances, were also highlighted. Astrazeneca and Daiichi are seeking FDA approval for their drug Enhertu as a "tumor agnostic" treatment, and the FDA is currently reviewing their application. Bristol Myers has received positive data from a trial of a subcutaneous formulation of Opdivo in kidney cancer, showing similar efficacy to the intravenous formulation. Biotech IPOs continue to be an important source of funding for the industry, with Alto Neuroscience and Fractyl Health preparing for initial stock offerings. Merck Manuals is focusing on a "one health" approach, integrating human, animal, and environmental health in medical education and practice.Philips has announced that it will stop selling sleep and respiratory devices in the US due to a consent decree from the FDA. This decision comes as Philips faces regulatory scrutiny and potential legal action related to quality issues with its sleep apnea devices. Medical device companies Stryker, Boston Scientific, and BD are set to post their earnings this week. Absolutions has received FDA breakthrough designation for its abdominal wall closure device, aiming to reduce the risk of hernia by distributing suture tension over a large area of tissue. Globus has laid off employees from NuVasive following their merger. Masimo has forced Apple to redesign its smartwatches in a long-running patent dispute.The pharmaceutical industry is in a race to develop groundbreaking drugs for pain relief. Tanezumab, developed by Eli Lilly and Pfizer, was dropped due to safety concerns. Attention has turned to Vertex Pharmaceuticals' candidate vx-548, which has shown positive results in phase 2 trials for chronic nerve pain. South Rampart Pharma has won fast track designation for its novel drug that activates pain signaling pathways without causing liver and kidney toxicities. Tonix Pharmaceuticals is repurposing an existing technology for the treatment of fibromyalgia, with positive late-stage results. These developments offer hope for patients suffering from chronic pain conditions and could generate significant revenue for the companies involved.Overall, these developments highlight ongoing challenges and changes in the medtech industry, including regulatory scrutiny, mergers, and patent disputes. Medtech companies must navigate these complexities while leveraging connected ecosystems, data, and strategic planning to drive innovation in healthcare.Thank you for tuning in to Pharma and Biotech daily. Stay informed, stay ahead.

The 2023 San Antonio Breast Cancer Symposium featured five days of research presentations, educational sessions, and advocacy meetings. Dr. Matthew Goetz, noted breast cancer researcher at the Mayo Clinic, explained the top research presented that will make an immediate difference for people diagnosed with breast cancer. Listen to the podcast to hear Dr. Goetz explain: a study on inavolisib, a promising new treatment for advanced-stage, hormone receptor-positive breast cancer that's stopped responded to tamoxifen or an aromatase inhibitor how the immunotherapy medicines Keytruda (chemical name: pembrolizumab) and Opdivo (chemical name: nivolumab) can be used to treat early-stage, triple-negative breast cancer overall survival results from the MONARCH-3 study on Verzenio (chemical name: abemaciclib) why overall survival is such an important study end point

