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Operationally ready by 2029, it will be the Company’s first-ever facility to cover the full manufacturing process for ADCs AstraZeneca intends to build a $1.5 billion manufacturing facility in Singapore for antibody drug conjugates (ADCs), enhancing global supply of its ADC portfolio. ADCs are next-generation treatments that deliver highly potent cancer-killing agents directly to cancer cells through a targeted antibody. The planned greenfield facility, supported by the Singapore Economic Development Board (EDB), will be AstraZeneca’s first end-to-end ADC production site, fully incorporating all steps of the manufacturing process at a commercial scale. Manufacturing of ADCs is a multi-step process that comprises antibody production, synthesis of chemotherapy drug and linker, conjugat…
A new research team at XSeed Labs – a collaboration between BioMed X and Boehringer Ingelheim, will develop disease models to understand wound healing and fibrosis. RIDGEFIELD, CT, May 16, 2024 – XSeed Labs – a collaboration between BioMed X and Boehringer Ingelheim, announces the start of its first research team on the Boehringer Ingelheim camp in Ridgefield, Connecticut. This research team’s main objective is to develop complex, physiologically relevant disease models that deepen our understanding of dysfunctional wound healing and fibrosis. The end goal is to study fibrosis, drug delivery strategies, and drug safety in parallel, in an effort to bridge the gap between research and development to improve patient outcomes accurately and efficiently. The new research team is led by Dr. Lo…
DEERFIELD, Ill. - 2024-05-15 Baxter International Inc. (NYSE:BAX), a global medtech leader, announced today the mission and logo for its proposed kidney care and acute therapies company, to be named Vantive. The Vantive mission, Extending Lives, Expanding Possibilities, will guide and inspire the proposed company, which will focus on vital organ therapies for acute and chronic kidney diseases and beyond. This larger purpose will drive Vantive employees to passionately develop solutions that meet the very human and often very individual needs of clinicians and patients, always striving to shape a better healthcare experience.   The Vantive logo includes a "V" motif divided into three parts to represent the innovative therapies, digital solutions, and advanced services the company delivers.…
More than half of all U.S. cervical cancer patients are underscreened1, which makes reducing barriers to sample collection and increasing access to screenings crucial to ultimately helping eliminate this deadly disease. Each year in the U.S., more than 13,000 patients are diagnosed with cervical cancer and approximately 4,000 die from this preventable disease, caused by HPV infection.1 Roche’s human papillomavirus (HPV) self-collection solution will improve access to testing by providing women the option to privately collect their own sample. Basel, 15 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the FDA approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United States. Screening for HPV can help identify women who are a…
-   Collaboration to leverage AbbVie's psychiatry expertise and Gilgamesh's innovative research platform to develop next-generation neuroplastogens for the treatment of psychiatric disorders NORTH CHICAGO, Ill. and NEW YORK, May 13, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Gilgamesh Pharmaceuticals today announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. This collaboration will leverage AbbVie's expertise in psychiatry and Gilgamesh's innovative research platform to discover novel neuroplastogens. Classic psychedelic compounds provide novel mechanisms to address mental health disorders, and some have shown promising clinical efficacy where other treatments have been ineffective. However, these first-generation comp…
The Danaher Beacon for Brain Injury Diagnostics seeks to identify mild Traumatic Brain Injury (TBI) earlier and more precisely. Scientists will evaluate new blood-based biomarkers using highly sensitive technology from Beckman Coulter Diagnostics. This approach could potentially be adapted for diagnosis of other neurological conditions. WASHINGTON, May 9, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR), a global science and technology innovator ("Danaher"), today launched a collaboration with Johns Hopkins University aiming to develop new methods for diagnosing mild TBI. As part of the Danaher Beacons program, researchers at Johns Hopkins University will leverage technology from Beckman Coulter Diagnostics, a Danaher subsidiary and leader in clinical diagnostics, to potentially est…
Axmed’s B2B marketplace aggregates demand for critical medicines in underserved regions to improve the availability, affordability, and distribution of life-saving medicine while extending manufacturer footprints in new markets.   Basel, Switzerland – May 8, 2024: For too long, low- and middle-income countries (LMICs) have borne the brunt of global health disparities—accounting for over 80% of the world's population and more than 90% of its disease burden—yet representing a mere 6% of global pharmaceutical revenue. Equitable access to high quality affordable medicines remains a daunting task, and addressing this challenge has never been more critical. Axmed, an innovative two-sided B2B marketplace platform, is taking a bold and meaningful step forward in addressing this disparity with the…
7 May 2024 UK-based Contract Research Organisation (CRO) Gentronix – a leading specialist toxicology firm based at Alderley Park – has been awarded the King’s Award for Enterprise after achieving a triple-figure revenue growth following rapid expansion in international markets. Gentronix recorded total growth of 239% in overseas earnings over the past three years, with the percentage of total sales exported rising from 71% to 81% over the same period, driving revenue to in excess of £10m per annum. The US has been a particularly strong area of growth and this market now makes up almost half of the firm’s international business, with demand continuing to increase across North America. As a result of the business’s success and enhanced overseas trading, Gentronix has received a prestigious K…
