Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Expanded Partnership Between Just – Evotec Biologics and Sandoz Enhances Biosimilar Development and Supply Security

(IN BRIEF) Just – Evotec Biologics and Sandoz have expanded their strategic partnership to advance the development and commercial manufacturing of biosimilars. This enhanced collaboration includes additional biosimilars in Sandoz’s pipeline and ensures long-term supply through Just – Evotec Biologics’ … Read the full press release

EIB Invests €37.5 Million in Nyxoah’s Innovative Sleep Apnea Solutions

(IN BRIEF) The European Investment Bank (EIB) has awarded Belgium-based medtech company Nyxoah €37.5 million in venture-debt financing to support the development of innovative treatments for obstructive sleep apnea (OSA). This funding, backed by the InvestEU Life Sciences programme, will … Read the full press release

SGS Expands Biopharmaceutical Services with New Stability Studies Capabilities in Birsfelden Laboratory

(IN BRIEF) SGS has expanded its laboratory in Birsfelden, Switzerland, to offer comprehensive stability studies as part of its biopharmaceutical service portfolio. Effective February 2024, the enhanced facility provides integrated services including controlled temperature storage and various analytical tests, ensuring … Read the full press release

Roche Launches Advanced Diagnostic Test for B-Cell Lymphoma Detection

(IN BRIEF) Roche has introduced the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, the first clinically approved in-situ hybridisation (ISH) test of its kind. Designed to enhance sensitivity in diagnosing B-cell lymphoma, the assay helps differentiate cancerous … Read the full press release

Merck and Michael J. Fox Foundation Collaborate to Advance Parkinson’s Research with Innovative Biomarker Technology

(IN BRIEF) Merck and The Michael J. Fox Foundation (MJFF) are collaborating to advance Parkinson’s disease research using Merck’s SMCxPRO® immunoassay technology. This initiative aims to detect biomarkers indicating cell dysfunction in PD patients, enhancing research into new treatment options … Read the full press release

QIAGEN Launches Enhanced QCI Interpret for High-Throughput NGS Labs

(IN BRIEF) QIAGEN has launched an upgraded version of its clinical decision support software, QIAGEN Clinical Insight Interpret (QCI Interpret), tailored for high-throughput next-generation sequencing (NGS) labs. The new release enhances performance metrics like turnaround time and diagnostic yield through … Read the full press release

Merck’s Darmstadt Expansion: New €62 Million Facility to Elevate Quality Standards in Life Science

(IN BRIEF) Merck is investing €62 million in a new quality control facility at its Darmstadt headquarters as part of a larger €1.5 billion investment program. Scheduled for completion by mid-2025, the state-of-the-art facility will consolidate 135 employees into a … Read the full press release

Swissport’s Frankfurt Air Cargo Center Renews CEIV Pharma Certification, Affirming Commitment to Quality Handling

(IN BRIEF) Swissport’s air cargo center at Frankfurt Airport has once again earned CEIV Pharma certification from IATA, highlighting its commitment to excellence in handling pharmaceutical products. This certification reaffirms Swissport’s dedication to maintaining high-quality standards in pharmaceutical logistics, supporting … Read the full press release

Breakthrough Phase II Trial Data Reinforces Potential of Survodutide as Leading MASH Treatment

(IN BRIEF) In a significant stride towards combating metabolic dysfunction-associated steatohepatitis (MASH), Boehringer Ingelheim unveils groundbreaking results from a Phase II trial sub-analysis of survodutide. Demonstrating impressive efficacy, up to 64.5% of adults with moderate to advanced fibrosis stages F2 … Read the full press release

Schnelldorf Facility Upgrade: Merck Boosts Life Science Distribution Capacity

(IN BRIEF) Merck, a leading science and technology company, has inaugurated its expanded Life Science distribution center in Schnelldorf, Germany, following a €180 million investment that nearly doubled its size to 25,000 square meters. The upgraded facility now includes manual … Read the full press release

Novartis Unveils Long-Term Efficacy of Remibrutinib in Chronic Spontaneous Urticaria at EAACI Congress

(IN BRIEF) Novartis has presented new data at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Congress, showcasing the sustained efficacy and safety of remibrutinib, a selective Bruton’s tyrosine kinase (BTK) inhibitor, in chronic spontaneous urticaria (CSU). Results … Read the full press release

Evotec Collaborates with Inserm and Lille University Hospital to Advance Obesity and Metabolic Disease Research

(IN BRIEF) Evotec SE announces a partnership with Inserm, Lille University Hospital, and Inserm Transfert to identify novel therapeutic targets and diagnostic markers in obesity and metabolic diseases. The collaboration, centered around the ABOS/DIABOMICS study led by Lille University Hospital, … Read the full press release

Almirall Launches AK Global Day Campaign to Raise Awareness of Actinic Keratosis and Sun Exposure Risks

