Tag Archives: FDA

FluMist Becomes First At-Home Self-Administered Flu Vaccine Approved by FDA

Posted on 21, September 2024 by EuropaWire PR Editor

(IN BRIEF) FluMist, a needle-free nasal spray influenza vaccine, has been approved by the FDA for self-administration in the US, making it the first flu vaccine of its kind to be used at home. Adults up to 49 years old … Read the full press release →

Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom

Tagged Adrian Kemp, AstraZeneca, At-Home Self-Administered, Dr. Ravi Jhaveri, FDA, flu vaccine, FluMist, influenza, Iskra Reic, safety

FDA Approves AstraZeneca’s Fasenra for Eosinophilic Granulomatosis with Polyangiitis, Offering New Hope for Patients

Posted on 18, September 2024 by EuropaWire PR Editor

(IN BRIEF) AstraZeneca’s Fasenra (benralizumab) has been approved by the US FDA for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis that can be fatal without treatment. The approval is based on results from the MANDARA … Read the full press release →

Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom

Tagged Adrian Kemp, AstraZeneca, Dr. Michael Wechsler, Eosinophilic Granulomatosis with Polyangiitis (EGPA), Fasenra, FDA, Joyce Kullman, Ruud Dobber, safety, vasculitis

Philips Reaches Final Agreement on Consent Decree for Respironics Business with DOJ and FDA

Posted on 10, April 2024 by EuropaWire PR Editor

(IN BRIEF) Royal Philips announces the final agreement on a consent decree for its subsidiary, Philips Respironics, with the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA). The decree primarily focuses on Respironics’ US operations, … Read the full press release →

Posted in Business, Electronics & Machinery, Financial, Government, Healthcare, Industrial, Investment, Management, Netherlands, News, Security & Safety, Technology

Tagged DOJ, FDA, Philips, Philips Respironics, Roy Jakobs, safety, Steve C. de Baca

FDA Approves Basilea’s ZEVTERA® for Severe Bacterial Infections, Including Pediatric Use

Posted on 4, April 2024 by EuropaWire PR Editor

(IN BRIEF) Basilea Pharmaceutica Ltd, a biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for ZEVTERA® (ceftobiprole medocaril sodium for injection). The approval covers its use in adult patients with Staphylococcus aureus bloodstream infections (bacteremia), … Read the full press release →

Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology

Tagged Adesh Kaul, Basilea, David Veitch, Dr. Marc Engelhardt, FDA, Pediatric Use, safety, Severe Bacterial Infections, Thomas Holland, Vance G. Fowler, Zevtera®

Borealis Achieves FDA Approval for Borcycle™ M Post-Consumer Recycled Plastics in Food-Grade Packaging

Posted on 28, March 2024 by EuropaWire PR Editors

(IN BRIEF) Borealis has received Letters of No Objection (LNOs) from the US Food & Drug Administration (FDA) for specific grades of its Borcycle™ M post-consumer recycled plastics (PCR) to be used in food-grade packaging. This milestone underscores Borealis’ commitment … Read the full press release →

Posted in Austria, Business, Chemicals, Environment, Industrial, Technology

Tagged Borcycle™ M, Borealis, circular economy, EverMinds™, FDA, food-grade packaging, Jonatas Melo, Mirjam Mayer, recycled plastics, sustainability, US Food & Drug Administration (FDA)

FDA Gives Nod to Fresenius Kabi’s Tyenne®: A Dual-Format Tocilizumab Biosimilar Advancement

Posted on 7, March 2024 by EuropaWire PR Editors

(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations. This marks a significant milestone in the company’s growth strategy (#FutureFresenius) and expands treatment options for inflammatory, autoimmune diseases, and … Read the full press release →

Posted in Business, Germany, Healthcare, Pharma & Biotech

Tagged #FutureFresenius, Actemra®, autoimmune diseases, Biosimilar, Cancer, cancer treatment, FDA, Food and Drug Administration, Fresenius Kabi, Genentech, Idacio®, inflammatory, inflammatory diseases, IV, IV formulation, Stimufend®, Subcutaneous formulation, subcutaneous tocilizumab biosimilar, tocilizumab, tocilizumab biosimilar, tocilizumab-aazg, Tyenne®

What’s new in cancer care across Europe in early 2024 (1 Jan – 5 Mar 2024): Advancements, Innovations, Research, Awareness

