GlaxoSmithKline said it is investigating bribery allegations the company is facing in Romania. According to claims the company has received, GSK allegedly paid physicians hundreds of euros -- and one doctor was paid thousands of euros -- to prescribe its Parkinson's disease medication Requip, prostate medications Avodart and Duodart, and other products. The company is also investigating similar claims in Iraq, Syria, Jordan, Lebanon, United Arab Emirates and Poland.
The FDA has granted 510(k) clearance to C2 Therapeutics for its Coldplay Cryoballoon Swipe Ablation System and Coldplay Cryoballoon Full Ablation System for treating Barrett's esophagus.
The Hourglass, a peripheral embolization plug from Emba Medical, obtained CE mark approval from European regulators. The Dublin-based firm said the device, which is being produced in Florida, provides over-the-wire delivery to improve placement.
Spine Pain Management has expanded its patent portfolio with one that completes claims for the Quad Video HALO, an accessory used to achieve video transparency in fluoroscopy devices. The product's safety testing is expected to conclude this quarter.
The National Institutes of Health has awarded Seattle-based Kineta a contract worth about $4 million to support the development of an immunotherapy for infectious diseases such as dengue fever and Ebola. The company will use the funds to advance a specific drug candidate into preclinical study.
The development of vaccines and other medical countermeasures for pandemic flu, including highly pathogenic avian influenza, relies on funding through the Biomedical Advanced Research and Development Authority's pandemic influenza program, but money allocated for the program has declined significantly in recent years, BIO President and CEO Jim Greenwood writes. To ensure the nation's preparedness against possible disease outbreaks, the government should increase funding for BARDA's pan flu program and boost the transparency of future budget allocations, he writes.
Boehringer Ingelheim and Hanmi Pharmaceutical announced a collaboration to develop and market HM61713, an EGFR mutation-selective tyrosine kinase inhibitor designed to treat EGFR mutation-positive lung cancer. Under the terms of the agreement, Boehringer will gain exclusive rights to license the product nearly worldwide, except for South Korea, China and Hong Kong. Hanmi is eligible for an upfront payment of $50 million and milestone fees of up to $680 million, plus sales royalties.
A study conducted by a University of Vermont researcher found that labeling biotech foods had "no direct impact" on opposition to the foods and boosted support for biotech foods in some demographics. The study was based on survey data that included over 2,000 responses from Vermont residents. Researcher Jane Kolodinsky said more research is needed to positively determine how labeling affects consumers' opinion of biotech foods.
A draft guidance has been released by the National Institute for Health and Care Excellence endorsing the use of three chronic hepatitis C drugs in the U.K. NICE recommended Bristol-Myers Squibb's Daklinza, or daclatasvir; Gilead Sciences' Harvoni, a combination of ledipasvir and sofosbuvir; and AbbVie's Viekirax, a combination of ombitasvir, paritaprevir and ritonavir, for use with or without Exviera, or dasabuvir.