Indian CDMO Piramal Pharma Solutions is beefing up its global API production, including in the U.S., where it has expanded in recent years.
The FDA has issued Biocon and partner Mylan a complete response letter for their biosimilar of chemotherapy drug Neulasta tied to manufacturing.
Clinical care experts and patient advocacy organizations call attention to why better patient understanding shapes the best integrated approach to orphan drug…
South Korean drugmaker gets a U.S. regulatory warning, new results in Takeda and Myovant’s trial for relugolix to treat uterine fibroids and more.
AbbVie began the next phase of its Singapore manufacturing expansion with a new biologics unit that complements the plant's existing API production.
Brought to you by the publisher of FierceBiotech and FiercePharma, the Fierce Innovation Awards Life Sciences Edition identify and showcase outstanding…
Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.
GlaxoSmithKline has worked hard to put 2013’s China bribery scandal behind it. And a U.S. judge just gave it an assist in that department.
While other companies fret about the impact of Brexit, Japan's Takeda will make another investment in its production operations in the European Union.
Amgen inked a biosim deal with Simcere, Gilead won a Chinese nod for Sovaldi, and Shanghai Pharma is in talks to buy part of Alvogen.
The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert.
Amgen is expanding its cancer and inflammation biosimilar presence in China with a new deal with Simcere.