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Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC)1 This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy2 The National Comprehensive Cancer Network® (NCCN®) Guidelines recommend routine testing for ALK, EGFR and PD-L1 biomarkers in people with early-stage NSCLC to inform adjuvant therapy selection Basel, 19 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment following tumour resec…
MELBOURNE, Australia, April 17, 2024 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a global leader in genomics-based tests in health, wellness and serious disease, is pleased to announce the Company has established a precision oncology division and announced its highly anticipated portfolio of new diagnostic tests under its geneType precision oncology brand. The proprietary-developed tests will provide invaluable information to medical oncologists, helping determine which therapies will have the most efficacious impact in treating a range of cancers including melanoma, lung, pancreatic, colorectal, breast, ovarian and brain cancers. Huge market opportunity for this advanced portfolio of methylation, mutation and liquid biopsy tests. Earlier d…
Process Performance Qualification (PPQ) Shortened by 50 Percent for Takeda’s New Prefilled Syringe Filling Line in Linz, Austria, for ENTYVIO® Subcutaneous (vedolizumab) Recognition Illustrates Takeda’s Patient-Centric Investment in Supply Flexibility and Demonstrates Build-up of Supply Chain Resilience Awarded Project Sets New Standard for PPQ for New Production Lines Helping to Shorten Time to Market OSAKA, Japan and CAMBRIDGE, Massachusetts, April 16, 2024 - Takeda (TSE:4502/NYSE:TAK) today announced that the International Society for Pharmaceutical Engineering (ISPE) has awarded the company top honors in the category Operations with the 2024 Facility of the Year Awards (FOYA). The awarded project demonstrates Takeda’s continuous patient-focused process improvements in its manufacturi…
Innovative GFAP blood biomarker test expands Labcorp's portfolio of tests for diseases including Alzheimer's disease, multiple sclerosis, glioblastoma and brain injuries BURLINGTON, N.C., April 15, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the availability of the nation's first test for glial fibrillary acidic protein (GFAP), a critical blood-based biomarker for the early detection of neurodegenerative diseases and neurological injuries. The new GFAP test – a first-of-its-kind test to be offered commercially nationwide – offers physicians a more efficient pathway to assess the presence and progression of neurodegenerative diseases such as Alzheimer's disease, multiple sclerosis, glioblastoma and injuries li…
IMPACT CKD model projects up to 16.5% of the population across eight countries to suffer from chronic kidney disease by 2032 A new modelling analysis by AstraZeneca, IMPACT CKD, forecasts up to 16.5% of the population across eight countries will suffer from chronic kidney disease (CKD) by 2032, including a rise of up to 59.3% in advanced-stage.1 Presented at the 2024 ISN World Congress of Nephrology (WCN’24) in Buenos Aires, the study highlights an urgent and growing global health crisis with profound economic and environmental implications.1 IMPACT CKD is the first study to examine and forecast the vast, multi-dimensional impact of CKD over a 10-year time horizon across eight countries — the United States, Brazil, the United Kingdom, Spain, Germany, the Netherlands, China, and Aust…
Five new launches reinforce Baxter’s focus on differentiated products and enhance the company’s Pharmaceuticals portfolio in critical therapeutic areas Products feature ready-to-use formulations to help support patient safety and offer added convenience for healthcare professionals DEERFIELD, Ill. - 2024-04-11 Baxter International Inc. (NYSE:BAX), a global leader in injectables, anesthesia and drug compounding, announced the continued expansion of its Pharmaceuticals portfolio with five injectable product launches in the U.S.  “These launches demonstrate Baxter’s focus on differentiated products that address unmet patient needs in key therapeutic areas, including anti-infective and anti-hypotensive medications,” said Alok Sonig, executive vice president and group president, Ph…
- Alpine is a clinical stage biotechnology company focused on discovering and developing innovative, protein-based immunotherapies - - Alpine’s lead product, povetacicept, demonstrated best-in-class potential in patients with IgA nephropathy (IgAN); Phase 3 to initiate in H2 2024 - - Povetacicept holds promise as a pipeline-in-a-product, with clinical studies in additional serious diseases underway - - Alpine’s protein engineering and immunotherapy expertise augments Vertex’s toolbox and capabilities - - Vertex to host investor call today, April 10, at 4:30 pm ET - BOSTON & SEATTLE--(BUSINESS WIRE)--Apr. 10, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a biotechnology company focused on discovering and developing innovative,…
