Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

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

Sweden submitted its official offer to host the The European Medicines Agency (EMA)

The European Medicines Agency (EMA) is currently looking for a new location in connection with the UK’s withdrawal from the EU. Sweden has now submitted its official offer to host the EMA. STOCKHOLM, 03-Aug-2017 — /EuropaWire/ — The offer guarantees … Read the full press release

Shire plc: total number of voting rights in the Company is 908,114,281 as of July 31, 2017

DUBLIN, 02-Aug-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) (the “Company”), in accordance with 5.6.1R of the Financial Conduct Authority’s (the “FCA”) Disclosure Guidance and Transparency Rules, notifies the market of the following: As at July 31, 2017, the … Read the full press release

Boehringer Ingelheim: Global survey reveals the emotional and practical challenges facing people with idiopathic pulmonary fibrosis (IPF)

61% of IPF patients are worried or extremely worried about experiencing an acute IPF exacerbation1  Survey underlines the importance of appropriate support and coping mechanisms for patients living with IPF1 Healthcare teams emphasise the need of a strong support network … Read the full press release

Sandoz today expands pilot project with leading charity World Child Cancer

Expanded partnership to help “even the odds” of survival for children with cancer in the Philippines, Myanmar, Mexico and Ghana In developed countries, the survival rate for childhood cancer is 80%, while in developing countries it can be as low … Read the full press release

Merck invests EUR 90 million in four sites in Germany, Switzerland and France

Relocations to drive focus on sites in Darmstadt, Schnelldorf (Germany), Buchs (Switzerland) and Molsheim (France) Sequential implementation until the end of 2022 € 90 million investment. Net impact of approximately minus 200 positions over 5 years DARMSTADT, 13-Jul-2017 — /EuropaWire/ … Read the full press release

Haemophilia A: data from Roche’s HAVEN 1 published in The New England Journal of Medicine (NEJM)

Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine HAVEN 1 showed emicizumab reduced bleed rate by 87% compared with on-demand bypassing agents All 12 secondary endpoints in HAVEN 1 were … Read the full press release

BASF to build new world-scale plant for ibuprofen in Ludwigshafen, Germany

New world-scale ibuprofen production plant in Ludwigshafen Additional capacity expansion of ibuprofen plant in Bishop, Texas Strengthening position in the ibuprofen market  LUDWIGSHAFEN, 30-Jun-2017 — /EuropaWire/ — BASF plans to build a new world-scale plant to produce ibuprofen in Ludwigshafen, … Read the full press release

DHL Supply Chain opens new pharmaceutical grade facility in Ireland

3,700 sq. m. (40,000 sq. ft) site dedicated to supporting Life Sciences manufacturers in Ireland Integrated transport and logistics services now available across temperature ranges DUBLIN, 30-Jun-2017 — /EuropaWire/ — Global logistics provider DHL Supply Chain is today opening a new … Read the full press release

France’s Ministry of Health and Social Affairs approves reimbursement for QIAGEN’s QuantiFERON-TB® Gold Plus latent tuberculosis test

Gold-standard test for latent tuberculosis infection will be covered by national health insurance Hilden, Germany, and Paris, France, 23-Jun-2017 — /EuropaWire/ — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that France’s Ministry of Health and Social Affairs … Read the full press release

DiaSorin, QIAGEN to develop new tests for DiaSorin’s LIAISON family of analyzers

Saluggia, Italy; Hilden, Germany, and Germantown, Maryland, USA, 23-Jun-2017 — /EuropaWire/ — DiaSorin (FTSE Italy Mid Cap: DIA) and QIAGEN (NASDAQ: QGEN; Frankfurt Stock Exchange: QIA) announced today a new collaboration to develop new tests for DiaSorin’s LIAISON family of … Read the full press release

Generic medicines accounted for 62% of all medicines prescribed in Europe in 2016

New data just released in the two largest global pharma markets show the substantial and growing level of savings made possible by increased use of generic medicines. HOLZKIRCHEN, 21-Jun-2017 — /EuropaWire/ — Generic medicines accounted for 62% of all medicines prescribed … Read the full press release

Sandoz: European Commission approves Rixathon for use in Europe

European Commission approves Sandoz Rixathon® to treat blood cancers and immunological diseases. Approval expected to broaden patient access to biologics and enable budget-constrained healthcare systems to reallocate resources to other healthcare priorities. Sandoz now has four biosimilars approved in Europe … Read the full press release

