After some high-profile crashes, the one-time biotech darling is inching toward success with its Hunter syndrome treatment, which today began a rolling BLA for accelerated approval.
GeoVax was using its HHS contract to develop its next-generation multi-antigen COVID-19 vaccine, which is in Phase IIb development.
Despite these cuts, the FDA should be able to stay above a “trigger” level that would prevent it from collecting fees from the pharma industry and deprive it of approximately half of its annual funding, according to The Washington Post.
Kennedy is planning modifications to the Vaccines Adverse Event Reporting System to identify whether vaccines contribute to an unstated problem. The reporting system is at the heart of the departure of CBER head Peter Marks.
During the first quarter, 22 rounds of biopharma layoffs in California affected about 995 employees total, while 17 rounds in Massachusetts impacted around 410 people, based on BioSpace estimates. Meanwhile, competition for jobs in those states increased year over year, according to BioSpace data.
Looking for a biopharma job in Massachusetts? Check out the BioSpace list of nine companies hiring life sciences professionals like you.
In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER director spoke to analysts about potential implications for drug review timelines and agency morale.
FEATURED STORIES
SpringWorks Therapeutics sprung out of Pfizer’s storeroom, when a rare disease advocacy group pushed to keep a program for neurofibromatosis alive. This method could work for “every rare disease under the sun,” advocates say.
SpringWorks Therapeutics is the perfect case study for rescuing a discontinued assets. It’s time to repeat the process for every rare disease, experts say.
The industry remains unwavering in the commitment to increased clinical trial accessibility and representation.
LATEST PODCASTS
The biggest conferences of the year dominated news this week: the American Society of Clinical Oncology annual meeting and the BIO International Convention.
In this second episode of our collaboration with DIA, we discuss the challenging, collaborative process of regulating advanced therapy product development with guests James Wabby, AbbVie and Rob Schulz, Suttons Creek, Inc.
AstraZeneca targets $80 billion in revenue by 2030, layoffs at Bayer, BMS and Pfizer continue to generate attention across the biopharma industry, Takeda takes a deep dive into the molecular glue space and conference season is in full swing.
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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. The blood plasma pharma is considering a buyout offer from the founding family and asset manager Brookfield, which would delist the company from the Spanish and Nasdaq markets.
  2. Eli Lilly on Monday announced a $3.2 billion all-cash deal to purchase Morphic and its pipeline of oral integrin therapies in a move to expand the pharma’s presence in the autoimmune diseases space.
  3. GSK on Wednesday restructured its contract with CureVac to gain access to the biotech’s influenza and COVID-19 programs for $430 million upfront and up to $1.13 billion in future payments.
  4. Eli Lilly is expanding its radiopharmaceutical portfolio with a $140 million upfront payment to Radionetics Oncology and the exclusive future right to acquire the biotech for $1 billion.
  5. Samsung Biologics announced Tuesday it has signed its largest contract ever—a $1.06 billion manufacturing deal with an unnamed pharmaceutical company headquartered in the U.S.
WEIGHT LOSS
  1. Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.
  2. After psychological side effects doomed the first generation of cannabinoid receptor 1–targeting drugs for weight loss, Novo Nordisk, Corbus Pharmaceuticals and Skye Bioscience are betting that a new mechanism of action will improve the safety profile.
  3. Scaling GLP-1 manufacturing capacity remains a key priority for the pharma industry, to help supply catch up with the insatiable demand for weight loss drugs.
  4. BMO Capital Markets analyst Evan Seigerman called it “another positive indication” for Eli Lilly, whose top-selling diabetes and weight loss drugs are gaining market share as manufacturing continues to expand, while noting the drugmaker could start to benefit heading into third quarter earnings.
  5. Venture Capital firms Atlas Venture, Bain Capital Life Sciences and RTW Investments have led a $400 million Series A for Kailera Therapeutics, the latest obesity biotech to hit the scene.
POLICY
  1. Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.
  2. Career conservative and former congressman Dave Weldon will, if confirmed, act as director of the Centers of Disease Control and Prevention, where his anti-vaccine views will mesh with those of selected Department of Health and Human Services head Robert F. Kennedy Jr.