(IN BRIEF) Almirall’s new data highlights the alarming lack of awareness regarding actinic keratosis (AK), a common precancerous dermatological condition linked to sun exposure, with more than one-third of affected individuals unaware of its causes. The survey, conducted across Spain, … Read the full press release

Global Study Unveils Barriers to Mental Health Care Access

(IN BRIEF) A recent study commissioned by Boehringer Ingelheim, conducted across eight G20 countries, sheds light on the challenges obstructing access to mental health care worldwide. The analysis reveals pervasive stigma, a shortage of mental health professionals, and inconsistent service … Read the full press release

Roche Announces Retirement of Head of Pharma Partnering and Successor Appointment

(IN BRIEF) Roche (SIX: RO, ROG; OTCQX: RHHBY) reveals the retirement of James Sabry, the Head of Roche Pharma Partnering, after fourteen years of service. Effective 1 July 2024, Boris Zaïtra, currently Head of Group Business Development, will take on … Read the full press release

European Parliament Approves Landmark Pharmaceutical Legislation Reform, Calls for Further Enhancements

(IN BRIEF) The European Parliament has achieved a significant milestone by approving the first reading of extensive reforms to EU pharmaceutical legislation aimed at fostering innovation and ensuring equitable access to medicines. While commending the progress, the European Society of … Read the full press release

Boehringer Ingelheim and OSE Immunotherapeutics Forge New Paths in Disease Treatment Collaboration

(IN BRIEF) Boehringer Ingelheim and OSE Immunotherapeutics announce a significant expansion of their partnership, introducing two novel projects to develop pioneering treatments alongside their ongoing anti-SIRPα immuno-oncology initiatives. The expansion includes broadening therapeutic evaluations to encompass cardiovascular-renal-metabolic (CRM) diseases and … Read the full press release

Roche and Amgen Collaborate on Breakthrough Lp(a) Test for Cardiovascular Disease Risk

(IN BRIEF) Roche Diagnostics has announced that its Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Developed in collaboration with Amgen, this innovative test aims to identify individuals at risk … Read the full press release

AstraZeneca Unveils Groundbreaking Advances in Cancer Care at ASCO 2024

(IN BRIEF) AstraZeneca is set to revolutionize cancer care with a slew of groundbreaking data presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting. Over 100 abstracts will showcase 25 approved and potential new medicines, including two late-breaking … Read the full press release

Sartorius and NVIDIA Deepen Collaboration for AI-Powered Biopharma Innovation

(IN BRIEF) Sartorius, a prominent life science group, is expanding its collaboration with NVIDIA to advance the development of new therapies by integrating NVIDIA’s AI-powered computing platforms with Sartorius’ expertise in life sciences and bioprocessing. Since 2020, Sartorius has integrated … Read the full press release

WACKER Expands Biopharmaceutical Capabilities in the USA for Advanced Therapies

(IN BRIEF) WACKER is strategically enhancing its BIOSOLUTIONS life-science division by bolstering capacities in biopharmaceuticals for advanced therapies. Its subsidiary, Wacker Biotech US, based in San Diego, is expanding mRNA and protein production to meet the surging demand for contract … Read the full press release

AstraZeneca Completes Equity Investment in Cellectis for Cell and Gene Therapy Development

(IN BRIEF) AstraZeneca has finalized its equity investment with Cellectis, a clinical-stage biotechnology firm, following a successful research collaboration agreement announced in November 2023. This partnership aims to harness Cellectis’ gene editing technologies to design up to 10 novel cell … Read the full press release

Bayer and Evotec Forge Partnership for Next-Generation Cardiovascular Therapies

(IN BRIEF) Bayer and Evotec have updated their strategic collaboration to focus on developing precision treatments for cardiovascular diseases (CVDs). Leveraging Evotec’s expertise in disease modelling using human induced pluripotent stem cells (iPSCs), the collaboration aims to identify and validate … Read the full press release

Positive Results from DESTINY-Breast06 Trial: Enhertu Shows Promise in HER2-Low and HER2-Ultralow Breast Cancer Patients

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu, a HER2-directed antibody drug conjugate (ADC), has demonstrated significant progress in treating HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. The high-level results from the DESTINY-Breast06 Phase … Read the full press release

AstraZeneca’s Truqap Receives EU Recommendation for ER-Positive Breast Cancer Treatment

(IN BRIEF) AstraZeneca’s Truqap, in combination with Faslodex, has received a positive recommendation from the European Medicines Agency (EMA) for treating estrogen receptor-positive, HER2‑negative locally advanced or metastatic breast cancer with specific genetic alterations. The recommendation follows promising results from … Read the full press release

Evonik Expands RESOMER® Biomaterial Production with Advanced Micronization Technology

