Industry News

Novartis announced  that the European Commission (EC) has approved EntrestoTM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart.

Mylan N.V.  announced the U.S. launch of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (mixed salts of a single entity amphetamine product), 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg, which is the generic version of Teva's Adderall® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

GSK announced that the European Commission has approved a variation to expand the current therapeutic indication for Volibris® (ambrisentan) to include its use in combination treatment for patients with pulmonary arterial hypertension (PAH). Volibris is indicated for treatment of PAH in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment.

The U.S. Food and Drug Administration  approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.

The injectable drug has been hailed as the first meaningful advance in treating haemophilia A in 20 years, and looks set to be a big earner for the partners. Elocta – a recombinant factor VIII Fc fusion protein (rFVIIIFc) – is already launched in the US, Canada and Australia under the Eloctate trade name, and is forecast to reach peak sales of $1.5 billion thanks to patient-friendly dosing that increases the time between injections.

Hic! Comet Lovejoy is living up to its name by releasing large amounts of alcohol - as much as 500 bottles of wine every second - into space, scientists have found. The discovery marks the first time ethyl alcohol, the same type in alcoholic beverages, has been observed in a comet, researchers said.

Merck, known as MSD outside the United States and Canada, today announced that the Board of Directors has increased the company’s quarterly dividend to $0.46 per outstanding share of the company’s common stock, up $0.01 from $0.45 per outstanding share paid last quarter. Payment will be made on Jan. 8, 2016, to stockholders of record at the close of business on Dec. 15, 2015.

The U.S. Food and Drug Administration approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.