Archive for May 2022

The FDA has put the squeeze on Sanofi’s first steps toward an over-the-counter (OTC) version of Cialis (tadalafil), Eli Lilly’s once-blockbuster erectile dysfunction drug. Source: Drug Industry Daily

In an effort to prepare for future health emergencies, the World Health Organization (WHO) has adopted a resolution geared toward delivering higher quality data and improving the conduct and coordination of clinical trials around the world. Source: Drug Industry Daily

Johnson & Johnson (J&J) has filed a complaint against Aurobindo Pharma charging the Indian generics maker with infringing on patents for J&J’s blockbuster prostate cancer therapy Erleada (apalutamide). Source: Drug Industry Daily

GSK announced yesterday that it is acquiring Cambridge, Mass.-based biopharma company Affinivax in a $3.3 billion deal, picking up at least two novel pneumococcal vaccine candidates and a promising vaccine technology platform. Source: Drug Industry Daily

The Senate’s bill to reauthorize FDA user fee programs for drugs, biologics and medical devices, introduced last week by Sen. Patty Murray (D-Wash.) and Sen. Richard Burr (N.C.), includes proposed reforms of the FDA’s accelerated approval program, a subject the House declined to address in its version of the user fee program reauthorization. Source: Drug…

A bipartisan pair of senators — Maggie Hassan (D-N.H.) and Bill Cassidy (R-La.) — are pressing federal agencies to close oversight gaps that delay generic drugs and in turn keep drug prices high. Source: Drug Industry Daily

Zealand Pharma will bring a new form of its antihypoglycemia drug Zealogue (dasiglucagon) to the FDA as a potential treatment for children with congenital hyperinsulinism (CHI). Source: Drug Industry Daily

The Department of Health and Human Services (HHS) has withdrawn a controversial and unpopular Trump-era final rule that would have required federal health agencies to reassess their regulations every 10 years or face eliminating those rules. Source: Drug Industry Daily

Teva Pharmaceuticals and Allergan will pay more than $161 million to the state of West Virginia to settle allegations that the companies contributed to the opioid epidemic. Source: Drug Industry Daily

Sens. Maria Cantwell (D-Wash.) and Chuck Grassley (R-Iowa) introduced a bill this week that directs the Federal Trade Commission (FTC) to hold pharmacy benefit managers (PBM) accountable for allegedly deceptive pricing practices that raise the costs of prescription drugs. Source: Drug Industry Daily