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A pharmacist advocate is urging manufacturers to provide more information on the reason for and expected duration of a drug shortage, so that healthcare providers can better plan for how the shortage will affect patient care. Read More
The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral. Read More
Manufacturers don’t appear to be waiting for FDA guidance to meet a Jan. 1 deadline of the new track-and-trace law, and instead have begun implementing an electronic version of a widely used tracking form to satisfy the law’s requirements. Read More
Mylan said yesterday it has launched a generic version of Warner Chilcott’s oral contraceptive Loestrin 24 Fe in the U.S., following final FDA approval. Read More
Biosimilars are expected to account for roughly 4 percent of all biologics sales over the next 10 years, saving the U.S. healthcare system an estimated average of $44.2 billion, according to new research that forecasts significantly lower savings from the products than another widely cited study. Read More
The number of patent lawsuits filed over generic drug challenges has spiked this year, a development that coincides with the widely anticipated “patent cliff” of many brand drugs losing protection. Read More
Generics giant Mylan confirmed its intention to merge with Abbott Laboratories and reincorporate in the Netherlands early next year, a move that comes as other U.S. pharma companies have abandoned their plans to move overseas in the face of new U.S. tax rules. Read More
Generic drug prices in Canada are up to seven times more expensive than those in comparable countries, according to a study that challenges a major price-setting deal between Canadian generics firms and provincial governments. Read More
A federal judge has struck down Mylan’s Paragraph IV ANDA challenge against Pfizer’s blockbuster cancer drug Sutent, ruling that the therapy’s patents are not invalid. Read More
Dr. Reddy’s Laboratories has settled a class-action lawsuit over its alleged role in delaying generic entry of AstraZeneca’s heartburn drug Nexium in return for assisting plaintiffs in their case against AZ and the remaining generics manufacturer defendants. Read More
Actavis’s birth control pill Lo Loestrin FE is safe from generic competition for the moment after a federal appeals court reaffirmed a lower court’s decision finding that ANDAs by generics makers Lupin and Amneal infringed the drug’s patent. Read More