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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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Incyte Corporation’s Phase III LIMBER-304 clinical trial has come to an end following a third-party investigation that forecasted poor results.
Voyager Therapeutics unlocked a potential $600 million plus $25 million upfront as Novartis exercised its option to leverage the company’s capsids against two undisclosed neurologic disease targets.
The FDA’s Oncologic Drugs Advisory Committee will meet March 9 to discuss Roche’s sBLA for Polivy in first-line DLBCL, while Acadia awaits potential approval of the first therapy for Rett Syndrome.
Shares of Praxis Precision Medicines dropped 48% Friday morning following mixed Phase II results for ulixacaltamide (PRAX-944), its candidate being studied in movement disorder essential tremor.
Sen. Bernie Sanders (I-VT), chairman of the Senate’s Health, Education, Labor and Pensions Committee, sent a letter to Sanofi and Novo Nordisk urging them to lower insulin prices.
Phase III data showed the combination of Roche’s Tecentriq and Exelixis’ Cabometyx fell short of its primary endpoint in renal cell carcinoma.
In 2022, Elon Musk’s Neuralink tried – and failed – to secure permission from the FDA to run a human trial of its implantable brain-computer interface, according to a report published Thursday.
MorphoSys AG announced Thursday it plans to drop its pre-clinical programs and cut 17% of its workforce in an effort to extend its cash runway.
Novo Nordisk announced Thursday it plans to expand its research and development operations in the greater Boston area and add over 200 new jobs this year.
Thymmune is backed by an A-list team of investors including Pillar VC, former Alnylam CEO John Maraganore and famed geneticist George Church.