Two generic drugmakers will pay $2.15 billion to Pfizer and Takeda Pharmaceutical to settle a patent fight over the heartburn treatment Protonix. Teva Pharmaceutical Industries will pay $1.6 billion, while Sun Pharmaceutical Industries will pay $550 million.
PDL BioPharma Inc. wants take Roche's Genentech business to arbitration over a royalty payment dispute. PDL said Genentech has underpaid royalties since at least 2007, and it wants to have Genentech's books and records inspected to determine if payments were accurate.
GlaxoSmithKline has dismissed one employee and a second resigned in the wake of a scandal over misrepresented data in a research paper published in 2010. The company says its investigation of recent allegations of questionable data has established that some information in the paper had been misrepresented.
In order to add assurance that the biosimilar candidate is as similar to the originator as possible, multiple tests should be used to assess similar qualities, an approach termed as “orthogonal” in the U.S. Food and Drug Administration draft biosimilar guidelines.
Biomarkers are the order of the day—an endogenous signal flare that’s fired, perhaps even before actual disease onset, warning of impending illness. The problem for the clinician, and way before that, the researcher at the bench is how do you detect that tiny, diagnostically incandescent signal.
Questcor Pharmaceuticals Inc. said it will pay at least $135 million to buy an autoimmune and inflammatory disease drug made by Novartis AG. Questcor said it will pay $60 million upfront for Synacthen and Synacthen Depot, which are approved in about 40 countries as a treatment for a variety of illnesses.
Federal prosecutors in New Jersey say a former executive for Bristol-Myers Squibb has admitted using his high-level position and access to nonpublic information to make about $310,000 from insider trades. Robert Ramnarine has pleaded guilty to securities fraud.
Apricus Biosciences Inc. said that its impotence drug Vitaros has been approved in 10 European countries. The company said Vitaros is now approved in the Netherlands, Germany, France, Italy, and the U.K., among other countries, for the treatment of erectile dysfunction.
The board of directors of the Irish drugmaker Elan Corp. PLC on Monday rejected an increased offer from Royalty Pharma and says it has received unsolicited interest from other parties it didn't name. Royalty's latest offer last week was for $13 per share plus up to $2.50 per share in payments based on performance milestones.
Federal health officials say they have found bacteria and fungus in drug vials from a Tennessee specialty pharmacy that recalled all of its injectable medicines last month. The Food and Drug Administration said in an online posting that it identified the growths in two unopened vials of a steroid injection distributed by the Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.
British drugmaker AstraZeneca PLC says it is to acquire Pearl Therapeutics Inc., a Redwood-City, California-based company involved in therapies for asthma and chronic obstructive pulmonary disease for at least $560 million. The deal could involve further payments of up to $590 million if if sales and drug development targets are met.
Through genetic engineering of laboratory models, researchers have uncovered a vulnerability in the way cancer cells diverge from normal regenerating cells that may help treat children with leukemia. The researchers are trying to understand the key pathways that distinguish how a normal blood cell grows and divides compared to the altered growth that occurs in leukemia.
Regeneron Pharmaceuticals Inc. and Bayer HealthCare said that their eye drug Eylea met its main goal in a new late-stage clinical trial. The companies said Eylea was more effective than a sham injection in treating a condition called myopic choroidal neovascularization, a retina disease that affects people who are severely myopic.
Arena Pharmaceuticals says its weight loss drug Belviq will be available to U.S. patients beginning next week, nearly a year after the drug was officially approved by federal regulators. The Food and Drug Administration approved Belviq last June for adults who are obese or who are overweight and have at least one serious medical condition, such as diabetes or high cholesterol.
Federal health experts are recommending changes to safety restrictions on former blockbuster diabetes pill Avandia, in light of a new analysis suggesting that the drug may not increase the risk of heart attack as previously believed. A majority of Food and Drug Administration advisers voted to modify or remove measures that currently limit patient access to GlaxoSmithKline's Avandia.