Kristen K. Ciombor, MD, MSCI, an assistant professor in the Division of Hematology/Oncology in the Department of Medicine at the Vanderbilt University Medical Center, recently spoke at an Around the Practice discussion regarding updates in the world of metastatic colorectal cancer (CRC). In this episode of the ONCOLOGY® On the Go Podcast, she discusses treatment updates, molecular testing options, and emerging targets in CRC. Ciombor also highlighted ongoing research in the space, including the phase 3 BREAKWATER (NCT04607421)1 trial and the phase 3 MOUNTAINEER-03 (NCT05253651)2 trial. She also discussed some of the most important presentations from the 2023 European Society for Medical Oncology (ESMO) Congress, including those covering the phase 2 MOUNTAINEER study (NCT03043313)3 and the phase 3 KEYNOTE-811 trial (NCT03615326).4 Additionally, she spoke about her work in the phase 2 ECOG-ACRIN trial (NCT04751370) assessing neoadjuvant nivolumab (Opdivo) plus ipilimumab (Yervoy) in patients with microsatellite instability-high or mismatch repair deficient rectal cancer.5 “I'm hoping that we see more treatment options for patients [and that] we identify more patient subtypes that we can target and find actionable alterations for,” Ciombor said. References 1. Kopetz S, Grothey A, Yaeger R, et al. BREAKWATER: randomized phase 3 study of encorafenib (enco) + cetuximab (cetux) ± chemotherapy for first-line (1L) treatment (tx) of BRAF V600E-mutant (BRAFV600E) metastatic colorectal cancer (mCRC). J Clin Oncol. Published online May 28, 2021. doi:10.1200/jco.2021.39.15_suppl.tps3619 2. Bekaii-Saab TS, Van Cutsem E, Tabernero J, et al. MOUNTAINEER-03: phase 3 study of tucatinib, trastuzumab, and mFOLFOX6 as first-line treatment in HER2+ metastatic colorectal cancer—Trial in progress. J Clin Oncol. Published online January 24, 2023. doi:10.1200/jco.2023.41.4_suppl.tps261 3. Strickler JH, Cercek A, Siena S, et al. Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER): a multicentre, open-label, phase 2 study. Lancet Oncol. Published online May 24, 2023. doi:10.1016/S1470-2045(23)00150-X  4. Janjigian YY, Kawazoe A, Bai Y, et al. embrolizumab plus trastuzumab and chemotherapy for HER2+ metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Survival results from the phase III, randomized, double-blind, placebo-controlled KEYNOTE-811 study. Ann Oncol. 2023;34(suppl 2):S851-S852. doi:10.1016/j.annonc.2023.09.1424 5. Ciombor KK, Hong SC, Eng C, et al. EA2201: An ECOG-ACRIN phase II study of neoadjuvant nivolumab plus ipilimumab and short course radiation in MSI-H/dMMR rectal tumors. J Clin Oncol. Published online June 2, 2022. doi:10.1200/jco.2022.40.16_suppl.tps3644

Meet Dr. Ulka Vaishampayan* – an oncologist and leading expert in treating people with kidney cancer, including renal cell carcinoma (RCC) which is the most common type of kidney cancer in adults. She understands all too well how scary and overwhelming hearing the words “you have cancer” can be for anyone – especially when facing an advanced diagnosis in RCC. In these cases, Dr. Vaishampayan believes that information is power and people can feel better prepared to move forward if they have a support system and strong patient-doctor communication.  On today's episode of the Cancer Horizons podcast, Dr. Vaishampayan shares information that's important to understand about RCC and navigating a diagnosis, key questions patients and caregivers should ask their doctor, and insights into a potential dual immunotherapy treatment option for certain patients. When it comes to making a treatment plan, Dr. Vaishampayan believes in involving her patients closely in the process. “In my practice I tend to explain what options are available to someone, including the pros and cons of each, and I sometimes make a recommendation about a treatment approach if I feel that's appropriate in their case,” she explains. “I would still explain the reasons for my choice. My intention is that either way it's a discussion, as it should be a joint or shared decision-making process.” Terry Broussard**, a man who was diagnosed with advanced RCC, also shares advice from his experience. In Terry's case, his doctor recommended the dual immunotherapy treatment combination Opdivo® (nivolumab) plus Yervoy® (ipilimumab), which is approved by the U.S. Food and Drug Administration for certain newly diagnosed adults whose kidney cancer has spread (advanced renal cell carcinoma) and have not already had treatment for advanced RCC. It is the first and only combination of two immunotherapies of its kind approved to treat advanced kidney cancer, or RCC. To learn more, listen to the podcast, visit www.Opdivo.com and see below for Important Safety Information. *Dr. Vaishampayan is a paid consultant of Bristol Myers Squibb. Dr. Vaishampayan's statements/opinions are those solely of Dr. Vaishampayan and are not necessarily those of Bristol Myers Squibb. Individual results/experiences may vary. **Terry is an actual patient who has been compensated by Bristol Myers Squibb. Terry's results may not be typical. Medication may not work for everyone. Indication OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with kidney cancer in certain people when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC. It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer. It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers. OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use. Important Safety Information for OPDIVO® (nivolumab) + YERVOY® (ipilimumab) What is the most important information I should know about OPDIVO + YERVOY? OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and YERVOY can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when OPDIVO is used in combination with another therapy. Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including: Lung problems: new or worsening cough; shortness of breath; chest pain Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdominal) pain or tenderness Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heart beat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems: decrease in your amount of urine; blood in your urine; swelling in your ankles; loss of appetite Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in the mouth or nose, throat, or genital area Eye problems: blurry vision, double vision, or other vision problems; eye pain or redness. Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with OPDIVO and YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: Chest pain; irregular heartbeat; shortness of breath; swelling of ankles Confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs Double vision; blurry vision; sensitivity to light; eye pain; changes in eye sight Persistent or severe muscle pain or weakness; muscle cramps Low red blood cells; bruising Getting medical help right away may help keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. Your healthcare team may also need to delay or completely stop your treatment if you have severe side effects. Possible side effects of OPDIVO + YERVOY OPDIVO and OPDIVO + YERVOY can cause serious side effects, including: See “What is the most important information I should know about OPDIVO + YERVOY?” Severe infusion reactions. Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO or YERVOY: chills or shaking; itching or rash; flushing; shortness of breath or wheezing; dizziness; feel like passing out; fever; back or neck pain Complications, including graft-versus-host disease (GVHD), of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO or YERVOY. Your healthcare provider will monitor you for these complications. The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); constipation; decreased weight; and dizziness. These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088. Before receiving OPDIVO or YERVOY, tell your healthcare provider about all of your medical conditions, including if you: have immune system problems such as Crohn's disease, ulcerative colitis, or lupus have received an organ transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area in the past and have received other medicines that are like OPDIVO have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if OPDIVO or YERVOY passes into your breast milk. Do not breastfeed during treatment with OPDIVO or YERVOY and for 5 months after the last dose of OPDIVO or YERVOY. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start receiving OPDIVO or YERVOY. You should use an effective method of birth control during your treatment and for 5 months after the last dose of OPDIVO or YERVOY. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with OPDIVO or YERVOY. You or your healthcare provider should contact Bristol-Myers Squibb at 1- 844-593-7869 as soon as you become aware of a pregnancy. Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO and YERVOY.

Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast  Here are the highlights: BIMZELX (bimekizumab) for Moderate-to-Severe Plaque Psoriasis: The FDA approved BIMZELX for treating moderate-to-severe plaque psoriasis, making it the first psoriasis treatment targeting interleukin 17A and interleukin 17F. The approval follows data from Phase 3 trials and comes after a prior delay due to COVID-related travel restrictions. Neoadjuvant Pembrolizumab for NSCLC: The FDA approved pembrolizumab for neoadjuvant and post-surgical adjuvant treatment in patients with resectable non-small cell lung cancer, adding to its indications in multiple tumor types. The approval was based on the phase 3 KEYNOTE-671 trial data. Adjuvant Nivolumab for Stage IIB/C Melanoma: The FDA granted approval to nivolumab for adjuvant treatment of melanoma in patients aged 12 and older with resected stage IIB or IIC disease, addressing the need to reduce the risk of recurrence. This is supported by the CheckMate76K trial data. Zilucoplan for Myasthenia Gravis: UCB Pharma's zilucoplan, a complement C5 inhibitor, received FDA approval for treating myasthenia gravis (MG), demonstrating rapid improvements in MG-specific efficacy outcomes based on the phase 3 RAISE study. IDP-126 (Cabtreo) First Triple-Combination Drug for Acne: Cabtreo, a triple combination topical gel for acne, received FDA approval as the first fixed-dosed, triple-combination treatment for patients aged 12 and older with acne vulgaris. Penbraya Meningococcal Vaccine in Adolescents: The FDA approved Penbraya, a vaccine covering the five most common serogroups causing meningococcal disease in adolescents, based on Phase 2 and Phase 3 trial data. It's administered as a two-dose series. Voxzogo in Dwarfism: Vosoritide (Voxzogo) was expanded for use in children under 5 with achondroplasia, the most common form of short-limbed dwarfism, after demonstrating safety and efficacy in this age group. QLOSI for blurry age-related near vision: The FDA approved QLOSI, a preservative-free eye solution, for the treatment of presbyopia, improving near visual acuity by pupil modulation and increasing depth of field. Maxigesic IV for Post-Op Pain: Maxigesic IV, a combination of paracetamol and ibuprofen, gained FDA approval for post-operative pain management, offering faster pain relief and reduced opioid usage. Xphozah for Chronic Kidney Disease: Tenapanor (Xphozah) was approved as an add-on therapy for patients with chronic kidney disease who can't tolerate or respond adequately to phosphate binders, based on phase 3 trial data, addressing high blood phosphorus levels. Zymfentra infliximab biosimilar for ulcerative colitis and Crohn's disease: Zymfentra, a subcutaneous infliximab biosimilar, received FDA approval for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn's disease, based on LIBERTY-UC and LIBERTY-CD study findings.  Intro and outro music Garden Of Love by Pk jazz Collective    

