FDA wants more info on Heplisav-B vaccine, delays NDA decision by 3 months | Drug for ulcerative colitis in children gets orphan status | FDA approves Zydus' Mesalamine suppositories for rectal use
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August 14, 2017
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Drugs & Biologics
FDA wants more info on Heplisav-B vaccine, delays NDA decision by 3 months
FDA wants more info on Heplisav-B vaccine, delays NDA decision by 3 months
(Robert Cianflone/Getty Images)
Dynavax Technologies said the FDA wants additional post-marketing study information pertinent to the safety of its Heplisav-B vaccine as a treatment for patients with hepatitis B virus infections, resulting in a delay in the FDA's decision on its new-drug application by up to three months. The delay, however, will not stall plans for Heplisav-B's commercial launch in early 2018, Dynavax said.
MD Magazine online (8/11) 
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Drug for ulcerative colitis in children gets orphan status
Cobitolimod, Index Pharmaceuticals' drug candidate for ulcerative colitis, has gained an orphan drug designation from the FDA as a treatment of children. The Toll-like receptor 9 agonist is in midstage trials for adults.
Rare Disease Report (8/10) 
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FDA approves Zydus' Mesalamine suppositories for rectal use
The FDA granted approval to Zydus Cadila's Mesalamine suppositories 1,000 mg to be administered rectally as a treatment for patients with inflammatory bowel diseases. The company will manufacture the drug in Ahmedabad, India.
India Infoline (8/14) 
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Galapagos reports positive results from pulmonary fibrosis study
Galapagos announced positive results from a Phase IIa clinical trial of its selective autotaxin inhibitor GLPG1690 for patients with idiopathic pulmonary fibrosis. The drug increased mean forced vital capacity in IPF patients by 8 mL compared with a reduction of 87 mL for placebo from baseline to week 12.
BioCentury (8/10) 
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FDA gives orphan status to Inventiva's MPS VI drug
The FDA granted orphan drug status to Inventiva's Odiparcil as a treatment for patients with the rare pediatric genetic degenerative disease Maroteaux-Lamy syndrome VI. The company plans to start patient enrollment in a Phase IIa study by the end of the year.
Reuters (8/10) 
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Global Focus
Merck's Erbitux gets expanded NICE recommendation
Merck's Erbitux, or cetuximab, was endorsed by the National Institute for Health and Care Excellence for National Health Service for use in combination with platinum-based chemotherapy for patients with recurrent or metastatic squamous cell cancer of the head and neck. The drug was previously available for that indication through the Cancer Drugs Fund.
PMLive (U.K.) (8/14) 
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Food & Dietary Supplements
Luvo recalls poultry products over undeclared allergen
Approximately 4,805 pounds of poultry products were recalled by Luvo because the products contain undeclared allergens and were mislabeled. The recalled products, which were labeled as Chicken Chile Verde but contain Turkey Meatloaf that has egg and fish allergens not on the Chicken Chile Verde label, have a "best before" date of June 13, 2018, and were shipped to distributors in 11 states.
Food Safety News (8/13) 
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Medical Devices
Bionix brachytherapy applicators to be marketed by Varian in North America
Varian Medical Systems reached a deal with Bionix Radiation Therapy to market and distribute Bionix's disposable brachytherapy tools, specifically Esophageal Applicator, or E-App, and Anorectal Applicator, or AR-1, in North America. The E-App is designed for upper-gastrointestinal cancer treatment, while the AR-1 is designed for the treatment of rectal and anal cancers.
DOTMed (8/11) 
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EU issues draft lists for notified body designation under IVD, device rules
Two draft lists that contain 171 codes for specifying notified bodies' scope of designation under the EU medical device and IVD rules were released by the European Commission's Notified Body Operations Group, along with another draft that lists the documents required to be submitted by the bodies when applying for redesignation. The group stressed that the lists are not yet official because they still need to be adopted or endorsed by the commission.
Medtech Insight (free registration) (8/11) 
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Hot Topics
Food and Drug Law Institute Highlights
Last call for proposals! Enforcement, Litigation and Compliance Conference; Deadline: Aug. 15
Last call for proposals! Enforcement, Litigation and Compliance Conference; Deadline: Aug. 15
What enforcement and compliance concerns are keeping you up at night? We invite industry stakeholders to submit a session topic that you would like to see addressed during the Enforcement, Litigation and Compliance Conference, scheduled for Dec. 6-7. Topics can cover the drug, medical device, food, dietary supplement or tobacco industries. Submit now.
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A great reference! How to Comply with Drug CGMPs, 2nd edition
A great reference! How to Comply with Drug CGMPs, 2nd edition
This resource provides members of the legal community and regulated industry with a concise reference on the compliance standards and governing principles for current Good Manufacturing Practices. Purchase your copy.
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