BioSpace

Corsera Health's Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech's mission and vision for the next generation of cardiovascular care in this special bonus episode. Corsera Health is featured in BioSpace's NextGen: Class of 2026 list, the top startups to watch in the U.S.HostAnnalee Armstrong, Senior Editor, BioSpaceGuestsRena Denoncourt, Chief Operating Officer, Corsera HealthMeredith Kaya, Chief Financial Officer, Corsera HealthDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

In this episode, you'll be listening to Jane Hughes, President of R&D and Co Founder of Verdiva Bio, and Jon Rees, CEO and cofounder of MitoRx Therapeutics. We'll discuss next-generation obesity solutions tackling GLP-1's muscle loss and adherence challenges, through innovative muscle preservation, oral administration and combination therapy.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsJane Hughes, President of R&D and Co-founder, Verdiva BioJon Rees, CEO and Co-founder, MitoRx TherapeuticsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Last week, the FDA declined to review Moderna's mRNA-based flu vaccine, with Center for Biologics Evaluation and Research Director Vinay Prasad himself signing the refuse-to-file (RTF) letter. Prasad said Moderna's comparator group “does notreflect the best-available standard of care,” while Moderna pushed back, saying CBER had previously found a standard-dose flu shot to be an “acceptable” comparator. Despite the shocking turn of events, HHS backed Prasad, saying Moderna didn't “follow very clear FDA guidance from 2024.”Regardless of the reasons, the development imperilsModerna's breakeven plans, affecting not just the company's investigational flu vaccine but also a flu-COVID combo shot and other parts of the company's pipeline. And for the broader industry, it highlights the regulatory uncertainty that persists into 2026, even as other countries move full speed ahead with novel modalities.That regulatory uncertainty extended this week to DiscMedicine, whose rare disease drug bitopertin was rejectedby the FDA. The company tried to convince investors that its planned Phase 3 trial would pave the way toward a refiling, but analysts raised concerns that the study was developed with oldFDA leadership. Disc's situation also raises questions about the FDA's Commissioner's National Priority Voucher, which bitopertin had received.Meanwhile, Compass Pathways dropped long-awaited data from two Phase 3 trials of its psilocybin-based COMP360, showing strong durability data that “clearly met the Street's bar for success,” according to Stifel analysts. The company plans to complete a rolling new drug application by the end of the year.Finally, the CDC has been left leaderless, again, with the departure of Jim O'Neill, who had been servingas acting director after the ouster of Susan Monarez last summer. And Sanofi's Paul Hudson was removed as CEO last week. He'll be replaced by Merck KGaA's Belén Garijo, who becomes just the second woman in charge of a Big pharmacompany.

Last year, the FDA announced it would be phasingout animal testing requirements for some therapies. The NIHfollowed suit. According to Thomas Hartung, professor and chair at Johns Hopkins Bloomberg School of Public Health, these policy shifts are an “overdue adaptation to scientific progress.” In this special edition of The Weekly, Hartung discusses howartificial intelligence (AI) and various non-animal models such as human organoids will transform drug development and delivery, especially now that the regulatory side is catching up. The FDA Modernization Act, now making its way through Congress, codifies the FDA's stated goal of starting to move away from animal testing. And in making that announcement last year, the FDA put out a roadmap for how to do this. In May, Hartung will attend the National Biotechnology Conference in San Diego as a keynote speaker. BioSpace is a media partner of the meeting, and Managing Editor Jef Akst will also attend to moderate the executive track. The 2026 National Biotechnology Conference runs May 11–14.You can find the agenda here.

In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe, Vice President and Chief Scientific Officer of Oncology at Danaher Corporation and Chief Medical Officer at Leica Biosystems, and Jennifer Fakish, Vice President and Franchise Head of Oncology at Danaher Corporation. We'll be discussing how antibody drug conjugates (ADCs) are transforming cancer care and with AI-powered pathology, doctors can now measure her HER2 more precisely to match patients with the best treatments. HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsDr. Rob Monroe, Vice President and Chief Scientific Officer, Oncology, Danaher Corporation; Chief Medical Officer, Leica BiosystemsJennifer Faikish, Vice President and Franchise Head, Oncology, Danaher CorporationDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Last Thursday, Hims & Hers launched a compounded versionof Novo's oral Wegovy, approved just before Christmas and launched in early January. Novo was, not surprisingly, none too pleased. FDA Commissioner Marty Makary denounced“illegal copycat drugs” in an X post the same day without naming Hims, which then said it would notsell the oral weight loss drug. Novo sued the consumer healthcare company for patent infringement, seeking potentially hundreds of millions in damages. Thenit emerged that FDA hit Hims with a warning letter last year about infestations of vermin at a facility it owns, including rodents, birds and insects, as well as a live spider in a production area.The timing of all the Hims drama is interesting, because BioSpace was already covering Novo, Lilly and their blockbuster GLP weight loss drugs as both companies—and others—reported 2025 fourth quarter and full year earnings. EliLilly and Novo both reported last Wednesday, and both spoke of Novo's oral Wegovy launch positively. But the calls had two very different tones, as Lilly beat Q4 2025 analyst consensus by more than a billion dollars while Novo projected sales to decline by 5% in 2026.In other recent earnings calls, AbbVie touted strong Skyriziand Rinvoq sales, and the company continues to follow Johnson & Johnson's lead into the psychedelics space. And Biogen discussed the highly anticipated readout of its tau-targetingtherapy for Alzheimer's.Finally, in gene therapy, Sarepta struggles to recover from last year's patient deaths as other DMD contenders near the market; uniQure pauses two arms of a clinical trial for Fabry disease; and Ultragenyx resubmits its in vivo gene therapy UX111 for the treatment of Sanfilippo syndrome type A.

In this episode of Denatured, Jennifer C. Smith-Parker speaks to Erik Digman Wiklud, CEO of Circio and Jacob Becraft, CO-founder and CEO of Strand Therapeutics. Since the mRNA vaccine breakthroughs of the COVID-19 era, attention has turned to what's next for programmable medicines. While first- generation mRNA prove the power of transient genetic instruction, its instability, immune reactivity, and short-lived expression have limited its use mainly to vaccines. Emerging platforms like circular and logic circuit RNA are expanding the field's therapeutic horizons.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsErik Digman Wiklund⁠, CEO, CircioJacob Becraft, Co-founder and CEO, Strand TherapeuticsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Pfizer reported the first data from its new obesity pipeline, picked up in the nearly $10 billion acquisition of Metsera last fall. While BMO Capital Markets said in a Tuesday note that the data “look competitive,” analysts clamored for more details on Pfizer's earnings call the same morning—and were left wanting more. Meawhile, Merck batted away accusations of “modest growth” from analysts on its own earnings call, as CEO Robert Davis touted “probably the broadest and widest pipelinewe've had in years.” These calls followed Roche last week and Johnson & Johnson before that, but earnings season is just getting started. On the docket today is Eli Lilly, which has been acquisitive of late, plus Novo Nordisk, Novartis, AbbVie and more.  On the regulatory front, the FDA is expected to decideon eight products this month, including REGENXBIO's Hunter syndrome gene therapy RGX-121. The biotech ran into a regulatory snag last week, however, as the FDA placed a clinical hold on two of its programs, including RGX-121. The agency also launched its much-anticipated PreCheck pilot program, which aims to make it easier for companies to build manufacturing plants in the U.S. And President Donald Trump's TrumpRx platform is delayed, potentially amid anti-kickback concerns.  In ClinicaSpace this week, we took a deep dive intothe resurgent psychedelics space, which could see two companies—Compass Pathways and Definium—submit FDAapplications this year. H.C. Wainwright analyst Patrick Trucchio told BioSpace 2026 is set to be “the biggest year from a clinical data standpoint,” since the firm began covering Compass in 2018. And check your inboxes Wednesday for BioPharmExecutive, where we take a look back at the banner IPO year that was 2021: Where are these companies now?

