Pharma News

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

The US Food and Drug Administration has issued guidance documents to help accelerate the development of prevention and treatment options for COVID-19. The FDA says the guidances make the process for submitting applications to initiate studies for...

Bristol Myers Squibb (BMS) and bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene-therapy company, have received a Refusal to File Letter from the US Food and Drug Administration (FDA) regarding the biologics license...

A roundup of developments from the UK (AstraZeneca) and the US (Amgen, Fresenius Kabi). UK AstraZeneca Gains Global Rights to Allergan’s Autoimmune Disease DrugAstraZeneca has completed its previously communicated agreement with...

The US Food and Drug Commissioner Stephen Hahn provided an update on FDA surveillance inspections during the COVID-19 pandemic. The FDA “will continue to utilize and implement additional alternative inspection tools and approaches while postponing...

AbbVie has completed its $63-billion acquisition of Allergan following receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court (Allergan is headquartered in Dublin,...

The Association of Accessible Medicines (AAM), which represents generic-drug and biosimilar manufacturers, has released a survey of AAM members indicating that the shipping of pharmaceuticals to the US has risen 224% as a result of the coronavirus...