An independent panel advising FDA is sharing its perspective on the approval process for COVID-19 vaccine. Much of the virtual Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is focused on the complexities of the pandemic and regulatory best practices. The optic of an independent panel of scientists discussing the prospect of safe and…
Feds accuse Teva of $300M in kickbacks for MS drug
Massachusetts federal prosecutors today claimed that Teva Pharmaceuticals funneled $300 million from a pair of charitable foundations to subsidize Medicare copayments for a multiple sclerosis drug. Teva Pharmaceuticals and Teva Neuroscience, the maker of Copaxone, simultaneously raised the drug’s price by 329%, allegedly violating the Anti-Kickback Statute and False Claims Act, according to the complaint…
Johnson & Johnson misses the mark on Q4 revenue
Johnson & Johnson (NYSE:JNJ) today reported fourth-quarter earnings that beat the consensus forecast on Wall Street, but its sales numbers were slightly off amid declining medical device revenue. The New Brunswick, N.J.–based pharmaceutical, medical device and consumer products giant reported profits of $4.0 billion, or $1.50 per share, on sales of $20.7 billion for the three…
Elemica branches out to pharma industry
Chemical industry digital supply chain company Elemica (Wayne, Pa.) said recently that it has extended its offerings to the pharmaceutical industry. Pharma companies using Elemica solutions will now benefit from improved collaboration, visibility, quality management, traceability and speed of execution across their global supply chains, according to Elemica. The company has been building digital solutions…
Redesign Science to use OpenEye Scientific software for drug development
Redesign Science and OpenEye Scientific announced that they have entered into a strategic partnership to integrate OpenEye’s Orion computational platform into Redesign’s drug-discovery platform. Santa Fe, N.M.-based OpenEye makes “cheminformatics” software for drug discovery, providing a reliable application programming interfaces (API) that customers use to build customizable programs and workflows. Its newly released Orion computational…
Mayo Clinic, W.L. Gore team up on stem cell therapy treatments
Mayo Clinic and W. L. Gore & Associates have announced a partnership to develop implantable cell therapies to treat debilitating conditions with no cure. The for-profit company, Avobis Bio, will combine a patient’s own stem cells with bioabsorbable scaffolds to stimulate the healing of perianal fistulas, painful tunneling wounds that affect patients with Crohn’s disease.…
GE Healthcare partnering on regenerative tissue manufacturing
GE Healthcare Life Sciences said today that it has entered into a strategic R&D and distribution partnership with Advanced Solutions Life Sciences — with a goal of personalized tissue regeneration. The partnership with Advanced Solutions Life Sciences is the latest in a string of investments and partnerships that GE Healthcare (NYSE:GE) has been making to further…