FDA
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
Rinvoq’s efficacy in alopecia areata is “impressive,” according to Guggenheim analysts, who said the drug could have a competitive edge over other JAK inhibitors in the space.
Long-term extension data presented at the Alzheimer’s Association International Conference showed amyloid plaque reaccumulation remained slow at up to 2.5 years of follow-up in patients who were taken off of treatment with Eli Lilly’s anti-amyloid antibody.
Looking for a biopharma job in North Carolina? Check out the BioSpace list of seven companies hiring life sciences professionals like you.
A new report found that 85% of pharma respondents are increasing their artificial intelligence investments, and 70% see AI as an immediate priority. Two experts discuss how biopharmas are implementing and adopting AI, including their increased use of external help with the process.
George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a second FDA division to his portfolio after Vinay Prasad’s sudden departure.
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.
FEATURED STORIES
What a CEO makes can be staggering from the seat of a rank-and-file employee, whose pay is typically in the five-to-six digit range.
Policy uncertainties are impacting biopharma dealmaking from continent to continent, with companies being asked to walk a tightrope on their relations with China.
Major pharmaceutical companies are committing billions to US manufacturing in an effort to avoid steep tariffs threatened by President Donald Trump.
FDA
In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment.
FDA
As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks’ legacy will carry on.
FDA
As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. Learn how strategic insights and targeted outreach can turn awareness into high-converting leads.
LATEST PODCASTS
Donald Trump continues to make waves in biopharma; Sage rejects Biogen’s unsolicited takeover offer; the obesity space sees more action with new company launches, IPOs and fresh data; and experts get ready for an important era in the Duchenne muscular dystrophy space.
Biopharma executives shared their thoughts on the potential impacts of the new administration; Annalee Armstrong recaps JPM and her talks with Biogen, Gilead, Novavax and more; Wegovy’s higher dose induces more weight loss; AstraZeneca and Daiichi Sankyo’s Dato-DXd scores its first FDA approval.
In this bonus episode, BioSpace’s vice president of marketing ⁠Chantal Dresner⁠ and careers editor ⁠Angela Gabriel⁠ take a look at Q4 job market performance and what we expect to see ahead.
Job Trends
2seventy bio, Inc., announced the completion of an asset purchase agreement by Novo Nordisk. Under the terms of the APA, Novo Nordisk has acquired the Hemophilia A program and rights to 2seventy’s in vivo gene editing technology outside of oncology and gene editing for autologous or allogeneic cell therapies of immune cells for the treatment of autoimmune disease.
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SPECIAL EDITIONS
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
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.
DEALS
  1. Protein degradation–focused Neomorph nabs its third Big Pharma deal of around $1.5 billion in less than a year.
  2. The deal follows a $1.06 billion U.S. contract in July 2024 and a $1.24 billion agreement with an Asia-based pharma a few months later.
  3. On the company’s Q4 earnings call where an eyepopping $88.8 billion in full-year sales were revealed, leaders shifted focus away from enormous takeovers to single-digit billion buy outs.
  4. With an eye toward advancing a novel antibody-drug conjugate for gastrointestinal cancers, ArriVent is the latest biopharma player to ink a deal with a Chinese biotech.
  5. Five years ago, Gilead signed a massive deal with Galapagos. After a restructuring, the pharma is still hunting for the potential it saw at the original signing.
WEIGHT LOSS
  1. Roche and Zealand plan to study petrelintide as a monotherapy and in combination with CT-388, a dual agonist of the GLP-1 and GIP receptors that Roche picked up in its recent acquisition of Carmot Therapeutics.
  2. BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.
  3. Analysts acknowledged the long-term manufacturing deal could dull Viking’s takeout prospects but hailed it as a smart move to ensure supply.
  4. The latest data showed 15.7% weight loss in patients with diabetes after 68 weeks. In December 2024, CagriSema returned another disappointing readout for Novo, eliciting weight-loss of 22.7% in patients without diabetes, below the pharma’s prior projection of 25%.
