Archive for November 2021
Indian Generics Maker Sun Pharma Recalls ED Meds in the U.S.
Indian Generics Maker Sun Pharma Recalls ED Meds in the U.S. Source: Drug Industry Daily
Read MoreDercher Enterprises Hit with Fourth 483 in 13 Years, New Quality Director Works to Overhaul Processes
Dercher Enterprises of Upper Darby, Pa., doing business as Gordon Laboratories, was hit with an eight-observation Form 483, and the company’s new quality director told FDAnews that he’s working to pull the company into full compliance. Source: Drug Industry Daily
Read MoreAdvocacy Group Pushes FDA to Disqualify Minneapolis IRB, Investigators from Running Trials
Public Citizen has called on the FDA to take strong action against two Minneapolis, Minn., investigators and the institutional review board (IRB) at Hennepin County Medical Center (HCMC) over investigational new drug (IND) and informed consent issues on some of their trials. Source: Drug Industry Daily
Read MoreHouse Passes Build Back Better Act With Drug Pricing Provisions Intact
After a long night which saw a vote on the Build Back Better Act delayed for many hours, the House of Representatives on Friday morning finally passed the nearly $2 trillion Build Back Better Act — including provisions meant to reduce the price of some prescription drugs. Source: Drug Industry Daily
Read MoreGAO Shines Spotlight on Dearth of Antibacterial and Antifungal Treatments, Despite Special Pathway Available to Developers
There aren’t enough drugs under development to treat antibacterial and antifungal infections in patients with limited treatment options, even though the FDA offers a particular pathway to help expedite such candidates, the Government Accountability Office (GAO) has reported. Source: Drug Industry Daily
Read MoreNICE OKs Injectable HIV Drug and Gives Conditional Approval to SMA Therapy
The UK’s National Institute for Clinical Evidence (NICE) has given a thumbs-up to the first dual-agent injectable HIV-1 treatment for use by the National Health Service (NHS). Source: Drug Industry Daily
Read MoreChinese API Maker That Sparked Global Controversy Over Impurity-Laden Heart Drugs Gets a Close-Out of its FDA Warning Letter
The FDA has closed out its three-year-old warning letter to Zhejiang Huahai Pharmaceutical’s site in Linhai, Taizhou because of corrective actions the manufacturer has undertaken. Source: Drug Industry Daily
Read MoreImmune Cell Decreases Halt Merck’s Dual-Agent Antiretroviral HIV Study
Citing declining lymphocyte and T-cell counts in some patients, Merck has stopped its phase 2 trial of a dual-agent HIV antiretroviral regimen and is probing similar studies for this concerning safety signal. Source: Drug Industry Daily
Read MoreCDC Expert Panel Endorses Pfizer, Moderna Boosters for All Adults
Within hours of the FDA authorizing booster doses of the Pfizer and Moderna COVID-19 vaccines for all adults, a Centers for Disease Control and Prevention (CDC) expert panel unanimously supported the decision. Source: Drug Industry Daily
Read MoreHouse Expected to Pass Build Back Better Act With Lightweight Drug Pricing Reform
The House debated the Build Back Better Act late into the night and was expected to pass the bill, which includes provisions aimed at lowering the price of some prescription drugs. Source: Drug Industry Daily
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