Recce recognized by the United Kingdom Government Innovation Agency among the most promising organizations for the UK AMR Inward Mission 2024 Recce chosen as one of 18 organizations globally for its potential to tackle the global health threat of AMR and superbugs Professor Dame Sally Davies, former England Chief Medical Officer, hosting a reception with selected organizations offering Recce strategic partnering opportunities in the AMR space SYDNEY, Australia, April 09, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced its selection by the United Kingdom’s (UK) Government Innovation Agency (Innovate UK) to partake in the prestigious UK Antimicrobial Resistance (AMR) Inw…
Portfolio expansion solidifies company's commitment to advancing cancer research and patient care BURLINGTON, N.C., April 8, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the strategic expansion of its precision oncology portfolio, solidifying its commitment to advancing cancer research and patient care on a global scale. The announcement underscores Labcorp's dedication to investing in scientific, diagnostic and laboratory innovations to support its pharmaceutical, biotechnology and clinical research partners in bringing groundbreaking therapies to market. Labcorp continues to demonstrate its leadership in precision oncology by expanding its portfolio of solutions that support the development of novel therapie…
Labcorp Plasma Detect is the first clinically validated, whole-genome sequencing MRD solution for early-stage colon cancer BURLINGTON, N.C., April 5, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the launch of Labcorp® Plasma Detect™, the first clinically validated, tumor-informed, whole-genome sequencing circulating tumor DNA (ctDNA) molecular residual disease (MRD) solution in early stage colon cancer to identify patients at increased risk of recurrence after surgery or adjuvant chemotherapy (ACT). This solution, which is designed for research use but also suitable for clinical applications, can be applied across solid tumors with a scalable and standardized approach to facilitate faster turnaround times whil…
Company recognized by a distinguished industry advisory board for its expertise and leadership in supporting the development of vaccines DURHAM, N.C., April 04, 2024 (GLOBE NEWSWIRE) -- Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, today announced it has been named “Best Contract Research Organization” at the 17th Annual Vaccine Industry Excellence (ViE) Awards. Winners were named across 13 categories, including Best Contract Research Organization, which recognizes the role of CROs in supporting the development of safe and effective vaccines. “We are honored to be recognized with this year’s ViE Award for Best Contract Research Organization,” said Amy McKee, MD, Chief Medical Officer &…
Dublin, Ireland, April 3, 2024 – ICON plc (NASDAQ: ICLR), a world-leading healthcare intelligence and clinical research organization, today announced that Chief Financial Officer, Brendan Brennan, will leave his role at ICON in quarter four this year for a new opportunity outside of the CRO industry.  Brendan has held the role since 2012 and will remain with the company in his current role as CFO to ensure a smooth transition to a newly appointed Chief Financial Officer.  ICON has commenced a search to identify the next CFO. “On behalf of the ICON Board and Leadership Team, I want to thank Brendan for his strong contributions to ICON over his 18 years, including 12 years as CFO,” said Steve Cutler, ICON’s CEO. “His effective leadership has contributed significant…
TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery More than 1.6 million people in the U.S. are affected by tricuspid regurgitation,1 which can severely impact quality of life Data from the TRILUMINATE™ Pivotal trial demonstrated that patients who received TriClip experienced a marked improvement in the severity of their symptoms and quality of life, with benefits sustained at one year ABBOTT PARK, Ill., April 2, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's first-of-its-kind TriClip™ transcatheter edge-to-edge repair (TEER) system that's specifically designed for the treatment of tricuspid regurgit…
Transaction to enhance Labcorp's laboratory services network  and expand access to the company's high-quality clinical laboratory services BURLINGTON, N.C. and MIAMI, March 28, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, and OPKO Health, Inc. (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, announced today that they have entered into an agreement for Labcorp to acquire select assets of BioReference Health, a wholly owned subsidiary of OPKO Health. Through this transaction, Labcorp will acquire BioReference Health's laboratory testing businesses focused on clinical diagnostics and reproductive and women's health across the United States outside of New York and New Jersey. This transaction includes pat…
