A complete response letter was issued by the FDA to Pfizer regarding its biologics license application for Retacrit, or epoetin alfa, a biosimilar of Amgen's Epogen and Janssen Biotech's Procrit, intended to treat anemias linked to chronic kidney disease, chemotherapy and perioperative settings. The letter was related to a warning letter issued in February regarding a facility in Kansas that is a potential manufacturing site for the product.
A drug-development model that combines biology and engineering may be the path toward precision medicine and individualized treatments, panelists said at a symposium hosted by the Massachusetts Institute of Technology. Scientists and businesses also will have to enlist citizens as collaborators to move precision medicine forward, said Cori Bargmann, president of science at the Chan Zuckerberg Initiative, who was joined by Nancy Simonian, CEO of Syros Pharmaceuticals, on a panel moderated by MIT President Emeritus Susan Hockfield.
Senate Republicans released the Better Care Reconciliation Act, a bill aimed at repealing provisions of the Affordable Care Act, including the medical device tax. A Congressional Budget Office analysis of the bill may be released as soon as Monday, and the Senate plans to vote on it soon after that.
A new formulation of Roche Holding's blockbuster cancer drug Rituxan called Rituxan Hycela can now be given as a subcutaneous injection within a five- to seven-minute period, unlike previous versions of the drug, which require infusion. Rituxan Hycela was approved for the treatment of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, and will be available to US patients in one to two weeks, according to Roche.
The FDA has given orphan drug designation to FibroGen's pamrevlumab, a treatment for patients with pancreatic cancer.
AstraZeneca's Daxas, or roflumilast, has been recommended by the National Institute for Health and Care Excellence as a treatment for chronic obstructive pulmonary disease in patients whose disease symptoms have worsened despite other treatments. NICE had previously rejected Daxas for normal funding, but two new trials that showed it helped relieve symptoms not under control with inhalers, along with AstraZeneca's base-case cost estimate, caused NICE to reverse its recommendation.
The Distal Radius Sterile Kit has been launched by DePuy Synthes for use in surgical treatment of wrist fractures. The presterilized, single-use kit of instruments and implants is intended for eliminating over 60% of the steps taken to process reusable kits.
The European Medicines Agency has accepted for review Shire's marketing application for its Veyvondi as an on-demand treatment and control of bleeding episodes in adults with von Willebrand disease.
NOW Health Group expanded its recall of Ellyndale Nutty Infusions nut butters, which were distributed online and in retail stores nationwide, because of potential Listeria monocytogenes contamination. The recall now includes Mango Chili Cashew Butter with a lot number of 2125156 and best-by date of 3/19; and Roasted Almond Butter with the lot number 2124119 and best-by date of 2/18.
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