Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

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

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