Archive for February 2022
J&J and Three Large Wholesalers Reach Opioid Settlement Deal of $26B
Johnson & Johnson (J&J) and three drug wholesalers have reached a deal to pay out $26 billion to settle thousands of lawsuits over their business practices, which plaintiffs claim fueled the deadly opioid crisis over the past two decades. Source: Drug Industry Daily
Read MoreFDA Issues Third Complete Response Letter for Mallinckrodt’s Terlipressin
The FDA has issued a third Complete Response Letter (CRL) to Mallinckrodt for the company’s investigational drug terlipressin for the treatment of adults with hepatorenal syndrome (HRS), a life-threatening syndrome involving rapid reduction in kidney function. Source: Drug Industry Daily
Read MoreBurst Biologics Warned for Failing to Guard Its Blood Products Against Contamination
Boise, Idaho-based Smart Surgical, which does business as Burst Biologics, failed to ensure that its blood products were free of the threat of infection and contamination, the FDA said in a warning letter to the company. Source: Drug Industry Daily
Read MoreAstraZeneca and Daiichi Sankyo Report Encouraging Results From Enhertu Trial
AstraZeneca and Daiichi Sankyo have released promising results from a phase 3 study of Enhertu (trastuzumab deruxtecan), saying the drug significantly improved both progression-free and overall survival in patients with HER2-low metastatic breast cancer. Source: Drug Industry Daily
Read MoreFor Kodiak’s Macular Degeneration Antibody, Just as Good Isn’t Good Enough
Kodiak Sciences’ antibody designed to treat age-related macular degeneration with eye injections every three to five months was no better than Regeneron Pharmaceutical’s Eylea (aflibercept), the currently approved drug for the condition, injected every two months, Kodiak reported. Source: Drug Industry Daily
Read MoreFDAnews Webinar Highlights Drawbacks to Remote Inspections
An FDA remote inspection can carry major drawbacks, including that they may last longer than an in-person visit and that the FDA doesn’t consider them to be a full substitute for an on-site inspection. Source: Drug Industry Daily
Read MoreSanofi, GSK Seek Vaccine Authorization as Both Primary Series and Booster
Sanofi and GlaxoSmithKline (GSK) will very soon be taking their COVID-19 vaccine candidate to U.S. and European regulators as both a primary series and booster, touting its 58 percent efficacy against symptomatic disease as proof that the shot works in a world with multiple COVID-19 variants. Source: Drug Industry Daily
Read MoreFDA’s Pre-Approval Inspections Fell by More Than 50 Percent in 2021, Report Says
The FDA’s Office of Pharmaceutical Quality (OPQ) used alternative tools because of the ongoing pandemic that reduced the number of facilities needing pre-approval inspections by more than 50 percent in fiscal 2021, OPQ said in its annual report released yesterday. Source: Drug Industry Daily
Read MoreTwo Companies Hit With FDA Warning Letters for Selling Unapproved and Misbranded Drugs for COVID-19
The FDA has accused two overseas companies of selling unapproved and misbranded drugs for COVID-19 to U.S. customers over the internet. Source: Drug Industry Daily
Read MoreTakeda and Code Bio Form Partnership to Develop Gene Therapies
Takeda Pharmaceuticals and Code Biotherapeutics are teaming up to develop gene therapies for treatment of rare diseases in a deal that is potentially worth up to $2 billion to Hatfield, Pa.-based Code Bio. Source: Drug Industry Daily
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