Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

New CERN-MEDICIS facility produces its first radioisotopes for medical research to diagnose cancers

GENEVA, 14-Dec-2017 — /EuropaWire/ — Today (12 Dec 2017), the new CERN-MEDICIS facility has produced radioisotopes for medical research for the first time. MEDICIS (Medical Isotopes Collected from ISOLDE) aims to provide a wide range of radioisotopes, some of which can … Read the full press release

EURORDIS and its members launch new position paper calling for urgent change to improve patients’ access to rare disease therapies in Europe

PARIS, 13-Dec-2017 — /EuropaWire/ — EURORDIS and its over 700 member patient organisations have launched a new position paper calling for urgent change to ensure patients’ full and fast access to rare disease therapies in Europe. The ‘Breaking the Access Deadlock to … Read the full press release

Sanofi’s Toujeo® met primary objective in the first head-to-head clinical trial comparing Toujeo with insulin degludec

First head-to-head randomized clinical trial comparing the efficacy and safety of Toujeo (insulin glargine 300 Units/mL) versus insulin degludec PARIS, 05-Dec-2017 — /EuropaWire/ — Sanofi’s Toujeo® met the primary study objective in the first large head-to-head clinical trial1, called BRIGHT study, … Read the full press release

Sanofi discontinues clinical development of its experimental Clostridium difficile vaccine

PARIS, 05-Dec-2017 — /EuropaWire/ — Following a planned interim analysis, the Independent Data Monitoring Committee (IDMC) for the phase III Cdiffense clinical trial program concluded that the probability that the study will meet its primary objective is low. Based on this, Sanofi has … Read the full press release

200 healthcare decision-makers gather to address the looming challenges of cost, access and sustainability in the coming wave of high-value medicines

LONDON, 01-Dec-2017 — /EuropaWire/ — On December 5-6, 2017, 200 high-level experts from government, academia, biopharmaceutical developers and patient organisations convene in London (UK) to address the mounting challenge of accessibility and patient access to high-value, high-cost medical therapies. The … Read the full press release

GSK: NDA submission to US FDA for single-dose tafenoquine for the radical cure of Plasmodium vivax malaria

Regulatory milestone affirms GSK’s strong commitment and scientific capabilities to fighting infectious diseases  LONDON/GENEVA, 29-Nov-2017 — /EuropaWire/ — GSK and Medicines for Malaria Venture (MMV) today announced the submission of a new drug application (NDA) by GSK to the United States … Read the full press release

GSK on UK Government’s Industrial Strategy: Meaningful targets, sustained efforts and coherent implementation will be critical to this strategy’s success

LONDON, 29-Nov-2017 — /EuropaWire/ — Responding to the launch of the Industrial Strategy White Paper, published today by the UK Government, Phil Thomson, President, Global Affairs, at GSK said: “A new, long-term industrial strategy for the country is important and welcome. We … Read the full press release

ViiV Healthcare begins phase III study on long-acting two-drug regimen in virally suppressed adults with HIV-1 infection

The ATLAS-2M study will evaluate injections every two months in virally suppressed patients LONDON, 29-Nov-2017 — /EuropaWire/ — Today (27 November 2017) ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, … Read the full press release

Medtronic announces U.S. commercial launch for its portfolio of Azure(TM) pacemakers with BlueSync(TM)technology

Azure(TM) with BlueSync(TM) Technology Improves Device Longevity  and Provides Automatic, Wireless Remote Patient Monitoring DUBLIN, 21-Nov-2017 — /EuropaWire/ — Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval and U.S. commercial launch for its portfolio of Azure(TM) pacemakers … Read the full press release

Thomas Dittrich appointed Chief Financial Officer and Executive member of the Board of Directors at Shire plc

DUBLIN, 21-Nov-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotech leader in rare diseases, today announced that Thomas Dittrich will join the company as Chief Financial Officer, and become an Executive member of the Board of Directors … Read the full press release

The Institute of Cancer Research welcomes the approval by NICE of new type of treatment for women with advanced breast cancer

LONDON, 16-Nov-2017 — /EuropaWire/ — The Institute of Cancer Research, London, welcomes the approval by NICE of a new type of treatment for women with previously untreated advanced breast cancer. Palbociclib and ribociclib, two new drugs approved today for use on the NHS, … Read the full press release

