Industry News

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.

Alzheon, Inc. announced publication of a newly elucidated molecular mechanism of action for tramiprosate, the active agent in the company’s lead clinical drug candidate, ALZ-801. The company’s Phase 3-ready candidate ALZ-801 is an optimized prodrug of tramiprosate, with a substantially improved pharmacokinetic and safety profile compared to tramiprosate.

Achillion Pharmaceuticals, Inc.announced the presentation of updated results from the ongoing phase 2 ‘604 Study’ being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies (Janssen). These results were presented as an oral presentation during the European Association for the Study of the Liver (EASL) 2017 International Liver Congress in Amsterdam. These results demonstrate that the triple combination of simeprevir, odalasvir and AL-335 has the ability to shorten treatment duration, offer high efficacy and be generally well tolerated in those whose disease is caused by hepatitis C virus (HCV) genotype 1 (GT1), one of the most prevalent causes of hepatitis C globally.

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Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it has launched Progesterone Capsules, 100 mg and 200 mg, a therapeutic equivalent generic version of Prometrium® (Progesterone) Capsules in the United States market, approved by the U.S. Food and Drug Administration (USFDA).