Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Peter Goldschmidt succeeded Claudio Albrecht as the Chief Executive Officer of STADA Arzneimittel AG

Goldschmidt: “I look forward to working with the highly experienced team at STADA and continuing the Group’s long-term growth” Supervisory Board Chairman von Au: “Goldschmidt is the right man that STADA needs to ensure the Group successfully retains its strong … Read the full press release

Lundbeck begins clinical development of yet another potential new treatment of Parkinson’s disease

New treatment might have the potential to slow or stop the progression of Parkinson’s disease. VALBY, 12-Sep-2018 — /EuropaWire/ — H. Lundbeck A/S (Lundbeck) begins clinical development of yet another potential new treatment of Parkinson’s disease with the enrollment of the … Read the full press release

AstraZeneca and Amgen announce US FDA Breakthrough Therapy Designation for tezepelumab in patients with severe asthma

AstraZeneca’s first Breakthrough Therapy Designation for a respiratory medicine Designation based on Phase IIb PATHWAY data that demonstrated tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthma CAMBRIDGE, 12-Sep-2018 — /EuropaWire/ — AstraZeneca and its partner Amgen Inc. (Amgen) … Read the full press release

Kuehne + Nagel deploys 35 new pharma trailers to strengthen its temperature-controlled overland services in Europe

Ensuring capacity for temperature-controlled overland services 35 new trailers facilitating intermodal KN PharmaChain connection SCHINDELLEGI, Switzerland, 05-Sep-2018 — /EuropaWire/ — With the ongoing market growth for temperature-controlled shipments, Kuehne + Nagel is investing in its European Pharma fleet to strengthen the … Read the full press release

Novartis announces EC approval for Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for adjuvant treatment of BRAF V600 mutation-positive melanoma

Approval based on COMBI-AD study demonstrating greater than 50% reduction in risk of disease recurrence or death in stage III melanoma patients   More than 50% of stage III melanoma patients are likely to recur to stage IV during their lifetime … Read the full press release

Alcon announces an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market

Decision based on five-year data from COMPASS-XT long-term safety study Alcon advises ophthalmic surgeons to cease further implantation BASEL, 31-Aug-2018 — /EuropaWire/ — Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from … Read the full press release

Philips on AI and adaptive intelligence in healthcare

AMSTERDAM, 31-Aug-2018 — /EuropaWire/ — At a time when health systems and healthcare professionals are under more pressure than ever to do more with less, the promise of intelligent technology that can deliver life-changing insights from all our data is … Read the full press release

Royal Philips to acquire US-based scale-up company developing and commercializing next-generation sensor technologies

AMSTERDAM, 31-Aug-2018 — /EuropaWire/ —  Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has acquired Xhale Assurance Inc, a US-based scale-up company developing and commercializing next-generation sensor technologies. Xhale Assurance’s unique, disposable pulse oximetry … Read the full press release

Royal Philips: the European Society of Cardiology to incorporate instantaneous wave-free ratio (iFR) into its updated revascularization guidelines

iFR-guided strategy now deemed beneficial in the assessment of the functional significance of intermediate coronary stenosis  Technique using iFR-guided strategy is non-inferior to FFR for guiding decisions for intervening on immediate lesions with stable angina or NSTE ACS MUNICH, 31-Aug-2018 … Read the full press release

Novartis: European Commission approval for Kymriah

The EC approval is based on the first global CAR-T registration trials, which included patients from eight European countries and demonstrated durable responses and a consistent safety profile in r/r pediatric B-cell ALL and r/rDLBCL Novartis is the only company with an approved … Read the full press release

Novartis: the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 has met the primary endpoint

SOLAR-1 evaluated BYL719 plus fulvestrant vs. fulvestrant alone in HR+/HER2- advanced breast cancer patients with PIK3CA mutations who progressed on or following treatment with an aromatase inhibitor with or without a CDK4/6 inhibitor[1] Approximately 40% of HR+ advanced breast cancer … Read the full press release

Iain Mackay will be GSK’s next Chief Financial Officer (CFO); he also joins GSK Board

Brentford, United Kingdom, 14-Aug-2018 — /EuropaWire/ — GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that Iain Mackay has been appointed GSK’s next Chief Financial Officer (CFO). He has also been appointed as an Executive Director to the GSK Board. Mr Mackay will … Read the full press release

Technical University of Munich scientists described a new class of designed macrocyclic peptides that are highly potent inhibitors of amyloid formation

MUNICH, 14-Aug-2018 — /EuropaWire/ — Effective therapeutics to counteract the formation of amyloid plaques in Alzheimer’s disease and type 2 diabetes are not yet available. Scientists at the Technical University of Munich (TUM) have now come a little bit closer to … Read the full press release

H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. announce European Commission approval for Rxulti® (brexpiprazole) for the treatment of schizophrenia in adults

Rxulti® (brexpiprazole) has been approved for the treatment of schizophrenia in adults. VALBY, 01-Aug-2018 — /EuropaWire/ — H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce that the European Commission has approved Rxulti® (brexpiprazole) for the treatment of schizophrenia … Read the full press release

Novartis extends agreement with the WHO for the donation of Egaten® for the treatment of liver fluke

Novartis extends agreement with the WHO for the donation of Egaten® for the treatment of liver fluke, a neglected tropical disease, also known as fascioliasis, that infects more than 2.4 million people globally[1] Since the start of the donation program in … Read the full press release

Roche’s phase III CAPSTONE-2 study showed superior efficacy of baloxavir marboxil in reducing influenza symptoms in people at high risk of complications from the flu

Baloxavir marboxil – an investigational oral, single-dose antiviral – is the first flu medicine with a novel proposed mechanism of action in nearly 20 years and to demonstrate significant efficacy in high-risk patients Influenza, or “flu,” represents a serious threat … Read the full press release

Roche’s Tecentriq in combination with Avastin receives FDA Breakthrough Therapy Designation as initial treatment for advanced or metastatic hepatocellular carcinoma

BASEL, 18-Jul-2018 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced … Read the full press release

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