Medical Tidbits,European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV

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Descovy is the First New HIV Treatment Backbone Approved in the EU in Over a Decade –

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 25, 2016– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. Descovy is Gilead’s second TAF-based therapy to receive marketing authorization in the European Union. read more

Allergan Breaks Ground on $200 Million Waco Facility Expansion

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today broke ground on a $200 million expansion of its Waco, Texas facility. The expansion will add 322,000 square feet of manufacturing space to the current facility, nearly doubling its current footprint. Once completed, the expansion is expected to add approximately 100 full-time jobs, with the potential for the expanded operations adding as many as 250 full-time jobs as the facility reaches full utilization. New positions that will be added include chemists, microbiologists, process engineers and production and maintenance technicians. read more

QT Vascular Submits IDE Requesting Permission to Begin Pivotal Trial of Its Drug-Coated Chocolate Balloon in The United States

PRNewswire/ — QT Vascular Ltd. (the “Company” or “QT Vascular“, and together with its subsidiaries, the “Group“), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced today it has submitted an investigational device exemption (“IDE“) for permission to begin the pivotal study of Chocolate Touch™, its drug-coated balloon, in the United States (“US“). read more

Amgen To Participate In The 2016 World Medical Innovation Forum™ On Cancer

PRNewswire/ — Amgen (NASDAQ:AMGN) today announced plans to participate in the World Medical Innovation Forum™ on cancer held April 25-27, 2016, in Boston. The World Medical Innovation Forum is a global gathering of senior corporate, investor and academic leaders. The forum was established to respond to the intensifying transformation of healthcare and its impact on innovation. This is the second year Amgen has participated in this event as a sponsor. read more

AZ enters US licensing agreement with Ironwood

Agreement includes US rights to Zurampic and lesinurad/allopurinol fixed-dose combination in gout

AstraZeneca today announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic® (lesinurad). Zurampic was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.

Under the terms of the agreement, Ironwood will acquire exclusive US rights to Zurampic. In addition, Ironwood will gain the exclusive US rights to the fixed-dose combination of lesinurad and allopurinol. AstraZeneca plans to submit the fixed-dose combination programme for regulatory review in the second half of 2016. Ironwood will pay AstraZeneca sales-related and other milestone payments of up to $265 million and tiered single-digit royalties on Product Sales. AstraZeneca will manufacture and supply Zurampic, provide certain support and services to Ironwood and undertake the FDA post-approval commitment on their behalf.

AstraZeneca PLC Announces Bevespi Aerosphere(TM) Approved by the US FDA for Patients With COPD

Demonstrated superior improvement in lung function versus mono-components and placebo

Only long-acting dual bronchodilator delivered through a pressurised metered-dose inhaler (pMDI) and first product to use AstraZeneca’s patented Co-Suspension(TM) Technology

AstraZeneca has announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “With the approval of Bevespi Aerosphere we are pleased to provide patients with the first LAMA/LABA in a pressurised metered-dose inhaler, delivered using our unique formulation technology. LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, which enables patients to breathe better and may help them be more active.”

Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the Treatment of Duchenne Muscular Dystrophy

 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-based therapeutics, today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Advisory Committee (PCNSC) met to review the new drug application (NDA) for eteplirsen as a treatment for Duchenne muscular dystrophy amenable to exon 51 skipping read more

Boston Scientific Receives U.S. FDA Approval For ImageReady™ MR-Conditional Pacing System

/PRNewswire/ — Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for a suite of products deemed safe for use in a magnetic resonance imaging (MRI) environment. The ImageReady™ MR-Conditional Pacing System, which includes ACCOLADE™ MRI and ESSENTIO™ MRI pacemakers, as well as the new INGEVITY™ MRI pacing leads, is designed to treat bradycardia, a condition in which the heart beats too slowly. Patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met. read more

MEDICREA Announces FDA Approval of First Patient-Specific UNiD™ Cervical Rod for Spine Surgery (Video)

LYON, France & NEW YORK–(BUSINESS WIRE)–MEDICREA®, (Paris:ALMED) (Alternext Paris: FR0004178572 – ALMED) the only medical device company offering patient-specific implant solutions for the treatment of spinal conditions, has announced FDA approval of the first-ever patient-specific UNiD™Cervical rod for spine surgery, secured by their complementary PASS OCT® posterior cervical stabilization system. read more

Ironwood Pharmaceuticals Enters into U.S. Licensing Agreement with AstraZeneca for Lesinurad

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) announced today that it has entered into a licensing agreement with AstraZeneca plc for the exclusive U.S. rights to lesinurad. Lesinurad 200mg tablets were approved as ZURAMPIC® by the U.S. Food and Drug Administration (FDA) in December 2015 for use in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with uncontrolled gout. read more

Gelesis Announces First U.S. Patient Enrolled in Pivotal Gelesis100 Weight-Loss Study

BOSTON–(BUSINESS WIRE)–Gelesis, a biotechnology company focused on the development of first-in-class products to safely induce weight loss and improve glycemic control, today announced the first patient enrolled from the United States (U.S.) in its pivotal GLOW (Gelesis Loss Of Weight) study. GLOW will assess the long-term safety and efficacy of Gelesis100, a novel oral capsulated device designed to achieve weight loss in adults who are overweight or have obesity, including those with prediabetes and type 2 diabetes. GLOW was initiated in November 2014 and has been ongoing at nine clinical trial sites across four European countries, where 125 patients have completed treatment. read more

Zymeworks and GSK Enter Second Strategic Collaboration to Develop and Commercialize Bi-Specific Antibodies

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc., a leader in the development of bi-specific and multi-specific antibodies and antibody drug conjugates, announced today that it has entered into a new licensing agreement with GSK for the research, development, and commercialization of novel bi-specific antibodies enabled using Zymeworks’ Azymetric™ drug discovery platform. Under the agreement read more

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