Posted on 5, March 2024 by EuropaWire PR Editors

(IN BRIEF) In early 2024, Europe’s medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for lung and breast cancer, and AstraZeneca’s Tagrisso for EGFR-mutated lung cancer. Diagnostic advancements … Read the full press release →

Posted in Finland, Germany, Healthcare, Insurance, News, Pharma & Biotech, Science, Society, Switzerland, Technology, United Kingdom

Tagged accessible cancer solutions, AstraZeneca, Aviva, BioNTech, breast cancer, breast cancer screening, cancer care, cancer diagnostics, cancer prevention awareness, cancer research, cancer treatment, colorectal cancer, Daiichi Sankyo, datopotamab deruxtecan, Duality Biologics, Eckert & Ziegler, EMA, FDA, genetic risk information, Inspirna, lung cancer, Merck KGaA, multi-cancer early detection, neuroendocrine neoplasms diagnostics, Novartis, ompenaclid, oncology, polygenic risk score, preventive healthcare, Professor Tim Maughan, ReSisTrace methodology, Stage III EGFR-mutated lung cancer, Swiss Re Institute, Tagrisso, treatment-resistant cancer cells, University of Helsinki, University of Liverpool

FDA Approves AstraZeneca’s Tagrisso Plus Chemotherapy for EGFR-Mutated Lung Cancer

Posted on 19, February 2024 by EuropaWire PR Editor

(IN BRIEF) AstraZeneca’s Tagrisso receives FDA approval for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) following a Priority Review. The decision is based on FLAURA2 Phase III trial results demonstrating that Tagrisso plus … Read the full press release →

Posted in Business, Education, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom

Tagged Adrian Kemp, AstraZeneca, chemotherapy, Dave Fredrickson, EGFR-mutated lung cancer, FDA, Laurie Ambrose, Pasi A. Jänne, Tagrisso

Cancer Treatment Advances: FDA Recognizes Breakthrough Potential of BNT323/DB-1303 for Endometrial Cancer

Posted on 21, December 2023 by EuropaWire PR Editors

(IN BRIEF) BioNTech and Duality Biologics have received Breakthrough Therapy designation from the FDA for their antibody-drug conjugate (ADC) candidate, BNT323/DB-1303. The designation is for the treatment of advanced endometrial cancer in patients who have progressed following immune checkpoint inhibitor … Read the full press release →

Posted in Germany, Healthcare, Pharma & Biotech, Technology

Tagged advanced endometrial cancer, antibody-drug conjugate, BioNTech SE, BNT323, Breakthrough Therapy, DB-1303, Duality Biologics, DualityBio, endometrial cancer, FDA, HER2, Human Epidermal Growth Factor Receptor 2, Prof. Özlem Türeci M.D., uterine cancer, Vivian Gu M.D.

Roche’s Elecsys NfL Test for Multiple Sclerosis Earns Breakthrough Device Designation from FDA

Posted on 9, November 2023 by EuropaWire PR Editor

(IN BRIEF) Roche, a leading healthcare company, has announced that its Elecsys Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The Elecsys NfL test is designed … Read the full press release →

Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland, Technology

Tagged Elecsys NfL Test, FDA, Matt Sause, multiple sclerosis, Roche

Sanofi’s ALTUVIIIO Granted Marketing Authorization in Japan for Hemophilia A Treatment

Posted on 26, September 2023 by EuropaWire PR Editor

(IN BRIEF) The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO, a novel factor VIII replacement therapy used to control bleeding in patients with hemophilia A. ALTUVIIIO, also known as efanesoctocog alfa, stands out … Read the full press release →

Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science

Tagged ALTUVIIIO, authorization, bleeding, Brian Foard, efanesoctocog alfa, FDA, hemophilia A, Japan, marketing, MHLW, partnership, Sanofi, Sobi, treatment

FDA Accepts AstraZeneca’s NDA for Capivasertib Combination Therapy in Advanced Breast Cancer

Posted on 12, June 2023 by EuropaWire PR Editors

(IN BRIEF) AstraZeneca’s new drug application (NDA) for capivasertib, in combination with Faslodex, has been accepted and granted Priority Review by the US FDA for the treatment of advanced breast cancer. The NDA is being reviewed under Project Orbis, which … Read the full press release →