  3. RFK Jr. as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has withdrawn as nominee for Attorney General. With Dr. Oz tapped to lead CMS and maybe Marty Makary at the FDA, it’s going to be quite the show.
  4. Makary is a pancreatic surgeon at Johns Hopkins who became known for battling medical mistakes and in recent years has been an outspoken critic of COVID-19 policies.
  5. The selection of controversial TV personality Mehmet Oz to run the agency overseeing Medicare and Medicaid follows Trump’s pick of RFK Jr. to run its parent department, HHS.
CAREER HUB
Since almost every job market has become more competitive, you need to start improving your skills. Here are a few tips that can help you in skill development.
The life science field offers a wealth of opportunities, even for those working outside of the field. Here are six life science jobs that don’t require industry experience.
With so many differences in research and regulation, it’s more important now than ever for job seekers considering moving outside of the U.S. to educate themselves before they make the leap.
To help you in your job search, here are just a few of the remote job options in the life science industry, along with the qualifications and skills necessary to be successful in each role.
When vetting the qualities of potential candidates at a career fair, listen to and take interest in the unique lived experiences of each job seeker you meet, as well as their skills and qualifications.
Job descriptions are the candidate’s first impression of a company. And if that introduction includes exclusionary language, they’re less likely to apply even if they are the perfect fit for the job.
Known as the Lone Star Bio Hotbed, Texas is home to multiple major players in the biopharma and biotech space and is currently a fast-growing hub for the life science industry.
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
As the Trump administration—including HHS Secretary Robert F. Kennedy Jr.—plays fast and loose with scientific studies and facts, there may be a more sinister force at play: censorship.
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. According to Jake Van Naarden, president of Lilly Oncology, the excess deaths could be due to the high rate of crossover in BRUIN CLL-321.
  2. Analysts called the data “very competitive” but raised questions about safety. Merck gained ownership of the ADC when it acquired VelosBio in November 2020 for $2.75 billion.
  3. The FDA’s year-end rush includes nine target action dates, mostly for rare disease and cancer therapies.
  4. Protara is advancing a cell therapy that triggers both adaptive and innate antitumor immune responses, while CG Oncology’s approach makes use of an oncolytic immunotherapy that preferentially targets cancer cells and proliferates inside them, destroying them from the inside.
  5. 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.
NEUROSCIENCE
  1. With an upfront payment of $50 million from Roche, the partnership will leverage Dyno Therapeutics’ in vivo gene therapy delivery technology, which synthesizes virus capsids with better functionality and manufacturability.
  2. Jefferies analyst Peter Welford noted that Roche’s pharma group came just slightly ahead of consensus expectations, driven by strong performance of its multiple sclerosis therapy Ocrevus and eye injection Vabysmo.
  3. Alto Neuroscience’s depression treatment failed to beat placebo just nine months after the biotech went public. The stunning failure called to mind Acelyrin, which faced a similar fate last year.
  4. Roche drops a third Alzheimer’s candidate this year, terminating a partnership with UCB just four years after agreeing to work together on new treatments for the neurological disease.
  5. Seaport Therapeutics, kick started by the former leaders of Karuna Therapeutics, has raised $225 million in an oversubscribed Series B to fund a pipeline of neuropsychiatric medicines.
CELL AND GENE THERAPY
  1. As the biotech implements a more focused strategy for its Roctavian hemophilia A gene therapy, BioMarin has recruited two seasoned pharma executives to bolster its C-suite.
  2. With the help of third-party investors, the new venture will focus on three genetic and rare diseases: tuberous sclerosis complex, erythropoietic protoporphyria and alpha-A1 antitrypsin deficiency.
  3. The recent invalidation of an AAV gene therapy patent overlooks the complexity of innovation in biotechnology and could put a broad swath of intellectual property at risk.
  4. Regeneron, Akouos and Mass Eye and Ear are testing therapies that can reverse genetic protein deficiency to restore hearing, with promising early results.
  5. Likely to miss its initiation target, bluebird bio has renegotiated the loan deals of its agreement with Hercules Capital, giving it until June 30 next year—at the latest.