Archive for May 2023

A New Jersey federal judge has ruled that Mylan cannot pursue a generic version of Janssen Pharmaceuticals’ injectable schizophrenia drug, Invega Trinza. Source: Drug Industry Daily

India-based drugmaker Champaklal Maganlal Homeo Pharmacy (CMHP) has drawn two FDA warning letters in recent weeks over untested glycerin in gastrointestinal products for children, among other serious current good manufacturing practice (cGMP) violations. Source: Drug Industry Daily

The FDA has spelled out when drugmakers may use generally accepted scientific knowledge (GASK) to support a drug or biologic application, in a new draft guidance. Source: Drug Industry Daily

The International Council on Harmonisation (ICH) has released a draft guideline on good clinical practice (GCP), designed to facilitate acceptance of clinical trial data by ICH member countries and regions. Source: Drug Industry Daily

Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from advanced gene and cell therapy, ICH E8 R1 recommendations and FDA’s sterilization pilot. Source: Drug Industry Daily

Republican lawmakers are renewing their push to speed FDA approvals by allowing the agency to automatically approve drugs and devices that have been approved and sold in other developed and trustworthy countries. Source: Drug Industry Daily

The Ironworkers District Council of New England Health and Welfare Fund has filed a class action complaint against Teva Pharmaceuticals accusing the company of a nearly decade-long anticompetitive scheme to delay generic competition for its QVAR (beclomethasone dipropionate HFA) asthma inhalers. Source: Drug Industry Daily

Ironwood Pharmaceuticals is acquiring VectivBio for $1.15 billion, netting a promising late-stage clinical asset aimed at treating severe, rare gastrointestinal conditions. Source: Drug Industry Daily

The best organizations use findings from both internal audits and third-party inspections to build knowledge for future improvement — using audit data to improve the audit program itself, says Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates. Source: Drug Industry Daily

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily