Podcasts about alecensa

Com uso recém-aprovado pela Anvisa, o fármaco Alecensa ainda não é fornecido pelo SUS

In episode 81 of the Summits Podcast, co-hosts Vince Todd, Jr. and Daniel Abdallah are joined by Betsy Beggs of Goldman Sachs. At 23 years old, Betsy was a young professional finding her footing in New York City when she was blindsided by a stage 4 ALK+ lung cancer diagnosis. Tune in as she bravely shares her cancer story. For more, listen to Sarah Beggs, Betsy's mother, share her story from a parent perspective: youtu.be/05CrU4ltf80

VIsit Nascentmc.com for medical writing assistance. Visit learnamastyle.com for freebies on medical writing and editing and ChatGPT. - Fasenra Pediatric Asthma Expansion: No details provided for this update. - Beqvez for Hemophilia B: FDA approved gene therapy, Beqvez, for adults with moderate to severe hemophilia B, which enables the production of clotting protein factor IX. This one-time treatment by Pfizer, derived from Spark Therapeutics, aims to replace frequent infusion therapies, demonstrating superior efficacy in a late-stage trial. - Anktiva for Bladder Cancer: Anktiva received FDA approval for treating BCG-unresponsive non-muscle invasive bladder cancer, enhancing NK and T cell proliferation. Based on a trial with 77 patients, it showed a 62% complete response rate, surpassing international clinical benchmarks, leading to its designation as a breakthrough therapy. - Pivya for UTI: FDA approved pivmecillinam (Pivya) for treating uncomplicated urinary tract infections caused by specific bacterial strains. This marks the first new antibiotic for such infections in the U.S. in over 20 years, backed by effective outcomes in three clinical trials. - Tovorafenib for Pediatric Low-Grade Glioma: Tovorafenib was approved for pediatric low-grade glioma patients with specific BRAF alterations, showing a 67% response rate in the FIREFLY-1 trial. It has been designated for accelerated approval due to its potential in treating these brain tumors. - Entyvio Maintenance for Crohn's Disease: Vedolizumab (Entyvio) received approval for subcutaneous administration as Crohn's disease maintenance therapy after initial intravenous induction. Supported by the VISIBLE 2 Study, it proved effective in maintaining clinical remission at 52 weeks. - Alecensa for NSCLC: Alecensa was approved as an adjuvant treatment post-tumor resection for ALK-positive non-small cell lung cancer. In the ALINA trial, it significantly extended disease-free survival compared to chemotherapy, particularly in early-stage patients. - SPG601 for Fragile X Syndrome: The FDA cleared SPG601 for a phase 2a trial in Fragile X Syndrome, addressing synaptic function through BK channel activation. This marks an advance for treating the core symptoms of the most common inherited intellectual disability. - Lumisight for Visualizing Breast Cancer: The FDA approved Lumisight and the Lumicell Direct Visualization System for use during lumpectomy surgeries to detect residual cancer tissues. This system, shown in the INSITE trial, improves surgical outcomes by reducing the need for second operations. VIsit Nascentmc.com for medical writing assistance. Visit learnamastyle.com for freebies on medical writing and editing and ChatGPT.

