Archive for December 2018
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, aside from minor recommendations from USDA that were addressed immediately, BTS enjoys a clean track record with all regulating agencies with no violations. Site 002…
Read MoreShutdown 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
Read MoreEMA 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
Read MoreEx-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 said in a court filing this week. Source: Drug Industry Daily
Read MoreFDA 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: Drug Industry Daily
Read MoreCanada 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
Read MoreEMA 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 draft reflection paper released for stakeholder comment. Source: International Pharmaceutical Regulatory Monitor
Read MorePfizer 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 its blockbuster pain treatment. Source: International Pharmaceutical Regulatory Monitor
Read MoreFDA 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
Read MoreFDA 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 competing Restasis (cyclosporine) generics was “built atop a tottering tower of conjecture.” Source: International Pharmaceutical Regulatory Monitor
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