News

With data from a mid-stage trial showing weight loss of up to 12.3% at 28 weeks in patients treated with PF’3944, “Pfizer is moving full speed into obesity clinical development,” BMO Capital Markets said Tuesday.
FEATURED STORIES
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Job Trends
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
THE LATEST
In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.
With new Alzheimer’s drugs receiving—and expected to receive—FDA approval, the market for diagnostic biomarker tests is set to expand.
This is the Danish company’s second obesity-focused acquisition in three weeks. Under the deal, Novo Nordisk receives the full rights to develop and commercialize Embark’s lead metabolic platform.
As the new CEO of LimmaTech Biologics, Haas’ IP and legal background sets him apart to lead the charge for the team’s bacterial vaccine pipeline.
FDA
However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.
Citing lack of evidence and manufacturing issues, the regulator has rejected Outlook Therapeutics’ bid to have its bevacizumab formulation approved for wet age-related macular degeneration.
In the latest salvo, Pfizer and BioNTech fired back at Moderna and asked the U.S. Patent and Trademark Office to invalidate patent claims over the COVID-19 vaccines they say are overly broad.
The company’s pamrevlumab has failed another late-stage study in Duchenne muscular dystrophy, unable to significantly improve functional motor abilities over placebo.
FDA
Bristol Myers Squibb announced Monday that Reblozyl is now approved as a first-line treatment for adults with anemia due to myelodysplastic syndromes who may require regular blood transfusions.
The Biden administration on Tuesday released a much-anticipated list of the first 10 medicines included in Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.