Pharma News

The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.

Akorn, a Lake Forest, Illinois-headquartered specialty generic pharmaceutical company, has announced it will move forward as an independent company following a decision from the Supreme Court of the State of Delaware to allow Fresenius Kabi AG, a...

The US Food and Drug Administration (FDA) has released two guidances, one final and one draft, to advancie the agency’s biosimilars policy framework. The guidances describe the agency’s plan to implement Congress’ direction that the FDA transition...

The US Food and Drug Administration (FDA) has issued final guidance, Data Integrity and Compliance With Drug CGMP, which updates a 2016 guidance for ensuring data integrity and compliance with current good manufacturing practice (CGMP), in response...

Boehringer Ingelheim (BI) has announced staff reductions in France as part of a post-integration plan of Sanofi’s animal-health business (Merial), which BI acquired in 2017. The reorganization includes the elimination of 327 positions (197 in human...

Mylan Pharmaceuticals is expanding its consumer-level voluntary US recall of valsartan-containing products to include all lots of valsartan-containing products within expiry. In November 2018, Mylan issued a voluntary recall to the consumer level...

Lupin, a Mumbai, India-headquartered pharmaceutical company, has received 22 observations from the US Food and Drug Administration (FDA) across its three facilities in Mandideep, India, which Lupin says are “largely procedural in nature.” Lupin’s...

Janssen Pharmaceuticals, one of the pharmaceutical companies of Johnson & Johnson, and argenx, a clinical-stage biotechnology company developing differentiated antibody-based therapies for treating severe autoimmune diseases and cancer, have...