Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Kuehne + Nagel expands its KN PharmaChain network with a new Logistics Hub in Santiago de Chile

Expanding KN PharmaChain network with strong local footprint Fully integrated laboratory and distribution centre Eco-friendly through use of geothermal energy SANTIAGO, Chile, 13-Jul-2018 — /EuropaWire/ — As of August 2018, a new Logistics Hub in Santiago de Chile will benefit … Read the full press release

AstraZeneca and Merck & Co., Inc. announce positive results from the randomised, double-blinded, placebo-controlled, Phase III SOLO-1 trial of Lynparza (olaparib) tablets

Lynparza met primary endpoint of progression-free survival in women with BRCA-mutated advanced ovarian cancer and showed a safety profile consistent with previous trials AstraZeneca and MSD’s Lynparza is the only PARP inhibitor to demonstrate significant activity in the 1st-line maintenance … Read the full press release

H. Lundbeck A/S initiates a phase I study of a potential new treatment of Parkinson’s disease

Lu AF28996 is the third compound added to Lundbeck’s clinical development pipeline in 2018. VALBY, 28-Jun-2018 — /EuropaWire/ — H. Lundbeck A/S (Lundbeck) again expands its pipeline of clinical development projects with the initiation of a phase I study of a … Read the full press release

Shire: U.S. FDA approval makes CINRYZE® available to help prevent angioedema attacks in children with hereditary angioedema

CINRYZE is the first and only therapy indicated in the U.S. to help prevent angioedema attacks in pediatric patients with hereditary angioedema (HAE) as young as 6 Shire is the only drug developer to complete a pediatric study for the … Read the full press release

U.S. FDA approval for Shire’s first submission for its new plasma manufacturing facility near Covington, Georgia

New facility will add 30% capacity to Shire’s internal plasma manufacturing network once fully operational Expanded capacity supports continued strong growth of Shire’s leading immunoglobulin portfolio and further strengthens ability to deliver complex therapies for rare immune-mediated conditions DUBLIN, 25-Jun-2018 … Read the full press release

The European Medicines Agency launches new online portal for orphan designation applications

EMA launches new submission portal today LONDON, 20-Jun-2018 — /EuropaWire/ — The European Medicines Agency (EMA) has launched a new secure online portal for orphan designation applications. The portal, named ‘Iris’, provides a single space where applicants can submit and manage the information and … Read the full press release

EMA and the European Commission update guidance to prepare pharmaceutical companies for UK’s withdrawal from the EU

Publication of updated Q+As and practical guidance LONDON, 20-Jun-2018 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to the questions-and-answers … Read the full press release

Boehringer Ingelheim’s Metacam® now also approved in Europe as analgesic and anti-inflammatory medicine to guinea pigs

Metacam® 0.5mg/ml Oral Suspension for Cats is now also approved in Europe for alleviation of mild to moderate post-operative pain associated with soft tissue surgery in guinea-pigs True market need to provide relief after painful  procedures and surgeries Boehringer Ingelheim is … Read the full press release

Novartis’ Alcon AcrySof IQ PanOptix intraocular lens unveils new data showing significantly improved near and intermediate distance vision

Better visual outcomes for patients with the AcrySof IQ PanOptix intraocular lens at near and intermediate distance vision[1]  Detailed findings presented at World Ophthalmology Congress 2018 Recent survey reveals 82% of people 60+ are willing to have advanced surgical options … Read the full press release

Dr. Christina Marrongelli to lead World Congress on Pharmacology & Chemistry of Natural Compounds

Marrongelli selected for her expertise in Botanical Drug Development LONDON, 15-Jun-2018 — /EuropaWire/ — As a leading expert in her field, Dr. Christina Marrongelli, PharmD has been chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to … Read the full press release

Sanofi launches worldwide stock purchase plan reserved for its employees

A plan taking place in almost 80 countries Subscription per five shares entitle the employee to one matching share[1] PARIS, 12-Jun-2018 — /EuropaWire/ — Sanofi launches today “Action 2018”, a worldwide stock purchase plan reserved for its employees. In doing such a … Read the full press release

University of Birmingham: ground-breaking research will be conducted into the very early stages of the development of chronic obstructive pulmonary disease (COPD)

A thousand people are needed for ground-breaking research being carried out by the University of Birmingham into an incurable lung condition. BIRMINGHAM, 12-Jun-2018 — /EuropaWire/ — Supported by the British Lung Foundation, Dr Elizabeth Sapey and Professor Robert Stockley, will be … Read the full press release

Dr Emmanouela Gbandi appointed as the Solving Kids’ Cancer Senior Trials Coordinator for Neuroblastoma at the University of Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU)

University of Birmingham researchers are leading the way with a ground-breaking role to enable more children with the rare cancer neuroblastoma to access potentially life-saving clinical trials more quickly. BIRMINGHAM, 12-Jun-2018 — /EuropaWire/ — In the first dedicated position focusing on … Read the full press release

GlaxoSmithKline plc completed the buyout of Novartis’ 36.5% stake in its Consumer Healthcare Joint Venture for $13 billion

Brentford, UK, 05-Jun-2018 — /EuropaWire/ — GlaxoSmithKline plc (LSE/NYSE: GSK) today announces that it has completed the buyout of Novartis’ 36.5% stake in its Consumer Healthcare Joint Venture for $13 billion (£9.3 billion*). The transaction, which was previously announced on 27 … Read the full press release

AstraZeneca and MedImmune present results from Phase III clinical trial of moxetumomab pasudotox in patients with hairy cell leukaemia

Trial meets the primary endpoint of durable complete response Majority of patients who had a complete response had no evidence of any remaining detectable cancer cells Phase III clinical trial results served as basis for recent US FDA regulatory submission … Read the full press release

