Industry News

Insights from experts working on-the-ground in lung cancer, compiled by Boehringer Ingelheim, shed light on challenges faced by patients with advanced stage adenocarcinoma, a type of non-small cell lung cancer (NSCLC), in being tested for EGFR mutations, leaving some without access to the most appropriate treatment for them.

U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications.

The European Commission has approved Boehringer Ingelheim's Praxbind (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding. Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to be approved in the European Union.

Mylan N.V.  announced the U.S. launch of Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo®. 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 used for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment.

GSK  announced that dosing has commenced in a phase III study evaluating sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of patients with giant cell arteritis (GCA).

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.