Posted in Healthcare, Pharma & Biotech, United Kingdom

Tagged 2022 San Antonio Breast Cancer Symposium, AstraZeneca, breast cancer, CAPItello-291 Phase III, capivasertib, CDK4/6 inhibitors, endocrine therapies, Faslodex, FDA, Food and Drug Administration, fulvestran, hormone receptor, metastatic breast cancer, NDA, New Drug Application, Priority Review, Susan Galbraith, The New England Journal of Medicine

La BEI investe in un’azienda irlandese di dispositivi medici per un dispositivo per il trattamento dell’acufene

Posted on 13, April 2023 by EuropaWire PR Editors

(NOTIZIA IN BREVE) La Banca europea per gli investimenti (BEI) ha investito 15 milioni di euro in Neuromod Devices Ltd per supportare la commercializzazione del suo dispositivo per il trattamento dell’acufene, Lenire. Il dispositivo ha ottenuto l’approvazione De Novo dalla … Read the full press release →

Posted in Banks, European Union, Financial, Healthcare, Investment, Ireland, Pharma & Biotech

Tagged Alessio Beverina, bimodal neuromodulation device, De Novo, dispositivo di neuromodulazione bimodale, dispositivo medico, dispositivo per il trattamento dell'acufene, Dr. Manus Rogan, Dr. Ross O’Neill, European Investment Bank, FDA, Fountain Healthcare Partners, Lenire, medical device, Neuromod Devices Ltd, neuromodulation, neuromodulazione, Panakès Partners, Scientific Reports, TENT-A1, TENT-A2, Thomas Östros, tinnitus, tinnitus treatment device

EIB invests in Irish medical device company for tinnitus treatment device

Posted on 13, April 2023 by EuropaWire PR Editors

(IN BRIEF) The European Investment Bank (EIB) has invested €15 million in Neuromod Devices Ltd to support the commercialization of its tinnitus treatment device, Lenire. The device has been granted De Novo approval from the US FDA and has shown … Read the full press release →

Posted in Banks, European Union, Financial, Healthcare, Investment, Ireland, Pharma & Biotech

Tagged Alessio Beverina, bimodal neuromodulation device, De Novo, Dr. Manus Rogan, Dr. Ross O’Neill, European Investment Bank, FDA, Fountain Healthcare Partners, Lenire, medical device, Neuromod Devices Ltd, neuromodulation, Panakès Partners, Scientific Reports, TENT-A1, TENT-A2, Thomas Östros, tinnitus, tinnitus treatment device

Roche Diagnostics: Globally, up to 75 percent of people living with Alzheimer’s disease have not been diagnosed

Posted on 8, December 2022 by EuropaWire PR Editors

The company announces FDA clearance for its Alzheimer’s disease Cerebrospinal Fluid (CSF) assays The Elecsys® Alzheimer’s disease (AD) CSF assays will be available on the cobas fully automated immunoassay analyzers, enabling patients to get broad access to high quality testing in a timely … Read the full press release →

Posted in Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology

Tagged Alzheimer, beta-amyloid, biomarkers t, CT scan, diagnosis, Elecsys AD CSF Abeta42, Elecsys AD CSF assays, FDA, MRI, pTau181 assays, Roche, tau proteins, Thomas Schinecker

Roche Diagnostics: a nivel mundial, hasta el 75 por ciento de las personas que viven con la enfermedad de Alzheimer no han sido diagnosticadas

Posted on 8, December 2022 by EuropaWire PR Editors

La compañía anuncia la aprobación de la FDA para sus ensayos de líquido cefalorraquídeo (LCR) para la enfermedad de Alzheimer Los ensayos Elecsys® para la enfermedad de Alzheimer (EA) en LCR estarán disponibles en los analizadores de inmunoensayo totalmente automatizados … Read the full press release →

Posted in Business, Healthcare, Pharma & Biotech, Science, Switzerland, Technology

Tagged Alzheimer, beta-amiloide, biomarcadores t, Diagnóstico, Elecsys AD CSF Abeta42, Elecsys Ensayos AD LCR, Elecsys® beta-amiloide, Elecsys® Phospho-Tau, FDA, patología de Alzheimer, proteínas tau, pTau181 ensayos, resonancia magnética, Roche, Thomas Schinecker, tomografía computarizada

