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  • PharmaCyte Biotech, Inc. , a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®,  announced that it has submitted a request for a pre-IND meeting with the U. S. Food and Drug Administration (FDA) for its planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC)

  • Novartis has been awarded the prestigious 2016 Prix Galien USA Award for Best Biotechnology Product for Cosentyx® (secukinumab), as well as the Prix Galien Foundation "Discovery of the Decade" Award for Best Pharmaceutical Product for the drug Gleevec® (imatinib mesylate). The awards were presented at a ceremony in New York City.

  • Novartis announced  that the US Food and Drug Administration (FDA) accepted the company's New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib) as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole.

  • Exalenz Bioscience announced receiving U.S. Food and Drug Administration (FDA) marketing clearance for its BreathID® Lab System and breath-test kits, developed for H. pylori bacterium detection. The company is preparing to penetrate the laboratory market in the United States by engaging with national and regional laboratories, to achieve a broad and material presence in a market with a potential that is estimated at hundreds of millions of dollars in sales per year.

  • Biogen announced that its New Drug Application (NDA) for nusinersen, an investigational treatment for spinal muscular atrophy (SMA), has been accepted by the US Food and Drug Administration (FDA) for Priority Review, and that the company’s Marketing Authorization Application (MAA) has been validated by the European Medicines Agency (EMA). Nusinersen had previously been granted Accelerated Assessment status by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The regulatory review process for these applications has now been initiated in the US and EU. Both the Priority Review and Accelerated Assessment designations can reduce the standard review time. If approved, nusinersen would be the first therapy for SMA, a leading genetic cause of infant mortality.

  • ARIAD Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ARIAD’s investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, in patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The FDA granted ARIAD’s request for Priority Review and has set an action date of April 29, 2017 under the Prescription Drug User Fee Act (PDUFA).

    “The FDA acceptance of our application is an important milestone in our ongoing efforts to discover, develop and deliver highly innovative treatments for patients with rare cancers,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “We are pleased that our significant R&D investments in brigatinib and our work with the FDA are bringing us closer to potentially offering a treatment option for patients with ALK+ NSCLC who are refractory to crizotinib. We look forward to continuing to work closely with the FDA during the brigatinib NDA review and remain committed to developing critical therapies for unserved and underserved small patient populations suffering from rare cancers.”

    ARIAD’s NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib. The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months from the filing of the application. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK-positive, ROS1-positive, and EGFR-positive NSCLC. ARIAD plans to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017.

    ARIAD is a small, research-driven biotechnology company. ARIAD has invested more than USD 1.3 billionin R&D since the Company was founded. In 2015, ARIAD generated USD 119 million in total revenue and invested USD 171 million, or 143 percent of revenue, in R&D.


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  • The U.S. Food and Drug Administration  approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain. The Amplatzer PFO Occluder device is manufactured by St. Jude Medical Inc. based in Plymouth, Minnesota.

  • Catalyst Pharmaceuticals, Inc.  announced  that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach to be taken in Catalyst's upcoming Phase 3 study evaluating Firdapse® (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS).

  • 2 November 2016
    Vertex's long-term data from Orkambi + Kalydeco shows potential to modify progression of cystic fibrosis

    Vertex Pharmaceuticals Incorporated announced the presentation of long-term data demonstrating that Orkambi (lumacaftor/ivacaftor) and Kalydeco (ivacaftor) show the potential to modify the progression of cystic fibrosis (CF).

  • Sanofi and Regeneron Pharma Inc. announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

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