Last week, we saw a few moving parts in the regulatory space, from new NCCN guidelines for pediatric neuroblastoma treatment to FDA Fast Tracks and Priority Reviews. Also last week, we covered research showing that a lower dose of an anti-emetic drug could have similar efficacy — and fewer side effects — than the standard, higher dose.  NCCN Guidelines Give Framework for Childhood Neuroblastoma Treatment The National Comprehensive Cancer Network recently published guidelines for the treatment of pediatric patients with neuroblastoma. This resource is geared toward mitigating unnecessary side effects and over treatment in patients with low-risk disease, while also developing the best treatment plans for high-risk patients.  CURE® spoke with Dr. Rochelle Bagatell, professor of Pediatrics and Solid Tumor Section Chief at Children's Hospital of Philadelphia, and Chair of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Panel for Neuroblastoma, who emphasized that while these guidelines can influence treatment strategies, conversations between patient families and clinicians and even insurance coverage, each patient's care should be as personalized as possible.  “There may be specific cases where the nuances of a particular patient's case means that you have to adjust your thinking from what's written on those nice, clear lines,” Bagatell said. “But the general guidance about how to think about the risk of recurrence, what general type of therapy would be appropriate, how much chemotherapy when to do surgery. Those are the kinds of things that patients and families can look at and bring to their doctor and discuss.” FDA Fast Tracks ARV-471 for Metastatic Breast Cancer Last week the Food and Drug Administration (FDA) granted a Fast Track designation to ARV-471, a novel drug being studied for the treatment of patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. Specifically, this indication of ARV-471 is for patients who previously underwent endocrine therapy.  Fast Track designations are given to drugs that show promise in treating serious conditions and fill an unmet need. The goal is to speed up the review and potential approval of these therapies.  ARV-471 is being studied in the phase 3 VERITAC-2 clinical trial, which is comparing ARV-471 to Faslodex in this patient population. Preclinical studies showed that the drug induced tumor shrinkage and degradation.  FDA Grants Priority Review for Alecensa in Some ALK-Positive NSCLC Also in FDA news from last week, the agency granted a priority review to Alecensa as a postsurgical treatment for patients with early-stage ALK-positive non-small cell lung cancer.  The priority review is based off findings from the phase 3 ALINA trial, which showed that the drug led to a 76% reduction in the risk of disease recurrence or death compared with chemotherapy treatment. Findings from this study also showed that at two years, 93.8% of patients taking Alecensa experienced disease-free survival (which is the time after treatment when patients do not have symptoms of complications from their cancer), compared with 63% in the chemotherapy group. At three years, disease-free survival rates were 88.3% and 53.3%, respectively.  With the priority review, the FDA said that they plan on making an approval decision on Alecensa on or by May 22, 2023, though those dates can always change.  Lower Dose of Nausea, Vomiting Drug Controls Chemo Symptoms Finally, research showed that a lower dose of a nausea and vomiting drug could be just as effective as the higher, standard dose when it comes to controlling chemotherapy-induced nausea and vomiting.  A study published in The Lancet Oncology found that a 2.5-milligram dose of olanzapine is not inferior (meaning it is no less effective) than a 10-milligram dose. Specifically, the researchers looked at the use of rescue medications, vomiting episodes and mild nausea over the course of 120 hours.  Notably, this lower dose can also lead to a decrease in side effects related to the drug, such as feeling of lethargy and drowsiness.  For more news on cancer updates, research and education, don't forget to subscribe to CURE®'s newsletters here.

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 today's episode, we'll be discussing the importance of crystallization process development in drug development and manufacturing. Crystallization plays a crucial role in ensuring the quality and effectiveness of a final drug product. It helps control the physical form of a compound, which is directly linked to its biological activity. Drug manufacturers must demonstrate that they understand and can control the physical properties and chemical purity of a drug substance.Cambrex, a pharmaceutical services company, specializes in bridging the gap between bench-scale development and manufacturing. They provide controlled crystallization processes to help their clients achieve clinical delivery timelines. By leveraging their expertise, Cambrex assists clients in developing robust crystallization processes that meet regulatory requirements and ensure the quality of the drug product.Healthcare insurer Humana has filed a lawsuit against the US Department of Health and Human Services (HHS) over Medicare Advantage (MA) audits. Humana relies heavily on revenue from Medicare and is challenging a rule implemented earlier this year that aims to recover overpayments in the MA program. The rule allows the HHS to retroactively audit MA organizations and recoup any overpayments made.Moving on, Beam Therapeutics has begun testing its first-of-its-kind cancer drug that utilizes base editing technology. This marks progress for the company after facing trial delays, and it is the first time in the US that a patient has received a base editing treatment.In other news, Jacob Thaysen, a former executive at Agilent Technologies, has been appointed as the new CEO of Illumina, replacing Francis deSouza who stepped down in June following a proxy fight with activist investor Carl Icahn. Thaysen's experience in the life sciences industry, particularly in the diagnostics sector, makes him well-suited to lead Illumina during this critical time.Roche has recently experienced success in the field of oncology with the approval of the subcutaneous administration of its cancer drug Tecentriq in the UK. This approval gives Roche an advantage over its competitors in the race to bring subcutaneous versions of their drugs to market. Roche also had positive news with its ALK inhibitor Alecensa, which showed promising results in reducing disease recurrence in patients with early-stage non-small cell lung cancer.Lastly, the text discusses how new technology trends, such as AI, virtual reality, and robotics, have the potential to address long-standing challenges in the healthcare industry. Hospitals, payers, and other healthcare companies are using these tech trends to navigate workforce shortages, economic pressures, and consumer demands.And that's it for today's episode. Stay tuned for more updates in the Pharma and Biotech world.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. The Federal Trade Commission (FTC) has allowed Amgen's $28 billion acquisition of Horizon to proceed, with conditions. This settlement may ease concerns about regulatory hurdles for future deals in the industry. However, FDA documents suggest that Sage's depression drug, zurzuvae, may face challenges in obtaining broad approval due to concerns about side effects. On a positive note, Roche has claimed success in a study for its targeted lung cancer drug, Alecensa, with unprecedented results. This could make Alecensa the first treatment specifically available after surgery for ALK-positive lung tumors.In terms of investment, Julie Yoo from venture capital firm Andreessen Horowitz believes that the healthcare industry is at an inflection point and compared it to the internet era of 1999. Biotech mergers and acquisitions (M&A) activity is also picking up again, with Amgen's acquisition of Horizon set to become the largest industry deal since AstraZeneca's buyout of Alexion. Drug pricing in the US is also a trending topic, with launch prices steadily rising in certain therapeutic areas like cancer.Moving on to policy news, the Biden administration has proposed new nursing home staffing minimums to improve the quality of care in these facilities. Walgreens CEO Roz Brewer is stepping down and will be replaced by an executive with "deep healthcare experience." Amir Dan Rubin, CEO of One Medical, is also resigning from his position. The Office of the National Coordinator for Health Information Technology has chosen the Sequoia Project to oversee the Trusted Exchange Framework and Common Agreement (TEFCA) once again.In other updates, Roz Brewer's sudden departure from Walgreens has left many wondering about the reason behind it. Psycheceutical is developing a topical delivery technology for ketamine, which could have broader implications for other drugs. Ketamine has shown promise in treating mental health conditions such as treatment-resistant depression. J&J's Spravato, an FDA-approved drug for treatment-resistant depression, is administered nasally, but clinicians believe that intravenous ketamine is more effective. Psycheceutical aims to explore the potential relief provided by applying ketamine topically on the back of the neck.The rare disease market has seen significant growth in recent years, with pharmaceutical companies exploring treatments for these conditions. Ketamine's effectiveness in battling mental health conditions is being recognized, shifting its perception from a party drug to a potential therapeutic option. The text also mentions upcoming events and recent articles on various topics.In regulatory news, the FTC has given clearance for Amgen's acquisition of Horizon Therapeutics, subject to certain restrictions. Alvotech has resubmitted a Biologics License Application (BLA) to the FDA seeking an interchangeable designation for its biosimilar of Humira. Lawmakers have called on Lilly, Novo Nordisk, and Sanofi to provide details on their insulin assistance programs. Alkermes has settled a patent lawsuit with Teva over the generic version of Vivitrol. Biontech and DualityBio are moving their antibody-drug conjugate (ADC) into Phase III trials for HER2-low breast cancer.Lastly, Bayer has reported positive early data for a Parkinson's cell therapy treatment it acquired in 2019. Epigenic, a Chinese startup, has raised funds to use CRISPR tools to edit the epigenome and alter gene expression without changing DNA. Catalent, a contract development and manufacturing organization (CDMO), is expanding its board and setting up a committee to review its business and capital allocation priorities. Several biotech companies have made advancements in constructing small-molecule drugs to target RNA, revolutionizing the industry.These developments highlight significant activities in the p

