Top News

FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays

July 19, 2018

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

FDA Forms Drug Shortages Task Force

July 19, 2018

FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

July 12, 2018

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Takeda Receives US Clearance for $62-Billion Acquisition of Shire

July 11, 2018

The company has received clearance from the United States Federal Trade Commission for the proposed acquisition of Shire, a deal valued at $62 billion.

Pfizer Announces Restructuring

July 11, 2018

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.

Biogen to Increase Stake in Samsung Bioepis Joint Venture for $700 Million

July 03, 2018

Biogen will pay Samsung BioLogics approximately $700 million to increase its stake in Samsung Bioepis to approximately 49.9%.

Novartis to Spinoff Alcon Eye Care Device Biz and Initiates $5-Billion Share Buyback

July 03, 2018

The pharma major intends to spinoff Alcon as a stand-alone eye-care devices company.

Sanofi to Sell European Generics Business for $2.2 Billion

June 29, 2018

Sanofi will sell Zentiva, its European generics business, to private equity investor Advent International.

GE Spins Off Healthcare Unit as Stand-alone Business

June 26, 2018

Strategic restructuring is designed to position GE Healthcare as a pure-play healthcare company.

FDA Approves First Cannabidiol-based Drug

June 25, 2018

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.