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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
Amgen is suing Sandoz to stop the French drugmaker from marketing a biosimilar of its top-selling product Neupogen in the U.S., charging that Sandoz didn’t follow the rules for biosimilar development. Read More
For the first time, pharmaceutical manufacturers will have to report certain financial payments to continuing medical education programs (CME) under the Physician Payments Sunshine Act. Read More
Bio-Rad Laboratories agreed to pay $55 million to settle federal investigations charging its subsidiaries bribed foreign officials in Russia, Vietnam and Thailand to win business. Read More
Any brand drugmaker in Europe can now sue to block the approval of a generic product that uses the brand’s drug as a reference, according to a recent ruling the EU’s highest court. Read More