Last week, Eli Lilly also responded to the President’s tariff warnings by investing $27 billion to construct four manufacturing facilities across the U.S. in five years.
The partners are pushing to expand Enhertu’s list of indications beyond its standing uses in breast, lung and gastric cancers.
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.
In the second podcast in a special series focused on BioSpace’s NextGen Class of 2025, Senior Editor Annalee Armstrong speaks with Kevin Marks, CEO of Delphia Therapeutics.
Delphia launched in May 2024 with the goal of forcing malignant cells to overactivate and die.
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.
FEATURED STORIES
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
Large pharmaceutical companies were out in force at this week’s 2024 Cell & Gene Meeting on the Mesa, as they look to expand their presence in the industry.
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
Sana Biotechnology, Inc., a company focused on changing the possible for patients through engineered cells, announced that it has commenced an underwritten public offering of $125.0 million of shares of its common stock.
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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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Thursday, Fate Therapeutics announced it terminated the 2020 collaboration agreement with Johnson & Johnson’s biopharma subsidiary Janssen. -
Aurinia and Sun Pharma agree to file a joint motion to dismiss a key patent dispute. -
Merck entered into a license and collaboration agreement with Chinese company Kelun-Biotech to develop seven antibody-drug conjugates candidates against oncology targets. -
Third Harmonic Bio drops its Phase 1b asset. -
See inside for BioSpace’s compilation of the five biggest M&A deals of 2022.
WEIGHT LOSS
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In what Guggenheim Partners called one of Metsera’s “critical program milestones” this year, its ultra-long-acting amylin injection MET-233i showed promising weight-loss over about eight months. -
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.
POLICY
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Following an investigation regarding antitrust practices against Pharmacosmos’ Monofer, CSL Vifor has proposed a sweeping multi-channel communication campaign designed to reverse allegedly misleading messages about its rival. -
Following a months-long safety review, the regulator on Thursday said it is now requiring updated black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies. -
The FDA will close out April with five target action dates around indications that include pediatric seizures and a neurological cancer in children. -
Novartis on Monday shared late-stage data for its potential multibillion-dollar drug Fabhalta, in what the company contends is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in IgA nephropathy patients. -
A federal court in Massachusetts has granted Pfizer and BioNTech’s motion to put on hold Moderna’s lawsuit over alleged patent infringement related to their COVID-19 vaccine Comirnaty.
Think of your career as a living, breathing thing. In order to keep it alive, you need to continually feed it so it can thrive. But how do you do that?
Knowing how to spruce up the document can help you be remembered. Here are some ways to set yourself apart with your cover letter!
The idea is to have a conversation with someone holding a job like the one you’d like to have and perform informational interviews to ask all about what the job is like.
When you’re evaluating a job offer it can be hard to look past the salary. But if a company can’t budge on their budget, it’s time to think about other things they may be able to offer you.
Virtually every aspect of what employers seek can be framed as an accomplishment – skills, values, experience, results, subject-matter knowledge, uniqueness, proof of performance.
How will you ensure that you aren’t overqualified for your next position?
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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The drug was approved as a second-line treatment for HCC patients who have an alpha-fetoprotein biomarker. -
Keytruda failed to show a statistical significance in overall survival and progression free survival in the Phase III trial. -
Luckily, primary malignant liver tumors in children are rare. They account for only 1 to 2 percent of all childhood cancers. The most common treatment is surgery and chemotherapy. However, not all can be treated by surgery and sometimes they do not respond to chemotherapy.
NEUROSCIENCE
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This week’s highlights in neurological diseases include Acadia receiving a CRL for its ADP drug, Sosei and Neurocrine’s schizophrenia drug study moving on to Phase II. -
This week, drugs developed by Neurocrine Biosciences, Akebia, Eliem and Athira all failed to meet expectations in clinical trials. -
Researchers have found that two common viruses—the varicella zoster and herpes simplex viruses—likely constitute a pathway that leads to Alzheimer’s disease. -
Roche signed a big $6 billion-plus collaboration deal with Poseida on blood cancers while its partner, AC Immune, parsed failed data on an Alzheimer’s drug to suggest a positive spin. -
The annual Alzheimer’s Association International Conference (AAIC) is running from July 31-August 4 at the San Diego Convention Center and online. Here are some of the highlights presented so far.
CELL AND GENE THERAPY
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Avidity has been given the go-ahead by the FDA to request accelerated approval of delpacibart braxlosiran—potentially the first disease-modifying treatment for facioscapulohumeral muscular dystrophy—with an application in the second half of 2026. -
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.
