Neurocrine’s Bid for Diurnal Could Snag Phase 3 CAH Drug
Neurocrine Biosciences has made a bid for the UK-based Diurnal Group, a move that could pull in a phase 3 candidate for treating congenital adrenal hyperplasia (CAH). Source: Drug Industry…
Two Universities Sue Novartis Over Drug Design Patent
The University of Michigan and University of South Florida are suing Novartis for patent infringement, claiming that the pharma giant used a complex method of crystal engineering developed by their…
No Financial Incentive to Complete Confirmatory Trials for Accelerated Approvals, Study Finds
A new study of cancer drugs awarded FDA accelerated approval debunks the theory that drugmakers benefit financially from postmarket confirmatory trials that support the approval. Source: Drug Industry Daily
Farxiga Trials Show Reduced Risk of Death and Worsening Heart Failure
AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin) cut the risk of cardiovascular death and worsening heart failure by 16.4 percent relative to placebo, researchers announced at the European Society of Cardiology Congress…
Bayer Racks Kerendia Win in Subgroup Analysis
A narrowly missed primary endpoint didn’t prevent Bayer from touting a phase 3 win for Kerendia (finerenone) as a cardioprotective agent for people with late-stage chronic kidney disease and type…
Industry Asks FDA for More Time and Transparency in Drug Shortage Guidance
FDA’s draft guidance on mitigating drug shortages is inconsistent with the law, would place an unnecessary weight on drug manufacturers and could make drug shortages worse, according to industry stakeholders’…
Westwood Laboratories Handed a Form 483 for Lack of Sterility Procedures
Westwood Laboratories’ Azusa, Calif., contract manufacturing facility lacks adequate sterility procedures, according to a Form 483 issued following a March 24 to April 5 inspection. Source: Drug Industry Daily
FDA Endorses Four Draft and Final ICH Quality Guidelines
The FDA endorsed a number of International Council for Harmonization (ICH) guidelines last week, issuing three draft guidances and one final guidance in support of the council’s recommendations on drug…
White House Orders Federal Agencies to Publicly Share Research Findings
The White House’s Office of Science and Technology Policy has issued a memo directing federal agencies with R&D spending to publicly share the findings and data from government-funded research as…
OPQ’s Annual Report Reveals Drop in Import Alerts, Other Quality Metrics
The FDA levied import alerts on 49 manufacturing sites in fiscal year 2021 for refusing inspections or records requests, noncompliant laboratory testing and noncompliant findings from inspections and records requests…
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