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. In recent biopharma news, Bavarian Nordic, a Dutch biotech company, has faced setbacks in its late-stage trials for respiratory syncytial virus (RSV) and COVID-19 vaccines. However, the company's CEO, Paul Chaplin, remains optimistic about the potential of the company in the travel vaccine market. Another development is that Eisai's Alzheimer's drug Leqembi has received approval in Japan and is still undergoing regulatory reviews in other countries. Intercept, a liver drug company, has agreed to a buyout by Alfasigma after failing to secure FDA approval for its research on nonalcoholic steatohepatitis (NASH). Bristol Myers' Opdivo has won a trial supporting its expanded use in lung cancer treatment, and new vaccines for respiratory syncytial virus (RSV) have the potential to be powerful tools, although their rollout poses challenges. In a merger deal worth $3 billion, HealthComp, a private equity-owned health benefits administrator, is set to merge with Virgin Pulse, a digital health and wellness company. The transaction aims to create an integrated platform for employer-sponsored health benefits, with investment firms joining forces for the merger. On the other hand, health insurer Centene is laying off 3% of its workforce due to challenges from Medicaid redeterminations and Medicare Advantage (MA) star ratings. Cano Health has sold its Texas and Nevada centers to a subsidiary of Humana for $67 million due to its worsening liquidity position. Lawmakers in Ohio have proposed minimum nurse-to-patient ratios to address nurse recruitment and retention and improve patient care. Nuance Communications has rolled out an automated clinical documentation tool called DAX Copilot, improving efficiency for healthcare providers.Roche has struck a deal to acquire preclinical RNA medicines from Ionis Pharmaceuticals, focusing on treatments for Alzheimer's and Huntington's diseases. Despite recent setbacks in phase 3 trials for respiratory syncytial virus (RSV) and COVID-19 vaccines, Bavarian Nordic CEO Paul Chaplin remains optimistic about the company's future in the travel vaccine market. ProQR's planned sale of eye drugs to Laboratoires Thea has fallen through due to certain ProQR personnel opting not to work for the French company. John Tsai has been appointed as CEO of UK heart drug startup Forcefield Therapeutics. The FDA staff have expressed "major concerns" with Brainstorm's ALS therapy. Obesity drugs like Ozempic and Wegovy could revolutionize the treatment of obesity and advance the understanding of the condition.Gilead Sciences has announced the discontinuation of a Phase III trial for its anti-CD47 antibody, magrolimab, in acute myeloid leukemia (AML). AbbVie has terminated its contract with Caribou Biosciences for the development of allogeneic CAR-T therapies. Astrazeneca and Bristol Myers Squibb have agreed to participate in the first round of price negotiations under the Medicare drug price negotiation program, despite filing lawsuits challenging the program. Italian pharma company Alfasigma has acquired Intercept Pharmaceuticals in an $800 million cash deal. Alto has reported positive Phase II data for post-traumatic stress disorder. Astellas has withdrawn its lawsuit challenging the inflation reduction act.BioNTech has announced plans to manufacture mRNA vaccines in Africa to address the vulnerability of relying on global supply chains for vaccine production. Proper chemical procurement is emphasized to avoid disruptions in the chemical supply chain for research and development (R&D) and drug manufacturing. AbbVie has terminated its contract with Caribou Biosciences as part of its strategy to cull cancer pipelines. AstraZeneca and Bristol Myers Squibb have reluctantly agreed to participate in the Medicare drug price negotiation program. Immunovant's stock has soared following positive Phase

