FDA clears ARIAD Pharmaceuticals' application for lung cancer treatment | FDA fast-tracks steatohepatitis drug from Nimbus | Neos' ADHD treatment gets FDA OK
February 3, 2016
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FDA clears ARIAD Pharmaceuticals' application for lung cancer treatment
The FDA has approved ARIAD Pharmaceuticals' investigational new drug application for AP32788, a tyrosine kinase inhibitor designed to treat non-small cell lung cancer patients with EGFR or HER2 mutations. A Phase I/II trial could be initiated in the second quarter of this year. Zacks (2/2) Share: Email
FDA fast-tracks steatohepatitis drug from Nimbus
Nimbus Therapeutics obtained fast-track status from the FDA for NDI-010976, an inhibitor of the acetyl-COa carboxylase enzyme, as a treatment for patients with nonalcoholic steatohepatitis. A midstage study is planned for the first half of this year. Seeking Alpha (free registration) (2/2) Share: Email
Neos' ADHD treatment gets FDA OK
Neos Therapeutics' Adzenys XR-ODT has received FDA approval to be used by attention-deficit/hyperactivity disorder patients who are at least 6 years old. The orally disintegrating tablet was developed to enhance catecholamine release to decrease impulsivity and distractibility as well as boost attention span. Modern Medicine (2/3) Share: Email
Mass. AG unlikely to win drug-price lawsuit
Massachusetts Attorney General Maura Healey has threatened to file a lawsuit against Gilead Sciences over the drugmaker's prices for two hepatitis C drugs, but legal experts say the AG would have little chance of winning. STAT/Pharmalot (2/2) Share: Email
Complimentary Pharmaceutical and Medical Device Compliance Conference
Hunton & Williams LLP host's the Third Annual Pharmaceutical and Medical Device Compliance Conference taking place in La Jolla on March 15 and Palo Alto on March 17. This event features Timothy Heaphy, Former US Attorney and Hunton & Williams' Partner, and Sheldon Bradshaw, former FDA Chief Counsel and Hunton & Williams' Partner. Register now.
Global Focus
EU OKs MRI-safe defibrillators from Biotronik
Regulators in Europe have given Biotronik CE mark approval to market its Ilivia implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator. The products, which are compatible with magnetic resonance imaging technologies, feature the firm's ProMRI and MRI AutoDetect systems. MassDevice.com (Boston) (2/2) Share: Email
Food & Dietary Supplements
Congress needs to pass national biotech labeling policy
Congress should pass a uniform national biotech food labeling standard because food costs in Wisconsin are likely to increase if states adopt separate labeling requirements, and food and agriculture industries cannot afford to comply with such a patchwork of state laws, writes Madison, Wis., resident Lucas Vebber in a letter to the editor of The Journal Times in Racine. The implementation of a science-based national policy is the solution to the labeling issue, he writes. The Journal Times (Racine, Wis.) (2/3) Share: Email
Salmonella risk prompts Sweet Superior Fruit to recall jalapenos
Possible salmonella contamination prompted Sweet Superior Fruit to recall its ePicosito Jalapenos. The affected products, with the code LOT ORTI04, were sold in Illinois and Texas. Food Poisoning Bulletin (2/2) Share: Email
FDA, CDC investigate salmonella outbreak linked to Garden of Life products
A salmonella outbreak that has sickened 11 consumers in nine states and was linked to Garden of Life RAW Meal Organic Shake & Meal products is being investigated by the FDA and CDC. The affected products were recalled by the company last month. KFVS-TV (Cape Girardeau, Mo.) (2/2) Share: Email
Medical Devices
Robotic catheter kit from Hansen gets FDA clearance
The Magellan Robotic Catheter eKit, developed by Mountain View, Calif.-based Hansen Medical, has obtained 510(k) clearance from the FDA. The product, which uses a robotic system, enables users to control third-party microcatheters. MassDevice.com (Boston) (2/2) Share: Email
Firm gets $2.25M grant for critical care monitoring system
The NIH awarded San Francisco-based Potrero Medical a $2.25 million Small Business Innovation Research grant. The firm will use the money for a study of its Accuryn Monitoring System, which is intended to spot physiological signatures of sepsis and other critical diseases. The product delivers data on intra-abdominal pressure, core temperature and urine output. MassDevice.com (Boston) (2/2) Share: Email
FDLI Items
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