News
Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
FEATURED STORIES
While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
Chiesi Group is taking KalVista Pharmaceuticals under its wing, paying $1.9 billion for the biotech’s oral therapy Ekterly to treat severe swelling episodes caused by the rare genetic disorder hereditary angioedema.
After a quarter in which sales topped $15 billion and key readouts went AstraZeneca’s way, the company is increasingly confident that its 2030 revenue target is in reach.
While sales for most of GSK’s shots slumped as vaccine skepticism continues to climb in the U.S., Shingrix jumped 20% to almost $1.4 billion in the first quarter, emerging as the pharma’s top-selling product.
The settlements delay the entry of generic copies of Pfizer’s Vyndamax by almost three years, stabilizing sales of a drug that generated $3.8 billion in the U.S. last year.
In briefing documents released Wednesday, the FDA raises doubts about two AstraZeneca assets set to be discussed Friday at the agency’s first drug-related advisory committee meeting in nine months.
Analysts will be watching as a generic version of semaglutide—marketed by Novo Nordisk as Wegovy for weight loss—launches in Canada as a test case for future price erosion in the U.S.
The FDA’s real-time clinical trial mechanism allows drug sponsors to transmit data immediately to the regulator through the cloud—a system that could “compress drug development timelines,” Jefferies analysts said.
Phase 2 data from PTC Therapeutics showed that the Novartis-partnered Huntington’s disease asset slowed progression by more than 50%. Analysts say the decision to initiate a last-stage trial reflects a lack of confidence in an accelerated FDA nod.
Sanofi and Novartis kick off the heart of earnings season; Lilly strikes its fourth pact in as many weeks; Regeneron earns landmark approval for a gene therapy for a type of genetic deafness, and also strikes a White House deal; FDA asks Amgen to withdraw Tavneos and, separately, issues Commissioner’s National Priority Vouches to three unnamed psychedelics companies.
Angel investors are raising the bar with tighter criteria, backing strong teams, realistic markets and clear paths to exit while applying deeper, domain-specific diligence to early stage bets.