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. In a recent webinar, experts discussed how artificial intelligence (AI) is revolutionizing regulatory approvals in the pharmaceutical industry. They highlighted the benefits of a more efficient drug approval process for both companies and patients. By incorporating AI into regulatory proceedings, pharmaceutical companies can optimize clinical trials, expedite the approval process, and deliver life-saving treatments more quickly. While there are limitations to AI, this technology has the potential to streamline the drug development timeline significantly.In labor news, over 75,000 members of the coalition of Kaiser Permanente unions have issued an unfair labor practice strike notice. They plan to strike from October 4 to October 6 if new contract terms cannot be agreed upon. Additionally, Deputy Administrator Jon Blum of the Centers for Medicare and Medicaid Services (CMS) has pledged to take a tougher stance on bad actors in the Medicare Advantage program. CommonSpirit, a Catholic health system, has reported an operating loss of $1.4 billion and has laid off 2,000 employees. Veradigm, a health IT company, has received a notice of delisting from NASDAQ but plans to appeal the decision. The presidents of the American Academy of Family Physicians and the American College of Physicians advocate for reforms in the national physician payment system.Medtronic has received the CE mark for its continuous glucose monitoring (CGM) sensor, positioning it as a competitor to Abbott and Dexcom. This smaller sensor no longer requires fingersticks for calibration, making it more convenient for patients. Virtual Incision, the developer of a miniaturized surgical robot, has raised $30 million in series C funding. Their robot will be used on the International Space Station next year. The FDA has shared a draft medical device harmonization plan to meet its MDUFA V goal, outlining deadlines for collaboration with regulatory partners. Intarcia's diabetes drug-device combo has been rejected by an FDA panel due to safety concerns. McKinsey predicts a resurgence of large medtech mergers as companies seek to improve margins and establish strong partnerships with hospitals.The FDA has expressed significant concerns about the stem cell therapy developed by BrainStorm for ALS treatment. Novartis has achieved success in a study of its radiopharmaceutical drug for gut cancer treatment, sparking competition in targeted radiotherapies. Eisai's Alzheimer's drug, Leqembi, has been approved in Japan and is undergoing regulatory reviews in other regions. Bristol Myers' Opdivo has secured a trial win, potentially expanding its use in lung cancer treatment. Exciting developments in obesity drug research, including drugs like Ozempic and Wegovy, may transform how doctors approach obesity treatment.That's it for today's episode of Pharma and Biotech Daily. Stay tuned for more updates on the latest news and trends shaping the pharmaceutical and biotechnology industries.

In deze podcast bespreekt internist-oncoloog Koos van der Hoeven recente ontwikkelingen op het gebied van de behandeling van het niet-kleincellig longcarcinoom. Hij bespreekt met longarts Egbert Smit de resultaten van de CheckMate 9LA-studie die hebben geleid tot een nieuwe behandeloptie: eerstelijnsbehandeling van patiënten met gevorderd niet-kleincellig longcarcinoom met nivolumab plus ipilimumab in combinatie met twee cycli chemotherapie versus chemotherapie alleen. Daarnaast worden de PD-L1-expressie en de consequenties voor de behandeling besproken.Referenties 1. Nederlandse richtlijn Niet-kleincellig longcarcinoom. Te raadplegen via richtlijnendatabase.nl/richtlijn/niet_kleincellig_longcarcinoom 2. Hendriks LE, et al. Ann Oncol 2023;34:358-76. 3. Overleving bij stadium IV-NSCLC zonder TKI-gevoelige mutaties (IKNL 2023). Te raadplegen via iknl.nl/kankersoorten/longkanker/registratie/overleving 4. Reck M, et al. J Clin Oncol 2021;39:2339-49. 5. Jassem J, et al. J Thorac Oncol 2021;16:1872-82. 6. Hellmann MD, et al. N Engl J Med 2019;381:2020-31. 7. Paz-Ares L, et al. Lancet Oncol 2021;22:198-211. 8. Reck M, et al. ESMO Open 2021;6:100273. 9. Paz-Ares LG, et al. J Thorac Oncol 2023;18:P204-22. 10. Gandhi L, et al. N Engl J Med 2018;378:2078-92. 11. West H, et al. Lancet Oncol 2019;20:924-37. 12. Samenvatting van de productkenmerken van Opdivo® (nivolumab). Te raadplegen via www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf 13. Advies van de commissie BOM (2021). Te raadplegen via www.nvmo.org/bom/nivolumab-en-ipilimumab-gecombineerd-met-2-cycli-chemotherapie-als-eerstelijnsbehandeling-voor-gemetastaseerd-niet-kleincellig-longcarcinoom/ 14. Van den Heuvel M, et al. Medische Oncologie 2021.Disclosures Prof. dr. E. Smit: Personal financial interests: none. Institutional financial interests: fees have been paid to my institution for speaker engagements and attendance to advisory boards of AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Bayer, DSI, Eli Lilly, MSD, Merck, Novartis, Pfizer, Sanofi, Takeda, Regeneron, Roche Genentech, Roche Diagnostics. Research support: AstraZeneca, Bristol Myers Squibb, Merck, MSD. PI for clinical studies sponsored by Amgen, AstraZeneca, Bayer, Clovis, Cullingan, Eli Lilly, Merck, MSD, Novartis, PharmaMar, Roche Genentech, Takeda. Prof. dr. ir. J.J.M. van der Hoeven: Astellas, AstraZeneca, Bayer, BMS, Daiichi Sankyo, Gilead, Novartis, medisch directeur van Hartwig Medical Foundation, voorzitter Oncomid, lid Adviescollege VIG en lid RVT DICA. 7356-NL-2300020

