Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according to the FDA’s outside experts.
In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The designation, granted last month, was the first of its kind to be announced publicly.
Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for DLBCL in a U.S. population, according to the FDA.
The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a stop to all shipments of the Duchenne muscular dystrophy therapy Elevidys following a third patient death linked to the underlying platform.
Despite the failure, BMS remains “encouraged” by Reblozyl’s clinical activity in myelofibrosis-associated anemia and will approach regulators to discuss potential submissions for this indication, for which few treatment options exist.
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.
FEATURED STORIES
Eli Lilly topped the list of the 20 biggest pharmas by market cap with a more than 39% improvement year-to-date in its share price. Other companies have not been so lucky.
Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.
Sage Therapeutics discontinued development of its lead candidate dalzanemdor after a third clinical failure, leading analysts to question the biotech’s future profitability.
ADC Therapeutics, Sutro Biopharma and Zai Lab are among those developing antibody-drug conjugates to address payload and toxicity challenges of current ADCs—and rapidly grow the multibillion-dollar market.
With two decisions originally scheduled for this week already announced, including BridgeBio’s approval in ATTR-CM, the regulator has just one PDUFA on its plate this holiday week.
RFK Jr. as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has withdrawn as nominee for Attorney General. With Dr. Oz tapped to lead CMS and maybe Marty Makary at the FDA, it’s going to be quite the show.
LATEST PODCASTS
This week, Lori, Greg and Tyler discuss the first surge of IPO activity this year plus gene therapy pricing,
The team comes together to discuss the dominant themes of what was an incredibly busy week of events in San Francisco during JPM 2024.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from Day 3 at JPM2024.
Job Trends
Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).
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SPECIAL EDITIONS
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
DEALS
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The Swiss contract manufacturer’s cash deal for Roche’s facility in Vacaville, California, is one of the world’s largest manufacturing sites for biologics—a major growth driver for Lonza and other CDMOs. -
Continuing 2024’s biotech initial public offering rally, Boundless Bio will debut Thursday on the Nasdaq with the proceeds used to advance its pipeline of extrachromosomal DNA cancer assets. -
Big Pharma’s appetite for safe and effective oral IBD drugs with novel mechanisms of action continues to grow, with my former company just the latest in a string of acquisitions in the space. -
Monday’s announced buyout of Virginia-based Landos Biopharma adds a mid-stage, oral NLRX1 agonist for ulcerative colitis and Crohn’s disease to AbbVie’s growing portfolio. -
Just weeks after Wegovy won FDA approval for cardiovascular disease, Novo Nordisk has bought mid-stage biotech Cardior Pharmaceuticals and its miRNA-targeting candidate for heart failure.
WEIGHT LOSS
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Siding With Novo and Lilly, Court Agrees to First Tackle ‘Cross Cutting Issues’ in GLP-1 LitigationsIn agreeing with Novo Nordisk and Eli Lilly, Pennsylvania judge Karen Spencer Marston said the court should first settle questions of gastroparesis diagnosis and sufficient warnings for side effects. -
Through its online pharmacy LillyDirect, Eli Lilly announced Tuesday it will allow patients to purchase single-dose vials of Zepbound—without the autoinjector—at a 50% discount or more versus other incretin obesity treatments. -
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them. -
Patients taking Novo Nordisk’s blockbuster GLP-1 drug appear to be more likely to harbor thoughts of suicide or self-harm, especially if they are already suffering from anxiety or depressive disorders, according to a new study.
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Experts say Novo Nordisk and Eli Lilly’s GLP-1 drugs are unlikely to reach more countries in the near term, but Sanofi’s diabetes treatment has gained ground globally.
POLICY
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The postponed ACIP meeting comes barely a week after Robert F. Kennedy, Jr. was confirmed as Secretary of Health and Human Services, despite controversy regarding his anti-vaccine history. -
Morale is low at the FDA, which was hit with layoffs this week following RFK Jr.’s confirmation. Biopharma leaders and agency insiders fear further workforce cuts could delay new medicines. -
Despite expectations of dealmaking leniency, new FTC chairman Andrew Ferguson told staff that he will retain the current 2023 FTC and DOJ guidelines on mergers, upholding stricter anti-trust scrutiny on deals. -
Recently appointed HHS Secretary Robert F. Kennedy Jr. in 2018 helped bring several cases against vaccine maker Merck, alleging injury linked to its HPV shot Gardasil. -
The hammer came down on an unspecified number of FDA employees this weekend, days after Robert F. Kennedy Jr. was confirmed as HHS Secretary.
Why are adaptive leaders so useful? And is adaptive leadership a quality that will benefit your life sciences career? Let’s explore this concept and find out.
Regardless of the field that you work in, mentioning top skills in your resume is a crucial step. Here are some tips to prepare the best leadership skills resume.
While you’re starting your job search and before you go into any interviews, think about how you want to talk about your job loss.
Reasons for investing in leadership development program in the biotech industry are divided into need and opportunity. Read the proper opportunity divisions here.
No matter in which industry you are, clear communication is very important. Follow these tips for clear communications to be prepared to fit in the work environment.
Virtual meetings might have enhanced the ways we connect with each other but it can be really hard to communicate with someone who doesn’t know the basic Zoom meeting etiquette.
HOTBEDS
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
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With $70 million upfront and more than $1.8 billion on the line, Roche will gain access to Flare’s drug discovery engine to bolster its oncology pipeline. -
Truist Securities analyst Asthika Goonewardene in an investor note said data for anito-cel—particularly its safety profile—will help differentiate the CAR T therapy from Legend Biotech and J&J’s entrenched Carvykti in relapsed and refractory multiple myeloma. -
In a tough fundraising space, cell therapy biotechs pursuing autoimmune indications review staffing to ensure the right expertise is in place to tackle the new disease area. -
Despite the PDUFA date being extended by three months for Merus’ zenocutuzumab, Truist Securities analyst Asthika Goonewardene in a Tuesday note to investors said the delay is not a cause for concern with an approval expected. -
Driven by the early approval of its updated COVID-19 vaccine, BioNTech far exceeded analysts’ expectations in the third quarter and reported its first quarterly profit in 2024. However, the German biotech also cut its outlook for the year.
NEUROSCIENCE
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BMO Capital Markets analyst Evan Seigerman said luvadaxistat’s inconsistencies between mid-stage trials raise questions about Neurocrine Biosciences’ developmental efforts moving forward. -
The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline. -
Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies. -
Days after Sanofi reported back-to-back failures for its BTK inhibitor, Roche’s fenebrutinib on Wednesday scored a mid-stage win in relapsing multiple sclerosis, demonstrating near-total elimination of disease activity. -
The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.
CELL AND GENE THERAPY
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While NK cell therapies can potentially avoid the serious side effects sometimes seen with CAR T cell therapies, experts say durability may stall their path to the market. -
BioSpace’s Lori Ellis discusses the risks and challenges of cell and gene therapy combination products with DIA speakers James Wabby, AbbVie and Rob Schulz, Suttons Creek, Inc. -
Belgian biotech Galapagos is teaming with Blood Centers of America to help deploy its decentralized CAR-T therapy manufacturing platform closer to treatment centers across the U.S. -
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma. -
While these technologies are now a therapeutic reality, the ASGCT 2024 annual meeting this week was a reminder of just how far we are from widespread use.
