Sinovac Hid CFDA Bribes, SEC Investigation from Shareholders, Lawsuit Claims
A class action lawsuit claims that Beijing-based Sinovac Biotech misled shareholders and bribed regulators at the China Food and Drug Administration to expedite its drug and clinical trial applications. Source:…
AAM Sues Maryland to Block Generic Drug Price Gouging Law
The Association for Accessible Medicines filed a lawsuit against the attorney general of Maryland, hoping to block the state’s recently passed law ostensibly banning generic drug price gouging. Source: Drug…
PTAB Invalidates AbbVie’s Humira Dosing Patent — Again
The PTO’s Patent Trial and Appeal Board once again ruled that a patent for AbbVie’s Humira was invalid and unpatentable, responding to additional challenges by Boehringer Ingelheim. Source: Drug Industry…
FDA Approves First New Sickle Cell Drug in 20 Years
The FDA on Friday approved Endari, the first new drug in nearly 20 years to treat sickle cell anemia complications. Source: Drug Industry Daily
Pacira Shutters DepCyt Operations After Years of Manufacturing Problems
Unable to resolve persistent manufacturing problems, New Jersey-based drugmaker Pacira Pharmaceuticals is ending production of its DepoCyt chemotherapy drug and closing the California plant where it is made. Source: Drug…
FDA to Expand High Performance Computing to Boost Clinical Trial Efficiency
The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials — as well as establish a new framework for regenerative…
Waiting Lists are Already Forming for Novartis AG and Kite Pharma's Not-Yet Approved CAR-T Drugs
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-stocks2.jpg" NAME"Waiting Lists are Already Forming for Novartis and Kite Pharma's Not-Yet Approved CAR-T Drugs" ALT"Waiting Lists are Already Forming for Novartis and Kite Pharma's Not-Yet Approved CAR-T Drugs"July…
Effective Immediately: Advaxis CEO Resigns, Interim Leader Named
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-personnel-leaving.jpg" NAME"Effective Immediately: Advaxis CEO Resigns, Interim Leader Named" ALT"Effective Immediately: Advaxis CEO Resigns, Interim Leader Named"July 7, 2017By Mark Terry, BioSpace.com Breaking News Staff... Source: BioSpace
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