Gilead has won a reversal on a ruling for its patent suit with Merck regarding its hepatitis C drugs Sovaldi and Harvoni after US District Judge Leonard Stark of Delaware decided Merck's patent was invalid and didn't fulfill a requirement disclosing how the treatment can be made without undue experimentation. Stark's ruling overturned a jury verdict that had required Gilead Sciences to pay Merck a record $2.54 billion for the patent infringement.
AstraZeneca received approval from the FDA to use its Imfinzi, or durvalumab, in patients with unresectable stage 3 non-small cell lung cancer that has not progressed after concurrent platinum-based chemotherapy and radiation therapy. The drug was previously approved to treat certain patients with urothelial carcinoma.
The FDA issued a complete response letter to Apricus Biosciences regarding its marketing application for topical erectile dysfunction cream Vitaros, or alprostadil. The agency raised chemistry, manufacturing, control and safety concerns related to the 2.5% concentration of DDAIP.HCl present in the cream that the company is hoping to address in time to provide a market update early next month.
An FDA panel has scheduled a review May 10 of Akcea Therapeutics and Ionis Pharmaceuticals' volanesorsen, being developed as a treatment for patients with familial chylomicronemia syndrome. Aug 30 is the PDUFA date for volanesorsen.
The FDA granted orphan designation to Hansa Medical's IdeS, which is being developed as a treatment for patients with Guillain-Barré syndrome. The company anticipates results later this year from two ongoing studies in highly sensitized patients who do not respond to available desensitization methods.
Pragma Pharmaceuticals is expected to launch Decadron, or dexamethasone, tablets this year. The drug is used to treat inflammation in disorders of organ systems, including dermatological, gastrointestinal, neoplastic, renal and respiratory diseases; allergies; and endocrine, hematologic, neurologic, ophthalmic and rheumatic disorders.
Health Canada has approved Roche and Genentech's Ocrevus, or ocrelizumab, as a treatment for adult patients with early-stage primary progressive multiple sclerosis and signs of inflammatory activity. The decision was backed by results of the ORATORIO study, in which the patients who were treated with Ocrevus had a 25% lower risk of disability progression sustained for at least 24 weeks versus placebo use.
San Francisco, CA-based Reishi D. International received a warning letter from the FDA because of serious violations of the Current Good Manufacturing Practice food regulations. The FDA observation noted that the firm's products were prepared, packed, or held under conditions that could result in contamination with filth or risk to health, and that the products were misbranded.
A Class II recall involving Roche's Accu-Chek connected diabetes management app has been issued by the FDA following reports of a software bug in the app's Bolus Advisor calculator feature, an error that could cause unexpected changes in the unit of measurement. The company updated the app and recommended that users of the feature track active insulin and insulin bolus amounts carefully for a minimum of eight hours.
Guardant Health secured Expedited Access Pathway designation from the FDA for its comprehensive next-generation sequencing-based liquid biopsy test for advanced cancer called Guardant360. Using next-generation sequencing, the assay allows genomic alterations in a panel of 73 genes to be detected from cell-free DNA withdrawn from blood.
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