Today Stories

Seeks to accelerate patient access to safe, effective, cutting-edge medical devices to diagnose and treat nervous systems disorders WILMINGTON, N.C.--(BUSINESS WIRE)-- The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been awarded a five-year contract to provide regulatory affairs support and related services for the Blueprint MedTech (BPMT) program, a new multi-institute/center initiative at the National Institutes of Health (NIH) supporting development of translational neurological devices. The BPMT program is a new NIH incubator with a collaborative reach across 11 NIH institutes, whose goal is to accelerate patient access to safe, effective, cutting-edge medical devices to diagnose and/or treat disorders of the nervous system.…

EDX Medical Group plc, (“EDX Medical” or the “Company”), which develops innovative digital diagnostic products and services for cancer, heart disease, neurology and infectious disease testing, today announces that it has acquired Torax Biosciences Ltd., a research company providing product development and pilot scale fabrication of immune-assays and diagnostic testing solutions. Torax becomes a wholly-owned subsidiary of EDX Medical and will provide an experienced point-of-care diagnostics technical team with proven skills in innovation and new product development. Torax will also provide additional UK laboratory capacity in Northern Ireland in support of EDX’s established laboratories in Cambridge. The Torax business operates under ISO 9001 and ISO-13485 accredited quality systems for IVD…

Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI Supplemental new drug application for TALZENNA and XTANDI combination granted U.S. FDA Priority Review NEW YORK--(BUSINESS WIRE)-- Pfizer (NYSE: PFE) announced today positive results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus XTANDI in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations.…

First peer-reviewed publication of phase III respiratory syncytial virus vaccine data in older adults, including those with comorbidities who are most at risk Expert perspective recognises a new era in vaccine design based on progress in respiratory syncytial virus research Vaccine on track to become available in 2023 pending regulatory decisions in the US, EU, and other countries GSK plc (LSE/NYSE: GSK) today announced the publication of positive phase III trial results for its respiratory syncytial virus (RSV) older adult vaccine candidate in the New England Journal of Medicine. The publication summarises the pivotal efficacy data (previously presented at IDWeek 2022), showing the vaccine candidate met the primary endpoint of vaccine efficacy against RSV-lower respiratory tract…

Cambridge and Cardiff, UK, 13 February 2023, Astex Pharmaceuticals (UK) (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system and The Medicines Discovery Institute, Cardiff University (“MDI”) announced today that they have entered into a multi-year, multimillion pound drug discovery research collaboration, aimed to identify new drugs to treat neurodegenerative diseases.   The collaboration brings together the world-leading research expertise of Dr Emyr Lloyd-Evans & Dr Helen Waller-Evans in lysosomal biology, the drug discovery capabilities of the MDI and the fragment-based drug discovery platform at Astex. The combined teams will focus on identifying compounds which mo…

Paris, February 13, 2023. Sanofi announced today that Dr. John Reed, its Global Head of R&D, will be leaving the company to pursue a new opportunity outside Sanofi. The company warmly thanks Dr. Reed for his leadership over these last years. Since joining Sanofi in 2018, John has laid the foundation for the company’s R&D transformation. He helped reshape Sanofi’s discovery and development of therapeutics, focusing efforts on first and best in class medicines that have the potential to transform the practice of medicine and improve the lives of people with serious diseases, whilst managing the integration and development of new technology platforms and partnerships, and driving R&D productivity. In 2023, Sanofi will launch two first or best-in-class medicines that will address m…

HS-001 consists of clusters of purified heart muscle cells derived from induced pluripotent stem cells (iPSCs). Clinical phase 1/2 study (LAPiS Study) will enrol 10 patients with advanced heart failure caused by ischaemic heart disease. Tokyo, Japan and Bagsværd, Denmark, 10 February 2023 – Heartseed Inc. (Heartseed) and Novo Nordisk A/S today announced that Heartseed has successfully dosed the first patient in a phase 1/2 clinical study (LAPiS Study) with HS-001 – an investigational cell therapy for heart failure. An independent safety evaluation committee has evaluated 4-week data on the patient, who lives with advanced heart failure and has given approval for the study to continue. Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood…

Abbott will gain an innovative, complementary solution in treating vascular disease through CSI's leading atherectomy system, which prepares vessels for angioplasty or stenting to restore blood flow CSI's offering will support Abbott's ability to provide better care for patients with peripheral and coronary artery disease ABBOTT PARK, Ill. and ST. PAUL, Minn., Feb. 8, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) and Cardiovascular Systems, Inc. (CSI), today announced a definitive agreement for Abbott to acquire CSI, a medical device company with an innovative atherectomy system used in treating peripheral and coronary artery disease. Under terms of the agreement, CSI stockholders will receive $20 per common share at a total expected equity value of approximately $890 million. CSI is a leader…

For the eighth consecutive year, Advanced Clinical continues elite Diamond Award status Chicago, IL (February 7, 2023) – Advanced Clinical, a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey, has earned the Best of Staffing® Client and Talent Awards by ClearlyRated for the eighth consecutive year and Diamond Award status for the fourth consecutive year. Best of Staffing® winners are industry leaders who have demonstrated high-quality service based on net-promoter ratings from their clients and the consultants who have been placed on client engagements. Diamond Award winners have won the Best of Staffing Award for at least 5 years in a row, meaning they consistently earn industry-leading satisf…

