Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Sanofi’s Sarclisa Becomes First Anti-CD38 Therapy Approved in the EU for Front-Line Treatment of Transplant-Ineligible Multiple Myeloma

(IN BRIEF) Sanofi’s Sarclisa has been approved by the European Union as the first anti-CD38 therapy in combination with VRd to treat adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. This approval is … Read the full press release

SGS Strengthens North American Operations with Acquisition of RTI Laboratories

(IN BRIEF) SGS has acquired RTI Laboratories, a leading environmental and materials testing service provider in Detroit, Michigan. The acquisition expands SGS’s capabilities in PFAS analysis and materials testing while enhancing its regional presence in the Midwest. The move supports … Read the full press release

AstraZeneca’s Calquence Gains U.S. Approval for First-Line Treatment of Mantle Cell Lymphoma, Following Positive Phase III Results

(IN BRIEF) AstraZeneca’s Calquence (acalabrutinib) has been approved by the U.S. FDA for the first-line treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval is based on … Read the full press release

University of Bristol Study Reveals Cortisol Rise Happens Before Waking, Not After

(IN BRIEF) A new study from the University of Bristol has challenged the long-standing belief that waking up triggers a spike in cortisol, the body’s stress hormone. Published in Proceedings of the Royal Society B, the research shows that cortisol … Read the full press release

FDA Grants Priority Review for AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan for EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release

Sarclisa Receives First Approval in China for Treatment of Relapsed or Refractory Multiple Myeloma

(IN BRIEF) Sarclisa, an anti-CD38 treatment developed by Sanofi, has been approved in China for treating adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least one prior therapy. The approval is based on the … Read the full press release

GSK Announces FDA Review of Convenient Prefilled Syringe for Shingrix Shingles Vaccine

(IN BRIEF) GSK has announced that the FDA has accepted its application to review a prefilled syringe version of Shingrix, its shingles vaccine. This new version, expected to be available from January 2025, eliminates the need for reconstitution, offering a … Read the full press release

Empa Researchers Create 3D-Printed Biodegradable Fungal Battery for Sustainable Power Solutions

(IN BRIEF) Empa researchers have developed a groundbreaking 3D-printed, biodegradable fungal battery, capable of powering sensors for agriculture and research in remote regions. This living battery uses two types of fungi, a yeast fungus and a white rot fungus, to … Read the full press release

Evonik Partners with ST Pharm to Accelerate RNA Therapeutic Development

(IN BRIEF) Evonik has partnered with ST Pharm to enhance its RNA and nucleic acid therapeutic services, combining ST Pharm’s expertise in customized nucleic acids with Evonik’s advanced lipid and lipid nanoparticle (LNP) drug product development solutions. This collaboration aims … Read the full press release

Empa Researchers Develop Nanocomplexes to Combat Antibiotic-Resistant Infections in Eye Surgery

(IN BRIEF) Researchers at Empa and the Cantonal Hospital of St. Gallen are developing new nanocomplexes to combat antibiotic-resistant bacteria and protect eye tissue following cataract surgery. Supported by the Heinz A. Oertli Fund for Ophthalmology, these nanocomplexes, based on … Read the full press release

Roche Shares Promising Phase IIb PADOVA Study Results for Prasinezumab in Early-Stage Parkinson’s Disease

(IN BRIEF) Roche has announced results from the Phase IIb PADOVA study evaluating prasinezumab in 586 individuals with early-stage Parkinson’s disease. While the primary endpoint of time to confirmed motor progression narrowly missed statistical significance, promising efficacy trends were observed, … Read the full press release

Tolebrutinib Receives FDA Breakthrough Therapy Designation for Progressive Multiple Sclerosis

(IN BRIEF) The FDA has granted Breakthrough Therapy designation to tolebrutinib for treating adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS), following positive results from the HERCULES phase 3 study. The study showed tolebrutinib delayed disability progression by 31% and … Read the full press release

Roche Launches Upgraded cobas Systems 2.0 to Revolutionize Molecular Diagnostics Efficiency

(IN BRIEF) Roche has received CE certification for its enhanced cobas® 6800/8800 systems 2.0, introducing significant improvements in laboratory diagnostics. The upgrade streamlines operations by reducing downtime, consolidating test menus, and increasing throughput, supported by innovative TAGS technology that detects … Read the full press release

Roche Vabysmo Prefilled Syringe Gains EU Approval, Transforming Retinal Disease Treatment

(IN BRIEF) Roche’s Vabysmo® (faricimab) prefilled syringe has received European Medicines Agency approval for treating three major retinal conditions: neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema caused by retinal vein occlusion (RVO). Serving over nine … Read the full press release

Evotec and Novo Nordisk Expand LAB eN² Program and Select First Projects to Advance Cardiometabolic Research

(IN BRIEF) Evotec and Novo Nordisk’s LAB eN² program, a translational drug discovery accelerator, has selected its first three academic research projects focused on addressing cardiometabolic diseases. The projects, from Boston University, Harvard University in collaboration with Mass General Brigham, … Read the full press release

Roche Presents Promising Data on Bispecific Antibodies at ASH 2024, Highlighting Advancements in Lymphoma Treatment

(IN BRIEF) Roche presented new data at the ASH 2024 meeting highlighting the effectiveness of its bispecific antibodies, Columvi and Lunsumio, in treating lymphomas. Long-term studies show durable remissions and immune system recovery with fixed-duration therapies, while real-world data emphasize … Read the full press release

Novartis Announces Compelling Long-Term Results for Scemblix® in Phase III ASC4FIRST Trial, Highlighting Superiority in Treating Chronic Myeloid Leukemia

(IN BRIEF) Novartis has announced promising 96-week results from the Phase III ASC4FIRST trial, showcasing Scemblix® (asciminib) as a superior treatment for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). Scemblix achieved significantly higher major … Read the full press release

AstraZeneca’s Imfinzi Granted Priority Review by FDA for Groundbreaking Perioperative Immunotherapy in Bladder Cancer

(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has been granted Priority Review by the FDA for the treatment of muscle-invasive bladder cancer (MIBC), potentially becoming the first perioperative immunotherapy in this curative-intent setting. Supported by results from the NIAGARA Phase III trial, … Read the full press release

Eckert & Ziegler and Ariceum Therapeutics Forge Global Supply Agreement for Critical Medical Radionuclides

(IN BRIEF) Eckert & Ziegler and Ariceum Therapeutics have signed a global supply agreement for critical medical radionuclides Actinium-225 (Ac-225) and Lutetium-177 (Lu-177). The radionuclides will be used in Ariceum’s lead radiopharmaceutical drug, satoreotide, targeting hard-to-treat cancers such as small … Read the full press release

Boehringer Ingelheim Launches EURICAN® L4 Vaccine to Combat Rising Leptospirosis Threat in Dogs

(IN BRIEF) Boehringer Ingelheim has launched EURICAN® L4, a new vaccine designed to protect dogs from leptospirosis, a potentially fatal disease spread through contaminated soil and water. Available in France and expanding across Europe in 2025, the vaccine targets four … Read the full press release