Food and Drug Administration (FDA)

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Shares of Cambridge, Mass.-based Mersana Therapeutics are up more than 7 percent in premarket trading after the company announced that it will be able to continue with its Phase I trial studying the antibody drug conjugate XMT-1522 as a potential treatment for some breast cancer patients.
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb gave a talk at The Pew Charitable Trusts on Friday, September 14, outlining the agency’s new approach to dealing with antimicrobial resistance (AMR).
FDA
The U.S. Food and Drug Administration (FDA) approved Teva Pharmaceutical Industries’ Ajovy (fremanezumab) to prevent migraine on Friday, September 16.
Dublin-based Allergan is acquiring Newport Beach, California-based Bonti with an upfront payment of $195 million.
Supernus Pharmaceutical, headquartered in Rockville, Maryland, is acquiring Biscayne Neurotherapeutics, located in Miami, Florida.
Without a doubt China has become one of the most important markets for pharma companies, given the vast patient population and the rising cancer rates. And it seems that western pharmaceutical companies are making greater inroads there.
Acorda Therapeutics’ week started off badly and has only gotten worse. It started off with the loss of an appeal for some of its Ampyra patents and has ended with the U.S. FDA’s decision to delay a ruling for its Parkinson’s disease treatment.
FDA
AstraZeneca and its research-and-development arm, MedImmune, announced that the U.S. FDA approved Lumoxiti (moxetumomab pasudotox-tdfk) for adults with relapsed or refractory hairy cell leukemia (HCL) who have had at least two previous systemic therapies, including with a purine nucleoside analog.
Purdue Pharma, best known for being the manufacturer of opioid drug OxyContin, is offering free doses of a treatment for opioid abuse as part of negotiations in more than 1,000 lawsuits.
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