Study published today in Clinical Trials: Journal of the Society for Clinical Trials examined clinical trial diversity across 495 GSK trials involving over 100,000 participants Results demonstrate real-world disease epidemiology data—compared to the conventional standard of US Census data—may be better benchmark to ensure clinical trial enrolment reflects the populations affected by diseases GSK commits to applying insights from the study and collaborating with regulators, patients, academics and other biopharma companies to make meaningful progress on clinical trial diversity GSK plc (LSE/NYSE: GSK) today announced results from a retrospective study on clinical trial diversity, investigating the historical representation of US-based participants in GSK clinical trials. The study looked…

Thermo Fisher and Celltrio bring first-in-kind automation platform to address critical scale-up challenges in biotherapeutics BURLINGTON, Ontario – (February 6, 2023) — Thermo Fisher Scientific, the world leader in serving science, and Celltrio, a leading manufacturer of robotics-based solutions for the life sciences industry, have announced their collaboration to bring a fully automated cell culture system to biotherapeutics customers. The collaboration will integrate the Thermo Scientific Momentum workflow scheduling software with the Celltrio RoboCell cell line automation platform to address the critical unmet market need for high-throughput automated cell line culturing and maintenance. Celltrio’s RoboCell systems distributed in Europe will now use Momentum software for work scheduling…

Thermo Fisher’s latest net-zero milestone to be achieved through 200-megawatt solar project WALTHAM, Mass.--(BUSINESS WIRE)-- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced it will power all of the company’s current U.S. sites with 100 percent renewable electricity by 2026. The company’s new 20-year virtual power purchasing agreement with EDF Renewables includes the full output of the 200-megawatt (MW) Millers Branch Solar project. The agreement with EDF Renewables will deliver approximately 545,000 MWh of renewable electricity annually from the Millers Branch Solar project in Texas. This project complements Thermo Fisher’s previously announced agreement with Enel North America for the Seven Cowboy wind project. Together, these projects will…

– Toward Health Equity Oncology Grant ™ Supports Initiatives to Break the Cycle of Health Inequity – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) awarded $7.6 million in grant funding to 24 U.S.-based, community organizations through the newly created Toward Health Equity (THE) Oncology Grant™. The funding will support evidence-based interventions that address barriers to care and social determinants of health including patient navigator training, cultural competency training, and services combating barriers such as transportation. “Gilead is committed to advancing health equity and supporting these vital patient advocacy organizations working to close gaps in breast cancer care,” said Deborah H. Telman, Executive Vice President, Corporate Affairs and Gener…

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Benlysta (belimumab), a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis. GSK plans to initiate a phase II/III trial of belimumab for systemic sclerosis associated interstitial lung disease (SSc-ILD) in the first half of 2023. Systemic sclerosis (SSc) is a rare autoimmune disease that causes atypical growth of connective tissues and can affect the musculoskeletal system, heart, lungs, kidneys, skin, and other organs. Interstitial lung disease (ILD) is the leading cause of death in SSc, affecting as many as half of people living with the disease.1,2 With limited treatment options available for SSc-ILD, this Orphan Drug De…

Approximately 60% of patients aged 12 years and older treated with Dupixent 300 mg weekly in the pivotal trial experienced histological disease remission; patients also significantly improved their ability to swallow compared to placebo Dupixent is now an option for the approximately 50,000 adults and adolescents living with severe uncontrolled eosinophilic esophagitis in the European Union (EU) Dupixent now approved to treat five diseases with underlying type 2 inflammation in the EU Paris and Tarrytown, N.Y. Jan 30, 2023. The European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by…

$1.15M contribution from Lilly will fund the purchase and installation of 150 refrigeration units by Direct Relief in low- and middle-income countries around the world INDIANAPOLIS and SANTA BARBARA, Calif., Jan. 26, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Direct Relief today announced a new initiative to expand access to medicines in low- and middle-income countries by boosting cold chain capacity in 17 countries. Supported by $1.15M in funding from Lilly, Direct Relief will purchase and install an estimated 150 medical-grade refrigeration units at 25 Life for a Child partner facilities in Africa, Latin America, the Caribbean and Southeast Asia. Cold chain – the transportation and storage of temperature-controlled medications – is a vital component of medical logistics,…

Approval based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease progression or death by 50% and increased overall survival by more than 6 months vs. chemotherapy AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. The approval by th…

Expansion of manufacturing facility in North Carolina will increase the number of patients who may benefit from the company's medicines INDIANAPOLIS, Jan. 24, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced plans to invest an additional $450 million and create at least 100 new jobs to expand its manufacturing capacity at the company's Research Triangle Park facility. The expansion includes additional parenteral filling, device assembly and packaging capacity to support an increased demand for Lilly's incretin products that treat diabetes. "As we move into 2023, Lilly is focused on finding innovative solutions to meet the growing demand for our medicines," said Edgardo Hernandez, executive vice president and president, Lilly Manufacturing Operations. "Expanding our op…

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial, which showed Jardiance® (empagliflozin) tablets significantly reduced the risk of kidney disease progression* or cardiovascular death in adults with CKD by 28% (absolute risk reduction [ARR]: 3.8%) compared with placebo, both on top of standard of care 1,2  Ingelheim, Germany and Indianapolis, US. 20 January 2023 - The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets, which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) an…

Charles River Edinburgh has been awarded Top Employer UK status for 2023. This internationally recognised award is given to organisations that show a passion and commitment to enriching the world of work for their employees. This is the second consecutive year that CRL EDI has received this award! According to the Top Employer Institute: "The Top Employers Institute programme certifies organisations based on the participation and results of their HR Best Practices Survey. This survey covers six HR domains consisting of 20 topics including People Strategy, Work Environment, Talent Acquisition, Learning, Diversity, Equity & Inclusion, Wellbeing and more." Our HR practices were benchmarked against thousands of organisations across the globe. In particular, the following practices stood ou…