Boehringer Ingelheim today presented positive data from the HORNBILL Phase I/IIa study of BI 764524, the first ever study exploring a potential treatment for people living with diabetic macular ischemia (DMI). The study found that BI 764524 was well tolerated following intravitreal administration of single and multiple doses, meeting its primary safety endpoints and showed early signs of potential efficacy.1  DMI is a common, irreversible complication of diabetic retinopathy (DR) that may lead to blindness.1,2,3,4­ It can develop when the light sensitive tissues of the central retina do not receive adequate blood supply over a longer time. There are currently no approved treatments for DMI.  The current standard of care for advanced DR includes intravitreal anti-VEGF treatment or invasi…
Noninvasive urine-based biomarker testing can support routine testing for graft dysfunction WEST HILLS, Calif.--(BUSINESS WIRE)-- For organ transplant recipients, life post-transplant involves a delicate balance between invasive monitoring and immunosuppression to reduce the risk of rejection, both of which may carry complications. Now, a simple, urine-based assay that detects the CXCL10 chemokine may make care more convenient and less invasive for the nearly 250,000 Americans living with a kidney transplant. Thermo Fisher Scientific One Lambda Laboratories, a CLIA facility in Fishers, Ind., has introduced a new CXCL10 testing service, which allows for non-invasive urine sample collection and testing, with results available in as little as 24 hours, providing valuable information faster th…
Flower Mound, Texas, USA – April 30, 2024 Stryker (NYSE: SYK), a global leader in medical technologies, announced today that it has completed the acquisition of mfPHD, a leader in modular stainless steel wall systems for hospitals and ambulatory surgery centers. Stryker will now be the provider of Fortress, a modular wall system that consolidates construction timelines, allowing for earlier operating room utilization as well as expedited room repair or modification when disruptive events occur. This acquisition allows for innovative product development opportunities to build out an ecosystem of embedded technologies delivering data and analytics for an intelligent operating room, minimizing downtime and costly renovations. "mfPHD aligns with Stryker’s enterprise strategic plans of expan…
New state-of-the-art research and development (R&D) facility at Ludwigshafen to expand discovery and development of new medicines across core therapeutic areas Investment reinforces the importance of the Rhineland-Palatinate site within AbbVie’s global network Construction of the new R&D building expected to complete in 2027 LUDWIGSHAFEN, Germany, April 29, 2024 – AbbVie breaks ground on a new central research building, “LUnA” (LUdwighafens neue Arbeitswelt) and is investing approximately €150 million in its second largest R&D location worldwide. A state-of-the-art research and laboratory building is being built on the main campus and will be home to more than 300 researchers and scientists. The facility will be built with modern and sustainable infrastructure features, creat…
More than 20 million people in the U.S. are living with peripheral artery disease (PAD) yet there have been limited treatment options The first-of-its-kind Esprit™ BTK Everolimus Eluting Resorbable Scaffold dissolves over time after it has opened blocked arteries below the knee (BTK) The Esprit BTK System is a dissolving stent that offers the possibility of better outcomes for people with the most severe form of PAD ABBOTT PARK, Ill., April 29, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK). The Esprit BTK System is designed to keep a…
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50% vs. Faslodex standard of care in a biomarker-altered population AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been recommended for approval in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the CAPItello-291 Phase III trial published in The N…
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- IQVIA (NYSE:IQV) today announced that Wendy Stewart, president of Clinical Operations at IQVIA, and Susan Barnes, senior director of IQVIA Biotech Strategic Operations, have been honored with the Healthcare Businesswoman's Association Luminary and Rising Star Awards, respectively. Wendy earned the award for her remarkable contributions to the healthcare industry, including her efforts in leading the teams responsible for the record-breaking delivery of COVID vaccine trials. She currently leads a diverse and global organization of over 12,000 employees that is accountable for overall operational delivery for clinical trials across 60+ countries. In addition she has made significant contributions to advancing opportunities for women in Clinical…
Upon completion, this acquisition will expand Lilly's growing U.S. capacity to produce the latest life-changing medicines INDIANAPOLIS and LINCOLNSHIRE, Ill., April 22, 2024 – Eli Lilly and Company (NYSE: LLY) and Nexus Pharmaceuticals, LLC today announced a definitive agreement for Lilly to acquire a manufacturing facility from Nexus, a leading sterile manufacturer in the pharmaceutical industry. The acquisition of this FDA-approved facility in Pleasant Prairie, Wisconsin will further expand Lilly's global parenteral (injectable) product manufacturing network and support increased demand for the company's medicines. Lilly estimates that production at this facility could begin at the end of 2025. “The acquisition of this state-of-the-art facility underscores our unwavering commitment to gr…
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…