EQT Credit supports Keensight Capital and ERES’ investment in Biovian

STOCKHOLM, 04-Jun-2018 — /EuropaWire/ — EQT Credit, through its Mid-Market investment strategy, is pleased to announce that it has provided the financing to support Keensight Capital and ERES’ (the “Shareholders”) investment in Biovian (or the “Company”), a leading European player in … Read the full press release

Medtronic chairman and CEO to participate at Goldman Sachs 39th Annual Global Healthcare Conference

DUBLIN, 30-May-2018 — /EuropaWire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that it will participate in the Goldman Sachs 39th Annual Global Healthcare Conference on Tuesday, June 12, 2018, in Rancho Palos Verdes, Calif. Omar Ishrak, Medtronic … Read the full press release

EMA, PMDA and the FDA host a workshop to discuss the development of antibiotics for children, London on 21-22 June 2018

Workshop with regulators from EU, Japan and US open for registration LONDON, 28-May-2018 — /EuropaWire/ — The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States’ Food and Drug Administration (FDA) are co-organising a workshop to discuss the development … Read the full press release

Sandoz announces European Commission approval for Zessly® (infliximab) for use in Europe

European Commission’s (EC) approval based on comprehensive data package confirming that Zessly® matches safety, efficacy and quality of reference medicine Biosimilars such as Zessly enable earlier patient access to important medicines and positively impact healthcare systems Zessly is the third EC … Read the full press release

Nestlé to combine its two scientific discovery units to build one impactful organization, Nestlé Research

Vevey, Switzerland, 24-May-2018 — /EuropaWire/ — Nestlé has today announced changes that further strengthen its research and development operations, the largest of any food company worldwide. Nestlé will bring together its two scientific discovery units, the Nestlé Research Center and the … Read the full press release

University of Liverpool researchers awarded £73k grant to help identify brain imaging biomarkers for drug treatment response in epilepsy

LIVERPOOL, 24-May-2018 — /EuropaWire/ — Researchers from the University of Liverpool have been awarded a £73k grant from Epilepsy Research UK to help identify brain imaging biomarkers for drug treatment response in epilepsy. Dr Simon Keller, from the University’s Institute Of Translational Medicine, … Read the full press release

Dupixent demonstrated significant improvement in multiple asthma endpoints in two Phase 3 clinical trials

Results showed Dupixent demonstrated a significant improvement in multiple asthma endpoints in two Phase 3 clinical trials in a broad population of patients with uncontrolled asthma, irrespective of minimum baseline eosinophil levels or other biomarkers of Type 2 inflammation Greater … Read the full press release

University of Nottingham Malaysia researchers discovered new natural compounds from a local fig plant that could lead to improved treatment for resistant hypertension

NOTTINGHAM, 21-May-2018 — /EuropaWire/ — Researchers have discovered new natural compounds in a fig plant species native to Malaysia that could lead to improved treatment for resistant hypertension. Dr Kuan Hon Lim and his team from the University of Nottingham Malaysia have isolated a new class of natural compounds from a local fig plant species that induce vasodilation in aorta tissue, … Read the full press release

GlaxoSmithKline to present comprehensive portfolio of respiratory research and scientific innovation at the American Thoracic Society (ATS) conference

Brentford, United Kingdom, 17-May-2018 — /EuropaWire/ — GlaxoSmithKline plc (GSK) will present extensive data from across its respiratory portfolio, pipeline and early phase research programmes at the American Thoracic Society (ATS) conference in San Diego, USA, 19-23 May 2018. Data presented … Read the full press release

UNIGE and HUG study on 1950s antibiotic treatments against urinary tract infections: Only one is as effective as the newer drugs

Two old drugs for combatting urinary tract infections are being prescribed once more in an attempt to protect newer antibiotics from bacterial resistance, and thus preserve their effectiveness. Only one of these drugs from yesteryear appears to be as effective … Read the full press release

Paul Scherrer Institute PSI inaugurates new treatment unit for proton therapy against cancer

With millimetre precision, certain tumours can be irradiated at the Paul Scherrer Institute PSI using protons – that is, positively charged elementary particles. PSI is the one place in Switzerland where this especially protective and precise option for radiation therapy … Read the full press release

ESC statement on inflammation in atherosclerosis: more evidence needed before anti-inflammatory drugs can join statins as standard treatment

SOPHIA ANTIPOLIS, 15-May-2018 — /EuropaWire/ — A European Society of Cardiology (ESC) consensus statement on inflammation in atherosclerosis is published today in the European Journal of Preventive Cardiology. (1) Written by the ESC Working Group on Atherosclerosis and Vascular Biology, the document … Read the full press release

Novartis division Sandoz receives US FDA complete response letter regarding the Biologics Licensing Application for its proposed biosimilar rituximab

Holzkirchen, Germany, 04-May-2018 — /EuropaWire/ — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab. Sandoz stands behind … Read the full press release

Novartis: Today’s FDA approval of Kymriah provides another opportunity for Novartis to build on its leadership in CAR-T development

Kymriah demonstrated an overall response rate of 50%, with median duration of response not yet reached at the time of data cut-off, indicating sustainability of response[1] Kymriah is the only CAR-T therapy FDA-approved for two distinct indications – in non-Hodgkin … Read the full press release

Chinese Patent Office issued patent for Merck’s CRISPR technology used in a genomic-integration method for eukaryotic cells

Merck today (23 APR 2018) announced that the Chinese Patent Office has issued a notice granting Merck’s patent application for the company’s CRISPR technology used in a genomic-integration method for eukaryotic cells. Patent in China covers integration of an external … Read the full press release