(IN BRIEF) Evonik has enhanced its capabilities for RESOMER® powder biomaterials at its Darmstadt site in Germany with the implementation of advanced solvent-free micronization technology. This innovation allows for the production of customized powders with varied particle sizes and material … Read the full press release

Evotec Biologics Unveils J.CHO™ High Expression System for Enhanced Antibody Production

(IN BRIEF) Evotec Biologics, the biologics arm of Evotec SE, has introduced its proprietary J.CHO™ High Expression System for antibody expression. J.CHO™ optimizes biotherapeutic production processes by providing higher productivity and quality for complex antibody formats. Engineered from Chinese hamster … Read the full press release

Sanofi’s Frexalimab Shows Promise in Phase 2 for Treating Multiple Sclerosis

(IN BRIEF) Sanofi’s experimental CD40L antibody, frexalimab, demonstrates encouraging results in a 48-week phase 2 study for relapsing multiple sclerosis (MS). Presented at the American Academy of Neurology Annual Meeting, the data reveals sustained reduction in disease activity and favorable … Read the full press release

Evotec Appoints Aurélie Dalbiez as Chief People Officer to Drive Organizational Excellence

(IN BRIEF) Evotec SE announces the appointment of Aurélie Dalbiez as their new Chief People Officer (CPO), effective June 15, 2024. Joining the Management Board, Aurélie brings over 25 years of international Human Resources leadership experience, previously serving as the … Read the full press release

Long-Term Study Shows Sustained Efficacy of Kesimpta in Treating Relapsing Multiple Sclerosis

(IN BRIEF) Novartis revealed promising data from the ALITHIOS open-label extension study, highlighting the enduring effectiveness of Kesimpta® (ofatumumab) in treating relapsing multiple sclerosis (RMS) over a span of up to six years. The study, presented at the American Academy … Read the full press release

AstraZeneca’s IMPACT CKD Model Forecasts Alarming Rise in Chronic Kidney Disease by 2032

(IN BRIEF) AstraZeneca’s IMPACT CKD model predicts a significant increase in chronic kidney disease (CKD) across eight countries, with up to 16.5% of the population affected by 2032, including a substantial rise in advanced-stage cases. Presented at the 2024 ISN … Read the full press release

Advancing Healthcare: Bosch and Randox Labs Partner to Revolutionize Molecular Diagnostics

(IN BRIEF) Bosch and Randox Laboratories Ltd. have forged a strategic partnership aimed at transforming molecular diagnostics with a focus on the Vivalytic analysis platform. With an investment of 150 million euros in joint research, development, and distribution, the collaboration … Read the full press release

EBRD Invests €22 Million to Propel Farmak’s Expansion into Polish Market

(IN BRIEF) The European Bank for Reconstruction and Development (EBRD) has provided a €22 million loan to Ukrainian pharmaceutical giant Farmak Group to facilitate its strategic acquisition of a Polish pharmaceutical company and to upgrade its IT systems. Farmak, a … Read the full press release

WACKER and Pantherna Collaborate to Ramp Up mRNA Production for ARDS Treatment

(IN BRIEF) WACKER’s mRNA competence center in Halle is gearing up to produce an active ingredient for combatting acute respiratory distress syndrome (ARDS) in collaboration with Pantherna Therapeutics. The center, equipped with four new production lines, will more than triple … Read the full press release

AstraZeneca’s Imfinzi Shows Promising Results in Phase III Trial for Small Cell Lung Cancer

(IN BRIEF) AstraZeneca announces positive outcomes from the ADRIATIC Phase III trial, revealing that its immunotherapy drug Imfinzi (durvalumab) demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS) among patients with limited-stage small cell lung cancer (LS-SCLC) … Read the full press release

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

(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

AstraZeneca and Daiichi Sankyo’s BLA for Datopotamab Deruxtecan Accepted by FDA for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been acknowledged by the US FDA for treating adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior systemic … Read the full press release

AstraZeneca and Sanofi’s Beyfortus Receives Approval in Japan for Prophylaxis against Respiratory Syncytial Virus

(IN BRIEF) AstraZeneca and Sanofi celebrate the approval of Beyfortus (nirsevimab) in Japan by the Ministry of Health, Labour, and Welfare for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in neonates, infants, and children entering … Read the full press release

AstraZeneca’s Truqap Gets Green Light in Japan for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca announces the approval of Truqap (capivasertib) in combination with Faslodex (fulvestrant) by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for treating adult patients with unresectable or recurrent hormone receptor-positive, HER2-negative breast cancer. The approval, based … Read the full press release

Merck Expands M LabTM Collaboration Center in Shanghai, Enhancing Biopharmaceutical Capabilities

(IN BRIEF) Merck, a prominent science and technology company, announces a €14 million expansion of its M LabTM Collaboration Center in Shanghai, bolstering its support for the biopharmaceutical industry in China. The expansion includes new facilities such as a biology … Read the full press release