FDA to review latest biosimilar candidate from Sandoz | Janssen pays milestone to Aduro after filing of IND application | Skin cancer drug from Pfizer, Merck KGaA gains breakthrough status
November 19, 2015
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FDA to review latest biosimilar candidate from Sandoz
The FDA has agreed to review pegfilgrastim, Sandoz's biosimilar for Amgen's Neulasta, used to prevent infection due to low white blood cell counts. Sandoz developed the first US biosimilar, Zarxio, and has submitted another biosimilar for Amgen's autoimmune disease drug Enbrel. PharmaTimes (U.K.) (11/18) Share: Email
Janssen pays milestone to Aduro after filing of IND application
An investigational new drug application has been filed with the FDA by Aduro Biotech for permission to conduct an early stage study of its metastatic castration-resistant prostate cancer drug, ADU-741. The submission triggered the payment of an undisclosed milestone fee from partner Janssen Biotech. Seeking Alpha (free registration) (11/18) Share: Email
Skin cancer drug from Pfizer, Merck KGaA gains breakthrough status
Pfizer's and Merck KGaA's avelumab has received breakthrough therapy status from the FDA as a treatment for metastatic Merkel cell carcinoma, a rare and aggressive skin cancer. The designation was granted based on data from a midstage trial involving metastatic MCC patients whose disease progressed following chemotherapy. PharmaTimes (U.K.) (11/18) Share: Email
House committee plans hearing on drugmakers' pricing practices
The House Committee on Oversight and Government Reform has scheduled a hearing in early 2016 to examine the drug-pricing practices of Turing Pharmaceuticals, Valeant Pharmaceuticals and other drugmakers. Committee member Rep. Elijah Cummings, D-Md., urged Rep. Jason Chaffetz, R-Utah, the committee chairman, to issue subpoenas to force the drugmakers to cooperate with the investigation. Chaffetz's spokeswoman, M.J. Henshaw, said subpoenas will not be issued now because the committee's investigation is still in its early stages. The Hill (11/18) Share: Email
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Global Focus
European decision expected on Enbrel biosimilar
A decision is expected Friday by the European Medicines Agency on whether to recommend a biosimilar of Amgen’s arthritis drug Enbrel, or etanercept. The biosimilar is made by Samsung Bioepis, a joint enterprise of Biogen and Samsung Biologics. Reuters (11/18) Share: Email
NICE rejects Amgen's PCSK9 inhibitor Repatha
The UK's National Institute for Health and Care Excellence has said it will not cover Amgen's novel injectable cholesterol drug Repatha because its benefits in reducing heart attack and stroke have not yet been shown in long-term studies. Reuters (11/18) Share: Email
Food & Dietary Supplements
Undeclared nuts prompt recall of Wegmans ravioli products
Undeclared cashews and almonds prompted Wegmans Food Markets to recall about 54,000 units of its Italian Classics Butternut Squash Ravioli. Affected items have the UPC number 77890 36434 and were distributed in 9-ounce packages to 88 Wegmans locations in Massachusetts, Maryland, Virginia, Pennsylvania, New Jersey and New York. Food Poisoning Bulletin (11/19) Share: Email
Medical Devices
FDA labels Boston Scientific's atherectomy components recall as Class I
A recall of 955 RotaWire Elite and WireClip torquer components of Boston Scientific's Rotablator atherectomy system has been categorized by the FDA as Class I. The recall was issued following three reports that the guidewire of the catheter fractured during plaque removal procedures in the coronary arteries. MassDevice.com (Boston) (11/18) Share: Email
Canada approves wound irrigation device from Innovacyn
The Puracyn Plus Professional Formula, a wound irrigation and management system from California company Innovacyn, has received approval from Canada's Medical Devices Bureau as a Class II medical device. The product, which is also indicated for lubricating and moistening wound dressings, is intended to enhance wound bed preparation. FDAnews (11/18) Share: Email
FDLI Items
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Learn how the final rules differ from what was proposed, what the new requirements are and what areas may be open to interpretation, and what regulated entities need to do to be in compliance by the implementation dates. Register now. Share: Email
Combination Products Workshop -- A Comprehensive Overview, Dec. 17, in Washington, D.C.
Get a comprehensive look at how the FDA makes its jurisdictional decisions, how a company can file a persuasive and accurate Request for Designation, and how to understand and fulfill the manufacturing practices required at this one-day workshop. Learn more. Share: Email
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