Such a change would put the U.S. more in line with guidance in other countries and with the World Health Organization, which recommends one dose for children and adolescents only if they have comorbidities.
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.
The drug, a small molecule protein inhibitor, brought in $132 million in the first quarter, missing consensus estimates by 17%.
As Q1 2025 earnings season continues, tariffs remain top of mind for pharma CEOs and investors. Meanwhile, the American Association for Cancer Research’s annual event kicks off this year’s oncology conference season. Plus, will the FDA become politicized under HHS Secretary RFK Jr.?
Nevertheless, Albert Bourla has been lobbying the U.S. government—as high as President Donald Trump himself—to skip the pharmaceutical industry tariffs, which Trump has threatened, in part as a way to shore up U.S. national security.
Despite executing perfectly, Octagon confronted a “scientific no-go,” CEO Isaac Stoner said in his LinkedIn post announcing the company’s impending closure.
The condition, recessive dystrophic epidermolysis bullosa, causes chronic wounds and has an 84% mortality rate by age 40.
FEATURED STORIES
While Novartis and Bayer got there first, AstraZeneca, Bristol Myers Squibb and Eli Lilly are all vying to bring their radiopharmaceutical assets to a market projected to be worth over $13 billion by 2033.
Several companies will head to the FDA seeking approval of new Duchenne muscular dystrophy treatments next year but the death of a patient taking Sarepta’s Elevidys raises important safety questions.
Eli Lilly and Novo Nordisk are in a global battle for dominance in the weight loss space. BioSpace takes a look at the territory covered and what’s to come.
LATEST PODCASTS
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.
In our anniversary episode, we discuss a rare earnings miss for Eli Lilly, a pivotal metabolic dysfunction–associated steatohepatitis victory for Novo Nordisk’s Wegovy, growing excitement about CAR Ts for autoimmune disease and the ongoing controversy over HeLa cells.
Pfizer, Sanofi and others report Q3 beats; AbbVie, Roche and Novartis strike big deals; the 2024 presidential election looms; and BioSpace takes a look back at 10 years of NextGen, our annual pick of young biotechs to watch.
Job Trends
Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today presented new data demonstrating for the first time the potential for redosing with an investigational, in vivo CRISPR/Cas9 genome editing therapy.
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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. 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.
  2. 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.
  3. 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.
  4. 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.
  5. The collaboration will see COUR and Roche’s Genentech leverage the biotech’s antigen-specific immune tolerance platform to develop and commercialize therapies for an undisclosed autoimmune disease.
WEIGHT LOSS
  1. Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines.
  2. Obesity continues to grab attention at the J.P. Morgan Healthcare Conference in San Francisco, with both Pfizer and Kailera Therapeutics outlining their plans in the space moving forward.
  3. IPO
    Metsera will use its IPO proceeds to fund the Phase III development of its injectable, ultra-long-acting GLP-1 therapy MET-097i, which last week achieved 11.3% weight loss in a Phase IIa study.
  4. The company’s lead asset is a potentially first-in-class oral GLP-1 receptor agonist that has the potential to be dosed weekly, which according to CEO Khurem Farooq can help improve accessibility and affordability.
  5. According to BMO Capital Markets, Medicare coverage of Lilly’s Zepbound opens the door to using secondary indications to secure CMS coverage for obesity drugs.
POLICY
  1. Analysts at Jefferies see Makary as a positive for the rare disease space, given his support for accelerated approvals and openness to “customizing regulatory pathways for rare diseases.”
  2. The Senate hearing for FDA Commissioner nominee Marty Makary comes after President Trump’s NIH pick, Jay Bhattacharya, was grilled by the legislative body on Wednesday.
  3. The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices.
  4. Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025.
  5. Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie and Eli Lilly strike mid-sized deals in obesity and molecular glues, priority review vouchers set to take a hit and immuno-oncology matures.
CAREER HUB
Here’s what to look for—and what to ask—before and during the interview process to find out whether an employer fosters an inclusive environment.
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
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.
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. Following an initial report from Reuters, Merck KGaA confirmed that it is in talks with SpringWorks for a potential acquisition, though details of its offer have yet to be revealed.
  2. Eli Lilly inked two collaborations on Monday, one focused on cardiometabolic diseases with South Korea’s OliX Pharmaceuticals and another for cancer therapies with Australia’s AdvanCell.
  3. Adding a new indication for the CAR T cell therapy could help BMS offset the loss-of-exclusivity headwinds it faces in the coming years.
  4. Kuro Oncology and partner Kyowa Kirin are on track for an NDA submission for ziftomenib in the second quarter of this year.
  5. Despite significant dips in its vaccines sales, the British pharma narrowly beat consensus estimates for Q4 2024 and raised 2031 sales projections to just over $50 billion.
NEUROSCIENCE
  1. 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.
  2. An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
  3. JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year.
  4. 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.
  5. Biogen’s proposed acquisition comes after two difficult years of regulatory and clinical challenges, during which shares of Sage Therapeutics have fallen by more than 90%.
CELL AND GENE THERAPY
  1. 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.
  2. 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.
  3. Vertex unveiled long-term durability data for Casgevy, while Beam presented Phase I/II findings for its investigational base editor BEAM-101, building up to a BLA by late 2026.
  4. Not developing potency assays and gaining knowledge about MOAs early in the drug development process not only can break ATMP success but can cause costs and delays that lead to company closures.
  5. The payment scheme will tie gene therapy payments to improvements in health outcomes—and could potentially boost the uptake of these sickle cell disease treatments.