Today Stories

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…

Pivotal Phase III IMbrave050 study investigating Tecentriq plus Avastin in people with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence following surgery met primary endpoint of recurrence-free survival New adjuvant treatments are urgently needed as an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery1 Data will be discussed with health authorities globally, including the US Food and Drug Administration and the European Medicines Agency to inform the next regulatory steps, and presented at an upcoming medical meeting Basel, 19 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMbrave050 study met its primary endpoint of recurrence-free survival (RFS) at the prespecified interim analysis.…

Partnership to Provide Cell and Gene Industry Integrated Solution including Cryoport's IntegriCell™ platform, and Supply Chain Services NASHVILLE, Tenn., Jan. 18, 2023 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport"), a leading global provider of innovative temperature-controlled supply chain solutions to the life sciences industry focused on the pharmaceutical and cell and gene therapy markets, today announced a new strategic partnership with Syneos Health® (NASDAQ: SYNH), the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. Both Cryoport and Syneos Health are world leading solutions companies with deep expertise and experience supporting clinical and commercial stage therapies. The partnership will support the global a…

Reading, January 18, 2023. Sanofi announces at the 53rd Annual Meeting of the World Economic Forum in Davos the launch of the Sanofi NextGen Scholarship, its first global higher education scholarship programme for people from numerous communities underrepresented in healthcare professions. The programme will help pay tuition and other expenses at institutions of higher education for students who are part of their nation’s ethnic minority groups, women, disabled people and members of the LGBTQ+ community who wish to pursue careers as doctors, nurses, scientists, researchers and other healthcare-related professions.  Launching this year in the UK and 4 other countries (Brazil, France, Japan and the U.S.), the Sanofi NextGen Scholarship programme will work hand-in-hand with leading higher edu…

AstraZeneca has completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts). Neogene will operate as a wholly owned subsidiary of AstraZeneca, with operations in Amsterdam, the Netherlands and California, US. Financial considerationsAstraZeneca has acquired all outstanding equity of Neogene in exchange for an initial payment of $200m. Under the terms of the agreement, AstraZeneca will pay up to $120m in additional contingent milestone-based and non-contingent consideration. Notes Neogene TherapeuticsNeogene Therapeutics, Inc. is a global biotechnology company focused on discovering, developing and manufacturing next-generation, tr…

Moderna becomes the latest member of the Association of the British Pharmaceutical Industry (ABPI), deepening the company’s UK connections. Moderna has become the newest member of the UK’s leading pharmaceutical industry body, building on the wider long-term commitment by the American-based company to expand its footprint and investment in the UK. Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, has high ambitions for rapid global growth. Key to these ambitions will be a new state-of-the-art vaccine research, development and manufacturing facility in the UK, creating valuable new jobs and building on the strength of the UK’s life sciences ecosystem. Founded in 2010 and now employing over 3900 people globally and around 30 in the UK, Moderna is bes…

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the successful completion of the cash tender offer, through a subsidiary, for all of the outstanding shares of common stock of Imago BioSciences, Inc. (Nasdaq: IMGO), at a purchase price of $36.00 per share in cash, without interest and subject to deduction for any required tax withholding. As of the tender offer expiration at one minute after 11:59 p.m., Eastern Time, on January 10, 2023, 31,307,028 shares of common stock of Imago were validly tendered and not withdrawn from the tender offer, representing approximately 89.2% of the total number of Imago’s outstanding shares on a fully diluted basis. All such shares have been accepted for payment in accordance with the t…

- Collaboration leverages Anima's mRNA Lightning technology platform and AbbVie's extensive expertise in Oncology and Immunology- Anima will receive an upfront payment of $42 million with potential for further milestones and royalties NORTH CHICAGO, Ill. and BERNARDSVILLE, N.J., Jan. 10, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV), and Anima Biotech (Anima), today announced a collaboration to discover and develop mRNA biology modulators for three targets across Oncology and Immunology. Anima will use its mRNA Lightning platform to discover novel mRNA biology modulators against the collaboration targets providing AbbVie exclusive rights to license and further develop and commercialize the programs. "This collaboration will give AbbVie access to Anima's leading technology platform and deep expe…

Research Triangle Park, N.C. (January 9, 2023) - Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, announced today that it has signed a multi-year research collaboration and option agreement with ReCode Therapeutics. Under this agreement, the companies will work together to potentially discover precision genetic medicines through the development of a novel platform for full gene insertion by single vector delivery of gene editing and DNA cargoes. This represents another step forward for AskBio in developing its gene editing and other nonviral delivery technologies and expertise. “The collaboration pairs AskBio’s expertise in synthetic DNA and CRISPR applications with ReCode’s novel SORT LNP delivery technology to potentially disco…

Acquisition to access global rights to baxdrostat, a novel aldosterone synthase inhibitor in development for blood pressure lowering AstraZeneca has entered into a definitive agreement to acquire CinCor Pharma, Inc. (CinCor), a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension as well as chronic kidney disease. The acquisition will bolster AstraZeneca’s cardiorenal pipeline by adding CinCor’s candidate drug, baxdrostat (CIN-107), an aldosterone synthase inhibitor (ASI) for blood pressure lowering in treatment-resistant hypertension. Baxdrostat represents a potentially leading next-generation ASI as it is highly selective for aldosterone synthase and spares the cortisol pathway in humans1. The opportun…