Industry News

  • Accelerate Diagnostics, Inc. announced the submission of a De Novo request for Evaluation of Automatic Class III Designation to the U.S. Food and Drug Administration (FDA) for its Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for positive blood culture samples.

    [adsense:336x280:8701650588]

  • BioLife Solutions, Inc., a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers, announced that it has entered into a ten-year supply agreement with Kite Pharma, a leading developer of chimeric antigen receptor (CAR) and T cell receptor (TCR) products for various cancers.

  • Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood. Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option.

  • Cipla Ltd announced this week that its proposed biotech subsidiary in South Africa will invest just over R1.3 billion into the country's first state-of-the-art biotech manufacturing facility, for the production of biosimilars. Cipla Ltd is a global pharmaceutical company and owner of Cipla Medpro, South Africa’s third largest pharmaceutical manufacturer, as well as Cipla BioTec, a biotechnology company focused on affordable and accessible biopharmaceuticals.

  • As part of its business strategy to build a meaningful & differentiating presence in Global Oncology Therapy market, 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 the roll-out of Gemcitabine InfuSMART in Europe. InfuSMART is a technology in which oncology products are developed in a Ready-To-Administer (RTA) bag.

  • 11 July 2016
    Open chromatin profiling key to identifying leukemia cells of origin

    Every cancer starts with a single cell, and Jackson Laboratory (JAX) researchers have found a precise and reliable way -- whole-genome profiling of open chromatin -- to identify the kind of cell that leads to a given case of leukemia, a valuable key to cancer prognosis and outcome. 

  • Teligent, Inc. , announced that it has received approvals of the Company's abbreviated new drug applications (ANDAs) from the U.S. Food and Drug Administration (FDA) for both Triamcinolone Acetonide Lotion USP, 0.1% and Triamcinolone Acetonide Lotion USP, 0.025%.  The FDA has now approved seven ANDAs from the Company's internally developed pipeline of topical generic pharmaceutical products.

  • The U.S. Food and Drug Administration approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older. Differin Gel 0.1% is distributed by Galderma Laboratories, L.P., based in Fort Worth, Texas.

  • Merrimack Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has granted seribantumab, also known as MM-121, Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy.

    Merrimack is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC that is designed to support a Biologics License Application to the FDA. Seribantumab is Merrimack's wholly owned, fully human monoclonal antibody that targets ErbB3.

    "We are pleased that the FDA recognizes the importance of investigating a novel, biomarker-directed agent such as seribantumab for patients with locally advanced or metastatic NSCLC who have been previously treated with an immunotherapy," said Dr. Akos Czibere, Vice President, Clinical Development at Merrimack. "Heregulin-positive cancer cells are characterized by their ability to escape the effects of a broad range of cancer therapies and potentially contribute to accelerated disease progression. The SHERLOC trial is designed to advance the development of a much-needed treatment option for patients with heregulin-positive NSCLC after they progress on immunotherapies. This is important because we find that more than 50% of patients with NSCLC are heregulin-positive."

    Seribantumab is designed to block heregulin-driven signaling and enhance the anti-tumor effect of the chemotherapy. Data from Merrimack's prior clinical studies have shown that standard-of-care therapy may be more effective and result in improved patient outcomes when combined with seribantumab. Merrimack is investigating the efficacy and safety of seribantumab plus standard-of-care therapy in the SHERLOC trial.


    The SHERLOC trial is a randomized, open-label, multi-center, Phase 2 study in patients with heregulin-positive, locally advanced or metastatic NSCLC. Merrimack expects to enroll approximately 280 heregulin-positive patients who will be randomized (2:1) to receive seribantumab in combination with either docetaxel or pemetrexed versus docetaxel or pemetrexed alone. The study's primary endpoint is overall survival with secondary endpoints including progression free survival, objective response rate, safety and quality of life measures. The study is designed to support a Biologics License Application to the FDA with data expected in 2018.

    << Pharma News


    Subscribe to PharmaTutor News Alerts by Email

Subscribe to Industry News