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  • Symbiomix, a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections, has announced submission of a new drug application (NDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV) to the U S Food and Drug Administration (FDA). Solosec is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, and is anticipated to be the first and only single-dose oral therapy approved for BV.

  • Kaleo, a privately-held pharmaceutical company, has announced the Auvi-Q (epinephrine injection, USP) auto-injector will be available by prescription starting February 14, and announced Auvi-Q affordability, a first-of-its-kind access programme for Auvi-Q. Through this new programme, patients with commercial insurance, even those with high-deductible plans, will have an out-of-pocket cost of USD 0. For patients who do not have government or commercial insurance, and have a household income of less than USD 100,000, Auvi-Q will be available free of charge. In addition, the cash price for Auvi-Q is USD 360 and will be available to those patients without government or commercial insurance. Each Auvi-Q prescription includes two auto-injectors and one trainer for Auvi-Q.

    “We met with patients and physicians and listened to the very real challenges in the current healthcare environment with obtaining access to affordable medicines,” said Spencer Williamson, president and chief executive officer of kaléo. “As a result, starting February 14, for more than 200 million Americans with commercial insurance, including those with high-deductible plans, the out-of-pocket cost for Auvi-Q will be USd 0.”

    Auvi-Q is a FDA-approved prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. It is an epinephrine auto-injector with innovative features such as voice instructions that help guide a user with step-by-step instructions through the epinephrine delivery process and an automatic retractable needle system, a first for epinephrine auto-injectors, that injects the epinephrine and retracts the needle back into the device within seconds.

    “We know how important it is that severely allergic patients have an epinephrine auto-injector that can be with them at all times and used correctly, even without training, during a panic-stricken allergic emergency,” said Eric Edwards M.D., Ph.D, vice president of product strategy at kaléo. “We are excited to make Auvi-Q, an epinephrine auto-injector with innovative features, available for millions of patients living with severe, life-threatening allergies.”


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  • Gilead Sciences, Inc., a biopharmaceutical company, announced that the company's Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been fully validated and is now under assessment by the European Medicines Agency (EMA).

  • Shire plc announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. SHP465 is being evaluated as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA is expected to provide a decision on or around June 20, 2017, the designated Prescription Drug User Fee Act (PDUFA) action date. Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.

  • Swedish Orphan Biovitrum AB (publ) (Sobi), an international specialty healthcare company, announces that the first patients have been enrolled in the A-SURE study (NCT02976753).  A-SURE is a 24-month real-world study evaluating the effectiveness of Elocta compared to conventional FVIII products in the prophylactic treatment of patients with haemophilia A in Europe.

  • Siemens Healthineers and Biogen announced  that the companies plan to jointly develop magnetic resonance imaging (MRI) applications with the intent of quantifying key markers of multiple sclerosis (MS) disease activity and progression. Biogen is a leading biotechnology company with a deep focus on neurological and autoimmune conditions, which for two decades has been at the forefront of delivering therapies to MS patients. Siemens Healthineers aims to enable healthcare providers to meet their current challenges and excel in their respective environments. To execute this strategy in the field of neurology, Siemens Healthineers will cooperate with Biogen and contributes its strength in medical imaging.

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  • Quest Diagnostics, the world's leading provider of diagnostic information services, has announced the launch of a new test service that helps physicians evaluate a patient's response to drug therapies used to treat infection with the hepatitis B virus (HBV). The first test of its kind available in the United States, the test is significant because it may help physicians tailor more effective treatments for the up to 2.2 million individuals infected with HBV.

  • Adamis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s New Drug Application (“NDA”) for its Epinephrine Pre-filled Syringe (“PFS”) product candidate for the emergency treatment of anaphylaxis.  Filed on December 15, 2016, the resubmission was intended to address the issues raised by the FDA in the agency’s June 2016 Complete Response Letter (“CRL”).  The FDA indicated that it considered the resubmission to be a complete response to the CRL.

  • Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Shri Ananth Kumar presided over the signing of Memorandum of Understanding (MoU) between the Bureau of Pharma PSUs of India (BPPI) and National Yuva Cooperative Society Ltd. (NYCS) here today, with the objective to setup 1000 Pradhan Mantri Bhartiya Janaushadhi Kendras in both urban and rural places of the country, as a part of "Mission 3000" kendras by March 2017. Shri Mansukh L. Mandaviya, Minister of State for Road Transport & Highways, Shipping, Chemicals & Fertilizers, was also present on the occasion.

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