President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
BioNTech will get CureVac’s early-stage cancer assets, including its mRNA-based glioblastoma therapy currently in Phase I development. CureVac had previously sued BioNTech for copyright infringement related to mRNA vaccine technology.
Nuvation Bio’s first approved product is Ibtrozi, a CNS-active ROS1 inhibitor that in pivotal studies showed high rates of treatment response in patients with non-small cell lung cancer.
The rehired staff, who number around 460, work with the CDC’s viral disease prevention efforts and sexual health testing labs, among others. The reinstatements are a ray of light in an acrimonious week that also saw protests and the complete overhaul of the agency’s vaccine advisory committee.
The eight new committee members replace the 17 Kennedy removed earlier this week. In “repopulating” the committee, the HHS Secretary fulfilled the fears of some analysts, naming scientists who appear to reflect his anti-vaccine views.
The downsizing comes after a year of workforce cuts and reorganization for Roche’s subsidiary.
FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s priorities, including accelerating cures and the rapid deployment of artificial intelligence.
FEATURED STORIES
While Thursday’s label expansion and traditional approval for the gene therapy is an important milestone, many challenges still face the Duchenne muscular dystrophy community.
On the heels of a Phase III flop for Pfizer’s Duchenne muscular dystrophy gene therapy candidate, the FDA has green lighted the expanded use of Sarepta Therapeutics’ Elevidys.
The pharma industry is staring down the barrel of a widespread loss of exclusivity, with more than 190 products going off-patent between 2022 and 2030. Here are some strategies company are employing to manage the drop in revenue.
Four executives with collective decades spent at BMS, Roche, Astellas, Eli Lilly and more gave their insights on navigating a biopharma career during a Monday DIA panel in San Diego.
The next six months for the FDA are primed to be as groundbreaking as the first six, with Eli Lilly’s donanemab and Lykos Therapeutics’ MDMA-assisted PTSD therapy on the docket, among others.
The FDA is facing four big target action dates in the final week of June, including one label expansion for a bispecific antibody and another for an investigational gene therapy.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. This webinar will show leaders how strategic insights and targeted outreach can turn awareness into high-converting leads. Watch now.
LATEST PODCASTS
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
Job Trends
A2 Biotherapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to A2B530 for the treatment of germline heterozygous HLA-A*02(+) patients with colorectal cancer that expresses carcinoembryonic antigen (CEA) and has lost HLA-A*02 expression.
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SPECIAL EDITIONS
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.
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.
DEALS
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Warning signs that preceded the current economic squeeze in the biopharma sector were not heeded by investors seeking rapid profits. Now, biotechs interested in making the leap to the public markets must get creative. -
Following a countersuit by Amgen and Horizon Therapeutics, the Federal Trade Commission has temporarily suspended its challenge to the multi-billion dollar merger between the two companies. -
Following its Scorpion Capital controversy in March, Harmony Biosciences is seeking to deepen its pipeline with an acquisition of Zynerba Pharmaceuticals’ cannabinoid therapies for neuropsychiatric disorders. -
Week in Review: Novo Nordisk Riding High, Novavax in the Black (For Now), Nektar Sues Lilly and MoreNovo’s weight-loss drug Wegovy improves cardiovascular outcomes, Novavax posts surprise Q2 profit, while Nektar Therapeutics files lawsuit against Eli Lilly for misconduct in drug development deal. -
The Securities and Exchange Commission has joined the mounting antitrust scrutiny of Illumina’s acquisition of the cancer diagnostics company, according to an SEC filing by the DNA sequencing giant.
WEIGHT LOSS
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Novo Nordisk’s investment of more than half a billion dollars is meant to expand its production capabilities in China and help it meet the global drug demand. -
Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact. -
Eli Lilly has partnered with Amazon Pharmacy to help fill online orders of its obesity drug Zepbound—as well as migraine and diabetes medicines—placed through the pharma’s online portal LillyDirect. -
Novo Nordisk’s blockbuster weight-loss drug Wegovy was approved on Friday by the FDA to reduce the risk of cardiovascular death, heart attack and stroke in adults who have cardiovascular disease and are obese or overweight. -
Novo Nordisk’s early-stage amylin and GLP-1 co-agonist elicited a 13.1% reduction in body weight, with an overall favorable safety profile, the Danish drugmaker reported Thursday at an investor event.
POLICY
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In the latest setback for the pharma industry and its allies, the United States District Court for the Southern District of Ohio dismissed a U.S. Chamber of Commerce lawsuit on the grounds of improper venue. -
Lobbying groups and individuals connected with the industry are supporting candidates from both parties, with a particular focus on the future of the 340B discount program and pharmacy benefit managers. -
Reiterating his ruling in a prior Inflation Reduction Act case, New Jersey District Court Judge Zahid Quraishi ruled that Novo Nordisk’s participation in the Medicare Drug Price Negotiation Program is of its own free will.
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The BIOSECURE Act’s prohibition on doing business with China-based companies may have implications for biotech and biopharma markets on both sides of the Pacific. -
With the BIOSECURE Act likely to be voted on in Congress this year, WuXi AppTec’s U.S. revenue dropped 1.2% in the first half of 2024 while the Chinese company increased its lobbying efforts.
No matter how much you justify ghosting, it’s likely to be seen as an unprofessional reputation-killer you may never recover from. Here are some situations in which you might be tempted to ghost and what to do instead.
Most of the interview process is out of your hands, for better or for worse. But what you can control are your actions.
Besides making sure you don’t accidentally reply all to that company-wide notice, here are some words to reserve for your texts with friends.
The words and phrases you choose in your resume and cover letter can have a surprisingly powerful impact.
How do you leave your nerves behind and show your interviewer the real you? Here are a few tips for mastering interview small talk.
For the third part of a six-part series examining the six most in-demand biotech careers, we take a detailed look at the rising career of an operations research analyst.
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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In 2023, the ADC market exceeded $10 billion, and this momentum is persisting into 2024, as evidenced by several strategic deals and a robust pipeline of candidate drugs.
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Gilead Sciences’ blockbuster antibody-drug conjugate Trodelvy has encountered some clinical speed bumps in 2024 in bladder and lung cancer. Still, analysts remain bullish on its prospects in the oncology space. -
The FDA on Thursday rejected Merck and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate patritumab deruxtecan in a Complete Response Letter, citing problems with a third-party manufacturer. -
AbbVie and Genmab on Wednesday announced the FDA has expanded the label of their bispecific antibody Epkinly, allowing it to be used in patients with relapsed or refractory follicular lymphoma. -
One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment.
NEUROSCIENCE
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The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy. -
The FDA has rejected Minerva Neurosciences’ treatment for negative symptoms in schizophrenia, noting a lack of data and other factors that led to the Complete Response Letter. -
In a Phase II study, Sanofi and Denali’s RIPK1 inhibitor SAR443820/DNL788 failed to meet the primary endpoint of improved functional performance in amyotrophic lateral sclerosis patients. -
Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it. -
The French drugmaker Thursday touted trial results in The New England Journal of Medicine showing frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis.
CELL AND GENE THERAPY
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Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy. -
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines. -
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. -
Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy.
