Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Sanofi Acquires 2.3% of Shares from L’Oréal as Part of Ongoing Buyback Program

(IN BRIEF) Sanofi has announced the acquisition of 2.3% of its shares from L’Oréal, a long-standing shareholder, as part of its ongoing share buyback program. The transaction, valued at €3 billion, reflects Sanofi’s commitment to creating sustainable value for shareholders. … Read the full press release

Roche Expands FDA Approval of PATHWAY® HER2 Test for HER2-Ultralow Breast Cancer Status

(IN BRIEF) Roche has announced that the FDA has expanded the approval of its PATHWAY® HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify HER2-ultralow status in HR-positive, HER2-negative metastatic breast cancer patients. This new approval offers a potential treatment … Read the full press release

GSK and ViiV Healthcare Secure European Commission Approval for Long-Acting HIV Treatment for Adolescents

(IN BRIEF) ViiV Healthcare has secured European Commission approval for its long-acting HIV treatment, Vocabria + Rekambys, for adolescents aged 12 and older. This approval offers a significant advancement in HIV care, providing an injectable treatment option that reduces the … Read the full press release

Sanofi’s Sarclisa Receives Approval in China for Newly Diagnosed Multiple Myeloma Treatment

(IN BRIEF) Sarclisa (isatuximab) has been approved in China for use in combination with the VRd regimen to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. The approval is based on positive results from … Read the full press release

GSK Announces EMA Review of Prefilled Syringe Presentation for Shingrix Vaccine

(IN BRIEF) GSK has announced that the European Medicines Agency (EMA) has accepted its regulatory application for a prefilled syringe presentation of Shingrix, its recombinant zoster vaccine (RZV) for preventing shingles. This new presentation simplifies administration for healthcare providers by … Read the full press release

GSK and University of Oxford Launch Cancer Prevention Research Program with £50 Million Investment

(IN BRIEF) GSK and the University of Oxford have launched the GSK-Oxford Cancer Immuno-Prevention Programme, a new research initiative focused on cancer prevention through vaccination. GSK is investing up to £50 million to explore how precancerous cells develop into cancer, … Read the full press release

Roche Reports Sustained Two-Year Improvements with Elevidys Gene Therapy for Duchenne Muscular Dystrophy

(IN BRIEF) Roche has reported positive results from the second year of the EMBARK Phase III trial of Elevidys (delandistrogene moxeparvovec), the first approved gene therapy for Duchenne muscular dystrophy (DMD). The results showed statistically significant and clinically meaningful improvements … Read the full press release

Yonsei University, Zymedi, and Evotec Awarded US$ 4.5 Million Grant for Novel Lung Disease Therapies

(IN BRIEF) Evotec, Yonsei University, and Zymedi have been awarded a US$ 4.5 million grant from the Korea Institute of Advanced Technology (KIAT) to develop first-in-class biologic therapies for lung diseases, specifically asthma and idiopathic pulmonary fibrosis (IPF). The project … Read the full press release

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