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Scientists who focus only on generating data risk missing their role in shaping strategy and driving innovation.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
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.
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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 therapeutic targets of many of our top startups are also reflected in recent big biopharma acquisitions and partnerships.
In a major pivot, Allogene Therapeutics will no longer focus on two of its studies testing blood cancer therapy cema-cel in an effort to extend its financial runway into 2026.
While initial public offering activity was light in 2023, the new year has recorded the first IPO plan—from California-based CG Oncology.
Eli Lilly on Thursday announced the rollout of a new digital healthcare platform to streamline consumer access to its weight-loss drug Zepbound and other medications.
With recent scientific advances, milestone approvals and increased dealmaking, the future of treatment for neurological diseases looks brighter—but continued investment, collaboration and patient-focused efforts are key.
The two agreements announced Thursday will allow AbbVie to leverage Umoja Biopharma’s VivoVec delivery platform, which enables patients’ cells to produce their own cancer-fighting CAR-T cells.
The regulator is launching an investigation of Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound and other GLP-1 receptor agonists following patient reports of suicidal ideation, alopecia and aspiration.
In the third deal in as many days, Roche is paying $66 million upfront to MOMA Therapeutics to find new drugs to go after cancer cell growth, with a potential $2 billion total in milestones and royalties.
Wednesday’s settlement resolves a legal dispute between Daiichi Sankyo Europe and Esperion Therapeutics regarding milestone payments under their cardiovascular drug collaboration.
The late-stage pharmacokinetic study was stopped early due to efficacy at interim analysis, Lyndra Therapeutics said Thursday. A six-month safety study will start in the second half of 2024.