As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic ...
The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s ...
With so many unknowns, Biogen is carefully eyeing its next-gen Alzheimer’s treatment diranersen as a high-risk, high-reward ...
When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the ...
In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor ...
Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma ...
Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a ...
Recent advances in ADC development have led to increasing diversity in antibody, linker and payload design. Successful drug ...
UniQure is ready to put its Huntington’s disease gene therapy through an advisory committee meeting—even as the broader rare disease space has been put on edge by recent FDA scrutiny of assets by ...
Supernus Pharmaceuticals and Indivior Pharmaceuticals are outlining a combined expected $2.2 billion in annual revenue, plus $125 million in cost savings that will include “natural redundancies.” ...
BioNTech’s leadership transition was announced earlier this year, with CEO Ugur Sahin and CMO Özlem Türeci leaving to start a new mRNA company. Guido Oelkers of Swedish Orphan Biovitrum AB will take ...
The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts ...
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