Alembic's generic Trilipix wins FDA nod | Fast-track status granted for Biohaven's trigriluzole | Loxo's solid-tumor drug gains orphan designation
May 15, 2017
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Drugs & Biologics
Alembic's generic Trilipix wins FDA nod
Alembic Pharmaceuticals' fenofibric acid delayed-release capsules, a generic version of AbbVie's Trilipix, has been approved by the FDA.
Reuters (5/14) 
Fast-track status granted for Biohaven's trigriluzole
The FDA has granted fast-track status to trigriluzole from Biohaven Pharmaceutical Holding, which has an ongoing midstage trial of the treatment in patients with spinocerebellar ataxia. The company anticipates top-line results from the study next year.
Reuters (5/15) 
Loxo's solid-tumor drug gains orphan designation
An orphan designation has been granted by the FDA to Loxo Oncology's LOXO-101, or larotrectinib, as a treatment for patients with solid tumors who have NTRK-fusion proteins or rare genetic abnormalities.
Seeking Alpha (free registration) (5/12) 
BLA for migraine drug filed by Eli Lilly
A biologics license application has been submitted by Eli Lilly and Co. for its monthly self-administered injection galcanezumab, a monoclonal antibody indicated to treat migraines. The submission was backed by positive data from a late-stage study in which treatment with the drug showed a significantly reduced number of migraine headache days each month.
Genetic Engineering & Biotechnology News (5/12) 
Global Focus
French authorities suspend trials of AB Science's masitinib
The French National Agency for Medicines and Health Products Safety has suspended the ongoing clinical studies of AB Science's AB1010, or masitinib, because of an EMA inspection from 2009 to 2015 that found good clinical practice violations in the late-stage trial of masitinib for mastocytosis. The company said a new quality system was implemented in 2015 and that trials in France can resume after it passes an upcoming independent audit.
BioCentury (5/12) 
Food & Dietary Supplements
Spinach products from Horton Fruit recalled over listeria risk
A voluntary recall has been issued by Horton Fruit for some of its bagged spinach products because of possible listeria contamination. The recalled items, which include Harris Teeter Farmer's Market ready-to-eat spinach in 10-ounce bags and Fresh Curly Leaf PEAK brand spinach in 2.5- and 10-ounce bags, were distributed in North Carolina, Illinois, Kentucky and West Virginia.
Food Safety News (5/13) 
Medical Devices
Hip replacement positioning system debuted by Corin
The Optimized Positioning System has been launched by the Corin Group for use in hip replacement procedures. The system, which helps determine the implant's best position depending on individual patient anatomy and movement, uses preoperative functional simulation and planning and comes with an intraoperative positioning system that uses laser guidance and 3D printing.
Healio (free registration)/Orthopedics Today (5/13) 
Cook Medical's esophageal atresia treatment device wins FDA nod
Cook Medical has obtained approval from the FDA for its Flourish Pediatric Esophageal Atresia Anastomosis, a device designed for nonsurgical treatment of esophageal atresia in infants age 1 year and younger. The device, which closes the gap in the esophagus using magnets, is only indicated for patients without a tracheoesophageal fistula or who previously underwent a surgical fistula repair.
Regulatory Focus (5/12),  Medscape (free registration) (5/12) 
Format for collecting data on medtech prices finalized by Indian regulator
A new format has been finalized by India's National Pharmaceutical Pricing Authority to help in collecting data for monitoring prices of 19 medical devices, the regulator said in a notification. All medtech groups and companies are now asked to provide the necessary information on their products following the prescribed format.
Business Standard (India) (tiered subscription model)/Press Trust of India (5/13) 
Hot Topics
Food and Drug Law Institute Highlights
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