Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Medtronic plc and American Well® to enable patient access to American Well’s telemedicine services on MCMS’ video-enabled platforms

Partnership Focused on Enabling Care for Chronic, Co-Morbid Patients DUBLIN and BOSTON, MA, U.S.A., 17-Oct-2017 — /EuropaWire/ — Medtronic plc (NYSE:MDT) today announced its Medtronic Care Management Services (MCMS) business and American Well® entered into a first-of-its-kind strategic partnership to enable … Read the full press release

Medtronic to open Innovation Center at the Singapore-Sichuan Hi-Tech Innovation Park

Facilitating Clinical Training for Physicians and Advancing Local Healthcare Efficiency in Central and Western China DUBLIN, Ireland and CHENGDU, Sichuan, 11-Oct-2017 — /EuropaWire/ — Medtronic plc (NYSE:MDT) today announced the groundbreaking of its Chengdu Innovation Center at the Singapore-Sichuan Hi-Tech Innovation … Read the full press release

Medtronic: U.S. FDA approval for the Endurant(TM) II/IIs stent graft system

New Indication Expands Treatment Options for AAA Patients with Hostile Neck Anatomy DUBLIN, 11-Oct-2017 — /EuropaWire/ — Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the Endurant(TM) II/IIs stent graft … Read the full press release

European Medicines Agency (EMA): Updated annex to excipient guidelines has new safety advice for 15 excipients

LONDON, 10-Oct-2017 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use. Excipients refer to everything in a medicine other than the active substance. While most excipients are considered inactive, some can have … Read the full press release

Alcon to introduce Clareon®intraocular lens at the XXXV European Society of Cataract & Refractive Surgeons (ESCRS) congress in Lisbon

Clareon® intraocular lens (IOL) implanted with a unique single-use automated pre-loaded delivery system debuts with new data presentations Congress program highlights Alcon’s 70-year legacy of innovation including 100 million AcrySof® IOL implants  New analyses show efficacy and safety of CyPass® Micro-Stent in patients … Read the full press release

Shenzhen China Resources Gosun Pharmaceutical Co. granted exclusive license to develop, manufacture and to commercialize Basilea’s antibiotic Zevtera® (ceftobiprole) in China, Hong Kong and Macau

BASEL, 02-Oct-2017 — /EuropaWire/ — Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that Basilea Pharmaceutica International Ltd. (Basilea) has entered into a license agreement with Shenzhen China Resources Gosun Pharmaceutical Co., Ltd. (CR Gosun) for Basilea’s antibiotic Zevtera®(ceftobiprole) in China, Hong … Read the full press release

Newcastle University: School of Pharmacy will be based in the impressive King George VI building

Students begin the first ever pharmacy degree at Newcastle University and are embarking on an exciting career path. NEWCASTLE, 02-Oct-2017 — /EuropaWire/ — Pharmacists work in a variety of settings to provide essential healthcare services, yet none will have the … Read the full press release

European Medicines Agency (EMA), EU healthcare payers discussed how their cooperation can contribute to boosting sustainable access to medicines for EU citizens

European Medicines Agency and healthcare payer organisations held joint meeting on 19 September LONDON, 29-Sep-2017 — /EuropaWire/ — The European Medicines Agency (EMA) and European Union (EU) healthcare payers met for the first time on 19 September 2017 at EMA’s offices … Read the full press release

GFK Healthcare study supported by Bayer polled adolescents on their attitudes toward sexuality and contraception

Not intended for U.S. and UK Media – GFK Healthcare study on ‘Youth and Contraception’ marks World Contraception Day 2017 Number of unplanned pregnancies remains high globally / Study supported by Bayer shows that adolescents want to be addressed as … Read the full press release

US FDA gives Actamax go signal to conduct trial on Actamax Adhesion Barrier

Parsippany NJ, US, 25-Sep-2017 — /EuropaWire/ — Actamax Surgical Materials LLC, a wholly owned subsidiary of DSM, focused on design of bioresorbable medical devices to reduce the burden of post-operative complications for patients undergoing surgery, announced it has received conditional approval … Read the full press release

Sanofi Genzyme, Alnylam Pharmaceuticals: APOLLO Phase 3 study of patisiran met its primary efficacy endpoint and all secondary endpoints

Investigational RNAi Therapeutic Patisiran Meets Primary and All Secondary Endpoints, with Highly Significant Reduction In Neuropathy Progression and Improvement in Quality of Life at 18 Months Relative to Placebo Alnylam Intends to File New Drug Application (NDA) in Late 2017 … Read the full press release

Merck: Grant for Growth Innovation (GGI) for 2017 winners announced in Washington, U.S.

Not intended for US/Canada based media The presentation of the grants coincides with the 10th International Meeting of Pediatric Endocrinology The awards program supports advancements in the field of growth and growth disorders DARMSTADT, 19-Sep-2017 — /EuropaWire/ — Merck, a leading … Read the full press release

GSK: US FDA VRBPAC’s vote brings us one step closer to approval of Shingrix

LONDON, 14-Sep-2017 — /EuropaWire/ — GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix … Read the full press release

Roche study combining Esbriet and nintedanib treatment: majority of the patients tolerated the combination treatment

New study combining Esbriet (pirfenidone) and nintedanib showing similar safety profile for the combination treatment to that expected for each treatment alone A second, retrospective, post-hoc, analysis suggests that treatment with Esbriet may be associated with a reduction of multiple … Read the full press release

Roche phase III BRIM8 study: 46% reduction in recurrence risk was observed in stage IIC-IIIB melanoma patients

