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Bagsværd, Denmark, 2 March 2023 – Novo Nordisk just announced plans to expand its research and development (R&D) presence in the greater Boston metro area, creating one of its largest R&D hubs outside of Denmark. This new hub, which will leverage the company’s existing presence in Lexington, Cambridge and Watertown, Massachusetts, will be home to the majority of Novo Nordisk’s US-based research and development activities.   Novo Nordisk anticipates adding more than 200 new jobs in the Boston area in 2023. Of these new positions, more than 150 will be lab-based and clinical development personnel in Lexington and Watertown and involved in data science, biology or chemistry research, and ribonucleic acid interference (RNAi) research and clinical development.    “The Boston area is the…
COPENHAGEN, Denmark, March 1, 2023 – BioInnovation Institute (BII), an international non-profit foundation incubating and accelerating world-class life science research, today announces that ten new companies have entered its Venture Lab acceleration program for early-stage companies. The cohort is strategically aligned with BII’s focus on supporting innovative early-stage start-ups within human and planetary health. The 12-month Venture Lab program is designed to support start-up companies with business acceleration, scientific, and team development, and provides a founder-friendly convertible loan of EUR 500,000 (approximately 4M DKK) plus access to labs and offices at the BII in Copenhagen. In becoming a part of the Venture Lab program, the early-stage companies also get an exclusive op…
Today marks Rare Disease Day 2023, the official international awareness-raising campaign for rare diseases which takes place on the last day of February every year. The main objective of the campaign is to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives. What is a Rare Disease? A rare disease is one which affects fewer than 1 in 2,000 people. Over 6,000 rare diseases are characterised by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Relatively common symptoms can hide underlying rare diseases, leading to misdiagnosis and a delay in treatment. Quintessentially disabling, the patients quality of life is affected by t…
The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance study1-4 Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain5,6 If approved by the European Commission (EC), this will be the seventh indication for upadacitinib in the European Union (EU), and the first JAK inhibitor for Crohn's disease, adding to AbbVie's gastroenterology portfolio NORTH CHICAGO, Ill., Feb. 27, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of upadacitinib (RINVOQ®, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) f…
-  Partnership Combines AbbVie's extensive capabilities with Capsida's novel adeno-associated virus (AAV) engineering platform -  Builds upon the neurodegenerative disease partnership announced in 2021 NORTH CHICAGO, Ill. and THOUSAND OAKS, Calif., Feb. 23, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Capsida Biotherapeutics Inc. ("Capsida") today announced an expanded strategic collaboration to develop genetic medicines for eye diseases with high unmet need. AbbVie's extensive capabilities will be paired with Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability to identify and advance three programs. The collaboration builds upon the neurodegenerative disease partnership announced in 2021. "This expanded collaboration with Capsida has the potentia…
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (NASDAQ: GILD), today announced the completion of the previously announced transaction to acquire Tmunity Therapeutics (Tmunity), a clinical-stage, private biotech company focused on next-generation CAR T-therapies and technologies. The acquisition of Tmunity complements Kite’s existing in-house cell therapy research capabilities by adding additional pipeline assets, platform capabilities, and a strategic research and licensing agreement with the University of Pennsylvania (Penn). It will provide Kite with access to pre-clinical and clinical programs, including an ‘armored’ CAR T technology platform, which potentially could be applied to a variety of CAR T’s to enhance anti-tumor activity, as well as rapid manufacturing process…
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…