Monsanto and KWS' glyphosate-resistant biotech sugar beet H7-1 was approved for reauthorization by European Food Safety Authority scientists. The crop was approved for processing and import in 2007 for 10 years by the European Commission.
Scientists from Russia proposed using hydrothermal liquefaction to convert food waste into biofuel. The method allows the direct production of biofuel from wet biomass, which requires less energy than dry biomass conversion.
A Republican tax bill that recently cleared the full House and the Senate Finance Committee would benefit multinational medical device companies, including those that operate only in the US, because it would implement a 20% corporate tax rate, down from a maximum of 35%; allow tax-free intangible corporate property transfers from foreign firms to US parents; and apply a 12.5% rate to foreign-earned intangible income. However, a provision that would repeal the Affordable Care Act individual mandate could put a full Senate vote at risk.
Neovasc raised about $27.8 million in a private placement of senior secured convertible notes and Series E warrants and $37.5 million in an offering of Series A units and Series B units. The company intends to use the proceeds for litigation expenses and general corporate functions, as well as to fund its ongoing Tiara clinical program and complete its Tiara-II study.
Roche Holding agreed to pay an undisclosed amount for Viewics, a Sunnyvale, Calif.-based laboratory business analytics firm that offers a cloud-based solution for integration of big data from information technology platforms. The acquisition, which is expected to be completed Tuesday, will make Viewics an integral part of Roche and help labs speed up data-driven informed decisions on their processes and operations.
Anthem has granted a positive coverage policy decision for artificial pancreas systems, including Medtronic's MiniMed system, after the JDRF persuaded the insurer through the Coverage2Control campaign to "make changes to coverage that enable better diabetes management," JDRF said. The decision means that the country's 25 biggest insurance companies now cover the MiniMed system, JDRF said.
AdvaMed President and CEO Scott Whitaker said he was optimistic that the medical device tax would not go into effect on Jan. 1, but that could be the result of a temporary moratorium and not a permanent repeal. Whitaker also said that AdvaMed will focus more on reimbursement reforms in its priorities next year, as well as ensuring that the FDA implements MDUFA IV as it was intended by Congress.
Glenmark Pharmaceuticals' Hailey 24 Fe, or norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, in 1 mg/20 mcg was granted approval by the US FDA. The drug is a generic version of Allergan Pharmaceuticals' Loestrin 24 Fe tablets.
Pfizer's Sutent, or sunitinib malate, was approved by the FDA as an adjuvant treatment for renal cell carcinoma in adult patients who are at high risk for disease recurrence after a kidney has been removed. The labeling for Sutent contains a boxed warning regarding the risk for severe liver damage.
Dueling trademark infringement lawsuits were filed by dietary supplement distributors Peak Wellness Nutrition and Peak Wellness Biopharma against each other in the US District Court for the Southern District of Florida and the US District Court in New Haven, Conn. PWN argues that PWB abandoned its mark in 2011 and PWN began using the mark in 2013, while PWB is accusing PWN of trademark infringement, unfair competition and violating the Connecticut Unfair Trade Practices Act, arguing it is selling supplements to customers who believe the products are coming from PWB.