While the new framework signals continued flexibility at the FDA regarding rare disease approvals, some analysts and advocates question what tangible impacts the new guidelines will have.
The star of the acquisition, which includes a contingent value right of $6 per share, is pegozafermin, an FGF21 analog in late-stage development for metabolic dysfunction-associated steatohepatitis.
In this deep dive, BioSpace explores the next big thing in obesity.
CDC
During a hearing in front of the Senate’s HELP committee, Susan Monarez addressed her controversial firing and recalled a conversation where Health Secretary Robert F. Kennedy Jr. allegedly said that “CDC employees were killing children and they don’t care.”
Listen now for a high-level discussion on overcoming pharmaceutical supply chain challenges through end-to-end integration.
Moving forward, Innate will focus on the clinical development of its antibody-drug conjugate IPH4502, the lymphoma candidate lacutamab and the AstraZeneca-partnered monalizumab.
FDA
In letters to Eli Lilly and Novo Nordisk, the FDA accused the companies of downplaying the risks of their GLP-1 weight loss drugs during a prime time special with Oprah Winfrey.
FEATURED STORIES
FDA
FDA Commissioner Marty Makary last week announced a directive that would limit industry participation in the agency’s advisory committees. But not only do company reps serve only as non-voting members, a 1997 law actually requires industry involvement.
Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.
Analysts have had to throw out their assumptions for the biopharma industry’s recovery heading into the first quarter earnings period given the ongoing tariff drama.
Johnson & Johnson’s Joaquin Duato is no longer the highest paid CEO in pharma. Meanwhile, just two women make the top 10.
AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.
FROM BIOSPACE INSIGHTS
BioSpace’s Q3 2025 U.S. Life Sciences Job Market Report reveals a turbulent quarter for biopharma hiring, with record declines in job postings, rising layoffs, and cautious employer sentiment shaping the industry’s employment landscape.
UPCOMING EVENTS
LATEST PODCASTS
In this episode, Lori and guests continue their exploratory discussion on AI and focus on the challenges of globalization and return on investment.
New revelations from the showdown between Novo Nordisk’s CEO and Bernie Sanders’ Senate health committee Tuesday; PhRMA’s legal victory in IRA case; the federal interest rate cut and anticipated approval for schizophrenia.
Infusions of Vertex and CRISPR Therapeutics’ Casgevy and bluebird bio’s Lyfgenia have begun; Moderna targets 10 approvals through 2027; more oral obesity drug data; the latest from ESMO and more.
Job Trends
Detailed positive results from the DESTINY-Breast06 Phase III trial showed that ENHERTU® demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemotherapy in patients with HR-positive, HER2-low metastatic breast cancer and the overall trial population following one or more lines of endocrine therapy.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
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
  1. With $70 million upfront and more than $1.8 billion on the line, Roche will gain access to Flare’s drug discovery engine to bolster its oncology pipeline.
  2. With Novo Holdings’ $16.5 billion buyout of Catalent being reviewed by regulators, what work the contract drug manufacturer may or may not be performing for Eli Lilly remains a point of contention.
  3. In a deal worth up to $285 million initially for the lead program, Novo Nordisk will gain access to Ascendis’ TransCon technology platform in an effort to find novel GLP-1 candidates with reduced dosing frequency.
  4. Biogen touted strong Q3 sales of its Alzheimer’s drug Leqembi a day after announcing a deal worth up to $1.45 billion with Neomorph to discover and develop molecular glue degraders.
  5. 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.
WEIGHT LOSS
  1. JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year.
  2. 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.
  3. Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines.
  4. 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.
  5. 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.
POLICY
  1. While the Trump administration has painted the jettisoning of staff and regulations as good for business, there are multiple reasons it’s unlikely to work out that way.
  2. At a sometimes-contentious U.S. Senate hearing, the Health and Human Services secretary was evasive on the rationale behind cuts being made to the department and his endorsement of the measles vaccine amid a rapidly growing outbreak.
  3. The third cycle of the drug price negotiations will involve drugs under Medicare Part B. New prices are set to take effect in 2028.
  4. The Most Favored Nation directive would allow drugmakers to directly sell their products to patients at a lower cost, cutting out what President Donald Trump called “the middlemen.”
  5. While industry groups decried the Trump administration’s new drug pricing order, analysts say it lacked details and the teeth to make a major impact without an act of Congress.
CAREER HUB
What is the culture like at your company? Are employees motivated to do their best work? Is your company using employee engagement strategies to improve productivity?
According to a survey by CareerBuilder, 23% of hiring managers spend less than 30 seconds reading a resume. Make the most of those seconds with these five tips to make your resume stand out.
We spoke with Alison Senkovich O’Sullivan, Senior Director of Human Resources at Athersys, about how to ace an interview and what candidates can do to prepare.
BioSpace spoke with Annick Deschoolmeester, Head of Human Resources at Pharvaris, about some of the ways she’s noticed small companies differ from large ones.
We sat down with Associate Director of Talent Acquisition Jennifer Metivier and Chief People Officer Jennifer Peterson of Obsidian Therapeutics to discuss what type of candidates they prefer.
If you’re considering a career change from pharma to biotech, you’ll be happy to hear that according to industry experts, the transition is more common than you might think.
Keep reading to take a look at some of the best pharma jobs for travelers. These jobs will allow you to see different parts of the world while working in an exciting and fast-paced 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
J&J reports today, just two weeks after Pfizer secured certainty on tariffs and drug pricing. Analysts expect to hear about plans from the rest of the industry during third period earnings calls.
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. At the heart of the deal is the drug candidate dordaviprone, which is months away from a regulatory verdict for its use in H3 K27M-mutated diffuse glioma.
  2. 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.
  3. Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.
  4. The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the drug in gastric and gastroesophageal cancers as BeiGene also pushes forward a pipeline of novel cancer therapies.
  5. The partners are pushing to expand Enhertu’s list of indications beyond its standing uses in breast, lung and gastric cancers.
NEUROSCIENCE
  1. The U.S. Court of Federal Claims ruled that Vanda cannot claim a breach of confidentiality for specifications that it did not develop itself.
  2. Cebranopadol, a dual-NMR agonist, reached the primary endpoint in a Phase III trial and matched placebo for safety, a significant concern in the analgesic field.
  3. Spravato’s monotherapy nod on Tuesday comes after a series of setbacks in the depression space.
  4. The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a previous pause.
  5. 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.
CELL AND GENE THERAPY
  1. FDA
    Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.
  2. In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum.
  3. In a deal expected to close in Q1 2025, Roche will gain access to Poseida’s off-the-shelf CAR T candidates.
  4. By mid-2025, the biotech will split into two entities: a new, as-yet-unnamed innovative medicines specialist and a cell therapy company, the latter of which will inherit the Galapagos name.
  5. BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.