Sanofi has acquired an exclusive global license to develop and market ImmuNext's INX-021, a preclinical monoclonal antibody designed to treat autoimmune diseases such as multiple sclerosis and lupus. Sanofi will provide milestone payments of up to $500 million as well as royalties tied to product sales.
Some major medical device industry lobbying groups are staying mum for now about the expected repeal of the US Affordable Care Act -- even though an extensive overhaul of the national health care system would affect medtech. With so much unpredictability around how the incoming Trump administration and the new Republican Congress will replace the ACA, the industry's representatives have been taking more of a wait-and-see approach. "Keep your powder dry," Greg Crist, executive vice president of public affairs at AdvaMed, says of the approach. Read the story.
The FDA has granted fast-track designation to TapImmune's double-blind placebo study that will assess its T-cell therapy TPIV 200 as a treatment for platinum-sensitive ovarian cancer in combination with chemotherapy. Three clinical sites have been approved to start patient enrollment.
Regulatory approval is expected soon for the proposed $43 billion acquisition of Syngenta by ChemChina, according to Syngenta CEO Erik Fyrwald. "We are working well with the US and the EU regulators now toward finalizing the agreements with them and expect to be finished in the not-too-distant future," Fyrwald said.
The FDA has issued its final guidance on repackaging drugs, which clarifies the agency's definition of repackaging and lists situations in which regulations would not be applied, such as when repackaging is done by federal facilities, state-licensed pharmacies or registered outsourcing facilities that meet the guidance's criteria. Meanwhile, a draft guidance has also been released by the agency regarding diluting, mixing and repackaging of biologics, stating that when such actions are done outside the scope of an approved biologics license application, the biological product would be considered unlicensed.
Plans to charge medical device, diagnostics and pharmaceutical companies fees of up to approximately $349,000 for every cost-effectiveness assessment has been postponed by the UK's National Institute of Health and Care Excellence until completion of the new UK government's life sciences strategy. "We have been working to create a new funding model for technology evaluation to meet the government's challenge to drive efficiency and deliver better value," said Sir Andrew Dillon, chief executive of NICE.
Nashik, India-based wholesalers Karwa Pharmaceuticals and Choudhary & Co. will be prosecuted by the Maharashtra FDA for procuring and stocking drugs without the correct purchase documents, which violates the country's Drugs and Cosmetics Act. The investigation showed that the wholesalers colluded with medical representatives and a drugmaker to purchase drugs at a discount using a fake purchase invoice meant for government hospitals and then stocked the drugs in medical stores.
Some bags of Hot Thin & Crispy Potato Chips are being recalled by Alabama-based Golden Flake Snack Foods due to the undeclared presence of milk. The products affected by the recall come in 5-ounce bags with a "best if used by" date of April 14, 2017, and have the product code Lot 364 5 or 365 5.
Boston Scientific has obtained approval from the CMS for a randomized study of its Watchman left atrial appendage closure device. The post-FDA approval, 888-patient trial seeks to assess the safety and efficacy of the device in treating patients with nonvalvular atrial fibrillation who cannot take oral anticoagulants.
A bone substitute has been launched in Europe by French medtech firm Safe Orthopaedics for its Walnut cervical cage. The company developed the device in partnership with a synthetic bone substitute specialist to allow for safer vertebral fusion and promote bone growth.
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