Roche announces a regulatory milestone for its cobas SARS-CoV-2 Qualitative PCR test for use on the fully automated cobas 6800 and 8800 analyzer systems

Posted on 24, October 2022 by EuropaWire PR Editors

The cobas SARS-CoV-2 Qualitative test is one of the first COVID-19 PCR tests performed on an automated, high throughput platform to receive FDA 510(k) clearance. This FDA clearance will ensure that the healthcare community has access to timely, reliable and accurate COVID-19 PCR testing … Read the full press release →

Posted in Healthcare, Pharma & Biotech, Science, Switzerland, Technology

Tagged 510(k) clearance, cobas SARS-CoV-2 Qualitative test, cobas®, cobas® 6800, cobas® 8800 Systems, COVID-19, FDA, Roche, SARS-CoV-2, SARS-CoV-2 Qualitative PCR test, Thomas Schinecker

Roche annonce une étape réglementaire importante pour son test PCR qualitatif cobas SARS-CoV-2 à utiliser sur les systèmes d’analyseurs cobas 6800 et 8800 entièrement automatisés

Posted on 24, October 2022 by EuropaWire PR Editors

Le test qualitatif cobas SARS-CoV-2 est l’un des premiers tests PCR COVID-19 effectués sur une plateforme automatisée à haut débit à recevoir l’autorisation FDA 510(k). Cette autorisation de la FDA garantira que la communauté des soins de santé a accès … Read the full press release →

Posted in Healthcare, Pharma & Biotech, Science, Switzerland, Technology

Tagged 510(k) clearance, cobas SARS-CoV-2 Qualitative test, cobas®, cobas® 6800, cobas® 8800 Systems, COVID-19, FDA, Roche, SARS-CoV-2, SARS-CoV-2 Qualitative PCR test, Thomas Schinecker

More markets around the world approve the Chr. Hansen’s Human Milk Oligosaccharides for infant formula

Posted on 12, September 2022 by EuropaWire PR Editors

(PRESS RELEASE) HOERSHOLM, Denmark, 12-Sep-2022 — /EuropaWire/ — Chr Hansen Holding A/S (CPH: CHR), a Danish bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries, has announced new regulatory approvals around the world for … Read the full press release →

Posted in Denmark, Food & Beverage, Healthcare, Pharma & Biotech, Science

Tagged 2’-FL, 2’-fucosyllactose, 3-FL, 3-fucosyllactose, 3’-sialyllactose, 3’-SL, 6’-sialyllactose, 6’-SL, breast milk, breastfeeding, Chr. Hansen, EFSA, European Food Safety Authority, FDA, Generally Recognized as Safe, GRAS, hepatology, HMOs, Human Milk Oligosaccharides, infant formula, infant health, infant microbiome science, Jesper Sig Mathiasen, lacto-N-tetraose, LNT, NASPGHAN 2022, Novel Food approval, Nutrition, pediatric gastroenterologists, pediatric gastroenterology, WHO, World Health Organization

GlaxoSmithKline: US FDA regulatory submission acceptance of New Drug Application for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor

Posted on 19, April 2022 by EuropaWire PR Editors

(PRESS RELEASE) LONDON, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON: GSK), a British multinational science-led healthcare company, has announced the third major regulatory milestone for its daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of … Read the full press release →

Posted in Healthcare, Pharma & Biotech, Science, Technology, United Kingdom

Tagged American Society of Nephrology, anaemia of chronic kidney disease, ASCEND programme, ASCEND-D, ASCEND-ND, CKD, daprodustat, dialysis patient, FDA, GlaxoSmithKline, HIF-PHI, Kidney Week 2021, renal anaemia

GlaxoSmithKline : acceptation de la soumission réglementaire de la FDA américaine pour la demande de nouveau médicament pour le daprodustat, un inhibiteur oral de la prolyl hydroxylase du facteur inductible par l’hypoxie

Posted on 19, April 2022 by EuropaWire PR Editors

(COMMUNIQUÉ DE PRESSE) LONDRES, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON : GSK), une multinationale scientifique britannique , a annoncé la troisième étape réglementaire majeure pour son daprodustat, un inhibiteur oral du facteur prolyl hydroxylase inductible par l’hypoxie (HIF-PHI), pour le … Read the full press release →

