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The EU’s orphan drug regulations are not adequately supporting the development of medicines for rare diseases, according to a new report conducted on behalf of the European Commission. Read More
The FDA’s Oncologic Drugs Advisory Committee voted 8-2 yesterday in support of Mesoblast’s stem-cell treatment Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease in children. Read More
To produce components needed for their COVID-19 vaccine candidates, Novavax has enlisted support from a South Korean biotech, while Johnson & Johnson has agreed to work with an Indian biopharma company. Read More
AstraZeneca has entered into an agreement with mAbxience of the INSUD Group to produce AZ’s COVID-19 vaccine for most of Latin America from manufacturing facilities in Mexico and Argentina. Read More
The House Select Subcommittee on the Coronavirus Crisis is questioning how vaccines are being chosen for accelerated development under the U.S. government’s Operation Warp Speed and calling for details on possible conflicts of interest among those who are making the choices. Read More
The FDA cited over-the-counter drugmaker Cosmax USA for violations at its Solon, Ohio facility, including training and quality control lapses. Read More
Health insurer Humana has filed a lawsuit against Teva Pharmaceuticals seeking to recover “substantial costs” it incurred in recalling and replacing the company’s heartburn drugs. Read More
The FDA expects sponsors of breast cancer trials to include men as well as women and the scarcity of men with the condition is not an acceptable reason for excluding them from a trial, according to a new final guidance from the FDA. Read More
Mexico’s drug regulators have approved RedHill Biopharma’s planned phase 2/3 trial of Yeliva (opaganib) in hospitalized COVID-19 patients with pneumonia. Read More