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 (FDA) has established a new Office of Digital Transformation to reorganize the agency’s information technology (IT), data management, and cybersecurity functions. The Office will report directly to the FDA...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has launched a voluntary novel excipient review pilot program, which is intended to allow excipient manufacturers to obtain FDA review of certain novel...

AbbVie and Regenxbio, a Rockville, Maryland-based bio/pharmaceutical company, have entered into a partnership to develop and commercialize Regenxbio’s RGX-314, a gene therapy for chronic retinal diseases, in a deal worth up to $1.75 billion ($370...

Sanofi has completed its $3.2-billion acquisition of Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics and vaccines company. Translate Bio has an early-stage pipeline in cystic fibrosis and other rare pulmonary diseases. Its lead...

Swedish Orphan Biovitrum (Sobi), a Stockholm, Sweden-based bio/pharmaceutical company specializing in rare diseases, has received an offer from private equity firms, Advent International and Aurora Investment, an affiliate of GIC, through Agnafit...

Adaptimmune Therapeutics, an Oxfordshire, UK-based T-cell therapy company, has entered into a strategic collaboration and license agreement with Roche’s Genentech to develop and commercialize allogeneic cell therapies to treat multiple oncology...

Perrigo has agreed to acquire Héra SAS (HRA Pharma), a Paris-based over-the-counter (OTC) consumer self-care company, for EUR 1.8 billion ($2.1 billion) from funds affiliated with the private equity firm, Astorg, and Goldman Sachs Asset...