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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.
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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.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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The biotech will use the oversubscribed Series C financing to advance its next-generation KRAS blocker FMC-376, which saw its first patient dosed in a Phase I/II clinical trial on Thursday.
Seeking a slice of the lucrative obesity market, Indian pharma companies are developing their own versions of Novo Nordisk’s blockbuster weight-loss drug Wegovy, Reuters reports.
The inspiration behind two blockbuster biopharma deals in 2023, anti-TLIA drugs have the potential to improve efficacy and durability of response for a number of autoimmune diseases, experts tell BioSpace.
ORI Capital announced Thursday that it has raised more than a quarter of a billion dollars for its second life sciences fund, which will invest in early-stage biotech companies using the firm’s proprietary AI-driven platform.
The settlement, which includes an upfront $75 million payment to Gavi, ends arbitration related to a 2021 advance purchase agreement involving Novavax’s prototype vaccine NVX-CoV2373.
Both Pfizer and Moderna surprised analysts with sales of COVID-19 vaccines and treatments, yet the companies still need to manage declining revenues in the years to come.
While COVID vaccine revenue dropped 43% compared to the same period last year, Moderna on Thursday reported a profit of $217 million which beat analyst estimates, driven by deferred payments and cost savings.
With the departure of AbbVie and AstraZeneca from the trade group, Pharmaceutical Research and Manufacturers of America has named new members to its leadership including Gilead Sciences chief Daniel O’Day.
After treatment with a CD19 CAR-T therapy, patients with systemic lupus erythematosus, idiopathic inflammatory myositis or systemic sclerosis achieved long-lasting remission, according to results published in the NEJM.
On the heels of Takeda’s $300 million licensing deal for rusfertide, Protagonist Therapeutics’ peptide mimetic lowered hematocrit levels in patients with polycythemia vera, a type of blood cancer.