Thermo Scientific™ LInspector™ Edge In-line Mass Profilometer Delivers Real-time, Full-Coverage Mass Loading Analysis for Battery Electrode Coating WALTHAM, Mass.--(BUSINESS WIRE)-- To address the needs of the rapidly growing battery market, Thermo Fisher Scientific today introduced the Thermo Scientific™ LInspector™ Edge In-line Mass Profilometer, which delivers full-width electrode mass loading measurement and provides battery manufacturers with the data needed to make better, safer batteries, more efficiently. The LInspector Edge analyzer introduces the next generation of metrology capabilities through a new analytical technique, in-line mass profilometry, measuring complete edge-to-edge coating profiles in milliseconds with unprecedented resolution and precision. Uniform, defect-free c…
The company’s drive to develop novel solutions for the world’s toughest healthcare challenges has earned it a spot on Fortune’s second annual list. From medical advances that tackle the world’s most pressing healthcare challenges to an internal culture focused on encouraging new and creative ideas, Johnson & Johnson has always put innovation front and center. For company leaders, it’s not just a trendy buzzword: A dedication to innovation has been instrumental since Johnson & Johnson’s founding in 1886. Innovation is also built into Our Credo, the mission statement that has guided the evolution of the company for more than 80 years. Now, that innovative drive has been formally recognized. Today, Johnson & Johnson was named to Fortune’s second annual ranking of America’s Most In…
Lausanne, SWITZERLAND and San Francisco, CA, USA, 26 March 2024 - Asceneuron SA, a clinical stage biotech company dedicated to targeting the root causes of neurodegenerative diseases, today announces that it has joined the Critical Path Institute’s, Critical Path for Alzheimer’s Disease (CPAD) Consortium. With its highly experienced leadership team and world class Scientific Advisory Board of leading experts in neurodegenerative diseases, Asceneuron is well positioned to contribute to the consortium. Asceneuron has an exemplary pipeline of O-GlcNAcase (OGA) inhibitors in clinical development that have the potential to halt disease progression in neurodegenerative diseases. Its lead asset, ASN51, is a potential best-in-class, orally administered, OGA inhibitor targeting tau aggregation and…
Cambridge Cognition Holdings plc (AIM: COG) has established a Scientific Advisory Board to provide scientific counsel and market insights, focusing on integrating blood-based biomarkers, collaborative cognitive assessments, and diversity in clinical trials. Chaired by Liam Kaufman, the board includes Professor Judith Jaeger, Professor John Harrison, and Francesca Cormack. Professor Jaeger, a neuropsychologist with extensive experience in clinical trials, brings expertise in early-phase projects and regulatory meetings. Professor Harrison, known for his work in cognitive skills enhancement, has aided over 80 CNS drug development organizations and contributed to Alzheimer’s disease studies. Matthew Stork, CEO of Cambridge Cognition, highlights the board's role in aligning with evolving tre…
Breyanzi offers a personalized treatment option delivered as a one-time infusion that provides deep and durable responses for patients with relapsed or refractory CLL or SLL who have historically had no standard of care In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with median duration of CR not reached, along with an established safety profile Breyanzi is now FDA approved for relapsed or refractory large B-cell lymphoma and CLL or SLL, bringing this differentiated CD19-directed CAR T cell therapy to more patients PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug…
Grant awarded to support the expansion of Almac’s small molecule API manufacturing plant Almac Sciences, a member of the Almac Group, has been awarded a Life Sciences Innovative Manufacturing Fund (LSIMF) Grant to support the expansion of its small molecule active pharmaceutical ingredients (API) manufacturing facility at its Global Headquarters in Craigavon, UK. The grant will support the installation of the expanded facility, already under construction, which is due for completion in Summer 2025. Once complete, the 30,000 sq ft facility will support small molecule API production at 100s kg to metric tonne scale. As announced by Jeremy Hunt, UK Chancellor, Almac was one of two UK pharmaceutical companies awarded the grant to support manufacturing expansion projects.  The Department for Sc…