Robert F. Kennedy Jr.’s removal of all remaining members of the CDC’s Advisory Committee on Immunization Practices raises questions about the upcoming meeting later this month. Analysts fear the committee could be more sympathetic to the HHS Secretary’s anti-vax viewpoints.
As of March 31, Recursion Pharmaceuticals had a cash position of $509 million. Following Tuesday’s layoffs, the biotech expects its runway to last into the fourth quarter of 2027.
Odyssey filed for an IPO in January but never revealed a fundraising target.
Merck’s Enflonsia will go up against Sanofi and AstraZeneca’s Beyfortus, which the partners plan to ship out early in the third quarter.
The reinstatement of the generic drug policy office is the latest reversal of course for Robert F. Kennedy Jr.'s HHS, which also recently rehired FDA staff responsible for making travel arrangements and those involved in user fee program negotiations.
Two weeks of upheaval at the CDC culminated Monday in the complete reconstitution of the CDC’s Advisory Committee on Immunization Practices as HHS Secretary Robert F. Kennedy Jr. pens op-ed criticizing “conflicts of interest” he says exist on the current committee.
FEATURED STORIES
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.
At a Thursday ASGCT 2024 session, CBER Director Peter Marks made the case for a better, “more convergent” global framework on cell and gene therapies, especially for rare diseases.
Launched in 2021, the public-private consortium on Wednesday updated ASGCT attendees on its efforts to bring adeno-associated virus gene therapies to more rare disease patients.
A new BioSpace report finds that life science professionals are prioritizing diversity less when job hunting. Still, DEIB programs don’t appear to be going anywhere.
Amylyx’s recent decision to withdraw its ALS drug Relyvrio from the market highlights an important business decision for companies: when to continue marketing or investigating a drug that has failed a pivotal or confirmatory study.
As Sarepta Therapeutics moves closer to full approval and an expanded label for its gene therapy, some experts push back on clinical efficacy and cost while others note the hope it provides patients with Duchenne muscular dystrophy.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s head of insights Lori Ellis and Colin Zick, partner at Foley Hoag LLP, spend time discussing some of the points brought up in the Bioprocessing Summit last month. They explore the connections between hammers, AI, The Planet of the Apes and monoliths.
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms.
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
Job Trends
Sana Biotechnology, Inc. announced that Cell Stem Cell has published a paper titled “Hypoimmune islets achieve insulin independence after allogeneic transplantation in a fully immunocompetent non-human primate.”
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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 acquisition provides the Swedish company with an approved JAK inhibitor for myelofibrosis, a rare bone marrow cancer that disrupts the body’s normal production of blood cells. -
The biopharma company scored two major wins on Tuesday: a court victory over HIV patent claims and an acquisition deal to expand its pipeline in cancer and inflammatory diseases. -
Novel therapies often pass through several owners on their way to the market. Here’s a look at some of the drugs that got dropped before they hit primetime. -
Japanese biopharma scoops up Iveric’s investigational drug for age-related blindness disease. The drug, which trails Apellis’ Syfovre, is awaiting FDA approval with a decision expected by August. -
The acquisition of Bellus Health will give GSK access to camlipixant, a potentially best-in-class P2X3 antagonist for chronic cough.
WEIGHT LOSS
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The regulator is launching an investigation of Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound and other GLP-1 receptor agonists following patient reports of suicidal ideation, alopecia and aspiration. -
Novo Nordisk’s partnerships with Flagship Pioneering-backed Omega and Cellarity, each worth up to $532 million, will explore novel treatment approaches to obesity and metabolic dysfunction-associated steatohepatitis. -
While GLP-1 drugs have exploded in popularity, they don’t work for everyone, and experts say phenotyping based on a greater understanding of the disease is the future of obesity treatment. -
Over the past year, obesity treatments have become the focus of intense media attention and discussion in healthcare — with increased focus on Wegovy and Zepbound. This attention has highlighted the need to address the global obesity epidemic. -
Eli Lilly has signed a multi-year contract with animal genomics biotech Fauna Bio to use its artificial intelligence platform to discover drug targets for obesity in a deal worth nearly half a billion dollars.
POLICY
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Daiichi Sankyo has secured a victory in its patent arbitration with Seagen, nabbing a $47 million award for attorneys’ fees and other costs, plus interest. However, a larger patent battle with Pfizer remains. -
In a potential challenge to Pfizer’s Prevnar 20, Merck’s Capvaxive has been recommended by the Centers for Disease Control and Protection for use in preventing invasive pneumococcal disease in adults. -
The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions. -
Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review. -
The FDA on Thursday rejected Merck and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate patritumab deruxtecan in a Complete Response Letter, citing problems with a third-party manufacturer.
Virtually every aspect of what employers seek can be framed as an accomplishment – skills, values, experience, results, subject-matter knowledge, uniqueness, proof of performance.
How will you ensure that you aren’t overqualified for your next position?
Have you ever wondered why some life science professionals seem very happy at work, and appear to love their jobs? At the same time, their co-workers in an identical position are miserable.
Arguments in the workplace are often unavoidable. There will be differences in opinion, strategy and planning efforts. To help, here are some tips on how to avoid arguments at work.
A recent BioSpace survey found that health insurance is one of the top considerations of life science professionals willing to relocate for a job. To learn more, we interviewed Carrie Richards Leary, a health insurance benefits professional.
According to a BioSpace poll, over half (56%) of respondents are not happy with their current life sciences position. Are you one of the 56%? You deserve to be happy! Start working towards your happiness and check out job opportunities at these top companies!
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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The FDA will close out April with five target action dates around indications that include pediatric seizures and a neurological cancer in children. -
As its lead oral targeted protein degrader moves through Phase III in partnership with Pfizer, Arvinas signs a licensing deal handing over all rights and responsibilities to Novartis. -
Roche said Monday that its bispecific T cell engager Columvi improved survival in a Phase III lymphoma trial, clearing the drugmaker to seek a full, expanded label that could drive sales growth. -
Data presented at the American Association for Cancer Research’s annual meeting sparked hope that we could be getting closer to treating pancreatic cancer, glioblastoma and other particularly difficult tumors. -
Novartis on Thursday announced that it is making $150 million in upfront payments to protein degradation biotech Arvinas, while separately revealing that its tender offer for MorphoSys has begun.
NEUROSCIENCE
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Recent data from the Phase III study of donanemab emphasize a correlation between amyloid and tau. Experts say a greater understanding of this link could further Alzheimer’s drug development. -
Following the FDA’s full approval of the Alzheimer’s drug Thursday, the Centers for Medicare and Medicaid Services confirmed broader coverage of Leqembi and released more details on a registry. -
Thursday, Eisai and Biogen’s Leqembi also became the first disease-modifying treatment for Alzheimer’s to win traditional approval. CMS coverage is expected to begin immediately. -
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end. -
After an FDA advisory committee unanimously recommended Leqembi’s full approval, questions linger around amyloid-related imaging abnormalities and a potentially cumbersome patient registry.
CELL AND GENE THERAPY
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Bluebird bio has re-emerged after a private equity buyout as Genetix Biotherapeutics, marking a return to its roots and a new path forward for manufacturing. -
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms. -
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record. -
The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing. -
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.
