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October 25, 2017
Catalent’s new Biologics & Specialty Drug Delivery unit will be led by Barry Littlejohn; Jonathan Arnold to lead Oral Drug Delivery.
Scott Gottlieb, MD, went before the House Committee on Energy and Commerce to give members the agency’s view on how to fight the opioid crisis, stressing the use of long-term treatment with drug therapy.
October 20, 2017
This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.
October 13, 2017
Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.
September 28, 2017
AbbVie, Amgen, AstraZeneca, Bristol-Myerse Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.
September 26, 2017
Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.
September 19, 2017
The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.
September 11, 2017
FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.
August 31, 2017
Faced with unprecedented flooding from Hurricane Harvey and days of persistent rain, Arkema’s Crosby, TX, plant lost all power, causing flammable chemicals to ignite.
August 30, 2017
FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.