There is ongoing progress in the urothelial carcinoma treatment landscape, but after radical resection, what adjuvant options are there for your patient? Special guest Shilpa Gupta, MD, joins us to discuss the various ways to individually approach the adjuvant treatment setting for your patients with radically resected urothelial carcinoma along with their multidisciplinary care team. Dr. Gupta is a genitourinary oncologist at the Cleveland Clinic. She has led several investigator-initiated trials in genitourinary cancers, help leadership roles within National Cancer Institute Trials, and is the chair of the Alliance-led phase 3 trial in bladder cancer, co-chair of the Southwest Chemotherapy Study Group (SWOG) S1206 trial in prostate cancer and SWOG champion of the Alliance A031701 trial in bladder cancer.Learn more about an adjuvant treatment option for patients with urothelial carcinoma.https://www.opdivohcp.com/efficacy/uc/adjuvantINDICATIONOPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.IMPORTANT SAFETY INFORMATIONSevere and Fatal Immune-Mediated Adverse ReactionsImmune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO. Early identification and management are essential to ensure safe use of OPDIVO. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment with OPDIVO. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.Withhold or permanently discontinue OPDIVO depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.Immune-Mediated PneumonitisOPDIVO can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (

Medical conferences often are a platform to showcase new clinical trophies. But that wasn't the case for Merck at this year's European Society for Medical Oncology meeting. The Big Pharma presented a series of trial flops for its megablockbuster cancer immunotherapy, Keytruda. We'll discuss if the Merck checkpoint inhibitor has reached a bottleneck or if it was just bad luck.  Also under discussion is the monkeypox test Emergency Use Authorization. Because monkeypox continues to spread in the U.S. and worldwide, the FDA granted its first EUA for a diagnostic test. This regulatory path was also used for COVID-19 tests. But the FDA learned a few lessons from the pandemic and hopes the new guidelines will help avoid the problems seen then.   To learn more about topics in this episode:  ESMO: AstraZeneca, Merck tout Lynparza's 'clinically meaningful' ovarian cancer survival edge but lose one in prostate cancer ESMO: Roche eyes untouched newly diagnosed lung cancer market for solo Tecentriq ESMO: Adding bempeg to Opdivo lowered response rate in Bristol Myers-Nektar failed cancer trial ESMO: GSK keeps the faith in anti-TIGIT plans; it's 'not always about being first' UPDATED ESMO: Amgen's Lumakras confirmatory lung cancer data leave door open for KRAS competitors ESMO: Gilead's Trodelvy makes surprise comeback with above-par breast cancer survival showing Here we go again: FDA opens up emergency authorizations to monkeypox tests Moderna sizes up private COVID vaccine market in US, where shots could cost $100 a pop Sony dives into nascent over-the-counter hearing aid market with WS Audiology partnership OTC birth control could be on the way from Perrigo, as FDA gathers expert panel Altimmune sees phase 1 success in tricky NASH indication with GLP-1 agonist Oramed phase 2 insulin drug data 'paint an exciting picture' in rocky NASH landscape Akero hits endpoints in midphase NASH trial, linking candidate to improvements in fibrosis BMS' preferred drug in its $74B Celgene buy is set to pay dividends, winning its first FDA nod The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