In this episode of Denatured, Jennifer C. Smith-Parker speaks with RTW's Rod Wong and Stephanie Sirota how shifting JPM deal timing masks record M&A potential; why oncology, obesity, psychedelics, and neuroscience are attracting fresh capital; and how “alpha stacking” shapes their investment edge in an age of chronic uncertainty. They cover topics discussed in RTW's new book, "Innovation is the Best Medicine."Hosts⁠⁠⁠⁠Jennifer Smith-Parker⁠⁠, Director of Insights, BioSpaceGuestsRoderick Wong, Managing Partner, Chief Investment Officer, RTW InvestmentsStephanie Sirota, Partner, Chief Business Officer, RTW InvestmentsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Roche made the biggest splash this week so far, announcing on Tuesday that GLP-1/GIP injectable CT-388 led to 22.5%weight loss in a Phase II trial. These numbers appear to put CT-388, which Roche acquired in its $2.7 billion Carmot buy, in line with Eli Lilly's Zepbound, according to William Blair analysts. Roche plans to start a Phase III study of CT-388 in the first half of this year and is also pairing the drug with a therapy from Zealand Pharma, with the aim of offering a weight lossoption with fewer gastrointestinal side effects. Meanwhile, Baseline Therapeutics debuted to challenge Lilly with a Phase III–ready GLP-1 for alcohol use disorder.  In the vaccines sector, Moderna took perhaps the biggest action to date amid Health Secretary Robert F. Kennedy's anti-vaccine policies and rhetoric, last week announcing that the company will no longer run late-stage vaccine trials for infectious diseases. “You cannot make a return on investment if you don't have access to the U.S. market,” CEO Stéphane Bancel saidthe World Economic Forum at Davos, Switzerland. Pfizer CEO Albert Bourla, also speaking at Davos, called RFK Jr.'s rhetoric and policies on vaccines “anti-science.”  Finally, Sarepta released new data on Monday for Elevidys, the company's embattled gene therapy for neuromuscular disease Duchenne muscular dystrophy. Plus, check out up-and-coming treatments for Alzheimer's and Parkinson's.

In this episode of Denatured, BioSpace editorial team members, Senior Editor, Annalee Armstrong, and News Editor, Dan Samorodnitsky, discuss their post-JPM takeaways and 2026 forecasts after speaking to a range of pharma and biotech executives and investors last week.Hosts⁠Jennifer Smith-Parker⁠, Director of Insights, BioSpace⁠Guests⁠Annalee Armstrong, Senior Editor, BioSpace⁠Dan Samorodnitsky, News Editor, BioSpaceDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

The 2026 J.P. Morgan Healthcare Conference concludedlast week without a big M&A deal. But the meeting was anything but boring, with President Donald Trump'sMost Favored Nation drug pricing scheme and the perpetual battle for supremacyin the obesity space between Eli Lilly and Novo Nordisk prime topics of conversation. Meanwhile, other companies like Biohaven refuse tocede the entire weight loss market, stating their intention to carve out apiece of the massive pie.  On the competitive front, Novo took a step forwardMonday with the news that its Wegovy pill reached nearly 3,100 patients since its launch on Jan. 5. Meanwhile, an FDAdecision for Lilly's own oral offering, orforglipron, has been delayed from March28 to April 10. Orforglipron is being reviewed under the FDA's new Commissioner'sNational Priority Voucher (CNPV) program, which aims to shorten the reviewperiod from 10–12 months to 1–2 months. Other voucher recipients—includingSanofi and Disc Medicine—have also had their decisions delayed.  While the FDA wasn't a primary focus at JPM, severalbiotechs sought to make clear during their investor presentations that they hadsecured alignment with the regulator on trial design or pathways to approval. This comesafter a year that has seen many of their peers experience regulatory whiplashas previous FDA guidance was seemingly reversed.  And on the business front, IPOs are back! This week, SpyGlass Pharma and AgomAb Therapeutics joined Veradermicsand Eikon Therapeutics on the rapidly accelerating IPO train. Aktis Oncology,which announced its bid in late 2025, debuted on the Nasdaq earlier this month. And in BioPharm Executive this week, Annalee Armstrongand Dan Samorodnitsky catch up with execs from Novo Nordisk, Korro Bio, Biohaven and Galapagos.

In this episode, BioSpace's Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel discuss Q4 2025 job market performance, sharing the latest BioSpace data. They touch on positive signs they saw last quarter and what this year might have in store for those seeking employment. Want to receive our latest quarterly job market reports as soon as they're published? ⁠⁠⁠Subscribe⁠⁠⁠ to Career Insider for our job market updates, job trends, career advice and more.

AbbVie bet nearly $5 billion for the ex-China rights to RemeGen's PD-1/VEGF bispecific and Novartis struck a $1.5 billion Alzheimer's-focused deal with China-based SciNeuro Pharmaceuticals as the 2026 J.P. Morgan Healthcare Conference got underway on Monday. These and other recent tie-ups speak to the therapeutic trends predicted to be hot this year by experts who spoke with BioSpace, who particularly noted that cancer and neuroscience would remain top of the list.  Meanwhile, attendees are still waiting for that “one big M&A deal.” Could it come from Merck? CEO Rob Davis expressed high confidence during the company's JPM presentation on Monday, revealing that Merck is open to deals in the range of “multi tens of billions of dollars.” On the weight loss front, Eli Lilly and Novo Nordisk both updated attendees on the state of play, with Lilly expressingconfidence in its supply chain to support the launch of obesity pill orforglipron and Novo continuing to lament the business it is still losing to compounders.  Just in time for JPM, the IPO window cracked open, with Aktis Oncology debuting on the public markets last week and Veradermics and Eikon Therapeutics announcing their bids to follow suit. A similar thaw occurred last year before the window slammed shut again as myriad policy changes frightened investors. How will this year play out?  2025 had its challenges, especially on the policy front. In his annual letter, Flagship CEO Noubar Afeyan cited “growing contempt” in the U.S. for the scientific method and arapidly emerging Chinese biopharma ecosystem among the greatest challenges facing the industry. And while the funding may now be flowing, it still favors later-stage companies. A .J.P. Morgan report released prior to the conference showed VC funding was down across the board last year, but especially for biotechs recruiting early rounds.  Finally, while JPM is the primary focus, the FDA hasn't taken the week off. Just prior to recording, the regulator requestedthat Lilly and Novo remove the suicide warning from the labels of certain GLP-1 medications after a comprehensive review found no increased risk of suicidal ideation and behavior with these drugs. On the policy front, the FDA continued its quest to accelerate the development of cell and gene therapies with new manufacturing exemptions.  The regulator also took action on two applications this week, approving a rare disease drug developed by Sentynl Therapeutics and Fortress Biotech and denying a cell therapy submitted by Atara Biotherapeutics. To learn about key upcoming FDA action, check out 6 FDA Decisions To Watch in Q1 2026 in ClinicaSpace this week.