Dr. Caroline McCoach discusses What are the options after a patient with an ALK-positive advanced NSCLC develops resistance on Alecensa-alectinib

GRACE is happy to present the 5th in our series ASCO 2016 Lung Cancer Roundtable, Highlights and New Approaches in Lung Cancer.  Featuring Jack West, MD, Janet Freeman-Daily, Everett Vokes, MD, and Suresh Ramalingam, MD, this roundtable discussion, moderated by Dr. West, highlights the newest and most intriguing discussions from ASCO 2016. Drs. West, Vokes and Ramalingam, along with patient advocate Janet Freeman-Daily, discuss the J-Alex trial and whether Alecensa should replace Xalkori as First-Line ALK Therapy.

GRACE is happy to present the 5th in our series ASCO 2016 Lung Cancer Roundtable, Highlights and New Approaches in Lung Cancer.  Featuring Jack West, MD, Janet Freeman-Daily, Everett Vokes, MD, and Suresh Ramalingam, MD, this roundtable discussion, moderated by Dr. West, highlights the newest and most intriguing discussions from ASCO 2016. Drs. West, Vokes and Ramalingam, along with patient advocate Janet Freeman-Daily, discuss the J-Alex trial and whether Alecensa should replace Xalkori as First-Line ALK Therapy.

GRACE is happy to present the 5th in our series ASCO 2016 Lung Cancer Roundtable, Highlights and New Approaches in Lung Cancer.  Featuring Jack West, MD, Janet Freeman-Daily, Everett Vokes, MD, and Suresh Ramalingam, MD, this roundtable discussion, moderated by Dr. West, highlights the newest and most intriguing discussions from ASCO 2016. Drs. West, Vokes and Ramalingam, along with patient advocate Janet Freeman-Daily, discuss the J-Alex trial and whether Alecensa should replace Xalkori as First-Line ALK Therapy.

Xalkori (critzotinib) was the first approved treatment for ALK+ and ROS1 lung cancer. Since then, other drugs have been approved or are currently undergoing scientific review. In this video, Dr. Owonikoko outlines these options for patients.

Xalkori (critzotinib) was the first approved treatment for ALK+ and ROS1 lung cancer. Since then, other drugs have been approved or are currently undergoing scientific review. In this video, Dr. Owonikoko outlines these options for patients.

Xalkori (critzotinib) was the first approved treatment for ALK+ and ROS1 lung cancer. Since then, other drugs have been approved or are currently undergoing scientific review. In this video, Dr. Owonikoko outlines these options for patients.