Industry News

U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for a 500mg chewable tablet formulation of mebendazole from Janssen Pharmaceuticals.

The United States Patent and Trademark Office (USPTO) has granted US patent for Cantargia AB’s (Cantargia) patent application concerning IL1RAP as a target molecule for antibody therapy of several solid tumor types. The granted patent follows the Notice of Allowance that was issued and communicated in June 2016. 

AstraZeneca announced that the Phase III AURA3 trial met its primary endpoint, demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The AURA3 randomised trial assessed the efficacy and safety of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso also demonstrated a safety profile consistent with previous trials.

Abbott announced that Health Canada has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people in Canada with coronary artery disease.

Agile Therapeutics, Inc., a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced that preparations are underway for an initial Phase 2 clinical trial of a novel contraceptive regimen, which will begin the development of its pipeline beyond its current lead product candidate, Twirla®, a once weekly contraceptive patch currently in phase 3 development. The planned Phase 2 clinical trial will examine the use of Twirla in an innovative regimen designed to allow women to experience shorter, lighter periods.

The U.S. Food and Drug Administration approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances. The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics, Inc. of Santa Ana, California.

Oncternal Therapeutics, Inc., a clinical-stage oncology company developing first-in-class therapies for rare and common malignancies, announced that TK216 has received Orphan Drug designation from the US Food and Drug Administration (FDA) for the treatment of Ewing sarcoma.

Amgen and Daiichi Sankyo Company, Limited announced the execution of an exclusive agreement to commercialize nine biosimilars in Japan. The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab.