(IN BRIEF) Roche presented positive phase I/II data for NXT007, its Chugai-engineered bispecific antibody for haemophilia A, at the 2025 ISTH Congress. In the NXTAGE study’s highest-dose cohorts (B-3 and B-4), none of the 30 participants experienced bleeds requiring treatment, … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged bispecific antibody, Chugai, clinical development, emicizumab, global supply chain, Haemophilia A, haemostatic normalisation, Hemlibra, ISTH Congress 2025, Levi Garraway, NXT007, NXTAGE study, phase I/II data, Roche, subcutaneous dosing, thromboembolic events
(IN BRIEF) GSK’s marketing authorisation application for linerixibat, an investigational ileal bile acid transporter inhibitor, has been accepted for review by the European Medicines Agency. The submission is supported by GLISTEN Phase III trial data showing that linerixibat rapidly and … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, United Kingdom
Tagged alcohol-related liver disease, bile acid transporter, cholestatic pruritus, chronic hepatitis B, EASL Congress, EMA, European Medicines Agency, FDA, GLISTEN trial, GSK, IBAT inhibitor, itch-related sleep interference, Kaivan Khavandi, linerixibat, Marketing Authorisation Application, MASH, NCT04950127, orphan drug designation, PBC, Phase III, primary biliary cholangitis, UK regulatory review
(IN BRIEF) The CHMP has recommended EU approval of Sarclisa alongside VRd for transplant-eligible NDMM, based on GMMG-HD7 trial results showing superior MRD negativity and PFS compared to VRd alone. This potential label extension would mark Sarclisa’s fourth EU approval … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged ASH 2024, autologous stem cell transplant, bortezomib, CHMP, dexamethasone, European Medicines Agency, GMMG-HD7, isatuximab, Journal of Clinical Oncology, lenalidomide, MRD negativity, Multiple Myeloma, NDMM, phase 3 study, progression-free survival, Sanofi, Sarclisa, transplant-eligible, VRd
(IN BRIEF) Merck has awarded its 2025 North American Advance Biotech Grant to Neoclease, a Boston-based startup developing AI-designed gene-editing therapies for Parkinson’s disease and other monogenic disorders. Neoclease will benefit from Merck’s technologies, contract testing, regulatory guidance, and hands-on … Read the full press release
Posted in Artificial Intelligence (AI), Awards, Business, Financial, Germany, Healthcare, Management, Pharma & Biotech, Science, Technology
Tagged 2025 North American winner, Advance Biotech Grant, AI in biotech, Boston biotech, early-stage biotech support, Emprove program, gene-editing therapies, life sciences innovation, M Lab Collaboration Center, Merck, monogenic diseases, NCX-L2, Neoclease, Parkinson's disease, Sebastian Arana, synthetic biology
(IN BRIEF) The University of Copenhagen, in collaboration with Rigshospitalet, has introduced a clinically validated gene-editing method to identify harmful inherited mutations that raise cancer risk. Developed at the university’s Biotech Research and Innovation Center, the CRISPR-Select technique allows scientists … Read the full press release
Posted in Denmark, Education, Healthcare, News, Pharma & Biotech, Science, Technology
Tagged BRCA2, breast cancer, BRIC, cancer diagnosis, cancer risk, CRISPR-Select, gene editing, genetic testing, genomic medicine, hereditary cancer, Maria Rossing, ovarian cancer, personalized medicine, Rigshospitalet, The Journal of Clinical Investigation, University of Copenhagen, variant classification
(IN BRIEF) BioNTech agreed to buy CureVac in an all-stock deal valuing CureVac at ~$1.25 billion, exchanging each share for $5.46 in BioNTech ADSs—a 55% premium to its recent stock price. The merger, expected to close in 2025, strengthens BioNTech’s … Read the full press release
Posted in Business, Financial, Germany, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Technology
Tagged 2025 closing, ADSs, Alexander Zehnder, all-stock acquisition, American depositary shares, BioNTech, BNT327, Cancer Immunotherapy, CureVac, delivery formulations, dievini Hopp BioTech, integration plan, KfW, merger premium, mRNA, mRNA manufacturing, oncology strategy, pan-tumor programs, partnership, regulatory approvals, transformational therapies, Tübingen subsidiary, Ugur Sahin
(IN BRIEF) SCHOTT Pharma’s Supervisory Board has prolonged CEO Andreas Reisse’s mandate until April 2026, reflecting his pivotal role in driving the company’s emergence as a world-leading manufacturer of pharmaceutical containment and delivery systems. CFO Dr. Almuth Steinkühler will step … Read the full press release
