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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.
If ultimately confirmed, Makary’s planned departure, broken by The Wall Street Journal Friday afternoon, would follow a controversial tenure in which his deputy and constant co-author Vinay Prasad riled biopharma feathers with myriad unexpected drug rejections. Prasad stepped down as biologics chief last week.
The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.
Eli Lilly’s latest manufacturing expansion will support production of obesity blockbusters and next-gen assets, while the new Lilly Lebanon Advanced Therapies site will take experimental genetic medicines from research to commercialization.
Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
With initial patients coming back for their second dose of Gilead’s twice-yearly PrEP injection, the pharma thinks the shot will hit $1 billion in sales this year, serving as “a cornerstone in Gilead’s revenue growth story.”
Before discontinuing the asset, Ascendis Pharma was studying onvapegleukin alfa in advanced or metastatic solid tumors, demonstrating a three- to four-month overall survival advantage over historical controls.
Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.
The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.
Catalyst Pharmaceuticals comes with a trio of approved drugs as Angelini Pharma expands its neuroscience offerings.
