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Of the 13 programs that the companies will advance, four will come from Hengrui Pharma and four from Bristol Myers Squibb. The remaining five assets will be jointly discovered.
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The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
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The San Diego-based startup, specializing in allogeneic engineered Treg and CAR-Treg cell therapies, plans to be in Phase I clinical trials in multiple indications in 2024.
The sweeping changes are meant to “reduce hierarchies” and “accelerate decision-making” as Bayer weathers several business crises and continues to suffer from the fallout of its disastrous Monsanto acquisition.
In a changing landscape, top companies are increasingly embracing remote work.
When combined with Tecentriq and chemotherapy, tiroagolumab increased median survival to 15.7 months compared to 11.1 months for patients with esophageal squamous cell carcinoma on chemo alone.
The team comes together to discuss the dominant themes of what was an incredibly busy week of events in San Francisco during JPM 2024.
The U.S. Patent and Trademark Office has sided with Daiichi over Seagen in a years-long patent saga concerning a key linker technology used in its blockbuster Enhertu antibody-drug conjugate for cancer.
The FDA on Tuesday extended the label for Takeda’s immune globulin infusion as a maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy.
Delaware Chancery Court Judge Paul Fioravanti on Tuesday ordered activist investor Carl Icahn to remove confidential information from his lawsuit against legacy Illumina board members.
Vertex Pharmaceuticals and CRISPR Therapeutics have secured another FDA approval for their Casgevy Cas9 gene-edited cell therapy, this time in treating transfusion-dependent beta thalassemia.
Disco Pharmaceuticals is taking to the biotech dance floor with seed funding from major players and pipeline programs in small cell lung cancer and colorectal cancer.