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Prescription Drugs Manufacturing Facilities

Latham & Watkins LLP

FDA Omnibus Reform Act: Examining the Policy Changes

Latham & Watkins LLP on

The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more

Goodwin

FDA Defers Decision on Bevacizumab Biosimilar

Goodwin on

The FDA has deferred its decision on the biologics license application for MYL-1402O, Mylan and Biocon’s biosimilar to Avastin® (bevacizumab). In a December 25th, 2020 company statement, Biocon cited the FDA’s need for more...more

Goodwin

COVID-19 Delays FDA-Approval of DaxibotulinumtoxinA

Goodwin on

Revance Therapeutics, Inc. recently announced that, because of COVID-19 travel restrictions, the FDA has been unable to complete its inspection of the manufacturing facility for Revance’s DaxibotulinumtoxinA for Injection...more

Robins Kaplan LLP

Financial Daily Dose 1.28.2020 | Top Story: Markets Tumble as Fears Spread Over Coronavirus Epidemic

Robins Kaplan LLP on

A mounting death toll (over 106 and counting) and fears of a coronavirus pandemic sent markets tumbling early on Monday and kicked off a selloff that continued all day....more

Robins Kaplan LLP

Financial Daily Dose 10.2.2019 | Top Story: Johnson & Johnson Pays Out $20 Million to Avoid First Opioid Trial

Robins Kaplan LLP on

Johnson & Johnson doled out $20 million to two Ohio counties rather than go through with its first federal opioid-related trial. The money is rather small potatoes for J&J, but it marks the “first time . . . the world’s...more

Holland & Knight LLP

Shortage of Relief: Recent Disasters Highlight Multifaceted Drug Shortage Problem

Holland & Knight LLP on

• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more

Jones Day

French ANSM Clarifies Guidance Related to Raw Materials for Pharmaceutical Use

Jones Day on

On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more

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