(IN BRIEF) Sanofi has obtained orphan drug designation in Japan for rilzabrutinib as a treatment for IgG4-related disease, a rare immune-mediated condition with limited treatment options. The designation from Japan’s Ministry of Health, Labour and Welfare is supported by positive … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Technology
Tagged Bruton tyrosine kinase inhibitor, BTK inhibitor, IgG4-RD, IgG4-related disease, immune thrombocytopenia, immune-mediated diseases, ITP, MHLW, Ministry of Health Labour and Welfare Japan, orphan drug designation, phase 2 clinical trial NCT04520451, rare disease treatment, rare diseases, rheumatology, RILIEF phase 3 study NCT07190196, rilzabrutinib, Sanofi, Sanofi Expands Global Regulatory Recognition of Rilzabrutinib for Rare Immune Mediated Diseases, Sanofi Secures Japanese Orphan Drug Status for Rilzabrutinib Following Positive Clinical Study Results, SCD, sickle cell disease, wAIHA, warm autoimmune hemolytic anemia
(IN BRIEF) Sanofi has received Breakthrough Therapy designation from the U.S. FDA and orphan drug designation from Japan’s Ministry of Health, Labour and Welfare for rilzabrutinib (Wayrilz) in warm autoimmune hemolytic anemia, based on data from the ongoing LUMINA 2 … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Retail, Science, Security & Safety, Technology
Tagged Breakthrough Therapy, BTK inhibitor, clinical trials, FDA, FDA Grants Breakthrough Status to Sanofi’s Rilzabrutinib for Rare Blood Disorder, IgG4-related disease, immune thrombocytopenia, Japanese Ministry of Health Labour and Welfare, Karin Knobe, LUMINA 2, LUMINA 3, orphan drug, rare diseases, rilzabrutinib, Sanofi, Sanofi Advances Rilzabrutinib with Breakthrough and Orphan Designations in wAIHA, sickle cell disease, Tailored Covalency®, wAIHA, warm autoimmune hemolytic anemia, Wayrilz
(IN BRIEF) Sanofi has received a positive recommendation from the European Medicines Agency’s CHMP for the conditional approval of Rezurock to treat late-line chronic graft-versus-host disease in adults and adolescents aged 12 and older. The opinion, based on clinical trial … Read the full press release
Posted in European Union, France, Healthcare, Marketing, Pharma & Biotech
Tagged belumosudil, CHMP, CHMP Recommends Conditional EU Authorisation for Sanofi’s Rezurock to Treat Late-Line Chronic GVHD, chronic graft-versus-host disease, clinical trials, conditional marketing authorisation, EU regulatory approval, European Medicines Agency, GVHD, haematology, rare diseases, Rezurock™, ROCK2 inhibitor, ROCKstar study, Sanofi, stem cell transplant
(IN BRIEF) Sanofi has secured regulatory approval in China for two innovative medicines, Myqorzo for obstructive hypertrophic cardiomyopathy and Redemplo for familial chylomicronemia syndrome. The approvals expand treatment options for patients with serious cardiovascular and rare metabolic diseases and underscore … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Technology
Tagged aficamten, cardiovascular disease, China NMPA, clinical phase 3 trials, familial chylomicronemia syndrome, FCS, Greater China, innovative medicines, Myqorzo, obstructive hypertrophic cardiomyopathy, oHCM, Olivier Charmeil, plozasiran, rare diseases, Redemplo, Sanofi, Sanofi Strengthens China Portfolio with Approval of Two Innovative Therapies for oHCM and FCS, siRNA therapy
(IN BRIEF) Evotec SE has announced that Esperion Therapeutics has nominated an oral preclinical development candidate for primary sclerosing cholangitis (PSC), marking a major milestone in their collaboration. The PDC, developed through Evotec’s integrated small molecule discovery platform and Esperion’s … Read the full press release
Posted in Business, Germany, Government, Healthcare, News, Pharma & Biotech, Science, Technology
Tagged ACLY biology, bile ducts, clinical development, collaboration, Cord Dohrmann, drug discovery, Esperion Therapeutics, Evotec Advances Collaboration with Esperion as New ACLY-Based Candidate Targets Primary Sclerosing Cholangitis, Evotec and Esperion Advance Novel Treatment Candidate for Primary Sclerosing Cholangitis, Evotec INDiGO, Evotec SE, fibrosis, Frankfurt Stock Exchange EVT, hepatology, IND-enabling platform, liver disease, milestone payment, NASDAQ ESPR, NASDAQ EVO, preclinical development candidate, primary sclerosing cholangitis, PSC, rare diseases
