(Reuters)—A groundbreaking deal between Allergan Plc. and a Native American tribe to shield the company’s patents in administrative proceedings could also be used be to protect them from challenges in federal court, legal experts say, potentially dealing a blow to generic competition. Allergan said on Friday it had transferred patents on its blockbuster dry eye…
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U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs
WASHINGTON (Reuters)—Republican and Democratic lawmakers on Thursday discussed ways to prevent drugmakers from using rules developed to safeguard patients to instead block the sale of cheaper medicines. The focus at a hearing, held by members of the House Judiciary Committee’s antitrust subcommittee, was on the use by some brand name drug companies of a U.S….
As Drug Prices Drop, Generics Makers Fight Back with Deals
NEW YORK (Reuters)—Generic drug makers are turning to mergers and acquisitions to shield themselves against a concerted effort by U.S. regulators to crack down on steep drug prices. Impax Laboratories Inc, Perrigo Company Plc and Alvogen Inc have been talking to advisers about strategic options for their generics businesses, ranging from acquisitions to increase scale…
Generic Drug Group Sues to Block Maryland Price-Gouging Law
(Reuters)—The main U.S. trade group for generic pharmaceutical companies filed a lawsuit on Thursday seeking to block a recently adopted Maryland law that lets the state attorney general sue generic drugmakers that sharply raise prices. The Association for Accessible Medicines filed the lawsuit in federal court in Baltimore to seek an injunction that would block…
U.S. FDA Moves to Prevent Pharma from “Gaming” Generic Drug System
WASHINGTON (Reuters)—The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals. FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA…
U.S. Could File Charges in Generic Drug Probe by Year-End
(Reuters)—U.S. prosecutors could file the first charges in their criminal investigation of generic drugmakers over suspected price collusion by the end of the year, Bloomberg reports. The antitrust investigation by the U.S. Department of Justice (DOJ) spans more than a dozen companies and about two dozen drugs, Bloomberg reports, citing people familiar with the matter….
Cephalon, U.S. States Reach $125 Million Settlement Over Generic Drugs
WASHINGTON (Reuters)—Cephalon has reached a $125 million settlement with 48 states in connection with its alleged efforts to delay generic versions of its blockbuster sleep disorder drug modafinil (Provigil) from entering the market, New York Attorney General Eric Schneiderman said on Thursday. The settlement with Cephalon, now owned by Teva Pharmaceuticals, comes a little more…
Generic TNF-Alpha Inhibitors Comparable to Established Brands
NEW YORK (Reuters Health)—Biosimilar tumor necrosis factor-alpha inhibitors appear equivalent to the branded original versions, according to a systematic review and meta-analysis. As Dr. G. Caleb Alexander tells Reuters Health by email, “biologic treatments represent a rapidly growing proportion of prescription drug expenditures and thus there is enormous interest in whether or not biosimilar products…
EMA Flags Faulty Generic Drug Data, Backs Sales Halt
(Reuters)—The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable. The EMA’s list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd., Mylan NV and Novartis AG’s Sandoz….
Sun Pharma Gets U.S. Subpoena over Generic Drugs Pricing
MUMBAI (Reuters)—The U.S. Department of Justice (DOJ) has subpoenaed India’s largest drugmaker Sun Pharmaceutical Industries Ltd. seeking information about the pricing and marketing of the generic drugs it sells in the U.S., the company said on Saturday. The DOJ’s antitrust division has also asked Sun Pharma’s U.S. unit for documents related to employee and corporate records…
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