GSK: Benlysta plus standard of care prolonged control of disease activity in patients with active systemic lupus erythematosus (SLE)

Final efficacy and safety results from phase II continuation study Madrid, Spain and London, UK, 19-Jun-2017 — /EuropaWire/ — GSK today announced results from a 10-year continuation study, which showed that Benlysta (belimumab) plus standard of care prolonged control of disease … Read the full press release

China: SGS to undertake extractables and leachables (E&L) testing at its Shanghai laboratory

GENEVA, 16-Jun-2017 — /EuropaWire/ — SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, today announced that it has significantly increased its capabilities to undertake extractables and leachables (E&L) testing at its Shanghai, China, laboratory. Its investment includes the … Read the full press release

Boehringer Ingelheim To Focus on Innovative Digital Solutions in Healthcare With Digital Lab “BI X”

New start-up as platform for digital transformation in data science, agile software development and user experience design Improvement of  human and animal health with innovative digital solutions BI X offers 50 new jobs at the company’s headquarters Investment of 10 … Read the full press release

Basilea Pharmaceutica updates on clinical phase 1/2a program with its anticancer drug candidate BAL101553 at American Society of Clinical Oncology (ASCO)

BASEL, 09-Jun-2017 — /EuropaWire/ — Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that updates were presented on the ongoing clinical phase 1/2a program with its anticancer drug candidate BAL101553, a novel tumor checkpoint controller, at the American Society of Clinical Oncology … Read the full press release

U.S. FDA premarket approval for QIAGEN’s automated artus® CMV QS-RGQ MDx kit for use on its QIAsymphony platform

High-throughput application of artus CMV QS-RGQ MDx Kit on QIAsymphony streamlines critical and frequently performed viral infection test for transplant patients Germantown, Maryland, and Hilden, Germany, 07-Jun-2017 — /EuropaWire/ — QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has … Read the full press release

QIAGEN receives worldwide license from The Johns Hopkins University for biomarkers for immune-oncology therapies in cancer treatment

Option to add new biomarkers for microsatellite instability (MSI) and mismatch repair (MMR) to QIAGEN’ s NGS panels Hilden, Germany, and Germantown, Maryland, 07-Jun-2017 — /EuropaWire/ — QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received a worldwide … Read the full press release

Bristol-Myers Squibb and QIAGEN to explore NGS technology to develop GEPs for I-O therapies in cancer treatment

NEW YORK and HILDEN, Germany, 06-Jun-2017 — /EuropaWire/ — Bristol-Myers Squibb Company (NYSE: BMY) and QIAGEN(NASDAQ: QGEN; Frankfurt Prime Standard: QIA) have signed an agreement to explore the use of next-generation sequencing (NGS) technology to develop gene expression profiles (GEPs) as  … Read the full press release

Shire to present ADHD research at the 170th Annual Meeting of the American Psychiatric Association (APA) in San Diego

Latest Research Supports Greater Understanding of the Evolving Needs of Adults with ADHD Lexington, M.A., 18-May-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) will present research on the evolving needs of adults living with Attention-Deficit/Hyperactivity Disorder (ADHD) at the … Read the full press release

Changes to Actelion’s executive team to take effect upon closing of the transaction with Johnson & Johnson

ALLSCHWIL/BASEL, SWITZERLAND, 17-May-2017 — /EuropaWire/ — Actelion Ltd (SIX: ATLN) today announced changes to its executive team that would only take effect upon closing of the transaction with Johnson & Johnson expected towards the end of the second quarter 2017. … Read the full press release

QIAGEN N.V. forms joint venture with Maccura Biotechnology Co., Ltd., a leading in vitro diagnostics (IVD) company in China

Partnership with a leading Chinese IVD company with goal to accelerate penetration of the world’s first complete Sample to Insight NGS solution in rapidly growing Chinese market Hilden, Germany, and Chengdu, China, 08-May-2017 — /EuropaWire/ — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt … Read the full press release

University of Bristol: New drug combination that could help thousands of children with arthritis discovered

BRISTOL, 05-May-2017 — /EuropaWire/ — A new drug combination that could help thousands of children with arthritis and prevent them from serious complications, including blindness, has been discovered by researchers and thanks to a trial funded by Arthritis Research UK and … Read the full press release