Posted in Healthcare, Pharma & Biotech, Science, Technology, United Kingdom

Tagged American Society of Nephrology, anémie des maladies rénales chroniques, anémie rénale, ASCEND-D, ASCEND-ND, daprodustat, FDA, GlaxoSmithKline, HIF-PHI), IRC, Kidney Week 2021, patient dialysé, programme ASCEND

Roche on Tecentriq’s US FDA Priority Review grant: New treatment options are urgently needed in early-stage non-small cell lung cancer

Posted on 3, August 2021 by EuropaWire PR Editors

Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme Based on results of the Phase III IMpower010 study, presented at ASCO, that showed adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive early-stage lung cancer, compared with … Read the full press release →

Posted in Healthcare, Marketing, News, Pharma & Biotech, Switzerland

Tagged atezolizumab, Cancer Immunotherapy, chemotherapy, FDA, Levi Garraway, lung cancer, non-small cell lung cancer, NSCLC, Real-Time Oncology Review, Roche, sBLA, supplemental Biologics License Application, Tecentriq®, treatment, tumours

The only new medicine in over a decade for patients with systemic lupus erythematosus gets Food and Drug Administration (FDA) approval

Posted on 2, August 2021 by EuropaWire PR Editors

(PRESS RELEASE) CAMBRIDGE, 2-Aug-2021 — /EuropaWire/ — AstraZeneca (LON: AZN), a British-Swedish science-led biopharmaceutical company, has announced that its Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus … Read the full press release →

Posted in Healthcare, Marketing, News, Science, Technology, United Kingdom

Tagged AstraZeneca, bronchitis, corticosteroid, cough, cutaneous lupus erythematosus, Dr. Richard Furie, FDA, herpes zoster, infusion-related reactions, lupus, lupus nephritis, Mene Pangalos, MUSE Phase II trial, myositis, nasopharyngitis, OCS, oral corticosteroid, pathophysiology of lupus, Saphnelo, SLE, systemic lupus erythematosus, therapy, TULIP Phase III trials, type I IFN, type I interferon, upper respiratory tract infection

Drugs for Neglected Diseases initiative: first all-oral treatment for Human African trypanosomiasis (sleeping sickness) gets US Food and Drug Administration (FDA) approval

Posted on 20, July 2021 by EuropaWire PR Editors

(PRESS RELEASE) PARIS, 20-Jul-2021 — /EuropaWire/ — Sanofi (EPA: SAN), a global biopharmaceutical company focused on human health, has announced fexinidazole approval by the US Food and Drug Administration (FDA) as the first all-oral treatment for both stages of the … Read the full press release →

Posted in France, Healthcare, News, Pharma & Biotech

Tagged Central African Republic, Democratic Republic of Congo, DNDi, Dr Bernard Pécoul, Drugs for Neglected Diseases initiative, FDA, fexinidazole, HAT, Human African trypanosomiasis, Luc Kuykens, National Sleeping Sickness Programs, neuropsychiatric symptoms, parasitic disease, Sanofi, sleeping sickness, Trypanosoma brucei gambiense, tse-tse fly, US Food and Drug Administration, WHO, World Health Organization

Aimmune Therapeutics now a Nestlé Health Science company

Posted on 14, October 2020 by EuropaWire PR Editors

(PRESS RELEASE) VEVEY, 14-Oct-2020 — /EuropaWire/ — Nestlé has successfully closed the acquisition of biopharmaceutical company, Aimmune Therapeutics, Inc. (Nasdaq: AIMT). The company which specializes in developing and bringing new treatments to people with potentially life-threatening food allergies joins Nestlé … Read the full press release →

Posted in Investment, Management, News, Pharma & Biotech, Science, Switzerland

Tagged acquisition, Aimmune Therapeutics, allergic reactions, allergies, AlMab7195, anaphylaxis, Andrew Oxtoby, Arachis hypogaea, asthma, EM, Eosinophilic Gastrointestinal Disease, European Medicines Agency, FDA, Greg Behar, monoclonal antibody, Nestlé, Nestlé Health Science, NHSc, oral immunotherapy, PALFORZIA®, Peanut Allergen Powder-dnfp, Pharmaceutical, science-bassed nutritional solutions, Swiss Agency for Therapeutic Products, SwissMedic, treating peanut allergy

