Industry News

F. Hoffmann-La Roche Ltd. obtained approval from the European Commission, for Alecensa® as monotherapy indicated for “the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)”. In addition, the EU marketing authorisation for Alecensa has been switched from conditional approval (given in February 2017) to a full approval for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line).

Mentice boosts its US development presence and adds a clinical training service line with the acquisition of Medical Simulation Corporation's (MSC) Medical Products division. Mentice is the global leader of simulation-based performance solutions for endovascular therapies.

The US subsidiary of Dr. Reddy’s Laboratories Ltd. announced that it has reached a settlement with the US Government, in a case that is more than six years old, involving packaging for five blister-packed prescription products. In a joint filing by the parties, Dr. Reddy’s and the US Department of Justice agreed to the settlement of the action without any adjudication of any issue of fact or law.

Teva Pharmaceutical Industries Ltd announced the exclusive launch of generic Viread®1 (tenofovir disoproxil fumarate) tablets 300 mg in the U.S.

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Aclaris Therapeutics, Inc a dermatologist-led biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved ESKATA™ (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses, or SKs. SKs are non-cancerous skin growths that affect more than 83 million American adults and can be an aesthetic skin concern. SKs tend to increase in size and number with age. The condition is more prevalent than acne, psoriasis and rosacea combined.

Novavax, Inc announced the Phase 3 trial of its RSV F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization will continue. Novavax also provided an update on its nanoparticle influenza vaccine candidate with proprietary Matrix-M™ adjuvant (NanoFlu™).

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for HAILEY^TM Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/20 mcg and Ferrous Fumarate Tablets), the generic version of Loestrin®1 Fe 1/20 Tablets, of Allergan Pharmaceuticals International Limited.

Celgene Corporation recently announced results from two phase 3 trials evaluating the efficacy and safety of the drug ozanimod. Ozanimod was invented by scientists at The Scripps Research Institute (TSRI). Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, and was compared to the first-line treatment, Avonex® (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS). The findings from the two pivotal phase 3 (SUNBEAM and RADIANCE Part B) trials pave the way for ozanimod to enter the New Drug Approval process with the U.S. Food and Drug Administration (FDA).

Dr. Reddy’s Laboratories Ltd. is pleased to announce that generic Azacitidine for injection 100 mg/vial, a bioequivalent generic version of VIDAZA® (azacitidine for injection), is approved by Health Canada