Mark Singer 58, anaplastic thyroid cancer, Barrington, RI   In the early stages of the pandemic, Mark knew something was wrong when he noticed a small lump on his neck. Soon after, he went to an ER for testing and received a diagnosis of anaplastic thyroid cancer, a very serious form of the disease which prior to 2017 had a one-year survival rate of 10% -20%.  After Googling “Best Cancer Hospitals in New England,” Dana-Farber moved to the top of his list for care. Mark started with a year of immunotherapy treatments with Nivolumab, also known as Opdivo, and Dupixent, which he still currently takes, for any side effects. Immunotherapy is a new cancer treatment that allows the body's own immune system to recognize and kill cancer cells.  Mark had a rapid and profound response and has shown no evidence of disease for over a year. In addition to immunotherapy, his care team was able to remove a cancerous tumor from his thyroid, several cancerous lymph nodes, and perform vocal-chord repaire surgery.  Today, Marks feels mostly back to his pre-cancer self. You can find him boating around Lake Winnipesaukee or riding on his Harley-Davidson motorcycle. He's supported by his wife, Mary, and their two children, Michael and Maggie. 

Listen to a soundcast of the May 27, 2022 FDA approvals of Opdivo (nivolumab) and Yervoy (nivolumab and ipilimumab) for advanced or metastatic esophageal squamous cell carcinoma, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphoma."”

Cancer drugs have rapidly evolved in the last decade. Alongside the significant benefits are new toxicity profiles that clinicians need to be aware of and manage.In this podcast, A/Prof Carlino interviews fellow Medical Oncologist Prof Georgina Long AO on the adverse events/toxicities associated with targeted therapies (combination BRAF/MEK inhibitors) and immunotherapies (anti-PD-1, anti-LAG-3 and anti-CTLA-4), particularly in melanoma, and how they should be managed.Some key points brought up during this deep dive in toxicity:With targeted therapies, cessation of treatment usually reverses the toxicity.Immunotherapy toxicities are driven by the immune system rather than the drugs themselves, and as such, cessation of treatment does not automatically resolve toxicity. Most toxicities need active treatment to resolve.It is crucial to educate your patients regarding temporarily ceasing therapy in response to toxicity, particularly fever.It is important to recognise that immunotherapy toxicity is not necessarily treated the same as the autoimmune disease it may mimic.Understanding the patient's history is crucial to identify if symptoms are a direct result of treatment.Ceasing immunotherapy treatment in the setting of toxicities does not mean you lose efficacy.It is important to understand the risk versus benefit when assessing your patient for re-challenge with immunotherapy after a toxicity.Medical Oncologists should have a referral network of experts for managing your patient's toxicities.This podcast is suitable for Oncologists, Emergency Medicine Physicians, GPs, Oncology Nurses and other healthcare professionals.SPEAKERSProf Georgina Long AO - Co-Medical Director, Melanoma Institute Australia | Chair, Melanoma Medical Oncology and Translational Research, Melanoma Institute Australia and Royal North Shore Hospital, The University of SydneyA/Prof Matteo Carlino - Medical Oncologist, Melanoma Institute Australia, Westmead and Blacktown Hospitals Clinical Associate Professor, The University of SydneyPlease note that this podcast was accurate at the time of recording (May 2022) but may not reflect the rapidly evolving treatment landscape and approvals in Australia.MIA's Education Program is proudly supported through unrestricted educational grants from: MSD, Bristol Myers Squibb, Novartis and HEINE.

On this week's episode FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss why Gilead is getting flak for a positive cancer drug study, what's gone wrong at bluebird bio and why the FDA has been so quick to expand approval of Bristol Myers Squibb's Opdivo for the treatment of neoadjuvant lung cancer.

Listen to a soundcast of the August 17, 2021, and August 19, 2021, FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced solid tumors, and Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinoma

The field of cancer immunotherapy exploded in 2011 with the FDA approval of an utterly novel, so-called “checkpoint” drug, the anti-CTLA-4 agent, Yervoy. The fires of that first-in-class success ignited a drug development rocket – the approval of the checkpoint-targeting drugs Keytruda and Opdivo occurred shortly thereafter. But then came a lot of dark, cold space. Until now. Frederic Triebel, the founder of Immutep, explains how his discovery – the checkpoint molecule called LAG-3 – is finally ready to reach for the stars.

Opdivo (nivolumab) for patients w/ resected esophageal/GEJ cancer w/ residual pathologic disease who have received neoadjuvant chemoradiotherapy & Rybrevant (amivantamab-vmjw) for adult patients with locally advanced/metastatic NSCLC w/ epidermal growth factor receptor exon 20 insertion mutations

Trodelvy (sacituzumab govitecan) for locally advanced/metastatic urothelial cancer who received platinum-containing chemotherapy & either PD-1/PD-L1 inhibitor. Opdivo (nivolumab) in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma.

