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House and Senate panels proceeded with advancing the FDA user fee reauthorization package last month, even while Trump and HHS called for negotiations on the amounts paid by industry to be reopened — and nearly doubled. Read More
The U.S. Supreme Court ruled that patent infringement lawsuits may only be filed where defendant companies are incorporated, and not simply in any location where their products are sold — a decision with serious implications for drugmakers. Read More
In yet another pressure point on generic drug prices, a class action suit filed in a Pennsylvania federal court claims Actavis, Teva, Sandoz, Fougera and Taro conspired to fix the prices of fluocinonide creams and gels. Read More
The PTO’s Patent Trial and Appeal Board upheld Shire’s patent claims — following a challenge from Green Cross — over methods for the manufacture of Elaprase (idursulfase), an enzyme replacement therapy for Hunter syndrome. Read More
A federal judge ruled that three generics manufacturers infringed on Novartis’ patents related to its Zortress treatment, used during kidney and liver transplants. Read More
Four major patents for Acorda Therapeutics’ successful MS treatment Ampyra were invalidated by a federal judge nearly a decade before they were set to expire — not a month after they were upheld by the PTO. Read More
The Maryland state legislature approved a bill to ban excessive price increases for generics and off-patent drugs, sending it to the state’s governor for final approval. Read More
For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro performance tests — as long as the generic is qualitatively the same as the reference product. Read More
In a lawsuit filed Monday, Sanofi says Mylan’s anticompetitive business practices blocked its EpiPen competitor, the Auvi-Q, from gaining a foothold in the epinephrine auto-injector market, resulting in hundreds of millions in lost sales. Read More
A California prosecutor is suing Boehringer Ingelheim and a Teva subsidiary, saying their $120 million agreement to push back the release of a generic Aggrenox blood thinner illegally delayed market competition for over seven years. Read More