News
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
FEATURED STORIES
Keytruda is set to lose exclusivity in 2028, meaning Summit may face competition from cheaper biosimilars. Meanwhile, other branded drugmakers are also seeking to improve on the blockbuster checkpoint inhibitor.
M&A and IPOs got off to a quick start in 2025 only to crash into a wall of policy challenges. Upfront payment for licensing transactions, however, grew as pharmas looked for less-risky deals.
Beam Therapeutics and Verve Therapeutics have each built their lead candidates on a technique billed as a safer alternative to conventional CRISPR. Clinical results have so far been promising.
Job Trends
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has accepted the company’s New Drug Application and granted Priority Review to inavolisib, an investigational oral therapy, in combination with palbociclib and fulvestrant.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
THE LATEST
Eli Lilly’s tirzepatide is expected to be worth $62 billion annually by 2030, according to Evaluate. That valuation would be three times larger than what AbbVie’s blockbuster Humira ever achieved.
Gilead is betting up to $750 million on Kymera’s anti-CDK2 molecular glue for solid tumors, while Sanofi elected to move forward with another protein degrader from the biotech, designed to target immune-mediated diseases.
The FDA is assessing the need for “further regulatory action” on Sarepta’s Duchenne muscular dystrophy gene therapy in the aftermath of two patient deaths, though the regulator has not yet specified what action this could be.
Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical officer for Usona Institute, a research organization advancing psychedelic science.
Despite Nektar’s share price shooting up as much as 175% on Tuesday, William Blair maintained that “there is an absence of clear differentiation” for rezpegaldesleukin in the atopic dermatitis space.
Robert F. Kennedy Jr. testified in front of largely combative congresspeople on vaccine policy, his MAHA report and more; the mass leadership exodus at the FDA continues as CDER and CBER shed key staff; Kennedy’s revamped CDC vaccine advisors convene for their first meeting; Novo and Lilly present new data at the American Diabetes Association’s annual meeting; and BioSpace recaps BIO2025.
In the latest installment of his column, Kaye/Bassman’s Michael Pietrack shares five ways leaders can help their teams after a layoff, from acknowledging emotions to reestablishing culture.
Leading companies spent $1.4 billion upfront on licensing deals and embarked on vast R&D programs. Clinical setbacks mean many companies are unlikely to ever recoup their investments.
With much to cover, Democrats tackled Kennedy’s MAHA report; the firing of all members of the CDC’s ACIP committee; and much more. Little was accomplished, as Kennedy demurred and members of Congress accused him of risking American lives.
In addition to cutting most of its staff, including two C-suite executives, Leap Therapeutics is winding down research and development activities and considering a sale or partnership opportunities.