Posted in Business, Financial, Germany, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged Almuth Steinkühler, Andreas Reisse, appointment, capital market, CEO extension, CFO Transition, corporate finance, delivery systems, executive leadership, Frankfurt Stock Exchange, Getinge, Hansgrohe, industrial engineering, IPO readiness, ledership, Nilfisk, Peter Goldschmidt, pharmaceutical containment solutions, process digitisation, Reinhard Mayer, SCHOTT Pharma, Supervisory Board, sustainable growth
(IN BRIEF) Boehringer Ingelheim and Eko Health have partnered to launch a canine-specific heart murmur detection solution in 2026. Leveraging Boehringer’s veterinary cardiology insights and proprietary algorithm alongside Eko’s AI-enabled digital stethoscopes and mobile app, the tool will help veterinarians … Read the full press release
Posted in Artificial Intelligence (AI), Business, Financial, Germany, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged AI algorithm, Boehringer Ingelheim, canine cardiology, Connor Landgraf, digital stethoscope, Dr. Erich Schött, early diagnosis, Eko Health, heart murmur detection, MMVD, mobile app, myxomatous mitral valve disease, partnership, pet health, veterinary innovation
(IN BRIEF) EQT Life Sciences has led a Series A investment in Mosanna Therapeutics to advance its lead drug candidate, MOS118—a nasal spray designed to treat obstructive sleep apnea—into Phase 2 trials. Co-investors include Pivotal bioVenture Partners, Forbion, Norwest, and … Read the full press release
Posted in Business, Environment, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Sweden, Switzerland, Technology
Tagged airway reflex restoration, Basel, biotech funding, Daniela Begolo, David Weber, EQT Life Sciences, Forbion, Forty51 Ventures, HTGF, MOS118, Mosanna Therapeutics, nasal spray therapy, neurological treatment, non-invasive sleep apnea therapy, Norwest, obstructive sleep apnea, OSA treatment, partnership, Phase 2 clinical trial, Pivotal bioVenture Partners, Redwood City, Supermoon Capital, sustainability
(IN BRIEF) Sanofi has launched early global shipments of Beyfortus (nirsevimab) in anticipation of the 2025–2026 RSV season, enabling healthcare providers to begin immunizations well before the typical onset of infections in November. In collaboration with AstraZeneca, Sanofi has significantly … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged AstraZeneca, Beyfortus, EU label, extended protection, global distribution, hospitalizations, infant immunization, lower respiratory tract disease, monoclonal antibody, newborn care, nirsevimab, pediatric health, public health, real-world studies, respiratory syncytial virus, RSV, RSV season, Sanofi, Thomas Triomphe, Vaccine Innovation, vaccine supply chain
(IN BRIEF) AstraZeneca’s Calquence, in combination with venetoclax, with or without obinutuzumab, has been approved by the European Commission for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows the positive results from the … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, BTK inhibitor, Calquence, chemoimmunotherapy, chronic lymphocytic leukaemia, clinical trial, CLL, Dave Fredrickson, European Commission approval, European Union, fixed-duration regimen, hematologic diseases, hematology, leukemia, obinutuzumab, oncology, progression-free survival, treatment option, venetoclax
(IN BRIEF) SCHOTT Pharma has begun construction on a new production facility for ready-to-use (RTU) cartridges at its Lukácsháza site in Hungary. The investment of over 100 million euros will expand the company’s manufacturing capacity to meet increasing demand for … Read the full press release
Posted in Business, Environment, Financial, Germany, Government, Healthcare, Hungary, Industrial, Infrastructure & Utilities, Investment, Management, Marketing, News, Pharma & Biotech, Science, Technology
Tagged Andreas Reisse, biologics, Diabetes, Eva Szabó, expansion, GLP-1 drugs, high-value solutions, hormone therapies, Hungary, insulin, investment, Lukácsháza, manufacturing capacity, Ministry of Foreign Affairs and Trade, Obesity, partnership, pharmaceutical industry, pharmaceutical packaging, ready-to-use cartridges, SCHOTT Pharma, sterile cartridges, sustainability, sustainable development
(IN BRIEF) Brenntag has acquired mcePharma a.s. in the Czech Republic to expand its capabilities in the pharmaceutical and biopharmaceutical value chain across EMEA. This acquisition strengthens Brenntag’s GMP services, including biobuffers and liquid blending, to meet growing demand in … Read the full press release
Posted in Business, Chemicals, Czech Republic, Environment, Financial, Germany, Government, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Technology
