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Makers of Zoloft (sertraline hydrochloride) and its generic versions are reporting shortages linked to increased demand during the pandemic coupled with supply chain issues caused by the impact of COVID-19 on manufacturers of active pharmaceutical ingredients (APIs). Read More
Federal lawmakers yesterday criticized the effectiveness of the FDA’s foreign inspections program, expressing outrage that the controversial anti-malaria drug hydroxychloroquine, which has been used to combat COVID-19, came from foreign plants that have never been inspected. Read More
BerGenBio has announced that the first COVID-19 patient was dosed with bemcentinib in a phase 2 trial to evaluate the drug as a potential treatment. Read More
The FDA’s changes in response to the COVID-19 outbreak will lead to permanent improvements at the agency, predicts FDA Commissioner Stephen Hahn. Read More
A group of U.S. academics and pharmacists has proposed a quality rating system for prescription drugs that would allow bulk buyers to assess the quality of drugs before they make purchases. Read More
Among the many urgent priorities it faces during the pandemic, the FDA is devoting substantial resources to monitoring fraudulent COVID-19 products, issuing two dozen warning letters in May — including, for the first time, one to a company selling a fake vaccine. Read More
A federal appeals court has ruled that Genentech must face a lawsuit filed by cancer treatment centers over its cancer blockbuster Herceptin (trastuzumab). Read More
HHS has expanded an existing partnership between its Biomedical Advanced Research and Development Authority (BARDA) and Emergent BioSolutions, awarding the Maryland company approximately $628 million to manufacture COVID-19 vaccines. Read More