Track-and-Trace Not Enough to Halt Drug Counterfeiters
March 4th 2014Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight.
Changing the Hepatitis C Treatment Landscape
February 27th 2014Widespread screening, along with new therapies that move patients from a chronic condition to a cure, is changing the landscape in treatment of hepatitis C, says an expert panel recently convened by the American Journal of Managed Care (AJMC).
New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman
February 25th 2014When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process for generic drugs, and combat the agency’s backlog of drug applications.
Ranbaxy Suspends Shipments, Addresses Quality and Integrity Problems
February 24th 2014Following the U.S. ban on all imports from Ranbaxy’s Toansa, India, facility, the drug maker has voluntarily suspended all shipments of bulk drugs from its manufacturing facilities both at Toansa and Dewas, in order to reassess quality controls at the plants.
Industry Takes EU to Task Over Pharmacovigilance Fees
February 21st 2014Europe’s main pharma industry bodies - EFPIA, EGA, EuropaBio, AESGP and EUCOPE - have issued a joint statement to express concern about “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010?.
Bringing New Rx Drugs to Market in 2014
February 19th 2014I did something today that I haven’t done in years: I checked out the US pharmaceutical R&D spend versus the rest of the world. Having known since the 80’s that the US owned this space, a quick look at the latest R&D figures confirmed my decades old understanding of the industry’s worldwide position.
Actavis to Acquire Forest Labs for $25 Billion
February 19th 2014Actavis and Forest Laboratories have entered into a definitive agreement under which Actavis will acquire Forest for a combination of cash and equity valued at approximately $25 billion or $89.48 per Forest share, Actavis announced in a press release.
How Good for UK Pharma is the European Union?
February 13th 2014As the United Kingdom debate about whether to stay in the European Union becomes more bitter and intense, an insight into how EU membership impacts on medicines and pharmaceuticals has appeared from a British politician who was until recently the UK Government Adviser on Life Sciences, George Freeman.