PTAB Declares St. Regis Tribe’s Restasis Patent Rights ‘Illusory’
In another blow to Allergan’s efforts to retain exclusivity for its dry-eye drug Restasis, the U.S. Patent Trials and Appeals Board said Allergan’s transfer of the patents to the St.…
Gottlieb Unveils Pilot for More Efficient Orphan Designation Requests
The FDA plans to launch a new pilot program to improve the efficiency of orphan designation submissions and reviews, Commissioner Scott Gottlieb announced Monday. Source: Drug Industry Daily
FDA to Expand Opioid Medication-Assisted Treatment Use, Issue New Draft Guidance
HHS Secretary Alex Azar said the FDA plans to expand the use of medication-assisted treatments for opioid addiction and will soon issue two new guidances on the topic. Source: Drug…
U.K. Could Seek Restitution from Pfizer if Legal Appeal Fails
Pfizer is fighting to preserve Lyrica’s use as the preferred physician’s treatment for nerve pain in the U.K. Source: BioSpace
FDA Grants Yisheng Biopharma's Clinical Treatment its Second Orphan Drug Designation
Beijing-based Yisheng Biopharma Co. is celebrating this morning after its lead immunology treatment snagged a second Orphan Drug Designation from the U.S. Food and Drug Administration. Source: BioSpace
ObsEva Fertility Drug Shows Some Promise in Late-Stage Trial
ObsEva Sa highlighted a data point from a late-stage trial that showed its fertility treatment nolasiban was successful in improving the pregnancy rate of some women following in vitro fertilization.…
Diabetes Market Heats Up as Eli Lilly’s Trulicity Combo Shows Improved Blood Sugar Control
Eli Lilly and Company published results from a new Phase IIIb clinical trial of Trulicity (dulaglutide) in combination with a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, which has shown improved blood sugar…
European Regulators Make Decisions on Several Companies’ Drugs
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) announced a string of approvals, as well as a couple rejections. Source: BioSpace
Vertex Pharmaceuticals Appoints Reshma Kewalramani as New CMO
Vertex Pharmaceuticals announced that Reshma Kewalramani will be the new chief medical officer and executive vice president, Global Medicines Development and Medical Affairs Source: BioSpace
Price of Teva's Generic Drug to Treat Wilson’s Disease Sparks Outrage
Patients are discovering that Teva’s generic isn’t really that much cheaper than Valeant Pharmaceutical’s branded drug to treat Wilson's Disease. Source: BioSpace