Boehringer Ingelheim and MiNA Therapeutics partner on the development of novel compounds to treat fibrotic liver diseases

Collaboration and licensing agreement focused on investigating up to three targets and has a potential transactional value of up to EUR 307 million, excluding royalties Expands Boehringer Ingelheim’s comprehensive R&D programme in non-alcoholic steatohepatitis (NASH) and fibrotic liver disease with … Read the full press release

Boehringer Ingelheim partners with the Cat Friendly Clinic programme in Europe, Asia, Africa and Australasia

The programme was set up by the International Society of Feline Medicine (ISFM), the veterinary division of the charity International Cat Care (ICC) Boehringer Ingelheim will promote the programme and develop informational tools and services to grow veterinarians’ and cat … Read the full press release

Novartis: positive topline results from the global MONALEESA-7 trial

MONALEESA-7 met primary endpoint of progression-free survival, demonstrating superior efficacy of Kisqali combination therapy vs. endocrine treatment alone in first-line treatment of premenopausal women with HR+/HER2- advanced breast cancer[1]  Kisqali is the first CDK4/6 inhibitor to be studied in a Phase … Read the full press release

Novartis announced results from the FUTURE 5 study on psoriatic arthritis (PsA)

Structural joint damage in psoriatic arthritis (PsA) patients taking Cosentyx® (secukinumab) was inhibited at 24 weeks versus placebo in all arms of the study[1] PsA can lead to reduced mobility and irreversible joint damage[2]     FUTURE 5 is the largest randomized controlled … Read the full press release

Bayer Scientific Magazine: “Targeting the causes of cancer” the cover story in the recently published 31st edition of “research”

Small molecules to treat cancer, Gene therapies for hereditary diseases, soil bacteria for better harvest yields and strategies to protect bees – the latest edition of research provides an exclusive insight into the current research projects at Bayer. All of … Read the full press release

Sanofi: Phase 3 study on dupilumab in adults and adolescents with severe, steroid-dependent asthma met its primary endpoint and key secondary endpoints

First study with a biologic to show benefit  in severe steroid-dependent asthma population that enrolled patients regardless of blood eosinophil levels or any other Type 2 biomarkers at baseline Pivotal program is first with a biologic to show consistent reductions … Read the full press release

Equistone: Concept Life Sciences acquires Edinburgh-based Aquila BioMedical

LONDON, 31-Oct-2017 — /EuropaWire/ — Concept Life Sciences (Concept), the integrated drug discovery, development and analytical services company backed by Equistone Partners Europe (Equistone), has acquired Edinburgh-based Aquila BioMedical (Aquila), to bolster its discovery capabilities. Aquila is an innovative pre-clinical contract … Read the full press release

SGS awarded ACG Associated Capsules’ site in Pithampur, India an EXCiPACT certificate

SGS, one of EXCiPACTs’s internationally recognized certification bodies, is proud to announce that we have awarded ACG Associated Capsules’ site in Pithampur, India an EXCiPACT certificate. GENEVA, 25-Oct-2017 — /EuropaWire/ — This demonstrates that the Pithampur site manufactures pharmaceutical excipients according … Read the full press release

QIAGEN Ergebnisse einer neuen Evaluierung im Bereich der Frauengesundheit die hohe Genauigkeit seiner Bioinformatik-Lösungen untermauern

Ergebnisse der Evaluierung der QCI-Plattform zur Interpretation klinisch relevanter Genvarianten werden auf der ASHG 2017 von Counsyl vorgestellt Orlando, Florida (USA), Germantown, Maryland (USA), und Hilden (Deutschland), 20-Oct-2017 — /EuropaWire/ — QIAGEN (NASDAQ: QGEN; Frankfurter Börse: QIA) gab heute bekannt, … Read the full press release

Frank Staud to lead STADA Group’s communication activities

Bad Vilbel, 18-Oct-2017 — /EuropaWire/ — Frank Staud assumed the role of Executive Vice President Corporate Communications, Branding and Sponsoring on October 1. The 48-year old Austrian is responsible not only for the image of the STADA brand, but also for … Read the full press release

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