BASEL, 14-Sep-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data for the phase III BRIM8 study, which was designed to investigate the efficacy and safety of Zelboraf® (vemurafenib) in the adjuvant (after surgery) treatment of people with … Read the full press release

AstraZeneca Phase III PACIFIC trial: Imfinzi demonstrated statistically-significant and clinically-meaningful improvement in PFS

Imfinzi improves progression-free survival (PFS) by more than 11 months compared to standard of care and is the first medicine to show superior PFS in this setting Data presented at the ESMO 2017 Congress follows FDA’s recent Breakthrough Therapy Designation … Read the full press release

AstraZeneca Phase III FLAURA trial supports Tagrisso’s potential as a new standard of care in 1st-line EGFR-mutated lung cancer

Phase III FLAURA trial results show Tagrisso reduced the risk of progression or death by more than half, with consistent benefit across all subgroups, including patients with and without brain metastases Unprecedented median progression-free survival (PFS) of 18.9 months compared … Read the full press release

High blood pressure: Medtronic to move forward with a new renal denervation pivotal trial

Published Simultaneously in The Lancet, the Late-Breaking SPYRAL HTN-OFF MED Study at ESC Successfully Isolates RDN Treatment Effect to Show Compelling Efficacy and Safety of Hypertension Procedure DUBLIN and BARCELONA, 04-Sep-2017 — /EuropaWire/ — Medtronic plc (NYSE:MDT) today announced its intent … Read the full press release

EMBO: new TREM2 research suggests a new therapeutic target in Alzheimer’s disease treatment

Uncovering the molecular mechanism behind a rare genetic risk factor of Alzheimer’s disease points to a new therapeutic target HEIDELBERG, 04-Sep-2017 — /EuropaWire/ — A gene called triggering receptor expressed on myeloid cells 2, or TREM2, has been associated with numerous … Read the full press release

Shire MYDAYIS now available by prescription in the United States

Mydayis, which is now available in the U.S., demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-dose, compared to placebo, in total score on a skill-adjusted math test that measures attention in ADHD Lexington, … Read the full press release

Novartis: ACZ885 led to 15% reduction in the risk of major adverse cardiovascular events (MACE) compared to placebo

Study showed a significant 15% reduction of major adverse cardiovascular events (MACE) in people with a prior heart attack and inflammatory atherosclerosis who were treated with 150mg of ACZ885, in addition to standard of care including lipid-lowering therapy Effect driven … Read the full press release

Novartis: ACZ885 reduced the rate of lung cancer incidence and mortality among study participants

Review of blinded, pre-planned oncology safety analyses revealed a 77% reduction in lung cancer mortality and 67% reduction in lung cancer cases in patients treated with 300mg of ACZ885 CANTOS is the first Phase III clinical trial to support a … Read the full press release

Novartis announces the appointment of Bertrand Bodson to the new role of Chief Digital Officer

New leader to drive the digital transformation Novartis has embarked upon BASEL, 28-Aug-2017 — /EuropaWire/ — Novartis announced today that Bertrand Bodson, Chief Digital and Marketing Officer for Sainsbury’s Argos, has been appointed to the new role of Chief Digital Officer, … Read the full press release

Medtronic: global randomized clinical trial to evaluate one-month dual antiplatelet therapy (DAPT) in patients with the Resolute Onyx(TM) DES during percutaneous coronary intervention (PCI)

First-of-its-Kind Randomized Clinical Trial Will Evaluate One-Month DAPT in Patients Following PCI Procedures with the Newer-Generation Durable Polymer Resolute Onyx DES DUBLIN, 18-Aug-2017 — /EuropaWire/ — Medtronic plc (NYSE: MDT) today announced a global randomized clinical trial that will evaluate one-month … Read the full press release

Shire submits MAA for lifitegrast: If approved it will address the signs and symptoms of dry eye disease in adults in Europe

Lifitegrast, if approved, would be the first and only new class treatment to address the signs and symptoms of dry eye disease in adults in Europe ZUG, 16-Aug-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) announces that the Marketing Authorization … Read the full press release

University of Southampton: new experimental drug in certain patients with diffuse large B-cell lymphoma

SOUTHAMPTON, 14-Aug-2017 — /EuropaWire/ — Patients with a common type of fast-growing cancer are being given fresh hope in a new clinical trial. Scientists at the University of Southampton are, for the first time, to trial a new experimental drug, in … Read the full press release

Sanofi files patent infringement suit against Merck Sharp & Dohme Corp. in US

PARIS, 10-Aug-2017 — /EuropaWire/ — Sanofi announced today that it filed a patent infringement suit against Merck Sharp & Dohme Corp. (“Merck”) on August 8, 2017 in the United States District Court for the District of New Jersey. In its suit Sanofi … Read the full press release

Acerta Pharma: US FDA accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib inhibitor

CAMBRIDGE, 07-Aug-2017 — /EuropaWire/ — AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib, … Read the full press release

Medtronic: treating paroxysmal atrial fibrillation with cryoballoon catheter ablation results in cost savings as compared to radiofrequency ablation

Data from Landmark Trial Published in the Journal of the American Heart Association DUBLIN, 03-Aug-2017 — /EuropaWire/ — A new health economic analysis from the landmark FIRE AND ICE Trial, sponsored by Medtronic plc (NYSE: MDT), was published today in the Journal of … Read the full press release

European launch of Medtronic CoreValve(TM)Evolut(TM) PRO valve for the treatment of severe aortic stenosis

DUBLIN, 03-Aug-2017 — /EuropaWire/ — Medtronic plc (NYSE:MDT) today announced CE (Conformité Européenne) mark and European launch of the CoreValve(TM)Evolut(TM) PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk … Read the full press release