Rare skin cancer drug from Merck, Pfizer wins FDA nod | FDA grants orphan status to OPKO's Dravet syndrome candidate | Apicore's generic Xenazine wins FDA nod
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March 24, 2017
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Rare skin cancer drug from Merck, Pfizer wins FDA nod
Pfizer and Merck KGaA's Bavencio, or avelumab, has received FDA approval as a treatment for patients at least 12 years old with metastatic Merkel cell carcinoma.
Reuters (3/23) 
FDA grants orphan status to OPKO's Dravet syndrome candidate
OPKO's candidate CUR-1916, an oligonucleotide-based anti-natural antisense transcript to treat Dravet syndrome, was given orphan drug status by the FDA. The company plans to begin a clinical study of the drug this year.
eMPR.com (3/23) 
Apicore's generic Xenazine wins FDA nod
Apicore's abbreviated new drug application for tetrabenazine tablets has been approved by the FDA. The drug, which is indicated for patients with involuntary movements associated with Huntington's disease, is a generic version of Valeant Pharmaceuticals' Xenazine.
Seeking Alpha (free registration) (3/23) 
Heart failure drug from Novartis fails to hit primary endpoint in Phase III study
A late-stage clinical trial of Novartis' candidate serelaxin, assessed as a treatment for patients with acute heart failure, failed to meet its primary endpoint. The drug plus standard of care did not reduce cardiovascular death or worsening heart failure in patients.
Reuters (3/22) 
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Global Focus
NICE to include anastrozole in familial breast cancer guidelines
Updated familial breast cancer guidelines have been published by the National Institute for Health and Care Excellence to include five-year use of anastrozole for postmenopausal women with a family history of breast cancer. Anastrozole joins tamoxifen and raloxifene as an option for doctors to prescribe to reduce the risk of patients developing the disease.
PharmaTimes (U.K.) (3/23) 
EU approves Amgen's chronic inflammatory diseases biosimilar
Amgen's Amjevita, a biosimilar version of AbbVie's Humira, or adalimumab, has been approved by the European Commission. Amjevita is intended to treat patients with chronic inflammatory diseases who need alternative or additional treatment options.
Seeking Alpha (free registration) (3/23) 
Reimagine the life science patient experience
The life science industry is undergoing rapid transformation, driven by consumer empowerment, clinical innovation and outcomes-driven health care policy. In this changing landscape, medical device and pharmaceutical companies are striving to connect with patients and deliver the best possible experience before, during and after therapy. Learn more.
Food & Dietary Supplements
Undeclared allergen prompts recall of over 20K pounds of jerky products
About 22,466 pounds of ostrich, beef and venison jerky products are being recalled by Whiskey Hill Smokehouse because the items do not mention soy as an ingredient. The recalled products, which were produced between March 3, 2016, and March 10, 2017, have the establishment number EST. 4993 or P-4993 and were shipped nationwide, including wholesale, catalog and internet sales distribution.
Food Safety News (3/23) 
Medical Devices
Study of InVivo's neuro-spinal scaffold approved by Canada
Health Canada has given InVivo Therapeutics approval to conduct a trial of its neuro-spinal scaffold for treating acute, complete AIS A cervical spinal cord injuries. The company said it is in the final stages of talks with site research ethics boards and is looking to announce the first clinical site "in the coming weeks."
MassDevice.com (Boston) (3/23) 
Zoll Medical's automated external defibrillators win approval in Canada
Health Canada has given Zoll Medical approval for its Zoll AED 3 and Zoll AED 3 BLS automated external defibrillators, which are indicated for use in pediatric and adult patients. The next-generation devices use audible and visual prompts to deliver real-time feedback so rescuers know the appropriate timing for effective CPR.
MassDevice.com (Boston) (3/23) 
EU OKs in vitro diagnostic assay from HTG
European regulators have given HTG Molecular Diagnostics CE mark approval for its HTG EdgeSeq ALKPlus Assay EU, which is intended to facilitate mRNA ALK gene rearrangement measurement and analysis in lung tumor samples from patients who had a previous diagnosis of non-small cell lung cancer. The in vitro diagnostic assay, which operates on the company's EdgeSeq next-generation sequencing system, can help determine which patients may respond to ALK-targeted treatments.
GenomeWeb Daily News (free registration) (3/23) 
Food and Drug Law Institute Highlights
Early registration ends March 31! Annual Conference, May 4-5, Washington, D.C.
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Food and Drug Law Journal: FDA-Required Tobacco Product Inserts and Onserts -- And the First Amendment
In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. This paper examines the FDA's authority to require effective inserts and onserts and shows how the FDA could design and support them to avoid First Amendment problems. Read the article.
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