Archive for June 2022
Pfizer Seeks Full FDA Approval for Oral COVID-19 Therapy Paxlovid
Pfizer is jockeying for full FDA approval of its oral antiviral COVID-19 treatment, Paxlovid, which would allow the company to sell the drug commercially. Source: Drug Industry Daily
Read MoreFagron’s API Facility in Minnesota Gets FDA Warning Letter
Netherlands-based Fagron drew a warning letter from the FDA for its facility in St. Paul, Minn., for inadequate equipment cleaning that could lead to cross-contamination of its drug products. Source: Drug Industry Daily
Read MoreNovartis Restarts Production at Its Millburn, N.J. Facility
Novartis said it has resumed operations at its Millburn, N.J., and Ivrea, Italy, plants after recently halting production over quality lapses related to the manufacture of radioligand therapy medicines. Source: Drug Industry Daily
Read MoreFDA Places Clinical Hold on Sanofi’s BTK Inhibitor in MS and Myasthenia Gravis Trials
Phase 3 studies of Sanofi’s tolebrutinib in both multiple sclerosis (MS) and myasthenia gravis have been placed on partial clinical hold following reports of drug-induced liver injury in trial participants. Source: Drug Industry Daily
Read MoreFDA Releases Guidance on ‘Fit-for-Purpose’ Clinical Outcome Assessments
In its latest guidance on patient-focused drug development, released yesterday, the FDA calls for high-quality clinical outcome assessments (COAs) for drug trials. Source: Drug Industry Daily
Read MoreFDA Posts Final Guidances on Adjuvant Therapies for Renal Cell and Bladder Cancer
The FDA outlined its latest thinking for sponsors of adjuvant therapies for renal cell and bladder cancer in two guidances released yesterday. Source: Drug Industry Daily
Read MoreSanofi Drops Monthly Out-of-Pocket Insulin Cost to $35 for Uninsured Patients Amid Controversy Over Insulin Prices
Sanofi will begin offering 30-day supplies of its insulin products to uninsured patients in the U.S. for $35 on July 1, the company announced Wednesday. Source: Drug Industry Daily
Read MoreOne Hundred Lawmakers Urge HHS to Help Lower Prescription Drug Prices
In a letter to HHS Secretary Xavier Becerra, 100 members of Congress called for the use of several controversial federal authorities — including compulsory licensing, “march-in rights” and royalty-free rights — to help lower the prices of prescription drugs. Source: Drug Industry Daily
Read MoreFDA Expert Panel Recommends Omicron-Updated COVID-19 Booster Shots
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19 to 2 yesterday in favor of including a SARS-CoV-2 Omicron component in COVID-19 booster shots. Source: Drug Industry Daily
Read MoreUveitis Prompts Partial Clinical Hold on Nuvation Bio Cancer Drug
Uveitis — an inflammation of the middle layer of the eye — in treated patients has prompted FDA to halt enrollment in Nuvation Bio’s phase 1/2 dose-escalation study of NUV-422, a checkpoint inhibitor under investigation for a wide variety of solid tumors. Source: Drug Industry Daily
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