In this episode of Denatured, Jennifer C. Smith-Parker speaks to Maha Katabi, general partner at Sofinnova Investments and Andrew Lam, managing director, head of Biotech Private Equity at Ally Bridge Group, about how M &A dynamics, dealmaking and global partnerships are reshaping portfolio valuations and paths to growth in 2026. HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsMaha Katabi, General Partner, Sofinnova InvestmentsAndrew Lam, Managing Director, Head of Biotech Private Equity, Ally Bridge Group (ABG)Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Obesity titans Novo Nordisk and Eli Lilly characteristically kicked off 2026 in the headlines. After capping 2025 with the first-ever FDA approval of an oral GLP-1 for obesity, Novo launched its Wegovy pill on Monday, starting at $149 per month out of pocket for the lower doses. Meanwhile, all eyes are on Lilly, which expects a greenlight for orforglipron as early as March. The oral weight loss play is set to be a key aspect of a pivotal year for Lilly, which hopes to more than double its annual revenue in just a few years.   Also pulling a rabbit out of a hat just before Christmas were nine drugmakers—including Amgen, Bristol Myers Squibb, Boehringer Ingelheim—which signed Most Favored Nation drug pricing agreements with the Trump administration, likely securing their businesses against the threat of tariffs. However, drug pricing will continue to be top of mind in 2026, experts told BioSpace, as only about half of Big Pharmas have signed a deal, and small and mid-sized companies haven't yet begun.   Another area biopharma leaders are watching with bated breath is the FDA. The overwhelming consensus from experts who spoke with BioSpace is that last year was a disaster—particularly from a workforce standpoint. Still, the agency approved 56 novel drugs, down just a tick from 2024's 59. Advisory committees fell off considerably, in both number and concordance, however, according to a report by Jefferies, as these meetings came under scrutiny by FDA leadership.  In 2026, will the unprecedented leadership turnover—especially at CDER—settle down? Will the new rare disease and cell and gene therapy policies bear first fruits? Also on the regulatory front, the CDC has already been busy this year, axing several childhood vaccines from its recommended schedule with potential implications for biopharma companies including Pfizer and Merck.   And if there's one area biopharma watchers anticipate even more than regulatory action, it's M&A action. Last month, analysts shared their top targets with BioSpace, listing names like Summit Therapeutics, Apogee Therapeutics and Axsome Therapeutics. Here at BioSpace, we'll stick with Viking.   Finally, don't forget to check out our NextGen Class of 2026—featuring 15 biotech startups whose mission and platforms cut through a challenging environment. And make sure to join us next week when senior editor Annalee Armstrong and news editor Dan Samorodnitsky will provide dispatches from the J.P. Morgan Healthcare Conference.  

In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO at Zymeworks and Josh Smiley, president and COO at Zai Lab, about how renewed confidence is driving biotech entering 2026. As we look towards conversations that will shape this year's J.P. Morgan Healthcare Conference, the biotech industry is fueled by improving market sentiments, visible at recent meetings like Jeffries in London, and reinforced by a wave of partnerships, strategic acquisitions and Chinese collaboration that is recalibrating investor expectations.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsKenneth Galbraith, CEO, ZymeworksJosh Smiley, President and Chief Operating Officer, Zai LabDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Eli Lilly is wrapping up 2025 with record-breaking weight loss in a late-stage trial for its triple hormone receptor agonist retatrutide. Results from the Phase III TRIUMPH-4 trial exceeded analyst expectations, leading BMO Capital markets to cleverly dub it “a true TRIUMPH.” Also in the weight loss arena, Zealand Pharma inked a deal with China's OTR Therapeutics worth up to $2.5 billion to collaborate on next-gen drugs for obesity and other metabolic diseases, and Rhythm Pharmaceuticals awaits a Dec. 20 FDA verdict for Imcivree in hypothalamic obesity.   Turning to the FDA, reports broke late last week that the agency was considering slapping a black box label—its strictest warning—on COVID-19 vaccines. Commissioner Marty Makary denied those reports on Monday, stating on Bloomberg TV that the FDA has “no plans” to make such a move. This follows an internal memo from Vinay Prasad leaked over Thanksgiving in which the CBER director claimed that “at least” 10 children have died “because of” COVID-19 vaccines. An internal safety review published last week refuted this conclusion, instead concluding that between zero and seven deaths could be linked to the shots.   Pfizer CEO Albert Bourla, for one, is tired of the recent rhetoric from HHS on vaccines and hopes they are “an anomaly” that will be corrected soon. With strong words about the administration's sentiment on vaccines, Bourla prominsed Pfizer's continued investment in vaccines despite declining revenue. Pfizer this week lowered its 2026 guidance to $62.5 billion in revenue, missing analyst consensus.  The FDA has also granted several approvals in the past week, to Amgen, Milestone Pharmaceuticals and AstraZeneca and Daiichi Sankyo. USAntibiotics also snagged a greenlight, for Augmentin XR, the first approval to be given under the agency's new Commissioner's National Priority Voucher (CNPV) program. Also this week, Johnson & Johnson scored a CNPV ticket—without even having to apply—for its investigational combo of Tecvayli plus Darzalex for relapsed or refractory multiple myeloma after the FDA was impressed by Phase III data.   In ClinicaSpace this week, we highlighted 5 of 2025's Defining Clinical Wins and The 5 Most Painful Clinical Trial Failures of 2025. This past week provided a few more on each front. In the winner's circle, Immunome's desmoid tumor drug and and Kyverna's CAR T for stiff person syndrome both aced pivotal trials, while Sanofi's MS drug tolebrutinib and Gilead and Arcus' TIGIT therapy domvanalimab each failed Phase III tests.   And in BioPharm Executive, we highlight 6 Biotechs That Could Be Big Pharma's Next M&A Target, and more M&A predictions for 2026.  

In this episode presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, professor of medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, and Department of Immunology, The Mayo Clinic; Marilyn Gellar, CEO, The Celiac Disease Foundation; and Dr. Paul Lizzul, chief medical officer, AnaptysBio, about the unmet need for effective treatments for celiac disease, the limitations of the gluten-free diet and the development of ANB033, a first-in-class CD122 antagonist designed to modulate IL-2/IL-15 signaling.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsDr. Joe Murray, Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine and Department of Immunology, The Mayo ClinicMarilyn Geller, CEO, Celiac Disease FoundationDr. Paul Lizzul, Chief Medical Officer, AnaptysBio Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Pfizer followed up its winning $10 billion bid forobesity startup Metsera by adding another molecule to its obesity cabinet, thisone from Chinese firm YaoPharma in a deal worth up to $1.9 billion licensing deal announced Tuesday. Meanwhile, Wave Life Sciences and Structure Therapeutics may have changed the weight loss landscape with early and mid-stagedata from their candidates that analysts called “very disruptive” and “highlycompetitive,” respectively.  At the FDA, the confusion and instability continuewith the retirement of agency veteran Richard Pazdur just three weeks into hisrole as CDER director. Pazdur's exit leaves the FDA with just three veteran leaders from one year ago. The CDC similarly made headlines last week as therevamped vaccines advisory committee voted to recommend postponing the hepatitis B vaccination from birth to two months of age for some infants. Meanwhile, the Clinical Trials on Alzheimer's Disease (CTAD)conference generated excitement in the space as Roche, Eisai and others presentednew data from their respective candidates. The star of the show was Roche'snext-gen antibody trontinemab, which lowered amyloid levels below the threshold of positivity in 92%of treated patients in a mid-stage study. Meanwhile, Eisai isdetermined to buck the losing the trend in the anti-tau space. The company's etalanetugreduced all measurable forms of MTBR-tau243—a specific biomarker of tau tanglepathology in Alzheimer's—in a Phase Ib/II trial, according to an oralpresentation at CTAD.  Finally, check outthis week's deep dives in BioPharm Executive on what pharmas are learning fromthe Chinese biotech sector and how Japan's pharma industry is setting itssights on the global market.

