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Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
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Novartis, Biogen, Takeda and Novo Nordisk are all betting on advances in the molecular glue degraders space, collectively investing billions in hopes of treating cancer, Alzheimer’s disease, cardiometabolic disease and more.
Some 90% of investigational drugs fail—and success rates are even more dire in the neuro space. Here, BioSpace looks at five clinical trial flops that stole headlines over the past 12 months.
Blackstone and Bain Capital are said to be among the final bidders for the Japanese company’s Mitsubishi Tanabe Pharma, sources told Reuters Friday.
Following news of RSV lower respiratory tract infections in infants immunized with Moderna’s investigational RNA vaccines, FDA advisors said the trial investigators should continue the study, while keeping an eye out for further safety signals.
The Institute for Clinical and Economic Review flagged five drugs whose prices were raised in 2023 with no evidence to support it. Meanwhile, the makers of these drugs have been reporting double-digit sales growth for many of these products.
Incyte is abandoning its ALK2 blocker zilurgisertib, which it was trialing for myelofibrosis-associated anemia, while iTeos will deprioritize the development of inupadenant after it failed to meet the biotech’s clinical bar in a Phase II study of metastatic non-small cell lung cancer.
Ocaliva recently failed to secure the FDA’s traditional approval for primary biliary cholangitis due to safety concerns.
The company had said in October said that it was looking to license out its ex vivo editor renizgamglogene autogedtemcel to focus its resources on its in vivo platform.
The EMA approved a kidney disease–related label expansion for the blockbuster GLP-1 drug after a study showed reduced risk of death by 20%.
Pfizer, facing increasing pressure from Novartis, is touting a Phase III win for Ibrance as the first clinical evidence supporting the CDK4/6 inhibitor class’ use in patients with a specific type of breast cancer.