The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying.
Many companies have foreshadowed deals to come during earnings calls in recent days. The return of M&A would be a welcome sign for the biopharma ecosystem, which has been battered by macro headwinds such as tariffs and the possibility of new drug pricing pressures.
Entrada is paring back its research staff even as it gears up to hire employees to support a planned clinical trial for a Duchenne muscular dystrophy candidate.
The American Association for Cancer Research’s annual conference featured updates from several companies on key candidates and assets, including Merck’s Keytruda and GSK’s Jemperli.
At the heart of the acquisition is Regulus’ farabursen, an miRNA-targeting oligonucleotide in early-stage development for rare autosomal dominant polycystic kidney disease.
GSK’s dealmaking will be “cautious and disciplined” under the current trade war, but the pharma will focus on looking for “opportunities created” amid these tensions, according to CEO Emma Walmsley. The company also reported a 4% earnings bump for the quarter.
It’s been a fraught road for the proposed merger between Acelyrin and Alumis, with Tang Capital’s Concentra Biosciences in February threatening to upend the deal with a proposed $3-per-share acquisition of Acelyrin.
FEATURED STORIES
Researchers in pharma and beyond have historically glommed onto a limited number of disease targets, limiting innovation. AI could change that.
Akero Therapeutics, 89bio, Boston Pharmaceuticals and more are working to bring novel treatment options for metabolic dysfunction-associated steatohepatitis to a market that could reach $16 billion by 2033.
While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh discuss how a slow and steady pace is a continuation of the pattern we have seen throughout the last three years.
Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona.
BridgeBio’s Attruby wins approval for transthyretin amyloid cardiomyopathy while the FDA accepts Alnylam’s application for Amvuttra in the indication; Cassava’s controversial Alzheimer’s drug flunks Phase III; Amgen’s MariTide fails to impress investors, Donald Trump’s controversial nominations continue.
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SPECIAL EDITIONS
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
DEALS
  1. Roche has once again returned to China to bolster its antibody-drug conjugate pipeline, this time striking a licensing deal with Innovent for $1 billion in biobucks.
  2. High profile failures and long timeframes for revenue have shifted investment away from Phase I, as VCs seek to mitigate risk, Pitchbook said in its 2025 outlook.
  3. BioArctic received $100 million upfront with another $1.25 billion in potential milestone payments on the line for two pyroglutamate-amyloid-beta antibodies.
  4. Photys is eligible for up to $186 million from Novo Nordisk for its PHICS small molecules that pair a kinase to a disease-causing protein for phosphorylation.
  5. BioSpace Senior Editor Annalee Armstrong reflects on the year that was, and what’s to come in 2025.
WEIGHT LOSS
  1. IRA
    The U.S. Centers for Medicare and Medicaid Services has named Novo Nordisk’s Wegovy, Ozempic and Rybelsus as part of the second round of the IRA drug price negotiation program, even as the pharma challenges the program.
  2. Donald Trump continues to make waves in biopharma; Sage rejects Biogen’s unsolicited takeover offer; the obesity space sees more action with new company launches, IPOs and fresh data; and experts get ready for an important era in the Duchenne muscular dystrophy space.
  3. It’s been a rocky few months for BioAge Labs, which shuttered a Phase II trial of its lead candidate azelaprag Tuesday after the molecule caused liver-based side effects.
  4. Versant Ventures continues to invest in the increasingly competitive obesity space, this time launching Helicore with $65 million and a GIP-targeting asset intended to induce higher-quality weight loss.
  5. IPO
    The GLP-1 IPO arena has been heating up for the past two years and Metsera’s ask is one the largest in recent history.
POLICY
  1. If confirmed, Susan Monarez will have her work cut out for her, facing a measles outbreak that has already killed two people—the first measles-related deaths in the U.S. since 2015.
  2. After withdrawing its nomination for Dave Weldon last week, the Trump administration is now reportedly considering Texas Republican Michael Burgess to head the Centers for Disease Control and Prevention.
  3. A group of medical experts expressed concern about growing “disinformation” and “misinformation,” calling for adherence to recommended vaccine schedules.
  4. Democratic senators from Georgia, Oregon, Maryland and New Mexico called the Trump administration’s decision to terminate hundreds of CDC staffers reckless and unfair.
  5. The CDC budget cuts could pose headwinds for HIV drugmakers like Gilead and Merck but are unlikely to severely cripple their HIV divisions, according to analysts.
CAREER HUB
Plus, tips on applying to multiple jobs at the same company, making new work friends, and how to ask for more time at the offer stage.
If you overidentify with your job, there are ways to find self-worth outside of work, starting with using your transferable skills somewhere else.
Transitioning from team member to manager has its challenges, including managing ex-peers. There are a few ways you can make the change easier.
Odds are, you won’t love every job. Is that OK? And what should you do if you’re struggling to find happiness at work?
While biopharma professionals cited age discrimination as an issue in a new BioSpace report, it’s not the only factor affecting older and younger people’s job searches.
Learn how to discuss career gaps and how to be a great hiring manager and interviewer.
Dry promotions include new titles and responsibilities without higher pay. What should you do if you’re offered this type of promotion?
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
Biopharma venture capital fundraising declined from $8.1 billion in the first quarter of 2024 to $6.5 billion in the first three months of this year, headlined by a clutch of massive funding rounds.
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
  1. Exelixis’ next-generation tyrosine kinase inhibitor zanzalintinib is being tested for colorectal cancer, renal cell carcinoma and head-and-neck cancer, with several readouts slated for the second half of 2025.
  2. Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of the industry’s top-performers are losing key market protections. Some companies are more prepared than others.
  3. Casdatifan’s progression-free survival benefits could help differentiate it from Merck’s Welireg in the kidney cancer arena, according to analysts at Truist Securities.
  4. Ono picked up Romvimza—previously known by its active ingredient vimseltinib—from its $2.4 billion acquisition of Deciphera Pharmaceuticals in April 2024.
  5. The failure in adjuvant melanoma could cause BMS and Opdualag to miss out on a market opportunity that is nearly twice as large as its current approved indication, according to analysts.
NEUROSCIENCE
  1. Cebranopadol, a dual-NMR agonist, reached the primary endpoint in a Phase III trial and matched placebo for safety, a significant concern in the analgesic field.
  2. Spravato’s monotherapy nod on Tuesday comes after a series of setbacks in the depression space.
  3. The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a previous pause.
  4. Computational research conducted by scientists from Washington University in St. Louis shows that GLP-1 agonists can have mental and cognitive health benefits but may also harm the kidneys and pancreas.
  5. Biogen’s effort to buy Sage reveals its “desire to expand its pipeline at a discount,” according to analysts from BMO Capital Markets.
CELL AND GENE THERAPY
  1. FDA
    Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.
  2. In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum.
  3. In a deal expected to close in Q1 2025, Roche will gain access to Poseida’s off-the-shelf CAR T candidates.
  4. By mid-2025, the biotech will split into two entities: a new, as-yet-unnamed innovative medicines specialist and a cell therapy company, the latter of which will inherit the Galapagos name.
  5. BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.