Medical Tidbits,Gilead Sciences Announces Acquisition of Nimbus Therapeutics’ Acetyl-CoA Carboxlyase (ACC) Program for NASH and Other Liver Diseases

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FOSTER CITY, Calif. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apr. 4, 2016– Gilead Sciences, Inc. (NASDAQ:GILD) and Nimbus Therapeutics, LLC today announced that the companies have signed a definitive agreement under which Gilead will acquire Nimbus Apollo, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its Acetyl-CoA Carboxylase (ACC) inhibitor program. Nimbus Therapeutics will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time. read more

Saxenda® demonstrated significant improvements in cardiometabolic risk factors over three years compared with placebo

– Today, new data from the three-year part of the phase 3a SCALE™ (Satiety and Clinical Adiposity – Liraglutide Evidence) Obesity and Prediabetes trial were presented at the Endocrine Society’s 98th Annual Meeting and Expo (ENDO 2016). The three-year part of the trial (n=2,254 adults with obesity or who were overweight with comorbidities and had prediabetes at baseline) data demonstrated that 160 weeks of treatment with Saxenda® (liraglutide 3 mg) (n=1,505) in combination with a reduced-calorie diet and increased physical activity resulted in significant improvements in cardiometabolic risk factors (such as blood pressure and cholesterol) compared with placebo (reduced-calorie diet and increased physical activity alone) read more

First-Ever Medtronic Harmony(TM) Transcatheter Pulmonary Valve Data Shows Positive Procedural Success In Early Feasibility Study

Medtronic plc (NYSE: MDT) today announced first-ever clinical data on the Harmony(TM) Transcatheter Pulmonary Valve (TPV) from its early feasibility study, demonstrating positive initial outcomes at six-months in patients with an indication for pulmonary valve restoration. The initial results were presented during the 65th Annual Scientific Session of the American College of Cardiology (ACC). Following the positive initial data unveiled today, a pivotal Investigational Device Exemption (IDE) study is planned to start in late calendar year 2016, pending approval from the U.S. Food and Drug Administration (FDA). read more

Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR

Agency requests standard three-month extension to review additional solicited information-

-New PDUFA date set for July 19, 2016-

LAVAL, Quebec and TARRYTOWN, N.Y., April 4, 2016 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Oral RELISTOR (methylnaltrexone bromide) new drug application (NDA) by three months to July 19, 2016.  The FDA extended the action date to allow for a full review of Valeant’s responses to recent information requests from the FDA. read more

U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV Therapy

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. read more

NCCN Expert Panel Sets the Record Straight on Palliative Care and its Value in the Cancer Care Continuum

The NCCN 21st Annual Conference kicked off with a look into the world of palliative care, exploring barriers to patient access and means to establish multidisciplinary palliative care teams.

FORT WASHINGTON, PA — The number of people being diagnosed with cancer in the United States is increasing year over year, reaching more than 1.6 million in 2015. As the cancer death rate also continues to rise, an increasing amount of attention has been focused on the unique challenges of patients, care teams, and caregivers facing a transition from active treatment to palliative care. read more

Pfizer and Allergan Issue Statement

“We are conducting a review of the U.S. Department of Treasury’s actions announced today. Prior to completing the review, we won’t speculate on any potential impact.”

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This communication is not intended to be and is not a prospectus for the purposes of Part 23 of the Companies Act 2014 of Ireland (the “2014 Act”), Prospectus (Directive 2003/71/EC) Regulations 2005 (S.I. No. 324 of 2005) of Ireland (as amended from time to time) or the Prospectus Rules issued by the Central Bank of Ireland pursuant to section 1363 of the 2014 Act, and the Central Bank of Ireland (“CBI”) has not approved this communication read more

The effect of the economic crisis on birth outcome in Spain

The unprecedented post-war European economic crisis which began in 2007 and the resulting fiscal austerity policies are generally considered to have had a negative impact on public health. A study published in the Annals of Human Biology by Carlos Varea and colleagues investigates the impact of the economic crisis on birth outcomes in Spain; specifically detailing temporal changes (from 2003-2012) in underweight at birth, birth weight being an important indicator of health outcomes throughout the life course. read more

Surgical Theater Unveils Medical Virtual Reality Visualization at NVIDIA GPU Technology Conference

SAN JOSE, Calif.–(BUSINESS WIRE)–Surgical Theater, a world leader in medical virtual reality, will present its first-of-its kind virtual reality surgical visualization platform for neurosurgery at the NVIDIA GPU Technology Conference (GTC 2016), on April 6 in Silicon Valley. read more

Braeburn Pharmaceuticals and Camurus announce Enrollment goals reached in two pivotal Phase 3 Trials of CAM2038 for treatment of opioid dependence

Braeburn Pharmaceuticals and Camurus (STO:CAMX) today announce that the enrollment goals for both the 24-week efficacy study and the 48-week safety study were met on 31 March. These two pivotal Phase 3 trials of long-acting subcutaneous buprenorphine injections, CAM2038, in patients with opioid dependence were designed to establish clinical efficacy and long-term safety of both weekly (q1w) and monthly (q4w) formulations. read more

Chugai Pharma Europe Announces Positive Phase III Results of Aplidin®

LONDON–(BUSINESS WIRE)–Chugai Pharma Europe Ltd. (CPE), a wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd. (TOKYO:4519), announced today positive results of a Phase III clinical trial called “ADMYRE” conducted by PharmaMar, with Aplidin® (plitidepsin) in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma (MM). The study achieved its primary endpoint with a statistically significant extension in progression free survival (PFS) compared with dexamethasone alone, as announced by PharmaMar on 31 March. read more

 

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