Pharma News

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

Granules Pharmaceuticals, a Hyderabad, India-headquartered pharmaceutical company, has completed its first inspection by the US Food and Drug Administration of its manufacturing facility in Chantilly, Virginia. The inspection took place December 4,...

Depomed, a Newark, California-headquartered specialty pharmaceutical company, has announced a restructuring plan to reduce staff by approximately 40% to approximately 70 employees. The decision follows Depomed’s agreement to sell its product,...

Fortress Biotech, a New York-based biopharmaceutical company acquiring, developing, and commercializing pharmaceutical and biotechnology products, has formed Tamid Bio, a subsidiary dedicated to developing adeno-associated virus (AAV) gene...

GlaxoSmithKline (GSK) plans to invest £40 million ($53 million) in strengthening initiatives in genetic research in the development of new medicines. The investment expands GSK’s previously announced effort to generate genetic sequencing data from...

CSL Behring, a specialty biotherapeutics company, has opened a new AU $230-million (US $173-million) manufacturing facility at its site in Broadmeadows, Victoria, Australia for producing albumin, a protein derived from human plasma that is used in...

Plasticell, a Stevenage, UK-based developer of stem-cell technologies and cell therapies, has partnered with Anthony Nolan, a research organization for blood cancers, to progress clinical development of Plasticell’s ex vivo expanded cord...

Amgen and Carmot Therapeutics, a Berkeley, California-headquartered biotechnology company, have entered into a multi-year drug discovery collaboration and licensing agreement. As part of the agreement, Carmot will apply its proprietary...

Shire and Rani Therapeutics, a San Jose, California-based company specializing in the oral delivery of large-drug molecules, have agreed to conduct research on the use of Rani’s pill technology for the oral delivery of factor VIII (FVIII) therapy...

Otsuka Pharmaceutical and Science 37, a Los Angeles, California-headquartered company focused on “site-less” clinical trials, have signed a strategic collaboration to support efforts to further digitize Otsuka’s mobile clinical study protocols with...

The US Food and Drug Administration (FDA) has released three new digital health policy documents to outline the FDA’s approach in the development and oversight of digital health tools. FDA Commissioner Scott Gottlieb issued a statement explaining...