Pliant follows in the footsteps of Acelyrin, which also enacted a stockholder rights program on Thursday to protect shareholders against Tang Capital’s growing stake in the company.
The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense.
As Marty Makary and Jay Bhattacharya sail through the Senate health committee vote, Weldon’s confirmation hearing is canceled. Guggenheim Partners heralded the last-minute move to revoke Dave Weldon’s nomination as “a positive sign for reigning in vaccine criticism.”
While Houston isn’t yet on the same level as major life sciences hubs, it has plenty to offer and room to grow, according to CNS Pharmaceuticals, RadioMedix and Greater Houston Partnership executives.
The move by Acelyrin’s board comes as the venture capital firm has taken larger and larger stakes in the company in an attempt to disrupt a merger with Alumis.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis and Miruna Sasu, CEO of COTA, discuss the challenges of inclusion and exclusion criteria of clinical trial patients, and reflect on current investment approaches around women’s health.
FEATURED STORIES
President-elect Donald Trump and his incoming administration are unlikely to attempt a wholesale restructuring of U.S. healthcare and could promote M&A activity, but controversial picks like Robert F. Kennedy could impact vaccine sales, experts say.
Not exactly known for its dealmaking, Sarepta Therapeutics has thrown down a massive wad of cash to work with Arrowhead Pharmaceuticals on RNAi-based medicines.
Intra-Cellular submitted its application to the FDA for Caplyta’s approval in major depressive disorder, potentially opening up an additional $1 billion in sales. Still, the stock remains “cheap,” according to Jefferies analysts.
FROM BIOSPACE INSIGHTS
While Quantum computing has been reported to be five years away for many years now, companies are preparing for it by setting foundations with AI in development.
LATEST PODCASTS
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
In this episode of Denatured BioSpace’s head of insights Lori Ellis discusses the public health consequences of vaccine hesitancy and the critical distinction between skepticism and cynicism with Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
A new executive order aims to smooth the path for getting U.S. manufacturing facilities up and running; HHS says it will require placebo-controlled trials for all vaccine approvals; tariff threats hit BioNTech; Novo Nordisk’s FDA application for an oral version of Wegovy is accepted; and more.
Job Trends
Bristol Myers Squibb announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT in adults with schizophrenia.
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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
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The deal, announced late Wednesday, will provide AbbVie with access to Cerevel Therapeutics’ pipeline of clinical-stage and preclinical candidates for psychiatric and neurological diseases. -
This week we discuss ups and downs in the weight loss and ADC markets - including Altimmune, Pfizer setbacks, AbbVie’s ImmunoGen buy and more. -
The acquisition will give Roche access to Carmot’s clinical portfolio of three GLP-1 receptor agonists, placing it squarely in the middle of the competition to treat overweight and obesity. -
AbbVie’s $10.1 billion ImmunoGen buy and Altimmune’s Phase II win demonstrate that the antibody-drug conjugate market is red hot in cancer and GLP-1 drugs for weight loss are an absolute craze. -
Facing the loss of Humira revenues from biosimilar competition, AbbVie is looking to grow its pipeline by acquiring ImmunoGen and its antibody-drug conjugate Elahere, which was granted FDA accelerated approval last year.
WEIGHT LOSS
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With GLP-1 agonists slated to become the best-selling drugs in 2024, the biopharma industry is already pivoting to explore treatments that preserve muscle mass as patients shed pounds. -
Sen. Bernie Sanders (I-Vt.) on Wednesday launched an investigation into the exorbitant prices of Novo Nordisk’s Ozempic and Wegovy blockbusters, and has asked the Danish drugmaker to justify their price tags. -
A report from the Kaiser Family Foundation estimates that the FDA’s recent approval of Novo Nordisk’s Wegovy to reduce the risk of heart attack and stroke in people with cardiovascular disease will open Medicare coverage to one in four beneficiaries with obesity. -
While Sanofi restructures and parts with employees from U.S. and Belgian sites, a new company in the GLP-1 space emerges from stealth.