FirstWord Pharma PLUS editors Michael Flanagan, Simon King and Becky Simon discuss the implications of two noteworthy news events in the field of gene therapy this week – bluebird bio's decision to walk away from Zynteglo reimbursement negotiations in Germany and Vertex's investment of $900m to increase its share of the economics in CTX001, a gene-editing sickle cell disease therapy being co-developed with CRISPR Therapeutics. They also discuss feedback from a key opinion leader who thinks Bristol Myers Squibb could be poised to lead the neoadjuvant non-small cell lung cancer market with its immunotherapy Opdivo and run the rule over Roche and Biogen's first-quarter results.

Enhertu (fam-trastuzumab deruxtecan-nxki) for locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma and received a prior trastuzumab-based regimen. Combination of Opdivo (nivolumab) + Cabometyx (cabozantinib) as first-line treatment for advanced renal cell carcinoma

Here are the links for everything discussed in Episode 51. Times are also below so feel free to skip around and get to the drugs that interest you. (1:15) New treatment for heart failure approved, Verquvo (4:57) Cabometyx + Opdivo for advanced RCC (9:26) Approval of Tepmetko for NSCLC with MET alterations CDC updates on COVID-19 & influenza reportingConnect with The Rx Daily Dose:Twitter      Instagram      YouTube      Linkedin       WebsiteEmail: therxdailydose@gmail.comConnect with Ian Parnigoni PharmD. on social media:Twitter       Instagram       Linkedin  ★ Support this podcast on Patreon ★

Here are the links for everything discussed in Episode 44, I'm also including times here so feel free to skip ahead to the topics that interest you. (1:20) Combination of Opdivo & Yervoy approved for mesothelioma (4:53) Nucala approved with new indication (8:08) New age group approved for Kalydeco (10:46) Xeljanz approved for pcJIA CDC updates on COVID-19 & influenza reportingConnect with The Rx Daily Dose:Twitter      Instagram      YouTube      Linkedin       WebsiteEmail: therxdailydose@gmail.comConnect with Ian Parnigoni PharmD. on social media:Twitter       Instagram       Linkedin  ★ Support this podcast on Patreon ★

Here are the links for everything discussed in Episode 35, I'm also including times here so feel free to skip ahead to the topics that interest you. (1:19) Added indication for Pomalyst for Kaposi sarcoma (4:50) FDA approves Kynmobi for Parkinson's (8:57) Opdivo & Yervoy approval for mNSCLC w/ PD-L1 CDC updates on COVID-19 & influenza reporting Connect with The Rx Daily Dose:Twitter      Instagram      YouTube      Linkedin       WebsiteEmail: therxdailydose@gmail.comConnect with Ian Parnigoni PharmD. on social media:Twitter       Instagram       Linkedin  ★ Support this podcast on Patreon ★

Here are the links for everything discussed in Episode 25. Approval of Isturisa for Cushing's Disease Added indication for Ofev in ILD New combination Opdivo & Vervoy for HCC CDC updates on COVID-19 CDC updates on influenza reporting Connect with The Rx Daily Dose:Twitter      Instagram      YouTube      Linkedin       WebsiteEmail: therxdailydose@gmail.comConnect with Ian Parnigoni PharmD. on social media:Twitter       Instagram       Linkedin  ★ Support this podcast on Patreon ★

It is a pleasure to share this interview with my long-term colleague Dr. Ralph Moss, former science writer and Assistant Director of Public Affairs at Memorial Sloan-Kettering Cancer Center. Dr. Moss authored or edited 12 books on cancer research and treatment, including The Cancer Industry, Questioning Chemotherapy, and Doctored Results. Writer of the award-winning PBS documentary “The Cancer War,” he currently creates The Moss Reports summarizing evidence-based treatments for 36 different cancer diagnoses. Listen to this podcast, and hear Dr. Moss' well-researched opinions on: The cancer breakthrough of the year The truth about Laetrile research at Sloan-Kettering The immune system and spontaneous regression of cancer When chemotherapy is and is not appropriate The success of Insulin Potentiation Therapy The most effective therapies currently in clinical use The value of immune checkpoint drugs like Keytruda and Opdivo The promise of cancer-killing viral therapy How far we have come in the last 40 years and why he is optimistic