  5. While drug developers work to mitigate the side effects associated with GLP-1–based obesity drugs, recent studies reveal that myriad variables are causing patients to stop treatment.
POLICY
  1. In a letter to the Department of Commerce, Novo Nordisk argued that unsanctioned compounded semaglutide, mostly from China, constitutes a national security threat to the U.S.
  2. Leerink Partners previews the drugs likely to be subject to the Inflation Reduction Act’s next price negotiations as the program expands to Medicare Part B and smaller biotechs.
  3. A February executive order on pharmaceutical price transparency does nothing to change the incentives that keep costs opaque. But drug companies and other stakeholders would reap the benefits of such disclosures.
  4. In a video posted to social media on Tuesday, HHS Secretary Robert F. Kennedy, Jr. claimed that there is a lack of clinical data to support the repeat COVID-19 booster strategy in children.
  5. Rouzbeh Haghighat was serving on the board of Chinook Therapeutics at the time of the Novartis acquisition and, according to the DOJ’s allegations, used confidential information to conduct insider trading.
CAREER HUB
In this job market report we’re reviewing life sciences job market movement in Q3 and what to expect for Q4 and beyond.
Staffing agencies say contract work is a great way to break into an industry and avoid a resume gap.
Plus, tips on applying to multiple jobs at the same company, making new work friends, and how to ask for more time at the offer stage.
Presentations are standard requirements in the hiring process for some biopharma positions. Here’s how to approach them.
Depending on their needs, candidates can choose among tools such as AI-powered resume generators, professional coaches and university career services to hone their applications.
Companies are relying on artificial intelligence–powered applicant tracking systems to keep up the evolving recruitment demands. Here is how.
Artificial intelligence and a flood of data in the pharmaceutical industry will likely change some of the current functions of its data scientists, experts say, but the ability to learn and adapt to new technologies will remain key in this role.
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
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.
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. Pfizer’s sasanlimab, when used with standard of care, reduced the likelihood of disease recurrence or progression, death due to any cause or persistence of cancer cells by 32% in patients with high-risk non-muscle invasive bladder cancer.
  2. The targeted drug release device TAR-200 shows promising response and disease-free survival rates in specific populations of patients with non-muscle-invasive bladder cancer.
  3. The FDA is currently reviewing Merck’s sBLA for Keytruda in head and neck cancer, with a target action date of June 23.
  4. The transaction is expected to close in the second half of 2025. With the deal, Merck KGaA is adding to its rare disease and oncology pipelines.
  5. With ivonescimab’s data coming solely from China, its prospects in the U.S., where Summit owns the rights, remain up in the air.
NEUROSCIENCE
  1. Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.
  2. Analysts do not believe the Phase III stumble for aticaprant will derail J&J’s broader neuroscience strategy, particularly given its recent $14.6 billion acquisition of Intra-Cellular Therapeutics and the success of Spravato for treatment-resistant depression.
  3. The new formulation of Keytruda, currently under FDA review, is sparking conflict with Halozyme, which makes enzymes that convert intravenous drugs into injectable versions.
  4. Biohaven in recent months has reported a clinical stumble in spinal muscular atrophy, alongside a Phase I readout for its protein degrader candidate that investors found underwhelming.
  5. After failing to hit the primary endpoint in a Phase III trial, Neumora is remixing study parameters in two replicate trials, with data expected in the first half of 2026.
CELL AND GENE THERAPY
  1. On the agenda for the FDA this month are two RNA-based treatments for rare diseases.
  2. The search for a partner for zerlasiran is ongoing, according to Silence. In the meantime, the biotech will focus its resources on divesiran, which it is testing for polycythemia vera and other hematologic indications.
  3. ITF, IntraBio and Orchard are among the companies that have won FDA nods in the past year for Duchenne muscular dystrophy, Niemann-Pick disease type C, metachromatic leukodystrophy and more.
  4. The companies were two years into a four-year, $400 million agreement aimed at developing and marketing gene therapies together.
  5. As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.