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The issues the industry is grappling with these days dovetail perfectly with topics on tap at the GMP Quality Management Virtual Summit 2023 Oct. 11 and 12, according to Steve Lynn, this year’s new conference lead. Read More
On Monday the U.S. Patent and Trial and Appeal Board (PTAB) ruled that Novo Nordisk, maker of semaglutide, did not choose the “obvious” research road drug, thereby denying Mylan Pharmaceuticals its challenge on two of Novo’s existing patents. Read More
With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining current recommendations for development programs and trial designs for treatment of moderate-to-severe cocaine use, methamphetamine use and prescription stimulant use disorder. Read More
The FDA has issued a revision to its Manual of Policies and Procedures (MAPP) describing how the Office of Generic Drugs will track and respond to ANDA suitability petitions, consistent with the commitments made in the GDUFA III commitment letter. Read More
CBER has issued warning letters to manufacturers for product sterility, failure to seek approval for drug and/or biologic products, inadequate labeling and GMP violations. Read More
Eli Lilly announced on Monday that it has received its second FDA complete response letter (CRL) related to findings from an inspection of the third-party contract manufacturing organization, this time for production of the company’s eczema drug, Lebrikizumab. Read More
Only about half of drug manufacturers have systems that comply with what regulatory bodies want to see in Quality Risk Management (QRM) — though the FDA and the International Council for Harmonisation (ICH) both released updated guidance on the topic earlier this year, said Beth Slater, industry veteran and founder and president of consulting firm Quality Confidential. Read More
A government shut down as of midnight on Saturday — the end of the fiscal year — appears likely as partisan disagreements about federal discretionary spending rage on with no clear end in sight. Read More
Boehringer Ingelheim (BI) has filed a motion for summary judgment in its case against HHS objecting to the Inflation Reduction Act’s (IRA) drug price negotiation program, claiming that the undisputed material facts entitle BI to judgment as a matter of law. Read More
Recommendations on labeling of injectable prescription drug product information submitted in an NDA or certain BLAs is the subject of an FDA guidance on dose banding. Read More