BTS Research Passed USDA Inspection 2018
BTS Research is finishing 2018 on a high note BTS Research is pleased to report this year's USDA inspection has been completed with 0 findings. Since BTS incubation in 2001,…
Shutdown Enters Day Seven With No Sign of a Breakthrough
The stalemate over funding for the federal government continues with no further votes scheduled on Capitol Hill this week. Source: Drug Industry Daily
EMA Seeks Comments on Rare Allergy Trials
The European Medicines Agency is seeking public comments as it prepares new guidelines for rare allergy clinical trials. Source: Drug Industry Daily
Ex-Insys CEO to Plead Guilty of Role in Subsys Bribery Scheme
Former Insys CEO Michael Babich has agreed to plead guilty in connection with a kickback scheme involving the company’s Subsys fentanyl spray, the U.S. Attorney for the District of Massachusetts…
FDA Denies PMRS Petition to Deny Chronic-Use Opioid NDAs
The FDA denied a petition from Pharmaceutical Manufacturing Research Services (PMRS) asking the agency to set a higher standard for NDAs for abuse-deterrent opioids for treatment of chronic pain. Source:…
Canada Clears Three Drugmakers of Blocking Generic Competitors
Canada’s Competition Bureau cleared Celgene, Pfizer and Sanofi of allegedly blocking generic competition, ending a two-year investigation. Source: Drug Industry Daily
EMA Considers Ways to Evaluate Non-Genotoxic Drug Impurities
Drug sponsors should assess the safety of non-genotoxic impurities (NGIs) in chemically synthesized drugs on a case-by-case basis, the EMA’s Committee for Medicinal Products for Human Use suggests in a…
Pfizer Loses Lyrica Patent Battle in UK Supreme Court
Pfizer’s appeal for a second patent on Lyrica (pregabalin) has been denied by the UK’s highest court, ending the pharma giant’s long-running fight against drug companies marketing generic versions of…
FDA Issues Guidance for Combination Hypertension Drugs
The FDA released final guidance for sponsors of fixed-combination hypertension drugs, with several clarifications of the draft document. Source: International Pharmaceutical Regulatory Monitor
FDA Parries on Teva 180-Day Exclusivity Suit
The FDA hit back at Teva’s lawsuit accusing the agency of changing its policy on granting 180-day exclusivity for generics — arguing that the company’s attempt to block exclusivity for…