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U.S. District Court Rules in Lilly’s Favor on Alimta Vitamin Regimen Patent

INDIANAPOLIS, Aug. 25, 2015 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. District Court for the Southern District of Indiana has ruled in the company’s favor regarding infringement of the vitamin regimen patent for Alimta® (pemetrexed for injection). read more

Mylan Confirms the U.S. Patent and Trademark Office Institutes Inter Partes Review Proceedings against Two Copaxone(R) 40 mg/mL Dosing Patents

HERTFORDSHIRE, England and PITTSBURGH, Aug. 25, 2015 /PRNewswire/ — Mylan N.V. (Nasdaq: MYL) today announced that the U.S. Patent and Trademark Office (PTO) has instituted inter partes review (IPR) proceedings against two Copaxone® 40 mg/mL patents, U.S. Patent Nos. 8,232,250 and 8,399,413, owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd.  The patents relate to methods for the treatment of multiple sclerosis through the administration of at least three 40 mg subcutaneous injections of glatiramer acetate over a period of seven days with at least one day between each injection. Mylan also has filed another petition for inter partes review of a related patent (U.S. Patent No. 8,969,302), which the PTO is expected to act upon shortly. read more

Sarepta Therapeutics Announces FDA Has Filed Eteplirsen NDA for the Potential Treatment of Duchenne Muscular Dystrophy for Patients Amenable to Exon 51 Skipping

FDA Grants Priority Review Status/ PDUFA Date is February 26, 2016

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 25, 2015– Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has filed the New Drug Application (NDA) for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. Approximately 13% of people with Duchenne muscular dystrophy are estimated to have a mutation addressable by Eteplirsen/exon 51 skipping . read more

Mainstay Medical Announces Additional US Patent Issued

Mainstay Medical International plc (Bourse: MSTY) (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, a new implantable neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), today announced the issuance of a new U.S. Patent:

AHF: Gilead Ups Stealth Marketing Campaign for PrEP, Skirting FDA Oversight

–(EON: Enhanced Online News)–AIDS Healthcare Foundation (AHF) is speaking out about the underhanded influence of Gilead money in pushing the use of its AIDS treatment, Truvada, for pre-exposure prophylaxis (PrEP) for HIV prevention. Gilead Sciences’, which on more than one occasion has said that it, “…does not view PrEP as a commercial opportunity and is not conducting marketing activities around Truvada as PrEP, is directly funding HIV/AIDS and community groups nationwide with ‘Gilead PrEP Grants.’ AHF believes the community grants and other such funding awarded by Gilead—which some groups have used to run advertising of their own promoting PrEP use—constitute a stealth marketing campaign that allows Gilead to bypass FDA oversight of its marketing statements. read more

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