Momentum is building behind New Approach Methodologies (NAMs) that offer stronger human relevance than traditional animal testing. The FDA issued on December 2 a draft guidance outlining specific product types for which the agency believes six-month non-human primate toxicity testing can be eliminated or reduced.  The guidance followed a proposed agency template for NAMs in April. There is also an initiative called the Validation and Qualification Network, with dozens of partners from regulators, like the FDA and European Commission, to Big Pharmas and CROs, such as Sanofi, Novo Nordisk, GSK and Charles River Laboratories, that had a July meeting. In addition, Reuters reported in September that AI-driven drug discovery picks up as FDA pushes to reduce animal testing.In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for NAMs development.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsPatrick Smith, Senior Vice President, Translational Science, CertaraStacey Adam, PhD, Vice President of Science Partnerships, Foundation for the National Institutes of HealthDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Vinay Prasad's memo, leaked over the weekend, has sent vaccine makers' stocks slipping and experts clamoring for more evidence to support the CBER director's claim that COVID vaccines have led to the deaths of at least 10 children. It's the latest insult to the vaccine sector from the healthcare administration this year, with other challenges coming on the CDC side, where the recently revamped advisory committee is heading into its next meeting with a brand new chair.  Elsewhere at the FDA, newly promoted Center for Drug Evaluation and Research Director Richard Pazdur has filed the paperwork to retire from the agency just weeks after reportedly reluctantly accepting the position.   Meanwhile, the Alzheimer's space is buzzing as the 2025 Clinical Trials on Alzheimer's Disease (CTAD) conference continues in San Diego. Last week saw a mid-stage flop for Johnson & Johnson's anti-tau candidate and the “definitive” failure of Novo's GLP-1 semaglutide—which analysts say may actually help uptake of anti-amyloid therapies from Biogen and Eli Lilly. Meanwhile, Roche announced positive results for its latest antibody, putting the pharma back in the game it had once stepped back from in the tumultuous days of Aduhelm.   In the weight loss space, Novo Nordisk revealed ‘competitive' mid-stage data for its next-gen amycretin, which showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes. Meanwhile, the pricing war for approved and future GLP-1s from Novo and obesity rival Eli Lilly rages on, with Lilly this week announcing another price drop for Zepbound through its LillyDirect self-pay platform.  In BioPharm Executive this week, we review the top venture capital rounds for female-founded biotechs and examine the 2026 biotech market outlook. 

Acquisitions have ticked up this month as all eyes were on Pfizer and Novo's fight over Metsera. The past week saw that deal finalized with Pfizer as the winner plus a handful of other M&A stories, including Merck's $9.2 billion buyout of Cidara Therapeutics and Johnson & Johnson's $3 billion bet on Halda Therapeutics. Additionally, a separate bidding war has broken out between Lundbeck and Alkermes for sleep biotech Avadel Pharmaceuticals. Outside of M&A, the FDA dominated headlines again this week. The agency effectively closed the loop on one of the messiest stories of the year—Sarepta's gene therapy Elevidys—when it formally added a black box warning for serious liver toxicities and risk of death and removed the nonambulatory indication from the label. The agency will also require that the company complete a postmarketing observational study of around 200 patients. This happened just as Richard Pazdur accepted the role of director of the Center for Drug Evaluation and Research (CDER) that was recently vacated by George Tidmarsh amidst conflict with Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad. By all accounts, Pazdur, a 26-year FDA veteran, is a highly respected and thoughtful regulator, and sources told BioSpace that if Prasad tries to supersede Pazdur's authority, “there will be hell to pay and resignations to be handed in.” In other FDA drama, FDA Commissioner Marty Makary is apparently butting heads with Health Secretary Robert F. Kennedy Jr. Meanwhile, the agency revealed details of its plausible mechanisms pathway teased by Makary earlier in his tenure. Finally, in Biopharm Executive this week, check out our deep dives into GLP-1 pricing. Coming off Trump's deal with both Eli Lilly and Novo Nordisk to offer their GLP-1s at a lower cost through the president's new direct-to-consumer platform, Novo CEO Maziar Mike Doustdar announced a sale on its company's products. Bargain bin pricing like this so early in a drug's market life is unprecedented. It's changing the investment calculations for the next-generation of obesity treatments. 

A lean funding environment has changed how biotechs approach workforce organization and executive hiring. Searches are becoming more targeted and intentional, and accountability–both for employers and candidates–is high. In this episode of Denatured, Leslie Loveless of Slone Partners describes how biotechs should approach building their executive teams, working with boards and investors to make decisions that will enable growth. She also discusses how the search and hiring processes has changed for both employers and candidates.This episode is presented in partnership with Slone Partners. HostChantal Dresner, Vice President of Marketing, BioSpaceGuestLeslie Loveless, Co-CEO and Managing Partner, Slone PartnersDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

One of biopharma's most memorable bidding wars finally came to an end on Friday—with Metsera right back in the arms of its original suitor, but with Pfizer paying around $10 billion for the rights to the obesity biotech, a nearly $3 billion increase over its original bid. But while Novo Nordisk may have bowed out of that race, the company still made headlines this past week, with CEO Maziar Mike Doustdar joining Eli Lilly head David Ricks at the White House on Thursday to announce a deal that will see their GLP-1 drugs offered at about $350 per month.   This marks a significant discount to the current list prices of $1086 and $1350 for Lilly's obesity drug Zepbound and Novo's comparator Wegovy, respectively. No matter how low they go, however, the GLP-1 leaders can still be undercut by compounders, Steven Grossman, policy and regulatory consultant and author of the FDA Matters blog, told BioSpace this week.   Speaking of Lilly, the Indianapolis-based pharma had a busy week, reporting 20% weight loss in a mid-stage study of its amylin agonist eloralintide that William Blair analysts said “validates [the] amylin agonist class.” Lilly also netted two new partners, inking a $1.2 billion RNAi pact with SangeneBio to target metabolic diseases and licensing a genetic eye disease therapy from MeiraGTx Holdings for up to $475 million.   On the regulatory front, the FDA awarded the second round of priority review vouchers under its new Commissioner's National Priority Vouchers program. Unlike the first cohort of vouchers, which was announced in October, this group mostly consisted of products already on the market—with the exception of Lilly's orforglipron.   Finally, BioSpace dives into one the hottest trends in the immunology and inflammation (I&I) space—pipeline-in-a-product. Possibly motivated by blockbuster drugs like AbbVie's Skyrizi and Rinvoq and Regeneron and Sanofi's Dupixent, companies are optimizing shots on multiple goals in this lucrative space.  

This conversation features insights from Oliver Eden, senior business unit director at Jabil, and Travis Webb, chief scientific officer at PII. Our guests continue their discussion on how autoinjectors and smart technologies can be integrated into clinical trials in a way that isn't problematic or burdensome for patients, particularly for patients that may not be tech savvy. They discuss that by focusing on patient experience, clinical trials can increase engagement and compliance.This episode is presented in partnership with ⁠PII⁠.Host⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestsOliver Eden, Senior Business Unit Director, JabilTravis Webb, Chief Scientific Officer, PIIDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Many of the top stories of 2025 are currently being written. We're on the edge of our keyboards, watching and waiting as Pfizer and Novo Nordisk duke it out over the right to acquire glittery obesity startup Metsera. In the latest development, Pfizer raised its original bid of around $7.27 billion to about $8.1 billion on Monday—only to be usurped again by the indefatigable Novo, which upped its own bid to a cool $10 billion.  Meanwhile, the unprecedented drama in the uppermost ranks of the FDA—another top story of 2025—continues as CDER Director George Tidmarsh exits the agency. Tidmarsh reportedly resigned Sunday after being placed on administrative leave amid an investigation into his “personal conduct” at the agency. On Monday, however, Tidmarsh told Endpoints News that he was “second-guessing” his decision.  Speaking of the FDA, the regulator appears to have done its own 180—on uniQure's investigational gene therapy for Huntington's disease, three-year data from which sent the biotech's stock into the stratosphere just five weeks ago. Despite previous agreements on protocols and statistical analyses, the agency “no longer agrees” that Phase I/II data for AMT-130 are adequate to provide primary evidence for the application, uniQure said, throwing the timeline for the BLA into question.  Another gene therapy player, Sarepta Therapeutics, took a hit this week, as two of its Duchenne muscular dystrophy drugs, Vyondys 53 and Amondys 45, failed a confirmatory trial. Sarepta still plans to file for full approval of the two exon-skipping therapies, however, based on what it called “encouraging trends” in efficacy. Finally, on the genetic medicine front, CBER director Vinay Prasad teased an upcoming paper that will detail the regulator's thinking and a new approach to gene editing approvals.  On top of all that, Q3 earnings continue to roll in, with Pfizer, Eli Lilly, Vertex, Bristol Myers Squibb, AbbVie, and more reporting results.  One more thing: Have you ever wanted to know more about the inner workings of the Biogen-Eisai Alzheimer's partnership? Check out this profile on BioSpace 40 under 40 honoree Neena Bitritto-Garg, Eisai alum and current CEO of Ensho Therapeutics. 

