Pharmaco - Today Stories

In the MCL cohort of TRANSCEND NHL 001, Breyanzi delivered responses in 85.3% of patients with a one-time infusion while demonstrating a consistent safety profile across clinical trials Breyanzi is the only CAR T cell therapy approved by the FDA for four distinct subtypes of non-Hodgkin lymphoma, bringing this personalized therapy to the broadest array of patients with B-cell malignancies PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted approval for Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of s…

DUBLIN, May 22, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced a strategic collaboration with Life Science Cares to drive social impact through employee volunteerism in the United States. This partnership reinforces Jazz's commitment to supporting the communities in which employees work and live. Life Science Cares is a collective effort to activate the financial and human capital of the life sciences industry across several regions in the U.S. – and partner with nonprofits – to disrupt the cycle of poverty and inequality in those communities. With hubs around Jazz's U.S. offices in Palo Alto, Philadelphia and San Diego, Life Science Cares will help enable Jazz's goals to harness the passion of its employees to make a meaningful difference in their communities…

Today Boehringer Ingelheim and OSE Immunotherapeutics SA (OSE), a clinical stage biotech company (ISIN: FR0012127173; Mnemo: OSE), announced a major expansion of their partnership. Two new projects to develop first-in-class treatments will be added to the ongoing anti-SIRPα immuno-oncology programs. The first involves broadening the therapeutic evaluation of an already partnered asset to reach more patients and the other a new asset acquisition: Reflecting an amendment of the existing collaboration and license agreement for the anti-SIRPα immuno-oncology compounds BI 765063 and BI 770371, which are being investigated in Phase I clinical studies in advanced solid tumors, development will now also be pursued in cardiovascular-renal-metabolic (CRM) diseases. A new preclinical program will…

Paris, New York, N.Y., and San Francisco, CA, May 21, 2024. Sanofi, Formation Bio and OpenAI are collaborating to build AI-powered software to accelerate drug development and bring new medicines to patients more efficiently. The three teams will bring together data, software and tuned models to develop custom, purpose-built solutions across the drug development lifecycle. This represents a first collaboration of its kind within the pharma and life sciences industries. Sanofi will leverage this partnership to provide access to proprietary data to develop AI models as it continues on its path to becoming the first biopharma company powered by AI at scale. Paul Hudson CEO, Sanofi“This unique collaboration is the next significant step in our journey to becoming a pharmaceutical company substan…

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…

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…

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…

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…

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…

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…