Abiomed Inc. received 510(k) clearance from the Food and Drug Administration for its new intra-aortic balloon, a technology designed to enhance blood flow to the heart and other organs.
Accentia Biopharmaceuticals shares surged after the Tampa, Fla.-based company announced it has entered into mutual confidentiality agreements with several unnamed pharmaceutical companies that have approached the company over SinuNase. Accentia said in a statement it believes that potential relationships could provide "upfront and milestone payments as well as enhance the commercial opportunity for SinuNase." Currently in Phase III trials, SinuNase, a treatment for chronic sinusitis, has been granted fast-track status by the Food and Drug Administration.
Anika Therapeutics Inc. said it obtained FDA approval for its cosmetic tissue augmentation. Anika said the product is an injectable soft-tissue filler for facial wrinkles, scar remediation and lip augmentation.
Bristol-Myers Squibb Co. said would pay $499 million as part of a tentative agreement it made with federal authorities to settle several probes into the drug company's pricing and sales and marketing activities
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