Policy uncertainties are impacting biopharma dealmaking from continent to continent, with companies being asked to walk a tightrope on their relations with China.
Imports of pharmaceutical products surged in March, most of which came from Ireland, historically one of the biggest exporters of medicines to the U.S.
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.
FDA
The oncologist and former University of California, San Francisco, professor has long been critical of COVID-19 mandates and the accelerated approval of cancer drugs.
A new executive order from President Donald Trump aims to cut down the 5-to-10-year timeline to build new facilities while stepping up the rigor of inspections on foreign plants.
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.
ALS
The Alchemab deal will further strengthen Lilly’s early-stage pipeline for amyotrophic lateral sclerosis, coming less than a year after the pharma licensed QurAlis’ antisense oligonucleotide to correct a specific protein alteration in ALS.
FEATURED STORIES
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.
Bo Wang is a renowned AI scientist at the University of Toronto. He’s bringing his open-source culture and computational biology to Xaira Therapeutics in June.
LATEST PODCASTS
Trump fingers Robert F. Kennedy Jr. to lead the HHS, lupus and ATTR-CM dominate headlines this week, bluebird bio has a cash gap to leap and RegenxBio eyes Sarepta in Duchenne muscular dystrophy.
A tale of two multi-billion schizophrenia deals, AstraZeneca touts strong sales while deflecting questions about an investigation into China exec, the Huntington’s pipeline builds momentum and layoffs continue with Sana Biotechnology and 23andMe.
In this episode of Denatured, BioSpace’s Head of Insights Lori and guests from Teva Pharmaceuticals and TOWER Capital discuss the opportunities, regulatory challenges and uncertainty surrounding AI.
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SPECIAL EDITIONS
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
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.
DEALS
  1. By far, the largest acquisition of 2024 was Novo Holdings’ yet-to-be-closed buyout of manufacturer Catalent at $16.5 billion. Outside of that, the leading pharmaceutical companies kept to less than $5 billion per deal.
  2. The Muna partnership will give GSK access to Muna’s MiND-MAP platform, which it will apply to postmortem brain samples to identify potential therapeutic targets for Alzheimer’s disease.
  3. One year after a potential $1.7 billion deal with Hansoh Pharma, GSK goes back to China to forge another alliance with DualityBio for another deal that could be worth up to $1 billion as it continues to build up its ADC portfolio.
  4. The Danish startup, whose lead candidate has parallels to Amgen’s MariTide, launches on the heels of Amgen’s Phase II data release for the drug last week.
  5. 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.
WEIGHT LOSS
  1. 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.
  2. As the year gets underway, analysts and biotech executives highlight cell therapy’s pivot from oncology to autoimmune diseases, a continued appetite for next-generation obesity drugs and an increased focus on neuromuscular, kidney and cardiovascular diseases.
  3. The data suggest the high dose nearly closes the efficacy gap with Zepbound.
  4. JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year.
  5. The updated guidance, which was largely driven by lower-than-anticipated sales of GLP-1 blockbusters Mounjaro and Zepbound, sent Eli Lilly’s shares cratering by as much as 8% Tuesday, even as the company forecasted robust 2025 revenue.
POLICY
  1. A group of medical experts expressed concern about growing “disinformation” and “misinformation,” calling for adherence to recommended vaccine schedules.
  2. Democratic senators from Georgia, Oregon, Maryland and New Mexico called the Trump administration’s decision to terminate hundreds of CDC staffers reckless and unfair.
  3. 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.
  4. The appeals court for the Federal Circuit upheld a lower court’s ruling, finding that Regeneron has not sufficiently established that Amgen’s biosimilar Pavblu violates key patents of Eylea.
  5. The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense.
CAREER HUB
Preparation is key to ensuring one stands out in an increasingly competitive job market. We asked an expert for tips.
Employees worried about layoffs can practice self-care, use employer resources and contact a mental health professional, if needed.
The first Bioversity cohort includes several graduates placed at Massachusetts life sciences companies.
The job response rate has risen year over year, according to BioSpace data, indicating competition for roles posted on our website has increased.
There are several ways you can maintain a good working relationship with your boss, starting with learning your manager’s work style, preferences and priorities.
To avoid overextending yourself and harming your work-life balance, how should you set and maintain boundaries at work?
Join us in this discussion on how you can optimize your chances of landing a new role despite a highly competitive job market.
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
Roche envisions its Indianapolis site as a “major hub” for the manufacturing of its continuous glucose monitoring systems. The news comes on the heels of an announced $700 million investment in North Carolina.
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. Ono picked up Romvimza—previously known by its active ingredient vimseltinib—from its $2.4 billion acquisition of Deciphera Pharmaceuticals in April 2024.
  2. 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.
  3. Amgen will continue to advance half of the combo, PRMT5 inhibitor AMG 193, for which it is running a mid-stage trial in MTAP-null advanced non-small cell lung cancer.
  4. In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis and Tom Whitehead continue to discuss the patient and caregiver experience, where Tom gives his insights to the future of CGTs.
  5. Leaked data showed that Pfizer’s mevrometostat has strong therapeutic potential in metastatic castration-resistant prostate cancer, while recent readouts also position the pharma as a strong contender in colorectal cancer and bladder cancer.
NEUROSCIENCE
  1. Amidst a “renaissance” of interest in neuropsychiatry, Seaport’s executive team is taking nothing for granted.
  2. J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference. Meanwhile, Biogen proposes to acquire struggling neuro partner Sage, and obesity dominates discussions as Pfizer goes “all in.”
  3. Lykos Therapeutics is currently working out ways to fund an additional Phase III study for its MDMA-assisted PTSD therapy following an FDA setback last year.
  4. An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
  5. The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners await the regulator’s decision on a new intravenous regimen following an underwhelming launch riddled with coverage and accessibility barriers.
CELL AND GENE THERAPY
  1. Bristol Myers Squibb aims to generate around $1.5 billion in savings through 2025—a goal that it hopes to reach by lowering third-party expenditures, focusing only on key growth brands and cutting some 2,200 jobs by year-end.
  2. When hiring job candidates to work on cell and gene therapies, companies look for more than just technical skills. Talent acquisition executives from Bristol Myers Squibb and Intellia Therapeutics offer an inside look at what they want in an employee.
  3. With nearly 90% of patients showing no detectable cancer cells after treatment, J&J and Legend’s Carvykti could stave off competition from emerging CAR T therapies such as Gilead and Arcellx’s anito-cel.
  4. In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified Huntington’s Disease Rating Scale, and neurofilament light chain levels to support the accelerated approval of its gene therapy AMT-130.
  5. Anito-cel has shown no signs of delayed neurotoxicity at around 9 months of follow-up, hinting at a safety profile that could set it apart from J&J and Legend’s Carvykti.