Industry News

- Read more about U.S. FDA grant Spark Therapeutics & Pfizer Breakthrough Therapy Designation for SPK-9001
Spark Therapeutics and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies' SPK-FIX program, in development for the treatment of hemophilia B. SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized, high-activity human factor IX variant, is being investigated in an ongoing Phase 1/2 trial as a potential one-time therapy.
- Read more about Advaxis’ AXAL Receives Fast Track Designation by the FDA
Advaxis, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), as a Fast Track product for adjuvant therapy for high-risk locally advanced cervical cancer patients. The investigation of AXAL in this under-served population will be conducted in accordance with the Special Protocol Assessment (SPA) recently granted by the FDA.
- Read more about FDA Approves Valeant & Progenics RELISTOR® Tablets
Valeant Pharmaceuticals International, Inc. and Progenics Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Valeant expects to commence sales of RELISTOR Tablets in the U.S. in the third quarter of 2016.
- Read more about Ajanta Pharma launch Omeprazole and Sodium Bicarbonate Capsules in US Market
Ajanta Pharma Limited received final approval from US FDA and launched Omeprazole and Sodium Bicarbonate Capsules in the US market, through its wholly owned subsidiary Ajanta Pharma USA Inc.
- Read more about Janssen’s Chewable Mebendazole Tablets NDA received Priority Review Designation by U.S. FDA
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.
- Read more about FDA Grants Auris Medical Fast Track Designation for Keyzilen
US Food and Drug Administration (FDA) has granted fast track designation for Auris Medical's Keyzilen^TM (AM-101) in acute peripheral (inner ear) tinnitus following cochlear injury or otitis media in adults.
- Read more about FDA approved generic of Nilandron
ANI Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) of the Abbreviated New Drug Application (ANDA) for nilutamide tablets which is first generic competitor to Nilandron®. Trailing twelve- month sales of Nilandron® were $23 million according to IMS Health.
- Read more about Cantargia gets US patent for method to utilize IL1RAP as target molecule
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.
- Read more about Astrazeneca’s Tagrisso met primary endpoint in phase III 2nd-line lung cancer trial
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.
- Read more about Abbott's Absorb™ bioresorbable stent approved by Health Canada
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.