Pharmaco - Today Stories

The acquisition of LumiraDx’s Point of Care technology received all required antitrust and regulatory clearances. LumiraDx’s transformative Point of Care solution will complement Roche’s diagnostics portfolio across Clinical Chemistry, Immunochemistry, Coagulation and Molecular, and across multiple disease areas. By integrating LumiraDx, Roche will further its ambition to deliver decentralised solutions that expand global access to testing in primary care settings worldwide. Basel, 29 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the completion of the acquisition of LumiraDx’s Point of Care technology, following the receipt of all required antitrust and regulatory clearances. Roche will now embark on the full integration of the company’s innovative multi-assay point of c…

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9) after up to four years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients. NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted conditional marketing authorization for DURVEQTIX® (fidanacogene elaparvovec), a gene therapy for the treatment of severe and moderately severe hemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74. DURVEQTIX is designed to enable people l…

CHINO HILLS, CA / ACCESSWIRE / July 25, 2024 / SOHM, Inc. (OTC PINK:SHMN) (the "Company"), a pharmaceutical and upstart biotechnologycompany that manufactures and markets generic drugs covering numerous treatment categories, announced that it has signed a new agreement with Standford University. In an exciting development, SOHM announces a groundbreaking collaboration of ABBIE Technology with Stanford University, one of the world's leading research institutions. This strategic partnership aims to bring together the innovative prowess of SOHM Inc. with the cutting-edge expertise of Stanford University to drive forward advancements in cell engineering and gene editing, Dr. David Aguilar, COO, said. Further, Dr. Aguilar added that the collaboration would encompass joint research projects, kno…

DH Diagnostics LLC Centers aim to accelerate drug development by speeding and streamlining development and commercialization of companion diagnostics. Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP)-certified laboratories will bring technologies and assays from multiple Danaher subsidiaries together under a single roof. WASHINGTON, July 17, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) ("Danaher"), a global science and technology innovator, announced the launch of two new Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP)-certified labs intended to accelerate the development of Companion Diagnostics (CDx) and Complementary Diagnostics (CoDx). "Our investments in these centers of innovation uniq…

Stryker has been once again named a top-scoring business on the Disability Equality Index® (DEI) by the nation’s largest disability rights organization, the American Association of People with Disabilities, and Disability:IN, the global business disability inclusion network, for our efforts to advance inclusion for people with disabilities. The Disability Equality Index (DEI) is a comprehensive benchmarking tool that helps companies build a roadmap of measurable, tangible actions that they can take to achieve disability inclusion and equality. “We are thrilled to be recognized as a 'Best Place to Work for Disability Inclusion' for the third consecutive year,” said Bernard O'Connor, president of Stryker's Allies for All Abilities (3A) employee resource group and Vice President, Advanced Ope…

Kalamazoo, Mich., USA – July 15, 2024 – Stryker (NYSE: SYK), a global leader in medical technologies, has completed the previously announced acquisition of Artelon, a privately held company specializing in innovative soft tissue fixation products for foot and ankle and sports medicine procedures. “Integrating Artelon’s portfolio into Stryker’s offerings will allow us to deliver best-in-class soft tissue fixation solutions,” said Tim Lanier, president of Stryker’s Trauma & Extremities division. “This acquisition strengthens our competitive edge. Leveraging Artelon’s unique synthetic technology and extensive expertise positions us to continue driving innovation and solidify our leadership in the foot and ankle and sports medicine segments.” Artelon’s technologies complement and expand th…

AstraZeneca today announced the successful completion of the acquisition of Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The acquisition bolsters the Alexion, AstraZeneca Rare Disease late-stage pipeline and expands on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism. In patients with hypoparathyroidism, a deficiency in parathyroid hormone (PTH) production results in significant dysregulation of calcium and phosphate, which can lead to life-altering symptoms and complications, including chronic kidney disease.1  This programme, together…

RESEARCH TRIANGLE PARK, N.C.– July 11, 2024 – IQVIA™ (NYSE:IQV) today announces that a leading, independent research firm, Everest Group, has recognized IQVIA as a Leader in its Life Sciences Regulatory and Medical Affairs Operations PEAK Matrix® Assessment 2024 survey, which measures both market impact and delivery effectiveness. The Everest Group report highlights IQVIA’s focus on innovation and its comprehensive portfolio of solutions that accelerates drug development from molecule to market. IQVIA partners with customers to plan, generate and disseminate trustworthy clinical and medical evidence which drives the right stakeholder dialogue throughout the asset lifecycle to advance regulatory and healthcare decision making that improves patient outcomes. A strong global footprint, along…

Acquisition to expand Lilly's immunology pipeline with oral integrin therapies INDIANAPOLIS and WALTHAM, Mass., July 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Morphic Holding, Inc. (NASDAQ: MORF) today announced a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for treatment of serious chronic diseases. Morphic's lead program is a selective oral small molecule inhibitor of α4β7 integrin for the treatment of inflammatory bowel disease (IBD) that has the potential to improve outcomes and expand treatment options for patients. This molecule (known as MORF-057) is being evaluated in two Phase 2 studies in ulcerative colitis and one Phase 2 study in Crohn's disease. Additionally, Morphic is developing a precli…

Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness Designed to simplify administration, Vabysmo PFS provides retina specialists a ready-to-use option Vabysmo PFS will be available for people living with nAMD, DME and RVO Basel, 05 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to 80 million people globally.1-4 The Vabysmo PFS…

INDIANAPOLIS, June 25, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced a collaboration with OpenAI that will allow Lilly to leverage OpenAI's generative AI to invent novel antimicrobials to treat drug-resistant pathogens. Antimicrobial resistance (AMR) is one of the top public health and development threats across the global health landscape. "Our collaboration with OpenAI represents a groundbreaking step forward in the fight against the growing but overlooked threat of antimicrobial resistance," said Diogo Rau, executive vice president and chief information and digital officer at Lilly. "Generative AI opens a new opportunity to accelerate the discovery of novel antimicrobials and the development of custom, purpose-built technologies in the battle against drug-resistant pa…

In 2024, Novo Nordisk plans to boost its current investments, aiming to allocate USD 6.8 billion towards production, a significant increase from the previous year's investment of USD 3.9 billion*. Bagsværd, Denmark, 24 June 2024 – Novo Nordisk today announced plans to invest 4.1 billion US dollars (approx 27 billion Danish kroner) to build a second fill and finishing manufacturing facility in Clayton, North Carolina, and grow its ability to produce current and future injectable treatments for people with obesity and other serious chronic diseases. Marking one of the largest manufacturing investments in Novo Nordisk’s history, the expansion will add 1.4 million square feet of production space for aseptic manufacturing and finished production processes, doubling the combined square footage o…

The cobas® c 703 and cobas® ISE neo analytical units, deliver higher testing capacity and increased automation helping to improve laboratory workflows and advance patient care. The new cobas c 703 analytical unit offers industry-leading high throughput clinical chemistry testing1 with up to 2,000 tests per hour and 70 reagent positions, doubling the existing clinical chemistry throughput on cobas pro integrated solutions. The new cobas ISE neo analytical unit delivers more efficient ISE testing, reducing hands-on time through automated maintenance. Basel, 24 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its new analytical units, cobas® c 703 and cobas® ISE neo, for the cobas® pro integrated solutions, in countries accepting the CE mark. The cobas pro integr…

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, providing diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is the tenth most common cancer worldwide.3 Basel, 20 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the first clinically approved, highly-sensitive in-situ hybridisation (ISH) test, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries accepting the CE Mark. The test is d…

– Analysis Shows Manufacturing of Yescarta in Second-Line Treatment of Relapsed/Refractory Large B-cell Lymphoma Can Help Reduce Time from Leukapheresis to Infusion vs. Third-Line+ Treatment – – Data Builds on Previous Evidence on the Association Between Timely Infusion and Patient Outcomes – – Preliminary Results Supporting Safety and Feasibility of Outpatient Administration of Yescarta and Tecartus ® to be Presented – SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced results from three new analyses for Yescarta® (axicabtagene ciloleucel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including both new clinical research and real-world evidence highlighting manufacturing and product characteristics of Yescarta, and outpatient admi…

Bold initiative to boost the capacity of research sites enters Beta testing and piloting RESEARCH TRIANGLE PARK, N.C. – June 12, 2024 – IQVIA (NYSE:IQV) today announced the launch of One Home for Sites™, a new technology platform that acts as a single sign-on and a single dashboard for the key systems and tasks a clinical research site needs to perform across all of the clinical trials it is conducting. Clinical research sites manage scores of usernames and passwords in dozens of software applications as they navigate through numerous tasks they must complete each day in conducting clinical trials. This technology overload reduces the time site staff have to recruit and treat patients and the number of trials a site is able to manage simultaneously. IQVIA One Home for Sites meets this chal…

Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive resected non-small cell lung cancer, as demonstrated in the Phase III ALINA study1 Alecensa’s approval addresses an urgent unmet need in the early-stage setting where about half of all people experience disease recurrence following surgery, despite adjuvant chemotherapy2 Early diagnosis and treatment of lung cancer can reduce the burden associated with progressive disease and give people the best possible chance of cure3-6 Basel, 10 June 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Alecensa® (alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with anaplastic lymphoma kinase (ALK)-positi…

AstraZeneca today announced the successful completion of the acquisition of Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments. This acquisition complements AstraZeneca’s leading oncology portfolio with the addition of the Fusion pipeline of RCs, including their most advanced programme, FPI-2265, a potential new treatment for patients with metastatic castration-resistant prostate cancer (mCRPC), and brings new expertise and pioneering R&D, manufacturing and supply chain capabili…

Labcorp® Tissue Complete, a comprehensive genomic profiling service, now available in Geneva and Shanghai to support global clinical trials Company expands leadership in liquid biopsy comprehensive genomic profiling for solid tumors with the integration of OmniSeq® INSIGHT circulating tumor DNA BURLINGTON, N.C., June 3, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced new strategic service offerings within its precision oncology portfolio. The enhancements strengthen Labcorp's leadership as a premier, single-source partner for biopharmaceutical companies in advancing cancer research and patient care both in the United States and globally. "Labcorp's portfolio expansion enhances our integrated service offerings a…

Collaboration leverages synergies of QIAGEN’s OmicSoft omics data through Evotec’s analysis platform PanHunter Customers accelerate target discovery decisions with high-quality multi-omic evidence, and expanded analysis capabilities Hamburg, Germany, and Venlo, the Netherlands, 03 June 2024:Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a collaboration to leverage QIAGEN’s OmicSoft Land Databases through Evotec’s PanOmics data access and analysis platform PanHunter. Combining comprehensive data sets with advanced analytics capabilities will enable enhanced multi-omics data insights, better disease understanding and more precise therapeutic interventions. Omics data offers exten…