Food and Drug Administration (FDA)
NEWS
It’s been a busy month for IPOs. Numerous biotech companies announced their intentions to publicly list their stock on an exchange in the U.S. or abroad in order to gain new funding to advance developmental programs.
AstraZeneca and its research-and-development unit MedImmune, announced positive overall survival (OS) data for its Phase III PACIFIC trial of Imfinzi (durvalumab) in patients with unresectable Stage III non-small cell lung cancer (NSCLC).
The U.S. Food and Drug Administration (FDA) gave BioMarin Pharmaceutical a thumbs-up for its Palynziq (pegvaliase-pqpz) to treat phenylketonuria (PKU).
Sun Pharma received approval from the U.S. Food and Drug Administration (FDA) for Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer (mCRPC). Sun will launch the drug in the U.S. via a licensing deal with Churchill Pharmaceuticals, the original developer of the drug.
AveXis, a Novartis company based in Illinois, is investing $55 million to build a new manufacturing facility in Durham, North Carolina.
Despite the advances in personalized medicine, a new survey of 1,001 Americans shows that the majority are not familiar with the concept.
Two months after a setback in the U.S. House of Representatives, Congress has authorized “right to try” legislation.
Most investors thought 2018 would be a big year for mergers and acquisitions in the biopharma industry because of changes to the tax law, and so far they’ve been right.
Dova Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved its Doptelet (avatrombopag) to treat thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.
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