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The clinical-stage biotech emerged from stealth on Thursday with several oral and injectable candidates, including a GLP-1 receptor agonist in Phase I trials, in an effort to challenge Novo Nordisk and Eli Lilly.
POLICY
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On the heels of a Phase III flop for Pfizer’s Duchenne muscular dystrophy gene therapy candidate, the FDA has green lighted the expanded use of Sarepta Therapeutics’ Elevidys. -
The pharma industry is staring down the barrel of a widespread loss of exclusivity, with more than 190 products going off-patent between 2022 and 2030. Here are some strategies company are employing to manage the drop in revenue. -
PTC Therapeutics said Thursday the FDA has lifted a partial clinical hold on its Huntington’s disease candidate PTC518 after displaying favorable clinical trends in a mid-stage study. -
Eli Lilly on Thursday said it is again suing spas and clinics over compounded and counterfeit forms of tirzepatide, the active ingredient in blockbusters Mounjaro and Zepbound, which the pharma says can cause harmful side effects. -
The Federal Trade Commission is supporting the U.S. Patent and Trademark Office’s proposed new rules requiring parties to a patent dispute to disclose all settlement agreements, including pharmaceutical drug settlements.
While continued learning opportunities are easy to access and many are quite affordable, the real question is, can you list these courses on your resume? And if you do so, what will recruiters in the biotech field think of them?
Some semblance of a work-life balance is already a challenge to maintain, but doing so when you’re working and living in the same space takes effort and one (or more!) of these strategies.
While you’ve likely answered many of these before, it never hurts to brush up on solid answers and think of new or recent anecdotes to illustrate your point.
How productive are you on a daily basis? The truth is, you probably don’t get as much done as you possibly can due to distractions. But, these productivity methods can help you for sure.
If you’re contemplating changing careers in the midst of the COVID-19 pandemic, the reality is that if it’s time to make a change, there’s no time like the present.
Oh, the world of professional email communication. It can be hard to navigate with various expectations across industries, age groups and cultures.
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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Immutep shares jumped nearly 20% on Friday after data showed its LAG-3 therapy—plus Keytruda—elicited strong response rates in head and neck squamous cell carcinoma patients in the front-line setting.
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Kazia Therapeutics is eyeing an FDA accelerated approval pathway for its investigational glioblastoma drug paxalisib, with Wednesday’s release of secondary overall survival data from a Phase II/III trial.
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Amgen has quietly discontinued the development of its Phase I bispecific T-cell engager AMG 794, which the company had been studying for several malignant solid tumors. -
GLP-1 receptor agonists could reduce the risk of 10 obesity-associated cancers, such as meningioma, multiple myeloma and colorectal cancer, according to an analysis of electronic health records. -
With the antibody drug conjugate market projected to hit $28 billion by 2028, some companies are looking to harness the drugs for immunotherapy.
NEUROSCIENCE
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The FDA plans to convene an advisory committee meeting to discuss the safety profile and efficacy of Eli Lilly’s Alzheimer’s candidate, the company announced Friday. -
The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals. -
In Monday’s neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.
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Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint. -
Boehringer Ingelheim has paid $27.3 million upfront to Sosei Heptares to develop a small molecule agonist of GPR52 to treat the positive, negative and cognitive symptoms of schizophrenia.
CELL AND GENE THERAPY
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Since Elevidys’ accelerated approval in 2023, experts have been clamoring for more data, particularly in older and non-ambulatory children. New results, presented Friday, show mobility improvements in 8- to 9-year-old patients after one year of follow-up. -
Lilly will use Rznomics’ proprietary ribozyme technology to develop RNA editing therapies for congenital hearing loss. -
After warnings that the dragged-out process was putting the cell therapy company at risk of bankruptcy, bluebird bio now has a new deal to offer shareholders. -
It’s another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a therapy approved. -
The cell engineering company, co-founded by oncologist and writer Siddhartha Mukherjee, does not see a path forward for its pipeline of early-stage cell therapies for two different types of cancer.
