President Donald Trump is considering tariff exemptions for certain “non-patented” pharmaceuticals, though the White House has yet to release specific guidelines.
Follow along as BioSpace tracks job cuts and restructuring initiatives throughout 2025.
The settlement agreement will extend market exclusivity for AbbVie’s JAK inhibitor in the U.S. until 2037—providing pediatric exclusivity is granted.
Ocaliva won accelerated approval for primary biliary cholangitis in 2016, which the FDA refused to upgrade to full approval last year after an advisory committee was unable to verify a favorable risk/benefit profile.
The biopharma job market remains challenging, based on BioSpace data. In August, job postings live on the website dropped 32% year over year. In addition, during the first eight months of 2025, over 26,000 people were laid off or projected to be laid off.
New York City has seen increased life sciences employment during the past decade as public funding and key projects like JLABS @ NYC have given the area a boost. A Partnership Fund for New York City executive discusses the city’s strengths and a notable challenge facing businesses.
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.
FEATURED STORIES
FDA
Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.
Robert F. Kennedy Jr. repeated a series of anti-vaccine talking points during his appearance in front of the Senate finance committee on Thursday, as Democratic and Republican senators alike hammered the Health Secretary on recent COVID-19 vaccine restrictions and his views on Operation Warp Speed.
As AAV9 and CRISPR programs navigate safety, delivery and scalability hurdles, small molecules offer a deployable, scalable bridge, complementing genetic approaches and accelerating meaningful impact for patients with Duchenne muscular dystrophy.
It can cure deadly diseases, save long-term healthcare costs and transform lives. But the U.S. insurance system still isn’t ready to pay for it.
IPO
Blank check deals dwindled after a crazy 2021. Now, biotechs are starting to turn to special purpose acquisition companies again as an easy route to the public markets.
IPO
Some of the biggest SPACs from the industry’s pandemic-fueled heyday are no longer on the market.
LATEST PODCASTS
CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out after reportedly sparring with other agency officials over communications strategy; Eli Lilly’s first Phase III readout for oral obesity drug orforglipron missed analyst expectations; and Arrowhead Pharmaceuticals addresses the recent woes of its of partner Sarepta.
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses the emerging geopolitical battle for AI supremacy and global AI governance with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.
George Tidmarsh takes over temporarily at CBER following Vinay Prasad’s abrupt departure; Replimmune trial leaders protest rejection reportedly driven by FDA’s top cancer regulator Richard Pazdur; Merck’s $3 billion savings push claims 6,000 jobs; and Pfizer CEO Albert Bourla addresses President Donald Trump’s new threats around Most Favored Nation drug pricing.
Job Trends
Tapping into the hidden job market can be challenging but is important in today’s employer-driven market. Three talent acquisition experts share tips for accessing hard-to-find roles.
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SPECIAL EDITIONS
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
Year-over-year BioSpace data shows there are fewer job postings live on the website and far more competition for them.
On election day, Tuesday, November 5, Americans will choose between former President Donald Trump and current Vice President Kamala Harris for their next president. The election will also see the rearrangement of Congress.
DEALS
  1. I&I
    The partnership with Matchpoint Therapeutics gets Novartis global rights on all molecules for several unannounced inflammatory diseases identified through the biotech’s discovery platform.
  2. What will Boston Pharmaceuticals CEO Sophie Kornowski do now that the company is selling off its pipeline and winding down operations? Whatever it is, data will take her there.
  3. The deal, which involves a $700 million upfront payment, gives AbbVie access to ISB 2001, a clinical-stage first-in-class trispecific antibody currently being tested for certain kinds of multiple myeloma as well as autoimmune indications.
  4. The deal gives AstraZeneca’s rare disease unit Alexion access to specialized capsids developed by the Japanese biotech JCR Pharmaceuticals for use in up to five of Alexion’s gene therapies.
  5. M&A
    In the second biggest acquisition of the year, Merck gains the commercial COPD drug Ohtuvayre, which could help offset the loss of revenue when Keytruda’s patent expires later this decade.
WEIGHT LOSS
  1. In December 2024, Teva also secured FDA approval for the other liraglutide brand Victoza, indicated for type 2 diabetes.
  2. Novo Nordisk has brought on other cardiometabolic collaborators this year, including United Laboratories International and Deep Apple Therapeutics.
  3. Eli Lilly drops a second Phase III readout for orforglipron; AbbVie committed to the psychedelic therapeutics space with the $1.2 billion acquisition of Gilgamesh’s depression asset; the CDC taps vaccine skeptic Retsef Levi to lead its COVID-19 immunization working group; and the FDA prioritizes overall survival in cancer drug development.
