Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
In this bonus episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel take a look at Q2 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.
Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump administration could move forward with its sweeping reorganization of the agency.
HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the heels of the landmark Yeztugo approval.
According to Makary, reducing user fees—which make up just under half of the FDA’s budget—could make it easier for smaller companies, individual investors and academics to participate in the process.
The molecule, developed in collaboration with Massachusetts-based Kailera Therapeutics, is headed for a new drug application in China and global clinical trials.
FEATURED STORIES
In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.
LATEST PODCASTS
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
In this episode presented by Element Materials Technology, BioSpace’s head of insights discusses how China, historically focused on manufacturing, is increasingly becoming an innovation leader, particularly in pharmaceuticals, with guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney. Ultimately, balanced strategies involve domestic capacity investments coupled with global collaboration.
Job Trends
AIM ImmunoTech Inc. today announced that the first subject has been enrolled at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen ® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi ® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC Study”).
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
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.
DEALS
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Shockwave Medical bolsters medical device portfolio with acquisition of Neovasc. -
Massachusetts-based biotech Leap Therapeutics announced Tuesday that it had entered into a merger deal with the privately-held Flame Biosciences, Inc. -
Elicio Therapeutics entered into a merger agreement as a wholly-owned subsidiary of Angion Biomedica Co. on Tuesday, becoming a Nasdaq-listed company. -
If the letter of intent to acquire your company has been signed, you might be asking what happens next. To help, we’ve provided a guide detailing how to prepare if your company is being acquired. -
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week.
WEIGHT LOSS
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During a press conference to announce a drug price deal for GLP-1s, President Donald Trump asked for more details about the ongoing bidding war between Novo Nordisk and Pfizer over obesity biotech Metsera. -
The nausea and other gastrointestinal side effects of weight loss drugs like Novo Nordisk’s Wegovy or Eli Lilly’s Zepbound will limit how much these drugs can help patients and stunt the overall obesity market unless we approach the problem head on. -
The agreement will also secure a $150 price for future weight loss pills from Novo Nordisk and Eli Lilly—at least initially. -
The highest dose of Eli Lilly’s eloralintide led to 20.1% weight loss after 48 weeks in a Phase II trial, exceeding analyst expectations and highlighting a “potentially best in class profile,” according to BMO Capital Markets. -
In an investor call Thursday, AstraZeneca CEO Pascal Soriot outlined his company’s approach to obesity drug development based on “the medical aspect” of weight loss, including driving down visceral fat.
POLICY
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Novo Nordisk CEO Lars Jørgensen has agreed to appear before the Senate health committee in a hearing on the prices of its blockbuster drugs Ozempic and Wegovy. -
The European Commission has tagged India-based pharma Alchem as being part of a global cartel that coordinates the pricing of a pharmaceutical ingredient in the antispasmodic drug Buscopan. -
The U.S. Supreme Court on Thursday upheld access to the abortion pill mifepristone, unanimously rejecting a challenge by a group of anti-abortion doctors seeking to undo the FDA’s approval of the drug. -
Based on promising response data from the Phase I/II TRIDENT-1 study, the FDA on Thursday granted Bristol Myers Squibb’s Augtyro accelerated approval for NTRK-positive locally advanced or metastatic solid tumors. -
Shifts in the FDA’s approach present an unprecedented opportunity to solve problems with patient access and trial design.
There is a common misconception that hiring slows down during November and December. If anything, this is when you should ramp up your efforts to find great candidates. There are several reasons for this.
Should you be looking for another job? Or are you actually in a good employment situation, and simply being carried away by others’ experiences on LinkedIn or Facebook?
Do you know what your “dream job” is? Would you be able to identify it if you had multiple job offers? Many people are in search of a dream job, but don’t really know how to find one and what makes it different than other average job opportunities.
What happens in the final moments of a job interview is probably one of the most overlooked aspects of the entire job seeking or hiring process, and how you conduct yourself at these critical final moments can sway the offer in your favor (or out of it), especially if you’re in tight competition with other highly-qualified applicants.
If you’re applying for multiple jobs at the same time, perhaps over several weeks or months, things can quickly spiral out of control. You can easily find yourself with 10 or 20 different versions of your resume or cover letter floating around on your desktop, requests for materials coming at you from every direction, and a long to-do list of follow-ups, thank you notes, and applications that need submitting.
Do you need a new job, like, yesterday? Whatever your reasons for needing (or wanting) a new employer as quickly as possible, if you’re looking to kick your job search into overdrive there are a number of things you can do to speed things along.
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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After several delays, BeiGene on Thursday finally secured the FDA’s approval for its PD-1 inhibitor Tevimbra for the treatment of unresectable or metastatic esophageal squamous cell carcinoma. -
Antibody-drug conjugate Adcetris, when used with rituximab or lenalidomide, improved overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma. Pfizer secured access to Seagen’s ADC in March 2023. -
BeiGene’s Brukinsa becomes the first BTK inhibitor approved for follicular lymphoma, the most common type of low-grade non-Hodgkin lymphoma. -
Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness. -
Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene.
NEUROSCIENCE
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Athira Pharma’s experimental Alzheimer’s therapy, fosgonimeton, continues to show signs of being able to improve cognition and function in patients. -
Eli Lilly’s investigational antibody donanemab met all of its primary and secondary endpoints in the Phase III TRAILBLAZER-ALZ 4 study, the company announced Wednesday. -
BioSpace sat down with Roche Global Head of Neurodegeneration Rachelle Doody, Ph.D. and Alzheimer’s Drug Discovery Foundation Co-founder Howard Fillit, M.D. to discuss the highlights. -
Full data from the Phase III Clarity AD trial show Eisai and Biogen’s lecanemab has a favorable safety profile in patients with Alzheimer’s disease. -
With $96 million in Series A financing, Cajal Neuroscience launched Tuesday to develop drug candidates to target neurodegeneration in Alzheimer’s and Parkinson’s diseases.
CELL AND GENE THERAPY
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The FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex-z. -
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study. -
The potential approval of Vertex’s IgAN therapy povetacicept in 2026 comes amid launch headwinds for the company’s non-opioid pain medicine Journavx and gene therapy Casgevy. -
With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair. -
The clinical hold comes days after Intellia voluntarily paused enrollment and dosing in the same two studies.