(IN BRIEF) Sanofi has boosted its venture capital arm, Sanofi Ventures, with a new $625 million multi-year commitment, raising the fund’s assets under management to more than $1.4 billion. Since 2012, Sanofi Ventures has invested over $800 million in more … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged AI in healthcare, Biotech, digital health, early-stage funding, Healthcare Innovation, immunology, IPOs, Jason P Hafler, medical breakthroughs, Neurology, Paul Hudson, rare diseases, Sanofi, Sanofi boosts its venture arm with fresh $625 million funding to support biotech and digital health startups, Sanofi expands Sanofi Ventures with $625 million to drive biotech and digital health breakthroughs, Sanofi Ventures, scientific progress, vaccines, venture capital
(IN BRIEF) The EIB has extended a €150 million loan to Alfasigma to fund its R&D efforts from 2025 to 2027, targeting new drugs in gastroenterology, hepatology, vascular medicine, rheumatology, and rare diseases. The financing, endorsed by EIB Vice-President Gelsomina … Read the full press release
Posted in Banks, Business, Economy, Financial, Government, Healthcare, Industrial, Investment, Italy, Luxembourg, Management, Marketing, News, Pharma & Biotech, Science, Technology
Tagged Alfasigma, biopharmaceutical innovation, EIB, European competitiveness, European Investment Bank, gastroenterology, Gelsomina Vigliotti, hepatology, job creation, partnership, patient-centred therapies, R&D financing, rare diseases, rheumatology, specialty care, Tatiana Simonelli, Vascular Medicine
(IN BRIEF) Rilzabrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, has received orphan drug designation from the U.S. FDA for sickle cell disease. This marks the fourth such designation for the drug, which has already been recognized for its potential … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged BTK inhibitor, fast track status, FDA, IgG4-related disease, immune thrombocytopenia, multi-immune modulation, orphan drug designation, preclinical data, rare diseases, rilzabrutinib, Sanofi, sickle cell disease, Tailored Covalency®, vaso-occlusive crises, warm autoimmune hemolytic anemia
(IN BRIEF) Sanofi and Sobi have renewed their partnership with the World Federation of Hemophilia (WFH) to support the WFH Humanitarian Aid Program for up to five years. The new agreement includes the donation of up to 100 million international … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Non Profit, Pharma & Biotech, Science, Technology
Tagged Alaa Hamed, bleeding disorders, Cesar Garrido, factor therapy, Foundation S, global health, healthcare professionals, hemophilia, humanitarian aid, Lydia Abad-Franch, Mark Skinner, medical collaboration, partnership, rare diseases, Sanofi, Sobi, treatment for all, WFH, World Federation of Hemophilia
(IN BRIEF) Rilzabrutinib, an investigational oral BTK inhibitor, has received orphan drug designation from the FDA for treating warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD), two rare conditions with no approved treatments. This designation, aimed at addressing unmet … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged BTK inhibitor, clinical trials, FDA, IgG4-RD, IgG4-related disease, immune thrombocytopenia, ITP, multi-immune modulation, orphan drug designation, phase 2a study, phase 2b study, rare diseases, regulatory review, rilzabrutinib, Sanofi, unmet medical need, wAIHA, warm autoimmune hemolytic anemia
(IN BRIEF) The European Economic and Social Committee (EESC) has called for a comprehensive European Action Plan on Rare Diseases by 2030, urging the EU and Member States to enhance cooperation and ensure equal access to diagnosis and treatment. At … Read the full press release
Posted in Belgium, Business, Environment, Financial, Government, Healthcare, Industrial, Investment, Law, Management, News, Politics
