Industry News

In a setback to Cipla, the Delhi High Court on Friday held that the Indian drug major was infringing Swiss pharmaceutical company Hoffman-La Roche's patent in lung cancer drug erlotinib hydrochloride, sold under the name of Tarceva.

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved NINLARO® (ixazomib) capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a once-weekly pill.

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.