The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
In response to the novel coronavirus (COVID-19), the US government is providing advanced development support for a rapid diagnostic test and support for potential vaccines and treatments.
The US Department of Health and Human Services' (HHS)...
The US Food and Drug Administration (FDA) has announced this week (March 10, 2020) that it will postpone most inspections of foreign facilities, effective immediately, through April 2020 in response to the novel coronavirus (COVID-19) outbreak....
Fujifilm Cellular Dynamics (FCDI), a developer and manufacturer of human-induced pluripotent stem cells (iPSCs), has begun operations of its new cGMP-compliant iPSC production facility in Madison, Wisconsin. FCDI invested JPY 2.5 billion ($21...
Bora Pharmaceuticals, a CDMO of non-sterile oral solid dosage forms, has agreed to acquire a GlaxoSmithKline’s (GSK) manufacturing facility in Mississauga, Ontario, Canada.
The GSK facility produces approximately 50 different products for over 100...
As part of its supply-chain surveillance plan for the novel coronavirus (COVID-19), the US Food and Drug Administration (FDA) reports that a manufacturer reported a drug for human use that was recently added to the drug shortages list related to a...
President Donald Trump and executives discuss progress and needs in advancing vaccines and treatments against coronavirus; also, news from Takeda and Vir Biotechnology.
White House Meets with Pharma Executives to Advance Coronavirus Treatments and...
AstraZeneca has completed an agreement with Atnahs Pharma, a UK-based pharmaceutical company, to divest its global commercial rights for five established hypertension medicines for $350 million.
The medicines include Inderal...
Takeda Pharmaceutical has acquired PvP Biologics, a San Diego, California-based pharmaceutical company developing treatments for celiac disease, in a deal worth up to $330 million. The acquisition follows the conclusion of a Phase I proof-...
As part of a strategy to divest non-core assets to reduce debt following its $62-billion acquisition of Shire in 2019, Takeda has completed the sale of select over-the-counter (OTC) and prescription drugs and announced the sale of additional...
Biogen and Sangamo Therapeutics, a genomic medicine company, have formed a global licensing collaboration agreement for gene-regulation therapies in neurology in a deal worth up to $2.72 billion ($350 million upfront and $2.37 billion in potential...
Gilead Sciences has agreed to acquire Forty Seven, Inc. a clinical-stage immuno-oncology company, for $95.50 per share in cash or $4.9 billion.
Forty Seven’s lead investigational lead product candidate is magrolimab, a monoclonal antibody in...
AbbVie has moved closer to finalizing its pending $63-billion acquisition of Allergan following approval by the European Commission of the divestiture of Allergan’s brazikumab, an investigational drug to treat autoimmune diseases, to AstraZeneca....
A roundup of developments from Malaysia (Biocon), Saudi Arabia (Grifols), UK (AstraZeneca), and the US (Merck & Co., Taro Pharmaceuticals).
Malaysia
Biocon Receives FDA Form 483 for Insulin Mfg Plant in Malaysia
The US Food and Drug...
GlaxoSmithKline (GSK) has agreed to sell to Stada, a Bad Vilbel, Germany-based company, a portfolio of 15 local and regional consumer healthcare brands in countries predominantly in Europe for an undisclosed amount.
The portfolio includes cold and...
Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company for T-cell redirecting cancer immunotherapies, has entered into a strategic collaboration agreement with GlaxoSmithKline (GSK) to develop novel adoptive cell therapies...