Tagged Ágnes Cser, Baiba Miltoviča, diagnosis, EESC, European Action Plan, health, Mónica García Gómez, rare diseases, sustainability, Tomislav Sokol, treatment, wellness
(IN BRIEF) AstraZeneca has entered into a collaboration and investment agreement with biotech firm Cellectis to fast-track the development of cutting-edge therapeutics in areas such as oncology, immunology, and rare diseases. This partnership will leverage Cellectis’ gene editing technologies and … Read the full press release
Posted in Business, Education, Environment, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged Adrian Kemp, André Choulika, AstraZeneca, Cellectis, gene therapy, immunology, Marc Dunoyer, oncology, partnership, rare diseases, sustainability
Accelerating projects on access to medicines, support for vulnerable communities, environmental conservation, and diversity and inclusion Creation of Sanofi Global Health, global nonprofit unit to provide 40 of the world’s poorest countries access to 30 essential medicines (PRESS RELEASE) PARIS, 7-Apr-2021 — … Read the full press release
Posted in France, Healthcare, News, Non Profit, Pharma & Biotech, Society
Tagged access to medicines, Cancer, cardiovascular disease, chronic diseases, climate change, Corporate Social Responsibility, CSR strategy, Diabetes, diversity, environmental protection program, Fabry, Gaucher, healthcare professionals, Inclusion, malaria, nonprofit unit, open letter, Paul Hudson, Pharmaceutical, Planet Mobilization, polio, Pompe diseases, preservation of the environment, rare diseases, Sanofi, Sanofi Global Health, sleeping sickness, support for vulnerable communities, tuberculosis, vaccines, WHO, World Health Organization, Zero plastic packaging
(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
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
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
World Pharma Pricing and Market Access Congress 2018 Business Design Centre, London United Kingdom SOMERSET, N.J. / LONDON, UK, 19-Mar-2018 — /EuropaWire/ — Alliance Life Sciences, a leading global life sciences consulting, pricing data and technology provider, announced that it is … Read the full press release
Posted in France, Germany, Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology, United Kingdom
Tagged advanced therapies, AI, Alan Crowther, Alliance Life Sciences, Big Data, Biotech, Commercial Operations, Contracting, diagnostic firms, Global Pricing, life sciences companies, life sciences consulting, management software, Market Access, medical device, medical device firms, pharma, pharma pricing, Pharmaceutical, pharmaceutical manufacturers, ppma, ppmaconf, PricentricOne, PriceRight, rare diseases, Reimbursement, Sophie Ferronato, tender, Water Street Healthcare Partners, Water Street partners, World Pharma Pricing and Market Access Congress
Expands Sanofi’s presence in specialty care and strengthens leadership in rare diseases Adds leader in the growing hemophilia market and provides platform for expansion in other rare blood disorders Drives meaningful shareholder value with ROIC expected to exceed cost of … Read the full press release
DUBLIN, 16-Jan-2018 — /EuropaWire/ — At Shire, we’ve been committed to the hemophilia community and the lives of every patient afflicted with this disease for more than 70 years. We are very proud of this legacy and take our role as … Read the full press release
Posted in Healthcare, Ireland, Pharma & Biotech
Tagged Chugai, Genentech, Hemlibra, hemophilia, Howard Mayer M.D., IP, patent, rare diseases, Roche, Shire
Marketing Authorization will enable patient access to ADYNOVI throughout Europe ZUG, 16-Jan-2018 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today that the European Commission (EC) has granted Marketing Authorization for ADYNOVI … Read the full press release
Posted in Healthcare, Pharma & Biotech, Switzerland
Tagged ADYNOVI, bleeding, Dr. Peter Foertig MD, hemophilia A, rare diseases, Shire, treatment options
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