In this episode of Denatured, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney discuss how China, historically focused on manufacturing, is increasingly becoming an innovation leader, particularly in pharmaceuticals. Ultimately, balanced strategies involve domestic capacity investments coupled with global collaboration.This episode is presented in partnership with Element Materials Technology.HostsJennifer Smith-Parker, Director of Insights, BioSpaceLori Ellis, Head of Insights, BioSpaceGuestsDr. Jihye Jang-Lee, Director of Technical Services, Element Materials TechnologyDr. Khanh Courtney, Biologics Technical Strategy Manager, Element Materials TechnologyDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Novartis started the week early with a Sunday afternoon announcement of the acquisition of neuromuscular drug developer Avidity Biosciences for $12B. That's the second biggest buy of the year after Johnson & Johnson's January acquisition of Intra-Cellular. The Avidity buy could read through positively to Dyne Therapeutics, as both are aiming to treat neuromuscular ailments with RNA-targeting therapies. Dyne shares have nearly doubled over the past month, jumping approximately 40% after Novartis' news dropped.  The Avidity deal is the latest in an uptick on the pharma M&A front. Also this week, Eli Lilly doubled down on gene therapy with a pick up of Adverum Biotechnologies and its lead program for wet age-related macular degeneration. And Roche, which last month acquired 89bio in a $3.5 billion deal centered on a MASH candidate, said in its third-quarter earnings call on Thursday that more deals could be in the future. Finally, beyond the big guys, Leerink Partners predicts which small- to mid-cap firms might also be on the hunt for new pipeline goodies.  Following the dealmaking news, Novartis held its earning call on Tuesday. CEO Vas Narasimhan downplayed the deals Pfizer, AstraZeneca and Amgen have made with the White House, saying they don't address the root of the drug pricing problem President Donald Trump hopes to solve.   On other earnings calls, BioMarin announced plans to divest the hemophilia gene therapy Roctavian. Regeneron faced further questions about Eylea and issues with the Catalent plant that's been tripping up its regulatory applications. But the company didn't address last week's news that it was dropping a CAR T asset picked up from 2seventy bio. These are but two of the latest examples of underperforming assets in the cell and gene therapy space.  BridgeBio had positive news for patients with limb-girdle muscular dystrophy this week after acing a Phase III trial for an investigational substrate supplementation therapy. Analysts predict the asset could be before the FDA later this year or early next.   Finally, with the U.S. government shutdown going on a month, BioSpace takes a look at how the FDA is operating. 

In this episode of Denatured, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney how in light of economic uncertainty, small biotechs can turn to international harmonization standards as a stable template. U.S. tariffs are redefining competitiveness in manufacturing nations like India, China, and other parts of Asia, with China emerging as a global innovator.This episode is presented in partnership with Element Materials Technology.HostsJennifer Smith-Parker, Director of Insights, BioSpaceLori Ellis, Head of Insights, BioSpaceGuestsDr. Jihye Jang-Lee, Director of Technical Services, Element Materials TechnologyDr. Khanh Courtney, Biologics Technical Strategy Manager, Element Materials TechnologyDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Novo Nordisk dominated the news cycle this week, with more leadership changes as the Novo Foundation replaced the company's board, which will now be headed by former CEO Lars Rebien Sørensen. Meanwhile, President Donald Trump promised last week that Novo's Ozempic will cost about $150 when he and Centers for Medicare & Medicaid Services Administrator Mehmet Oz are done negotiating, though Oz clarified that said negotiations have not yet begun. Over in Berlin, the 2025 European Society for Medical Oncology featured presentations from Akeso and Summit Therapeutics on PD-1/VEGF inhibitor ivonescimab in first linenon-small cell lung cancer (NSCLC) and Exelixis' oralkinase inhibitor zanzalintini in colorectal cancer. In addition to reporting that ivonescimab “significantly improved” progression-free survival in first-line NSCLC, Summit said on a Q3 call Monday that it would submit a regulatory application with the FDA for the drug in second-line EGFR-mutatedNSCLC. In other cancer news, shares of Replimune soared after the FDA accepted its resubmitted biologics license applicationfor RP1 in advanced melanoma, nearly three months after its July rejection. Also on the regulatory front, the FDA named the first nine recipients of its Commissioner's National Priority Voucherprogram. Winners of the expedited review vouchers include Regeneron, Disc Medicine and Sanofi. The FDA agency also awarded its second-ever platform designation to Krystal Biotech—after granting the first such designation to Sarepta Therapeutics earlier this year for its AAV vector andthen rescinding it after the platform was linked to multiple deaths. Finally, Sandra Retzky, formerly director of the FDA's Office of Orphan Products Development, joins the lengthy leadership exodus at the agency this year. In BioPharm Executive, BioSpace look at how Johnson & Johnson weathered the erosion of its cornerstone drug Stelara. And is hair loss the new weight loss? Two biopharma companies—Veradermics and Pelage Pharmaceuticals—reeled in large financing rounds for their respective hair loss/regrowth programs. They're part of an uptick in mega rounds of late, butexperts say it's not a full biotech comeback just yet.

In this episode of Denatured, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney will explore how healthcare and pharmaceutical players — from hospitals and universities to manufacturers and investors — are rethinking their strategies amid global supply chain disruption.The conversation highlights both immediate operational responses and long-term structural shifts shaping a more resilient, agile, and locally grounded ecosystem, especially in light of U.S. tariffs.This episode is presented in partnership with Element Materials Technology.HostsJennifer Smith-Parker, Director of Insights, BioSpaceLori Ellis, Head of Insights, BioSpaceGuestsDr. Jihye Jang-Lee, Director of Technical Services, Element Materials TechnologyDr. Khanh Courtney, Biologics Technical Strategy Manager, Element Materials TechnologyDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

This episode continues the discussion with Oliver Eden, senior business unit director at Jabil, and Travis Webb, chief scientific officer at PII, as they dive into the nuance, challenges and opportunities of autoinjectors and combination drug delivery systems.In this conversation they focus on supporting decentralized clinical studies and how connected technology can improve patient compliance, trust and cleaner data processing.This episode is presented in partnership with ⁠PII⁠.Host⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestsOliver Eden, Senior Business Unit Director, JabilTravis Webb, Chief Scientific Officer, PIIDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Johnson & Johnson kicked off Q3 earnings season on Tuesday with the announcement that it is splitting its orthopedics and medtech operations and that it has yet to reach a drug pricing deal with the White House, though CEO Joaquin Duato did say those discussions are ongoing.  In advance of its Nov. 5 earnings call, Novo Nordisk, under the direction of new CEO Maziar Mike Doustdar, has been busy making moves, doubling down on MASH last week with its $5.2 billion buy of Akero. Then this week, Novo became the latest company to cut cell therapy, following Takeda's recent exit from the space. Meanwhile, as the government shutdown continues, so too does the chaos at the CDC, where more than 1,000 employees received termination notices last Friday—only for hundreds to be told never mind. At the FDA, however, there is some consistency despite the overhaul, with the agency on track for an average number of approvals this year. And a recent report on breakthrough designations shows that the regulatory award often leads to an FDA greenlight. On the legislative front, the BIOSECURE Act is back, as a slimmed down version passed the Senate last week as part of the defense spending bill. The latest version of BIOSECURE, which is meant to distance American biopharma from Chinese collaborators, doesn't name specific companies as previous iterations did and must still gain the Senate's support. 

