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FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
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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 companies have been embroiled in a row about compounded GLP-1 drugs that escalated to a lawsuit last month. The legal action has now been dropped and the former adversaries have struck a deal that could increase access to Novo’s obesity medicines.
Hansoh’s olatorepatide achieved 19% weight loss at 48 weeks in a Phase 3 trial in China, handing partner Regeneron a glimmer of hope for a pipeline in desperate need of reinvigoration.
Roche’s shares tumbled nearly 5% on news that a key pillar in the five-pronged clinical plan for the breast cancer asset giredestrant was unsuccessful.
Azetukalner, a Kv7 potassium channel opener, reduced the frequency of focal onset seizures by a placebo-adjusted rate of 42.7%. Xenon Pharmaceuticals believes this is the highest such efficacy “observed in a pivotal epilepsy study,” CEO Ian Mortimer said Monday.
Ipsen will withdraw Tazverik’s follicular lymphoma and epithelioid sarcoma indications as emerging data point to an elevated safety risk in patients undergoing treatment.
The FDA’s cancer advisors will discuss AstraZeneca’s application for the oral SERD camizestrant in breast cancer and the AKT inhibitor Truqap in prostate cancer.
Some biotechs that had seen regulatory setbacks under Center for Biologics Evaluation and Research director Vinay Prasad experienced stock bumps Monday morning. Under Prasad’s leadership, the rare disease space has suffered a series of controversial rejections.
Incyte is looking to expand the use of its PD-1 blocker Zynyz to treat non-small cell lung cancer. The FDA’s rejection did not flag problems with the drug’s efficacy or safety.
A “significant number of patients” could see a cure for multiple myeloma within the next two decades, one expert told BioSpace. Here are five therapies that could change the treatment paradigm.
Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle feathers in biopharma after presiding over the rejection of several rare disease therapies.