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.
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.
Acelyrin and Alumis plan to close their merger in the second quarter of 2025, pending clearances and shareholder approval.
The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices.
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.
Less than two months after two FDA-related setbacks, Atara Biotherapeutics is again cutting its workforce in half. This time, it’s also hitting pause on two CAR T programs, including one affected by an FDA clinical hold in January.
FEATURED STORIES
This week marked the start of the third-quarter earnings season, with Johnson & Johnson exceeding Wall Street’s expectations. Pfizer is projected to have a strong quarter, while Eli Lilly could pull ahead of Novo Nordisk in the obesity space. Moderna, by contrast, has a decidedly negative outlook.
Artificial intelligence won’t replace people in biopharma, but it is infiltrating every step of drug development, including in some ways that aren’t so obvious.
Sanofi looks to follow a deep history of Big Pharma offloading their consumer healthcare businesses.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can help organizations navigate a rapidly evolving regulatory environment with senior director of regulatory innovation and technology, Michelle Gyzen.
Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report.
HHS Secretary RFK Jr. removes the COVID-19 vaccine recommendation for healthy kids and pregnant women—the latest in a string of changes to vaccine policies; judge issues an order to halt HHS’ reorganization and mass layoff plans; Rocket Pharmaceuticals’ pivotal Danon disease trial is on hold after a patient death; and President Trump has named Mehmet Oz to spearhead his Most Favored Nation drug pricing policy.
Job Trends
Takeda Canada Inc. is pleased to announce its support of the Canadian Inflammatory Bowel Disease Research Consortium’s $1 million PIONEER Grant in its second year.
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SPECIAL EDITIONS
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.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
DEALS
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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. -
In a presentation led by Robert J. Bradway, Amgen chairman and chief executive officer, the company covered recent acquisitions, Repatha and Lumakras updates, biosimilars and its broader financial outlook. -
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week.
WEIGHT LOSS
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Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy. -
Eli Lilly joins up with Camurus to make long-acting versions of the pharma’s obesity and diabetes drugs, joining the industry’s growing pipeline of programs that are differentiated by the frequency of dosing. -
Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report. -
Regeneron’s shares have declined nearly 17% following the failure of the company’s Dupixent follow-up itepekimab. -
The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations.
POLICY
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While Bristol Myers Squibb did not explicitly mention China as the company expands and diversifies its manufacturing capacity, Cellares said the BIOSECURE Act would be a boon to its own growth. -
The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz. -
The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues. -
Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer. -
Policy changes by health insurance companies will likely determine which Humira biosimilars rise to the top.
Why should you research prospective employers as you approach your life sciences job search?
These words are used frequently for a reason. But what are companies really getting at with these job description buzz words?
You made it through the hardest parts of the job-seeking process — you crafted an excellent application, thoroughly researched the company and aced the interviews. Now you just need to decide whether to accept the offer extended to you.
Some hiring managers will not hire those who don’t thank them; others, given two equal candidates, will choose the one who sent a thank you.
Do you wake up every morning dreading going to work? If this happens to you even once a week, it may be time to start looking for a new gig.
Here are three reasons why you need to boast a little, and ways to do just that.
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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AstraZeneca has been struggling to find an effective use for its anti-CTLA-4 antibody tremelimumab. It may have finally found it. -
Less private investment and innovation in the development of new antibiotics are impeding efforts to combat drug-resistant infections. -
Of these six patients, three had a partial response (PR) with their tumors shrinking by more than 30%. -
Triumvira’s inaugural program is directed against HER2, a well-known tumor-associated antigen that is expressed in multiple tumors. -
The oncogenicity and neurotoxicity risks of AAVs and possible mitigation strategies were the primary focus on Thursday.
NEUROSCIENCE
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Recently published research into repairing nerve damage caused by injury may also pay off in treating some of the most vexing neurodegenerative diseases like Alzheimer’s. -
Alzheon Inc. unveiled promising data from a Phase II biomarker trial of its investigational drug ALZ-801 to treat early Alzheimer’s disease. -
Research on Alzheimer’s, specifically in neuroscience, continues with the Alzheimer’s Drug Discovery Foundation, Critical Path Institute, Abbvie, AlzeCure Pharma and more. -
BioVie announced topline results from a Phase II biomarker study in Alzheimer’s disease showing patient improvements in cognition and reductions in neural inflammation.
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NIH researchers found that symptomatic herpes viruses were associated with neurological symptoms, but there was no evidence that herpes viruses are linked to Alzheimer’s disease.
CELL AND GENE THERAPY
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In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that keep cell and gene therapies from the market. -
Interim results from a small group of children in a Phase I/II trial are essentially in line with that of Elevidys, according to BMO Capital Markets analysts. -
The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases. -
J&J has a multi-year head start, but Gilead believes it can win market share by delivering a drug with better safety and at least as good efficacy. -
While an adverse event reported in Intellia’s gene therapy trial was a “non-concern” for analysts, it follows a handful of patient deaths in other trials for the modality and sent the company’s stock tumbling in pre-market trading.
