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The UK healthcare cost watchdog gave the final green light for national coverage of GlaxoSmithKline’s skin cancer drug Tafinlar, a decision that was made in record time, according to the drug’s evaluators. Read More
The president-elect of the European Commission said yesterday that oversight of EU drug policy will remain under the health directorate, marking an about face on a decision last month that would have switched the responsibility to the industry department. Read More
Johnson & Johnson has spent $200 million on production of an Ebola vaccine that is set to begin human testing in the U.S., Europe and Africa in January, but talk of potential collaboration with GlaxoSmithKline remains only theoretical at this point. Read More
Mylan recalled 15,966 bottles of the blood pressure drug metoprolol succinate tablets due to a product mix-up, the third recall in the past five months involving generic versions of AstraZeneca’s Toprol-XL. Read More
Takeda has asked a federal court to rescind the FDA’s approval last month of Hikma Pharmaceutical’s gout treatment Mitigare, claiming that the agency improperly cleared the rival company’s drug application without referencing Takeda’s own gout therapy Colcrys or its safety warnings. Read More
Brandmaker Endo Pharmaceuticals and generics firm Impax Laboratories are facing their third lawsuit over allegations the companies cut an anticompetitive deal to delay generic competition on Endo’s pain medication Opana ER. Read More
A federal judge has dismissed to a local court a lawsuit alleging AstraZeneca negotiated illegal pay-for-delay settlements with generic firms to keep versions of its heartburn drug Nexium off the market. In his decision however, the judge also indicated that deals putting off generic competition can still qualify as “reverse payments” under antitrust statutes, even if no cash changed hands. Read More
The FDA wants to understand how patient perceptions of medications change when pharmacies switch from brand to generic products or between the same generics made by different manufacturers. Read More
A federal judge has dismissed some claims in a case alleging Teva and Pfizer-subsidiary Wyeth forged an anticompetitive agreement to delay generic competition on Wyeth’s antidepressant Effexor XR. Read More
Spectrum Pharmaceuticals wants an extra four months of market exclusivity on its cancer drug Fusilev, arguing the FDA’s delay in approving the drug’s name entitles it to a revised approval clock. Read More
Canadian generics makers have promised to cap the costs of 18 top-selling, high-volume products to 18 percent of their brand reference’s price, under a sweeping drug pricing deal that will result in a roughly $3.8 billion industry-wide revenue reduction. Read More
The U.S. Trade Representative’s Office has launched a review of India’s intellectual property regime that will focus in large part on pharmaceutical IP issues, including the country’s policy of providing access to affordable medicines. Read More