  4. While Truist Securities analysts said the results from the ATTAIN-2 trial leave “room for competition,” they also pointed to a manufacturing advantage that could unlock a “double-digit billion dollar opportunity” for Eli Lilly.
  5. Closely watched data from Eli Lilly and Viking Therapeutics this month have reignited the discussion around oral weight-loss drugs—and their ultimate place within the anti-obesity medication market.
POLICY
  1. FDA
    Perhaps the most interesting of the pile of FDA rejection letters was for Lykos Therapeutics’ MDMA therapy. Letters sent to Stealth BioTherapeutics, Regeneron and more were also released as the agency also promised future CRLs “promptly after they are issued to sponsors.”
  2. CDC
    The new additions would bring ACIP membership to 14 total. Several of the proposed members have taken part in anti-vaccine activity or made anti-vaccine statements.
  3. YouTube has shut down a channel containing hundreds of videos of comments made by doctors and other influencers—including CBER Director Vinay Prasad, Health Secretary Robert F. Kennedy Jr. and NIH Director Jay Bhattacharya—during the pandemic. This comes as Prasad reveals further details about last week’s updated COVID-19 approvals.
  4. Albert Bourla heralded the president’s COVID-19 leadership and Operation Warp Speed initiative as a Nobel Prize–worthy achievement and said that Pfizer stands by the integrity of the data already shared.
  5. CDC
    In an opinion piece in the Wall Street Journal, Health Secretary Robert F. Kennedy Jr. said he will roll chronic disease programs into a new Administration for a Healthy America.
CAREER HUB
Global employee engagement fell two percentage points in 2024, according to Gallup, while BioSpace found that workforce sentiment decreased among biopharma professionals. Additionally, a recent BioSpace poll suggests engagement could continue to decline in 2025.
M&As are stressful for multiple reasons, including role changes and getting laid off when staffs combine. Two talent experts share tips for navigating the transition period of your company’s merger or acquisition.
Turn your career aspirations into reality with this step-by-step guide to creating and implementing a strategic professional development plan for 2025.
Being laid off is bad enough. When companies mishandle the layoff process, it can make the situation even worse. Four biopharma professionals share how some employers are getting it wrong.
Job postings in California took a dip in December during the holiday period, but activity is expected to pick up in January.
As market values increase for computational biology and data science, biopharma companies are looking to hire R&D professionals in those areas. A biotech talent acquisition expert shares his insights on these in-demand roles.
Gratitude, a key part of stoicism, can benefit those working in—and being served by—the pharmaceutical 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
CDC
Former CDC director Susan Monarez and former chief medical officer Debra Houry will appear in front of the Senate HELP Committee on Sept. 17.
REPORTS
Landing a job remains challenging for life sciences professionals, according to a new BioSpace report. While 59% of surveyed organizations are actively recruiting, nearly half of unemployed survey respondents had been out of work for at least six months, and 20% of surveyed employers expect to lay off employees this year.
This report investigates anticipated job search activity and hiring outlook for the remainder of 2024.
CANCER
  1. For $1.3 billion in aggregate—including upfront and milestone payments—Bayer will get exclusive global access to Kumquat Biosciences’ small-molecule KRAS G12D blocker.
  2. Phase Ib data show Hernexeos can elicit a confirmed objective response rate of 44% in patients with HER2-mutated NSCLC who had previously been treated with a directed antibody-drug conjugate.
  3. The recent announcement of RFK Jr.’s termination of mRNA vaccine contracts is the latest effort to undermine this promising technology at the federal level. Pharmaceutical companies and private investors must fill the gap and ensure that research into this critical resource continues.
  4. FDA
    Arguably the FDA’s most anticipated decision this month is for a subcutaneous induction formulation of Biogen and Eisai’s Alzheimer’s drug Leqembi, which, according to Eisai, could “help reduce the burden on healthcare professionals and patients.”
  5. Strand Therapeutics’ lead asset is STX-001, an intra-tumor self-replicating mRNA therapy that carries a payload expressing the immunomodulatory protein IL-12.
NEUROSCIENCE
  1. The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of challenges.
  2. The small molecule, vatiquinone, had already flunked a Phase III trial, but the company pushed ahead with an approval bid anyway.
  3. Waltham, Massachusetts–based Skyhawk Therapeutics has been collecting collaborations with larger companies in spades since launching in 2018.
  4. Praxis’ vormatrigine reduced seizures by 56.3%, an effect size that, according to analysts at Truist Securities, exceeds that of its closest competitors.
  5. The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome.
CELL AND GENE THERAPY
  1. The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry.
  2. The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma. ALLO-647 was being used as a preparative lymphodepletion therapy.
  3. FDA
    As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more were top of mind.
  4. The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety study, as had been feared, Jefferies analysts said Monday.
  5. Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe infection exacerbated by immunosuppression.