Industry News

Alembic Pharmaceuticals Limited announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg.

Tonix Pharmaceuticals Holding Corp. a company that is developing innovative pharmaceutical products to address public health challenges, announced it will present additional analyses of data from its Phase 2 study in military-related posttraumatic stress disorder, or PTSD, at the 72nd Annual Scientific Convention of the Society of Biological Psychiatry (SOBP) on May 20, 2017 in San Diego.

Medrobotics Corp., a medical robotics company, announced at the Royal Australasian College of Surgeons meeting in Adelaide that it has received TGA regulatory clearance to market the Flex® Robotic System for colorectal procedures. Medrobotics is the first and only company to offer minimally invasive, steerable and shapeable robotic products for colorectal procedures in Australia. The Flex® Robotic System is the world’s first robotic surgical platform to offer Scarfree™ access to hard-to-reach anatomy in otolaryngology and colorectal procedures. This provides surgeons treatment options that may not be possible with straight, rigid instruments.

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AstraZeneca and MedImmune, its global biologics research and development arm,  announced that tralokinumab, an anti-interleukin-13 (IL-13) human monoclonal antibody, did not meet its primary endpoint of a significant reduction in the annual asthma exacerbation rate (AAER) in the overall population of severe, uncontrolled asthma patients, compared with placebo in STRATOS 1, the first of two pivotal Phase III trials.

Torrent Pharma, announced that it has completed the acquisition of Regestrone and Pregachieve brands for India from global Pharma player Novartis AG, Switzerland.

Roche Diagnostics UK and Ireland launches the next generation of INR patient self-monitoring meter for patients on warfarin anticoagulant therapy. The new CoaguChek INRange meter allows patients to send their results to their clinic via an App on their phone using wireless connectivity.

Takeda Pharmaceutical Company Limited announced that ALUNBRIG™ (brigatinib) has received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under Accelerated Approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ALUNBRIG, which previously received Breakthrough Therapy Designation from the FDA, is a once-daily oral therapy that may be taken with or without food.

ProQR Therapeutics N.V. announced that the Company can start the Phase 1/2 trial for QR-110, named PQ-110-001, in Leber’s congenital amaurosis Type 10 (LCA 10) patients. QR-110 is a novel investigational RNA therapeutic targeting LCA 10 due to the p.Cys998X mutation, a severe genetic rare disease that causes children to lose sight in the first years of life. LCA 10 is one of the most prevalent forms of gene-related blindness in children worldwide and currently there are no therapies commercially available.

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Alder BioPharmaceuticals, Inc. a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced the presentation of positive data from its Phase 2b clinical trial evaluating eptinezumab (formerly ALD403) for the prevention of migraine.

Glenmark Pharmaceuticals, a global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar, which will assess its pharmacokinetics in comparison to XOLAIR® (omalizumab) in healthy adult volunteers between 18 – 65 years of age.