Tagged acquisition, biobuffers, biopharma, biopharmaceutical value chain, Brenntag, customer solutions, EMEA, GMP, GMP facilities, Gust Desmedt, Ivan Mikes, Joakim Rehné, liquid blending, market expansion, mcePharma, OTC product development, partnership, Pharmaceutical, rapid growth, specialized services, sustainability
(IN BRIEF) Roche announced the European Commission’s approval of a label extension for Evrysdi® (risdiplam) to include a new 5mg tablet, offering a room-temperature stable alternative to the original oral solution for individuals with spinal muscular atrophy (SMA). The tablet, … Read the full press release
Posted in Healthcare, Pharma & Biotech, Science, Switzerland, Technology
Tagged 5mg tablet, bioequivalence, clinical development, clinical study, disease-modifying treatment, European Commission, Evrysdi, family caregivers, label extension, Nicole Gusset, non-invasive treatment, PTC Therapeutics, risdiplam, Roche, SMA, SMA Europe, SMA Foundation, SMA patients, SMN protein, spinal muscular atrophy, treatment flexibility
(IN BRIEF) The European Investment Bank (EIB) has signed a €20 million financing deal with Leyden Laboratories to support the development of its innovative pan-influenza nasal spray, which aims to protect against seasonal and pandemic viral infections. The funding, guaranteed … Read the full press release
Posted in Banks, Business, Economy, Environment, Financial, Government, Healthcare, Industrial, Investment, Luxembourg, Management, Marketing, Netherlands, News, Pharma & Biotech, Science, Technology
Tagged antiviral protection, avian flu, biodefense, EU4Health, European Commission, European health defense, European Investment Bank, Hadja Lahbib, HERA Invest, influenza, InvestEU, Koenraad Wiedhaup, Leyden Labs, nasal spray, non-vaccine approach, Pandemic Preparedness, partnership, respiratory viruses, Robert de Groot, sustainability
(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) Novartis has announced that its Phase III PSMAddition trial of Pluvicto™ in combination with standard of care (SoC) has met its primary endpoint, showing a significant benefit in radiographic progression-free survival (rPFS) and a positive trend in overall … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged androgen receptor pathway inhibitors, cancer research, clinical trials, FDA approval, FDA regulatory review, metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, mHSPC, Novartis, Novartis oncology, overall survival, Phase III PSMAddition, Pluvicto, progression-free survival, prostate cancer, prostate cancer treatment, PSMA-positive, radioligand therapy, treatment options
(IN BRIEF) Novartis has presented new data from the Phase III NATALEE trial at ASCO 2025, showcasing Kisqali’s ability to reduce the risk of recurrence in pre-menopausal patients with high-risk early breast cancer. The data reveals a 33% reduction in … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged adjuvant treatment, ASCO 2025, Black patients, Breast Cancer Treatment, CDK4/6 inhibitors, DDFS, disparities in healthcare, early breast cancer, EBC, endocrine therapy, HR+/HER2-, invasive disease-free survival, Kisqali®, metastatic breast cancer, Novartis, Phase III NATALEE, post-menopausal, pre-menopausal, recurrence-free survival, RFS, ribociclib, Risk Reduction, survival benefit
(IN BRIEF) Eckert & Ziegler successfully hosted the 3rd annual Boston Radionuclide Theranostics Forum, bringing together industry leaders to discuss radionuclide theranostics’ role in transforming precision oncology. The event featured expert presentations on advancements in radiopharmaceuticals, clinical development challenges, and … Read the full press release
Posted in Berlin, Business, Financial, Germany, Government, Healthcare, Industrial, Investment, Management, Marketing, Media, News, Pharma & Biotech, Science, Technology
Tagged Boston Radionuclide Theranostics Forum, clinical development, Dr. Harald Hasselmann, Eckert & Ziegler, German American Business Council, Industry innovation, Morrison Foerster, nuclear medicine, patient access, precision oncology, radionuclide theranostics, radiopharmaceutical community, radiopharmaceuticals, radiotherapy, Solomon Partners
(IN BRIEF) Roche presented promising 96-week data from the Phase II FENopta study, showing that its investigational drug, fenebrutinib, significantly reduced relapse rates and prevented disability progression in patients with relapsing multiple sclerosis (RMS). The study revealed an annualized relapse … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged Bruton’s tyrosine kinase, BTK inhibitor, clinical data, clinical research, clinical trial, data, disability, disability progression, fenebrutinib, FENopta, Levi Garraway, multiple sclerosis, Phase II, relapse rates, relapsing multiple sclerosis, RMS, Roche, treatment
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