Roche unveils new Anti-SARS-CoV-2 serology test to quantitatively measure antibodies in people exposed to SARS-CoV-2

Posted on 18, September 2020 by EuropaWire PR Editors

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development … Read the full press release →

Posted in Healthcare, News, Pharma & Biotech, Switzerland

Tagged Anti-SARS-CoV-2 S, antibodies, antibody test, COVID-19, Elecsys Anti-SARS-CoV-2 S test, Elecsys Anti-SARS-CoV-2 serology test, Elecsys®, Emergency Use Authorisation, EUA, FDA, Roche, SARS-CoV-2, SARS-CoV-2 vaccine, Thomas Schinecker, vaccines

Rare disease: Enhertu of AstraZeneca and Daiichi Sankyo now with Orphan Drug Designation in the US for treatment of gastric cancer

Posted on 22, May 2020 by EuropaWire PR Editors

(PRESS RELEASE) CAMBRIDGE, 22-May-2020 — /EuropaWire/ — Enhertu, jointly developed by British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca and the second-largest pharmaceutical company in Japan Daiichi Sankyo (Daiichi Sankyo Company, Limited), has just been granted Orphan Drug Designation (ODD) in … Read the full press release →

Posted in Healthcare, Pharma & Biotech, Science, United Kingdom

Tagged AstraZeneca, cancers, cytotoxic chemotherapy, Daiichi Sankyo, DESTINY-Gastric01 trial, disorders, Enhertu, FDA, gastric cancer, gastroesophageal junction cancer, oncology, rare diseases

SGS unveils test method to identify nitrosamine impurities in drug products, raw materials and APIs

Posted on 26, March 2020 by EuropaWire PR Editors

(PRESS RELEASE) GENEVA, 26-Mar-2020 — /EuropaWire/ — Inspection, verification, testing and certification company SGS announced it has developed a test method to identify nitrosamine impurities in drug products, raw materials and APIs. In 2018, the presence of the nitrosamine N-nitrosodimethylamine … Read the full press release →

Posted in Healthcare, News, Pharma & Biotech, Science, Switzerland

Tagged carcinogen, contaminated products, EMA, FDA, genotoxins, Mark Rogers, medicines, metformin, N-nitrosamine formation, NDMA, NDMA traces, nitrosamine, nitrosamine impurities, Ranitidine, regulatory warnings

EMA announces the appointment of Dr Hilmar Hamann as Head of the Information Management Division

Posted on 16, January 2020 by EuropaWire PR Editors

(PRESS RELEASE) AMSTERDAM, 16-Jan-2020 — /EuropaWire/ — The European Medicines Agency (EMA) appoints Dr Hilmar Hamann as Head of the Information Management Division. Prior to joining EMA, Dr. Hamann has served as the Director for the Office of Business Informatics … Read the full press release →

Posted in Healthcare, Management, Netherlands, News, Pharma & Biotech, Technology

Tagged Agency from the United States Food and Drug Administration, appointment, automation, chemical kinetics, chemist, Dr Hilmar Hamann, EMA, FDA, informatics, Information Management, IT, molecular physics, Pharmaceutical, robotic process, technologies, University of Göttingen

SGS provides latest unsafe product notifications to retailers and manufacturers with the launch of new digital platform

Posted on 12, July 2019 by EuropaWire PR Editors

(PRESS RELEASE) GENEVA, 12-Jul-2019 — /EuropaWire/ — SGS launches its new ‘Product Recalls’ digital platform. It is an online database that provides instant access to the latest unsafe product notifications (non-food) from the EU and USA to consumer goods manufacturers … Read the full press release →

Posted in Business, Industrial, Internet & Online, News, Retail, Switzerland, Technology

Tagged Andy Gibbard, CPSC, digital platform, FDA, manufacturers, Product Recalls, RAPEX, RASFF, retailers, SGS, unsafe product notifications

PDA Explores the Transformation of Healthcare at 4th Annual European Meeting

Posted on 10, June 2019 by EuropaWire PR Editors

EMA, MHRA and FDA among regulatory agencies participating (PRESS RELEASE) BERLIN, 10-Jun-2019 — /EuropaWire/ — The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in … Read the full press release →

Posted in France, Germany, Healthcare, Ireland, Media, Netherlands, News, Pharma & Biotech, Science, Switzerland, United Kingdom

