Epilepsy treatment from GW Pharmaceuticals wins FDA orphan status | FDA reviewers still concerned over efficacy of Sarepta's DMD therapy | Midatech to seek approval for uveitis drug next year
April 22, 2016
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Epilepsy treatment from GW Pharmaceuticals wins FDA orphan status
GW Pharmaceuticals' cannabis-derived drug Epidiolex secured orphan-drug status from the FDA as a treatment for patients with tuberous sclerosis complex, a rare genetic disorder associated with epilepsy. Four late-stage trials are underway, and results could be released this year.
Reuters (4/21) 
FDA reviewers still concerned over efficacy of Sarepta's DMD therapy
FDA staff reviewers reiterated doubts they previously raised regarding the effectiveness of Sarepta Therapeutics' Duchenne muscular dystrophy drug eteplirsen, as well as the drug's trial design and statistical analysis. An FDA advisory panel is scheduled to consider eteplirsen on Monday, and a final decision from the agency is expected in May.
The Boston Globe (tiered subscription model) (4/21),  Proactive Investors (4/21) 
Midatech to seek approval for uveitis drug next year
Midatech Pharma announced plans to submit an investigational new drug application next year for OpsiSporin as a treatment for the eye disease uveitis after preclinical studies showed the drug yielded a strong response rate at multiple dosages.
ProactiveInvestors.co.uk (U.K.) (4/21) 
FDA clarifies compounding rules with issuance of guidelines
A set of three draft guidelines has been released by the FDA to further clarify regulations governing compounding operations. The guidelines address what is needed to compound without a prescription, what standards must be met in hospital compounding and what factors must be present for a facility to be considered a large-scale compounder, as well as what good manufacturing practice requirements must be met.
FDAnews (4/22) 
Global Focus
Prostate cancer drug from Sanofi wins NICE backing
Sanofi's Jevtana, or cabazitaxel, along with prednisone, has been endorsed by the UK's National Institute for Health and Care Excellence for the treatment of patients with metastatic hormone-relapsed prostate cancer who experienced disease progression following docetaxel treatment.
BioCentury (4/21) 
EU backs development of cancer immunotherapy
The European Commission has granted about $9.34 million in funding to a consortium that includes SalvaRx, as well as its iOx Therapeutics unit, to develop a novel cancer immunotherapy candidate through the combination of iOx's iNKT agonist and a cancer vaccine from the Ludwig Institute for Cancer Research. The funding was given through the Horizon 2020 program.
London South East (U.K.)/Alliance News (U.K.) (4/21) 
Food & Dietary Supplements
List of recalled Back to Nature Foods cookies expanded
Back to Nature Foods has expanded the list of cookie products it is recalling because of the possible presence of milk not declared on the label. The recall now includes Classic Creme cookie packs sold nationwide that bear the UPC code 19898-01103 and have best-by dates of Aug. 13 and Oct. 8, 21 and 22.
ConsumerAffairs.com (4/21) 
Medical Devices
Cartiva's cartilage implant wins positive vote from FDA panel
Premarket approval has been recommended by the FDA's Orthopaedic and Rehabilitation Devices Panel for the Cartiva Synthetic Cartilage Implant, a device intended for treating degenerative or posttraumatic arthritis in the first metatarsophalangeal joint. The panel voted in favor of the safety and effectiveness of Cartiva's implant, and a majority said the benefits of the device outweigh the risks.
Medscape (free registration) (4/21) 
3D breast biopsy system from Hologic cleared by FDA
The FDA has given Marlborough, Mass.-based Hologic 510(k) clearance for its Affirm, a table-based biopsy system for 3D breast imaging. The system, which is already available in Europe, allows 3D breast images to be taken when patients are lying down.
The Boston Globe (tiered subscription model) (4/21) 
Canada OKs stent graft from W.L. Gore
Health Canada has given W.L. Gore & Associates approval to market its Excluder iliac branch endoprosthesis. The device, intended for use with the company's Excluder AAA endoprosthesis, is indicated for endovascular treatment of patients with common iliac artery aneurysms or aortoiliac aneurysms.
MassDevice.com (Boston) (4/21) 
FDLI Items
H. Thomas Austern Memorial Writing Competition
The Food and Drug Law Institute (FDLI) sponsors the H. Thomas Austern Memorial Writing Competition to encourage law students interested in the areas of law that affect food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. Winning papers will be considered for publication in the Food and Drug Law Journal. The 2016 competition deadline for submission is June 10. Learn more.
Food and Dietary Supplements -- 2016 Annual Conference, May 5-6
The breakout sessions at this year's Annual Conference will cover today's hot topics surrounding food and dietary supplement laws and regulations, including a session on GMO labeling. Given the recent activity in the Senate on the Anti-GMO labeling bill, this session will be one that you don't want to miss! View the agenda.
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