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Following a series of setbacks that included two failed preapproval inspections and 24 citations, Hospira says the FDA has signaled the all-clear for its new Visakhapatnam, India, manufacturing facility and production is underway. Read More
The Court of Appeal in London has upheld Eli Lilly’s vitamin regimen patent for its blockbuster cancer drug Alimta, blocking Actavis from marketing a generic version of the drug until 2021. Read More
A Luxembourg-based nonprofit set up by European pharma groups is one step closer to launching a counterfeit drug repository system, having finalized contracts with three software firms to help implement the system. Read More
The FDA plans to investigate how well people who have suffered hearing loss — specifically older adults — are able to understand the risk information in TV drug ads. Read More
Two institutional buyers of Gleevec want to stop its manufacturer, Novartis, from delaying generic competition of the blockbuster leukemia drug, saying a patent litigation settlement between the brandmaker and generics maker Sun Pharma was construed solely for that purpose. Read More
The FDA wants manufacturers to better control the amount of excess drug or biologic they put in injectable vials and ampules to ensure proper patient dosing. Read More
AbbVie’s hepatitis C drug combo Viekira Pak was 100 percent effective in patients with genotype 1b and liver cirrhosis without the additional use of the antiviral ribavirin, the company said Wednesday. Read More
A panel of experts in Australia is recommending that the government establish three new drug approval pathways to expedite listing on the Australian Register of Therapeutic Goods and speed novel treatments to patients. Read More
The UK’s healthcare costs regulator is asking Santen Pharmaceutical to provide more information on its Ikervis eye drops following a preliminary recommendation denying its use for the treatment of severe keratitis in adults with dry eye disease that didn’t improve with tear substitutes. Read More
The Canadian government plans to require mandatory reporting of drug shortages, in a move that will bring it in line with U.S. and European shortages policies. Read More