In this discussion, BioSpace's vice president of marketing ⁠⁠Chantal Dresner⁠⁠ and careers editor ⁠⁠Angela Gabriel⁠⁠ take a look at job market performance in the second quarter of 2025.They discuss biotech and pharma job posting trends, wider U.S. employment data, the new $100,000 H-1B visa fees and more.Want to receive our latest quarterly job market reports as soon as they're published? ⁠⁠Subscribe⁠⁠ to Career Insider for our job market updates, job trends, career advice and more.

The U.S. government is now in its second week of a shutdown—with the FDA having paused acceptance of all new drug applications for the duration. But it was business as usual at the CDC, which adopted the recent recommendations of its newly revamped advisory committee on chickenpox and COVID-19 vaccines. And another senior leader, National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, was fired last week, after filing a whistleblower report.  Across the country, cell and gene therapy leaders arrived in Phoenix for the annual Meeting on the Mesa, as the space remains in a state of flux—with regulatory and M&A momentum being stalled by commercial and market challenges. Takeda, for one, is looking to offload its cell therapy platform after years of hefty investment.  President Donald Trump's long-awaited tariffs did not hit on Oct. 1 as promised. But in the face of the looming levies, Pfizer signed a drug pricing deal with the White House that provides a three-year exemption. Amgen appears to be climbing onboard as well, announcing that its lipid-lowering drug Repatha will be available at a steep discount. These moves are all well and good for Big Pharma players, but a recent report from CRB reveals most smaller biopharma companies are not planning any investments to offset tariffs.  In our weekly weight loss segment, Skye Bioscience's cannabinoid receptor 1-targeting candidate nimacimab failed to outpace placebo in reducing body weight but elicited “intriguing synergy” in combination with Novo Nordisk's Wegovy, according to William Blair analysts. And regulatory documents shed further light on Pfizer's $4.9 billion takeover of Metsera, in which the New York pharma beat out two higher bidders for the promising obesity startup.  Finally, make sure to check out The 5 Most Powerful Women in Biopharma and BioSpace's inaugural 40 Under 40, highlighting 40 young leaders who have made an impact on the biopharma industry.  

Clinical trials can present many challenges for patients–particularly injections.Oliver Eden, senior business unit director at Jabil, and Travis Webb, chief scientific officer at PII, discuss nuance, challenges and opportunities of autoinjectors and combination drug delivery systems.Additionally, they advocate that drug delivery systems enter the conversation earlier in clinical development stages given interdependencies. This episode is presented in partnership with PII.Host⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestsOliver Eden, Senior Business Unit Director, JabilTravis Webb, Chief Scientific Officer, PIIDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Genmab closed out a busy third quarter for M&A in biopharma, picking up cancer biotech Merus for $8 billion. This deal—the year's fifth largest—came just a week after Pfizer acquired rising obesity star Metsera for $4.9 billion. Just seven days later, Metsera made the New York–based pharma look like a genius with mid-stage data for one of the deal's centerpiece therapies, MET-097i, showing 14% placebo-adjusted weight loss over 28 weeks.After months of tarrying and threats, President Donald Trump announced last week that 100% tariffs would take effect Oct. 1—with broad exceptions for companies that have taken steps to build out their domestic manufacturing footprints. One company that has answered that call—as well as a letter sent by the president to 17 of the largest pharma companies requesting action on his most-favored-nation drug pricing policy—is Pfizer. In a joint oval office announcement with Pfizer CEO Albert Bourla and HHS officials, Trump said Pfizer would offer all new medicines at MFN prices.Meanwhile, over at the FDA, CDER Director George Tidmarsh, who has flown relatively under the radar since taking the post in July, took to LinkedIn to address the subject of relying on surrogate endpoints in drug approvals. In a since deleted post, Tidmarsh called out Aurinia Pharmaceuticals' lupus drug as an “egregious” example of this phenomenon. CDER's sister agency, CBER, also made a splash last week, publishing three draft recommendations intended to accelerate the development of cell and gene therapies.Speaking of CGT, maybe the biggest clinical development news of the year emerged from this space last week when uniQure announced that its gene therapy for Huntington's disease, AMT-130, slowed disease progression by 75% after three years. With these data in hand, uniQure plans to file for FDA approval of the treatment in the first quarter of 2026. If successful, AMT-130 would be the first genetic therapy for the intractable neurodegenerative disease.Finally, biopharma's glass ceiling just got a little more tightly sealed. Emma Walmsley, the industry's first female CEO, is stepping down after nine years at GSK, handing the reins to current chief commercial officer, Luke Miels. When Walmsley officially departs on Dec. 31, she will leave Vertex CEO Reshma Kewalramani and incoming Takeda CEO Julie Kim to represent the sisterhood at the highest ranks of the biopharma industry.

The FDA is working to reapprove GSK's long-dormant drug Wellcovorin (leucovorin) for cerebral folate deficiency, which the agency linked to “developmental delays with autistic features.” This immediately followed a much-anticipated press conference in which President Donald Trump, flanked by Health Secretary Robert F. Kennedy Jr and other healthcare administrators, linked the use of Tylenol during pregnancy to rising rates of autism.  Meanwhile, Pfizer woke us all up Monday with the news that it had acquired breakout obesity rockstar Metsera for $4.9B. The deal should pump new life into Pfizer's portfolio, which over the last two years has suffered three discontinued assets. Bite-sized deals—or those at or below the $5 billion mark—have defined biopharma recently, with Roche picking up metabolic dysfunction-associated steatohepatitis biotech 89bio for a potential $3.5 billion last week and Novartis putting another $5.7 billion on the line with partner Monte Rosa Therapeutics in a second molecular glue agreement.  Another therapeutic space primed for M&A action is psychedelics. After AbbVie bought Gilgamesh Pharmaceuticals' lead depression asset for $1.2B last month, BioSpace spoke sought opinions from experts on who might be next to take the plunge. A few potential names included Eli Lilly, Bristol Myers Squibb and Merck.  On the policy front, the CDC's revamped vaccine advisory committee convened for their first meeting to discuss COVID-19, MMRV and hepatitis B vaccine schedules. Industry watchers who spoke to BioSpace commented on the “lack of knowledge” and dearth of previous experience on the committee. And while the advisors ultimately voted to change the schedule for the MMRV vaccine, it appears unlikely to significantly affect manufacturers' bottom lines. Finally, in rare disease, Stealth BioTherapeutics secured its long-sought approval for elamipretide—now Forzinity—in Barth syndrome—a disorder that would fall under the purview of the FDA's new Rare Disease Evidence Principles framework for ultra rare diseases affecting less than 1,000 people in the U.S. And we said “Bye Bye Bluebird,” as the famed gene therapy biotech—which was recently bought out by two private equity firms—returned to its original moniker, Genetix Biotherapeutics.  Lastly, make sure to sign up for Biopharm Executive here for access to a special deep dive into China biopharma.  

