Duchenne muscular dystrophy drug from BioMarin gains rare disease designation | Sun Pharmaceutical's acne drug receives FDA approval | Antifungal drug from Vical gets QIDP designation

August 21, 2015
FDLI SmartBrief
News for the food and drug law community

Drugs & BiologicsSponsored By
Duchenne muscular dystrophy drug from BioMarin gains rare disease designation
The FDA has granted rare pediatric disease designation to BioMarin Pharmaceutical's drisapersen as a treatment for Duchenne muscular dystrophy patients amenable to exon 51 skipping therapy. The treatment also holds orphan-drug, fast-track and breakthrough-therapy designations. Zacks (8/20) Share: Email
Sun Pharmaceutical's acne drug receives FDA approval
The FDA has approved Sun Pharmaceutical's supplemental new drug application for extended-release Ximino, or minocycline HCl, to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients at least 12 years old. The drug is expected to be available later this year. BioSpectrum Asia (8/20) Share: Email
Antifungal drug from Vical gets QIDP designation
The FDA has granted qualified infectious disease product designation to Vical's VL-2397, or ASP2397, as a treatment for invasive aspergillosis. The designation qualifies the experimental candidate for priority review. Zacks (8/20) Share: Email
Poll: Americans concerned by high drug prices
A survey by the Kaiser Family Foundation found 72% of the public says prices for prescription drugs are too high. Large majorities also said pharmaceutical companies should disclose pricing methods, Medicare should be able to negotiate drug prices and limits should be placed on the cost of therapies for serious conditions. Fox Business/The Associated Press (8/20) Share: Email
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Global FocusSponsored By
Pfizer's breast cancer drug accepted for EMA review
A marketing application submitted by Pfizer for Ibrance, or palbociclib, as a treatment for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer, in combination with endocrine therapy, has been accepted by the European Medicines Agency. The submission was backed by data from two studies. PharmaTimes (U.K.) (8/20) Share: Email
Skin cancer drug from Novartis wins EU approval
The European Commission has granted approval to Novartis' Odomzo, or sonidegib, for the treatment of locally advanced basal cell carcinoma in adult patients who are not suitable for curative surgery or radiation therapy. The approval was granted based on midstage trial data that showed 56% of patients achieved treatment response. PharmaTimes (U.K.) (8/20) Share: Email
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Food & Dietary Supplements
Undeclared allergen triggers recall of fried cookies from Powell Trading
The use of peanuts not mentioned on the label prompted Powell Trading to pull packages of Nice Choice Fried Cookie -- Seaweed from the market. The affected products with the product code 26.05.2016 and UPC number 4 711202 222089 were distributed in 114-gram packages in British Columbia, Canada. Food Poisoning Bulletin (8/20) Share: Email
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Medical Devices
Higher fees set for medtech export certificates in U.S.
Applicants for medical device export certificates will be charged new fees by the FDA starting Sept. 1. The FDA, which will calculate fees using a new formula, may charge as much as $175 for original certificates and $85 for subsequent certificates for the same product. MassDevice.com (Boston) (8/20) Share: Email
Wedge implant from Tyber Medical lands FDA clearance
The TyWedge Opening Osteotomy Wedge System, a wedge implant from Morristown, N.J.-based Tyber Medical, has received 510(k) clearance from the FDA. The product comes with PEEK coating particularly indicated for initial stability and fusion. FDAnews (8/21) Share: Email
Stent system from Boston Scientific gets FDA OK
The Innova Vascular Self-Expanding Stent, a technology designed by Boston Scientific to address blockages or narrowing in the proximal popliteal artery or superficial femoral artery, has received approval from the FDA. The product, available in sizes ranging from 20 mm to 200 mm in length and 5 mm to 8 mm in diameter, includes a nitinol self-expanding stent with advanced delivery technology. FDAnews (8/20) Share: Email
FDLI Items
FDLI's 2015 Advertising & Promotion Conference -- early bird rate ends next Friday!
On Oct. 1-2, this event will bring together the regulated industries and the regulators responsible for overseeing the advertising and promotion of prescription drugs, medical devices, biologics and animal drugs. Industry experts will explore the uncharted territory of biosimilar and mobile medical application advertising, examine the latest rules affecting social media promotions, dissect recent court decisions and provide practical takeaways. Visit our agenda for new speakers! Register to gain a broad, deep understanding of how to advertise and promote in a highly regulated environment. Hurry -- early bird rates end next Friday, Aug. 28. Share: Email
Registration now open -- FDLI Goes Global Conference: Expanding Your Marketplace -- Guidance for U.S. Businesses Working Globally
This conference will shift our focus to markets around the globe, and the way foods, drugs, tobacco and medical devices are regulated. The regulatory structure in the United States is complicated, but an added layer of doing business on a global scale is learning the legal landscape in other countries. During this two-day global summit, attendees will learn about cultural, legal and regulatory challenges, and opportunities in other countries and regions of the world. This conference will offer specialized focus on food, drugs, medical devices, tobacco, trade and development. Register now and join us on Nov. 4-5. Share: Email
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Senior Corporate Attorney, R&D/Corporate
ASTELLAS US - Northbrook, IL
VP, Associate General Counsel, Regulatory
Associate General Counsel
ASTELLAS US - Northbrook, IL
Associate/Deputy General Counsel for Healthcare*
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