Industry News

- Read more about Hilleman Laboratories advances two vaccines into clinical stage
Hilleman Laboratories, a first-of-its-kind joint-venture between Merck Sharp & Dohme (MSD) and the Wellcome Trust, announced the initiation of Phase I/II clinical trial of its innovative vaccine, an oral, lyophilized, heat-stable Rotavirus vaccine, against Rotavirus disease.

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- Read more about ICMR Govt.of India, and Sun Pharma joined in public private partnership for Maleria Free India
Indian Council of Medical Research (ICMR), Ministry of Health & Family Welfare (MOHFW), Govt. of India, Govt. of Madhya Pradesh and Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies), today, announced India’s first public-private-partnership agreement for Malaria Free India and other innovation in preventive health. This was announced by Dr Soumya Swaminathan, Director General – ICMR, Principal Secretary Health Mrs. Gauri Singh Govt of Madhya Pradesh and Dilip Shanghvi, Managing Director, Sun Pharma as a unique effort to draw public – private sector collaboration in promoting preventive health measures. The publicprivate-partnership stakeholders will jointly undertake malaria control & elimination programme by setting-up Management & Technical Committees to provide oversight for disease surveillance & elimination.

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- Read more about Lupin re-introduced Methergine oral tablets in US
Lupin and its US subsidiary have re-introduced Methergine (methylergonovine maleate) oral tablets 0.2mg for the prevention and management of postpartum hemorrhage (PPH). Methergine is the only FDA-approved oral uterotonic and is a preferred oral agent in the management of PPH.
- Read more about Accuray seeks US FDA marketing approval for Radixact treatment delivery system
Accuray Incorporated, a radiation oncology company, announced the submission of its 510(k) premarket notification with the Food and Drug Administration (FDA) for the company’s Radixact Treatment Delivery System. Accuray also submitted 510(k) premarket notification for its treatment planning and data management systems, Precision Treatment Planning System and iDMS Data Management System.
- Read more about ChemoCentryx receives FDA oProducts development grant for orally administered complement 5a receptor inhibitor CCX168
ChemoCentryx, Inc., announced that the U.S. Food and Drug Administration (FDA) has awarded the Company a one-year grant of $500,000 to assist in the clinical development of CCX168, the Company's lead drug candidate for the treatment of patients with anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, or AAV. CCX168 is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR.
- Read more about FDA accepts resubmission of new drug application for RAYALDEE®
OPKO Health, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted OPKO's resubmission on April 22, 2016 of the New Drug Application (NDA) for RAYALDEE® (calcifediol) for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
- Read more about Aurobindo Pharma receives USFDA approval for famotidine tablets (OTC)
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 10 mg and 20 mg (OTC). This product is expected to be launched in Q2 FY16-17.
- Read more about Collegium Receives FDA Approval for Xtampza™ ER
Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Xtampza™ ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- Read more about Intuity Medical receive US FDA nod to market POGO Automatic Blood Glucose Monitoring System
The US Food and Drug Administration (FDA) has granted marketing approval for Intuity Medical's POGO Automatic Blood Glucose Monitoring System.The POGO System is the first blood glucose meter and multi-test cartridge to provide automatic testing with lancing, blood collection and analysis in one easy step. By combining all of the necessary blood glucose testing supplies into a convenient, self-contained 10-test cartridge, POGO provides ease of use and discretion for millions of patients who need to regularly test their blood glucose in the management of their diabetes.

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- Read more about Pharnext opens first US study site for PLEO-CMT phase 3 trial of PXT3003
Pharnext, announced the opening of the first US trial site for its PLEO-CMT pivotal phase 3 clinical trial of its lead pleodrug PXT3003 in Charcot-Marie-Tooth disease type 1A (CMT1A). The clinical trial, which began enrolling patients in December 2015 in Europe, is intended to determine whether PXT3003 is effective and well tolerated in patients with CMT1A. PXT3003, developed using Pharnext's Pleotherapy R&D platform, is an oral fixed-low dose combination of (RS)-baclofen, naltrexone hydrochloride and D-sorbitol.