In this episode, Lori Ellis and Colin Zick spend a little time further discussing some of the points brought up in the Bioprocessing Summit last month. AI is a tool, a powerful one but a tool. Understanding this, they explore the connections between hammers, AI, The Planet of the Apes and monoliths.In the end, it is all about compliance.Host⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestColin Zick, Partner, Foley Hoag LLP Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

A global shift may be underway in biopharma as the White House prepares legislation that would would place restrictions on drugs brought to the U.S. from China, and pharma companies exit the U.K. in droves. President Donald Trump is reportedly writing an executive order that would clamp down on the pharmaceutical industry's ability to buy new molecules from biotechs based in China, while Sanofi, Merck and more have canceled or suspended investments in the U.K. following a sizeable increase in a mandatory levy in the region. In other business news, Novo Nordisk's newly appointed CEO Maziar Mike Doustdar hit the ground running, cutting around 9,000 employees and informing those who remained that they would need to return to the office. Novo's headcount had climbed 81% in five years as its revenue soared—and then fell. The obesity juggernaut has been a key presence at the European Association for the Study of Diabetes' annual meeting this week, announcing that it would seek FDA approval for a high-dose formulation of Wegovy, and presenting new data for long-acting amylin analog cagrilintide. Meanwhile, Reuters reported that Eli Lilly's orforglipron could potentially qualify for the FDA's recently launched Commissioner's Priority Voucher, which could see the oral obesity candidate approved this year.  The gene therapy space was hit with more bad news as Capsida Biotherapeutics reported the death of a patient being treated with its investigational gene therapy for epileptic disorders. This follows an unfortunate trend in 2025 that has also seen deaths attributed to Sarepta's approved Duchenne muscular dystrophy gene therapy Elevidys and a monoclonal antibody used for lymphodepletion in a study of Allogene's CAR T cell therapy cema-cell. According to a new analyst survey, however, doctors are still prescribing Elevidys to ambulatory patients.  Meanwhile, on the regulatory front, FDA Center for Drug Evaluation and Research Director George Tidmarsh reportedly told two separate groups last week that he “would like to get away” from advisory committee meetings, but quickly appeared to walk the comments back in a statement to Endpoints News.  Finally, in BioPharm Executive, BioSpace takes a deep dive into the FDA's new crackdown on pharmaceutical drug ads, and spotlights Akeso CEO Michelle Xia who built the biotech from a $3 million angel fundraising round to its current $15 billion valuation.  

The Make America Healthy Again Commission released itssecond report Tuesday, recommending, among other efforts, an investigation into a possible link between vaccines and the uptick in chronic disease. At a livestreamed MAHA commission meeting, Health Secretary Robert F. Kennedy painted a dire picture of the country's health, saying the U.S. now has “the highest chronic disease burden of any country in the world.” Looking back to last week, all eyes were on HealthSecretary Robert F. Kennedy Jr.'s appearance before the Senate Finance Committee. The combative showdown amounted to little more than political theater, according to industry watchers, with Kennedy accusing former CDC Director Susan Monarez of lying in an op-ed published in the Wall Street Journal about his alleged request that she approve vaccine advisors' recommendations in advance of their meeting later this month.Over at the FDA, BioSpace combed through the latest cache of publicized complete response letters (CRLs), including one for Lykos' MDMA-based therapeutic for post-traumatic stress disorder. Going forward, the agency has promised to release CRLs in real time. The greater transparency could help companies spinning on a carousel of confusion caused by all the recent regulatory change. In other FDA news, we take a deep dive into new expert panels, which some commentators view as one-sided, and into the new rare disease approval framework, which one critic called “all wrapper and no gift.” And in the weight loss space, the FDA debuted a consumer “green list” for GLP-1 ingredients. Meanwhile, at the World Conference on Lung Cancer inBarcelona, several data readouts caught our attention. In particular, Summit Therapeutics released disappointing data for its PD-L1/VEGFa bispecific antibody ivonescimab in Western populations—a finding some analysts said could have readthroughs to Bristol Myers Squibb/BioNTech's first ever global data readout for its L1/VEGFa bispecific.Finally, in Biopharm Executive this week, check out features on contingent value rights, which have been getting tacked on to biopharma deals more and more, Amgen's pipeline beyond the obesity drug MariTide and Novartis' recent deal spree, which included the $1.4B acquisition of Tourmaline on Tuesday.

In this episode, Mike Garrett, CEO of Taconic Biosciences, discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment. He explains that investors now demand more robust translational data showing real potential to impact human health, rather than just basic in vitro results, forcing researchers to generate better evidence packages earlier in development.This episode is presented in partnership with ⁠⁠Taconic Biosciences.Host⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestMike Garret, CEO, Taconic BiosciencesDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

We returned from the Labor Day holiday to a spate of intriguing deals, including two that could surpass $2 billion: Vertex's new pact with Enlaza for autoimmune disease—which the Casgevy maker hopes could ease conditioning for the sickle cell/beta thalassemia gene therapy—and Novartis' agreement with Arrowhead for neurodegenerative diseases such as Parkinson's.  But as we look ahead, Thursday's Senate Finance Committee will be the focus this week, as Health and Human Services Secretary Robert F. Kennedy Jr. will answer questions after the ousting of CDC Director Susan Monarez. Her departure is reportedly linked to changes to the regulation of COVID-19 vaccines, for which the FDA last week issued restricted approvals to Moderna, Pfizer/BioNTech and Novavax and rescinded the emergency use authorizations. The next ACIP meeting—where COVID-19 vaccines will be on the agenda—is set for Sept. 18 and 19.   In the weight loss arena, Novo Nordisk presented results from a real-world study this weekend at the European Society of Cardiology Congress in Madrid showing that Wegovy cut the risk of heart attack, stroke or death by 57% compared to Eli Lilly's tirzepatide in people with obesity and cardiovascular disease. The company also continues to throw money into the space, last week inking a $550 million deal with Replicate for RNA-based treatments for obesity and diabetes. Meanwhile, Lilly is dropping studies of one oral obesity candidate as another nears a regulatory filing. Finally, the FDA greenlit the first GLP-1 generic for obesity.   We also discuss reactions to the FDA's new guidance on radiopharma drug development, four recent approvals for rare diseases, and everything you ever wanted to know about SPACs. 

Eli Lilly posted data Tuesday from a second Phase III trial of its oral weight loss therapy orforglipron, providing the company with all it needs to head to the FDA with a new drug application. For more in-depth discussion on the oral weight-loss space, check out a special episode of The Weekly. And stay tuned to BioSpace for more unique coverage of this market as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland. On the business side of biopharma, AbbVie turned back to neuropsychiatric therapies this week, acquiring partner Gilgamesh Pharmaceuticals' lead depression candidate for $1.2 billion. The deal is a display of resilience for AbbVie in the neuropsychiatric space as well, after the stunning failure last November of schizophrenia asset emraclidine—picked up in its nearly $9 billion acquisition of Cerevel Therapeutics. And is the cooler late summer weather thawing the IPO market? Neuropsych-focused LB Pharma revealed in an SEC filing on Friday that it plans to take the plunge, ending a six-month stalemate in biotech IPOs.  Finally, the Department of Health and Human Services (HHS) has been busy this past week. On Monday, the CDC named Retsef Levi—a known vaccine critic—to head the agency's COVID-19 immunization working group, just as reports surfaced that the Trump administration could be “within months” of banning the COVID-19 vaccine in the U.S. Meanwhile, the FDA issued new draft guidance for cancer drug developers that prioritizes the use of survival data, and the agency began publishing drug-related adverse event reports daily.   HHS itself has also been the subject of recent headlines, announcing that it will no longer recognize employee unions, and last week, hundreds of HHS staffers penned an open letter calling on Secretary Kennedy to tone down what they called “dangerous and deceitful statements” that have fostered distrust against federal health workers, exposing them to physical harm. This followed the Aug. 8 shooting at CDC headquarters in Atlanta.   Finally, multinational pharmaceutical companies spent more than $48 billion on partnerships with China in the first half of 2025 alone, according to a new report from IQVIA—more than in all of 2024.  