Tagged 4th PDA European Annual Meeting, Amsterdam, automation, Basel, Berlin, biopharmaceuticals, data quality management, data science, digitalization, Dublin, EMA, European Medicines Agency, FDA, Felix G. Rebitschek, Healthcare, HPRA, London, Manufacturing, manufacturing technologies, Max Planck Institute, medicines, MHRA, Paris, PDA, pharmaceuticals, PIC/S, regulators, Virtual Reality, Walter Morris, WHO, Zurich

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

Posted on 18, July 2018 by EuropaWire PR Editors

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 →

Posted in Healthcare, Pharma & Biotech, Switzerland

Tagged Avastin, carcinoma, FDA, Roche, Sandra Horning, TECENTRIQ, treatment

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

Posted on 25, June 2018 by EuropaWire PR Editors

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 →

Posted in Healthcare, Ireland, Pharma & Biotech

Tagged Andreas Busch Ph.D., angioedema, biotechnology, CINRYZE, FDA, hereditary angioedema, rare diseases, Shire

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

Posted on 28, May 2018 by EuropaWire PR Editors

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 →

Posted in Education, Healthcare, Pharma & Biotech, Science, Technology, United Kingdom

Tagged antibiotics for children, antimicrobial resistance, EMA, FDA, PMDA, workshop

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

Posted on 4, May 2018 by EuropaWire PR Editors

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 →

Posted in Healthcare, Pharma & Biotech, Switzerland

Tagged CAR-T, FDA, Kymriah, leukemia, Liz Barrett, lymphoma, Novartis, oncology, Stephen J. Schuster MD, tisagenlecleucel

FDA Approves Roche’s TECENTRIQ as initial treatment for certain advanced bladder cancer patients

Posted on 24, April 2017 by EuropaWire PR Editors

First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable to receive cisplatin chemotherapy BASEL, 24-Apr-2017 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) … Read the full press release →

Posted in Healthcare, Pharma & Biotech, Switzerland

Tagged bladder cancer, FDA, Roche, Sandra Horning MD, TECENTRIQ

Roche’s Marketing Authorisation Application and Biologics License Application for OCREVUS accepted by EMA and FDA

Posted on 29, June 2016 by EuropaWire PR Editors

OCREVUS is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis (MS) FDA grants Priority Review Designation for OCREVUS Biologics License Application (BLA) BASEL, 29-Jun-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced … Read the full press release →

Posted in Healthcare, Pharma & Biotech, Switzerland

Tagged EMA, FDA, OCREVUS, Roche, Sandra Horning M.D.

AstraZeneca announces that FDA accepted sNDA and granted Priority Review for BRILINTA® (ticagrelor) for patients with history of heart attack

Posted on 4, May 2015 by EuropaWire PR Editors

LONDON, 4-5-2015 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted Priority Review for BRILINTA® (ticagrelor) tablets for patients with a history of heart attack. … Read the full press release →

Posted in Healthcare, Management, Pharma & Biotech, Science, United Kingdom

Tagged AstraZeneca, BRILINTA® (ticagrelor), Elisabeth Björk, FDA, patients with history of heart attack, sNDA

Novartis: FDA grants priority review designation to investigational medicine for the treatment of heart failure

Posted on 16, February 2015 by EuropaWire PR Editors

Decision could speed access to LCZ696 for HFrEF patients in the US, reducing total review time from 12 to 8 months Filing is based on results from the landmark PARADIGM-HF study[1] Nearly six million people live with heart failure in … Read the full press release →

Posted in Healthcare, Pharma & Biotech, Switzerland

Tagged David Epstein, FDA, investigational medicine, Novartis, treatment of heart failure

Roche received second Breakthrough Therapy Designation from FDA for its investigational cancer immunotherapy MPDL3280A (anti-PDL1)

Posted on 3, February 2015 by EuropaWire PR Editors

Second FDA Breakthrough Therapy Designation for MPDL3280A following bladder cancer in 2014 BASEL, 3-2-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received a second Breakthrough Therapy Designation from the United States Food and … Read the full press release →

Posted in Business, Healthcare, Pharma & Biotech, Switzerland

Tagged breakthrough therapy designation, Cancer Immunotherapy, FDA, investigational cancer immunotherapy, lung cancer, MPDL3280A (anti-PDL1), Roche

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