Mylan agrees to pay $465M to settle EpiPen misclassification claims | Pfizer's Besponsa for ALL gets FDA nod | AstraZeneca, Merck get expanded approval for Lynparza
August 18, 2017
FDLI SmartBrief
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Drugs & Biologics
Mylan agrees to pay $465M to settle EpiPen misclassification claims
Mylan agrees to pay $465M to settle EpiPen misclassification claims
(Joe Raedle/Getty Images)
EpiPen maker Mylan agreed to pay $465 million as part of a final settlement deal with the Justice Department, resolving claims that the firm overcharged the US government by misclassifying the epinephrine auto-injector as a generic product under Medicaid's Drug Rebate Program while it was being marketed and priced as a branded treatment. The settlement, which requires Mylan to reclassify EpiPen and pay rebates applicable to its new classification effective April 1, was criticized by several lawmakers who believe the settlement is too low.
Reuters (8/17),  The Hill (8/17) 
Pfizer's Besponsa for ALL gets FDA nod
Pfizer's Besponsa, or inotuzumab ozogamicin, was approved by the FDA as a treatment for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.
Seeking Alpha (free registration) (8/17) 
AstraZeneca, Merck get expanded approval for Lynparza
AstraZeneca and Merck received approval from the FDA to expand the indication for Lynparza, or olaparib, to cover use as a maintenance therapy in patients with recurrent ovarian cancer that is responsive to platinum-based chemotherapy. The drug was previously approved as a treatment for women with advanced ovarian cancer who had at least three prior treatments with chemotherapy and were no longer responding to it.
Reuters (8/17) 
Alexion adds patents to Soliris
Alexion has gained three new patents for its expensive biologic drug Soliris, or eculizumab, for paroxysmal nocturnal hemoglobinuria. Amgen has a potential eculizumab biosimilar in its pipeline.
FiercePharma (8/16) 
FDA commissioner vows action to boost generic-drug development
Makers of brand-name drugs "game the system and game the rules" of a patient safety program to prevent generic-drug makers from obtaining adequate samples for equivalence studies, says FDA Commissioner Scott Gottlieb, who has vowed action to curb the practice.
USA Today (8/15) 
Global Focus
UK MHRA widens patient access to Dovonex psoriasis ointment
Dovonex, a psoriasis ointment, was approved by the UK's Medicines and Healthcare products Regulatory Agency to be sold in pharmacies to treat patients who are at least 18 years old and who have mild to moderate psoriasis. Dovonex was previously available as a prescription-only drug.
PharmaTimes (U.K.) (8/18) 
Food & Dietary Supplements
Undeclared wheat allergen spurs recall of chicken caesar salad
Missa Bay issued a voluntary recall of about 1,719 pounds of Cumberland Farms Chicken Caesar Salad because it contains undeclared wheat allergen. The recalled products, which have the establishment number of P18502B and were produced on Aug. 1, were distributed to retail locations in seven Northeastern states.
Food Poisoning Bulletin (8/17) 
Medical Devices
HeartSciences announces EU approval, launch of MyoVista hsECG
European regulators gave HeartSciences CE mark approval for its MyoVista high sensitivity electrocardiograph testing device, a technology that uses Continuous Wavelet Transform to measure cardiac energy per heartbeat. The device, which is a combination of traditional 12-lead resting ECG tracings, ECG interpretive analysis and informatics, has also been launched by the company in Europe.
MassDevice (Boston) (8/17) 
FDA clears Globus Medical's robotic guidance, navigation system
The FDA granted Globus Medical clearance to market its robotic guidance and navigation platform, Excelsius GPS, which is designed for use in traditional and minimally invasive orthopedic and neurosurgical procedures. The system facilitates accurate screw placement in spine and orthopedic surgery and can function with intraoperative CT, preoperative CT and fluoroscopic imaging modalities.
Becker's Spine Review (8/17) 
Data show positive results for Endologix's endografts
Preliminary data from a 458-patient study showed Endologix's AFX and AFX2 endografts demonstrated an 84.7% rate of freedom from aneurysm-related complications, compared with 82% for other bifurcated aortic endografts. Further randomization in the study will be stopped by the company based on the number of additional participants needed for proving superiority, while five-year follow-up of current participants will be continued.
Seeking Alpha (free registration) (8/17) 
Food and Drug Law Institute Highlights
New program! Drug Quality Security Act Conference, Nov. 15, Washington, D.C.
New program! Drug Quality Security Act Conference, Nov. 15, Washington, D.C.
Hear from panels of key government regulators and industry experts as they explore current issues surrounding the DQSA's Title I (Compounding Quality Act) and II (Drug Supply Chain Security Act) -- four years after implementation. Register now.
Now available for purchase: A Practical Guide to FDA's Food and Drug Law Regulation, 6th Edition
Now available for purchase: A Practical Guide to FDA's Food and Drug Law Regulation, 6th Edition
Structured to serve as a reference and as a teaching tool, this book provides an introduction to the laws and regulations governing development, marketing and sale of food, medical products, tobacco and cosmetics. Learn more.
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