Oral therapies are projected to account for 25% of the anti-obesity medication market by 2030—but first returns have largely disappointed. This month, shares of both Eli Lilly and Viking Therapeutics took a hit as investors reacted negatively to highly anticipated Phase III and Phase II results for their respective candidates.While the 9.1% placebo-adjusted weight loss generated by Lilly's orforglipron over 72 weeks was an efficacy miss by most analyst accounts, tolerability tripped up oral VK2735's otherwise best-case efficacy scenario—10.9% weight loss after just 13 weeks. These murky results have left observers wondering, just how game-changing these pills will be and which ones will be most effective?In such a hot space, Lilly's and Viking's results—which follow Novo Nordisk's new drug application for an oral form of Wegovy in May—are only the tip of the iceberg. Stay tuned to BioSpace for further in-depth coverage of the space as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland.

While AI represents a significant advancement in efficiency for early-stage drug discovery, it won't dramatically change the 90% clinical trial failure rate. Most failures stem from fundamental gaps in biological understanding rather then the processes where AI is able to have the most impact.The discussion highlights AI's strengths and ability to reduce preclinical costs. However, they caution that AI faces significant limitations in predicting complex biological properties like toxicity due to insufficient data, and regulatory acceptance of AI-only safety assessments remains unlikely, meaning traditional clinical trials will continue to be necessary.This episode is presented in partnership with ⁠Cresset⁠.Host⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuests⁠Mutlu Dogruel⁠, VP of AI, Cresset⁠Mark Mackey⁠, CSO, CressetDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Three months after taking heat over an error-riddled first report, Health Secretary Robert F. Kennedy's Make America Healthy Again Commission was due to submit a new strategy report to President Donald Trump last week. While the report is delayed—for disputed reasons— Politico obtained a draft copy, which homes in on creating a new vaccine framework and streamlining access to investigational drugs, specifically for children. The new strategy also touches on pharma lobbying, with plans to address alleged conflicts of interest within HHS—which, incidentally, a new JAMA study found have dropped dramatically over the past 25 years. In other HHS news, Kennedy is reviving the Task Force on Safer Childhood Vaccines—which has been dormant for 30 years, and the secretary voiced his support of mRNA vaccines for cancer.   Meanwhile, weight loss continues to coral the headlines. Viking Therapeutics reported greater than 12% weight loss after 13 weeks for its obesity pill VK2735, but tolerability tanked the biotech's stock. As Viking, Eli Lilly and Novo Nordisk begin to report data from these oral options, manufacturing comes into focus, and Novo's pending approval of an oral form of Wegovy specifically puts the spotlight on the variability of high-dose peptides.  Speaking of Novo, the Danish pharma appears to be sucking in some oxygen after a difficult run. Last week, the FDA approved Wegovy as just the second drug for metabolic dysfunction-associated steatohepatitis (MASH), and on Monday, Novo teamed up with GoodRx to offer Wegovy and Ozempic and $499 per month if patients skip insurance. Not to be outdone, fellow weight loss warrior Lilly announced a $1.3 billion partnership with AI/ML startup Superluminal Medicines to advance new small molecules for cardiometabolic diseases and obesity. Lilly has also been active on the policy front, saying that it will soon announce higher prices for its drugs in markets like Europe in an effort to “align prices across developed countries.”  Always a contentious topic, pricing plays a key role in why the pharmaceutical industry fails to command the same respect as steelworkers or other all-American pursuits. Also in BioPharm Executive this week, BioSpace takes a deep dive into how the Trump administration is using Most Favored Nation pricing to target pharma companies and pursue a broader trade war.  

In this Denatured discussion, the conversation revolves around unpacking the patent policy changes that could make or break biotech companies. Guests Aaron Cummings and Anne Li of Brownstein Hyatt Farber Schreck highlight critical issues posed by the Patent Office including recent changes to the Inter Partes Review (IPR) such as discretionary denial and a proposed patent property tax.Cummings and Li also discuss how biopharma can work with the administration as changes are being proposed and evaluated and stress the importance of individual advocacy and engagement.Host⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestsAaron CummingsAnne Elise Herold Li, Shareholder, Brownstein Hyatt Farber SchreckDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Vinay Prasad is back at the FDA as chief of the FDA's Center for Biologics Evaluation and Research. Prasad's return—which hit the news wires Saturday morning—came just 10 days after his unexpected exit on July 29, following blowback over the saga involving Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy Elevidys, and a campaign by conversative personalities to oust the outspoken physician.Elsewhere in the government, Gray Delany, former head of HHS' and President Donald Trump's Make America Healthy Again agenda, has been fired—days after Health and Human Services Secretary Robert F. Kennedy Jr. axed 22 mRNA vaccine contracts under the Biomedical Advanced Research and Development Authority. Delany's ouster came after he allegedly butted heads with other agency officials over how announcements were made, according to reporting from Endpoints News. The mRNA contract cuts, meanwhile, have sparked criticism from the scientific community and concern that the growing anti-mRNA sentiment could also have a negative effect on research for cancer therapeutics.In somewhat related news, the Annals of Internal Medicine is refusing to retract a large-scale study it ran in July that pointed to the lack of an association between childhood aluminum exposure through vaccination and chronic conditions, despite Kennedy's criticism. In an op-ed published earlier this month, the Health Secretary took issue with the study's design.In obesity news, biopharma darling Eli Lilly suffered a rare chink in its normally impenetrable GLP-1 armor. The first Phase III trial for oral weight loss therapy orforglipron read out last week, and the results were underwhelming, at least to Wall Street. Truist Securities wrote that the data support approval but “leaves room for competition.” This is good news for a whole host of companies, including Roche, Viking, Terns and Rhythm Pharmaceuticals, who all have weight loss pills at various stages of development.And in gene therapy, the hits just keep coming. The FDA has limited the use of bluebird bio's gene therapy Skysona to patients with cerebral adrenoleukodystrophy for whom no other therapies or stem cell donors are available, due to a heightened risk of blood cancers. This follows safety issues in gene therapy trials experienced by Allogene, and, of course, Sarepta Therapeutics. This week in ClinicaSpace, Dan Samorodnitsky explored the future of AAV technology. And in BioPharm Executive, Annalee Armstrong sat down with Chris Anzalone, CEO of Arrowhead Pharmaceuticals—Sarepta's key strategic partner—to learn how his company has been weathering the storm.

In this thought-provoking episode, Cresset Group's CSO, Mark Mackey, and VP of AI, Mutlu Dogruel, dissect the emerging geopolitical battle for AI supremacy, revealing how China's DeepSeek model fundamentally disrupted the AI landscape by achieving GPT-4 level performance for just $6 million versus OpenAI's reported $100+ million investment. The discussion exposes a critical divide in global AI governance: Europe's "regulatory fortress" approach with the AI Act creates strict but vague rules that leave companies navigating a complex maze, while the US employs a "Wild West" philosophy of sector-specific oversight and red-teaming strategies. In the race for global AI dominance, China is leaping ahead of the US and the EU.This episode is presented in partnership with Cresset.Host⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestsMutlu Dogruel, VP of AI, CressetMark Mackey, CSO, CressetDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.