Today Stories

The FDA approval of the first dispersible single tablet regimen containing dolutegravir increases age-appropriate treatment options for children living with HIV ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi B.V. (Shionogi) as shareholders, has announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of pediatric patients weighing 10kgs to <25 kgs with human immunodeficiency virus type 1 (HIV-1). In addition, a supplemental new drug application (sNDA) has been approved for Triumeq tablet, lowering the minimum weight that a child wi…

- Abbott and LISC invest more than $37 million to empower and grow diverse small businesses that provide manufacturing and essential products for healthcare companies - Initiative supports Abbott and LISC's commitment to increase diversity in healthcare and generate jobs and strengthen economies in underinvested communities ABBOTT PARK, Ill., and NEW YORK, March 30, 2022 /PRNewswire/ -- Abbott (NYSE: ABT) and the Local Initiatives Support Corporation (LISC) announced a $37.5 million initiative to provide diverse small businesses with the tailored growth capital, loans and support they need to compete, grow and create jobs. The initiative will support greater diversity in the healthcare industry by advancing a more inclusive supply chain for Abbott and other healthcare companies, while cont…

Ion Torrent Genexus Dx Integrated Sequencer enables rapid NGS for diagnostic applications and clinical research CARLSBAD, Calif., (March 29, 2022) -- Thermo Fisher Scientific today launched the CE-IVD marked Ion Torrent Genexus Dx Integrated Sequencer, an automated, next-generation sequencing (NGS) platform that delivers results in as little as a single day. Designed for use in clinical laboratories, the fully validated system enables users to perform both diagnostic testing and clinical research on a single instrument. “Next-generation sequencing has become an essential tool to bring the promise of precision medicine therapies to patients. With the automated, easy-to-use Genexus Dx Integrated Sequencer, any hospital – including regional and community hospitals – can bring NGS in-house, gi…

* Companies to leverage proprietary IgM antibody technology platform to discover agonists against three oncology targets and three immunology/inflammation targets * Collaboration to create, develop, manufacture and commercialize new class of potential therapeutics combining the superior features of multi-valent IgM antibodies over conventional IgG antibodies for stimulating cell surface receptors * IGM to receive $150 million upfront payments, potentially over $6 billion in aggregate development, regulatory and commercial milestones Paris, March 29, 2022 – Sanofi (NASDAQ: SNY) and IGM Biosciences, Inc. (Nasdaq: IGMS) today announced the signing of an exclusive worldwide collaboration agreement to create, develop, manufacture, and commercialize IgM antibody agonists against three oncology t…

Establishment of the first end-to-end Australian capability for product development and commercial scale production of mRNA, DNA and recombinant vaccines  By bringing together the technology, product development, GMP manufacturing, clinical and regulatory expertise of key consortium partners Technovalia, Sypharma and BioNet, Genetis will provide a unique Australian-based vaccine contract and product development manufacturing hub for Australian and offshore research organisations seeking access to quality capability and TGA approved products.  The founding partners have been sharing common interest and commitment in the fight against the COVID-19 pandemic through the rapid development, production and/or evaluation of several COVID vaccines. BioNet has established a strong DNA and mRNA manuf…

Construction begins on a new state-of-the-art manufacturing facility at Kent Science Park designed to support the manufacture of regulatory approved cannabis-based medicines This represents a significant commitment to the UK by GW Pharmaceuticals, now part of Jazz Pharmaceuticals, investing $100 million (£75m) and creating more than 100 highly skilled jobs LONDON, March 25, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and its subsidiary, GW Pharmaceuticals ("GW") – a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines – today announced the official initiation of construction of its new, state-of-the-art manufacturing facility at Kent Science Park (KSP) in Sittingbourne. The new state-of-the-art facility will be approximately…

On-shore manufacturing facility based in Melbourne, Australia, expected to produce up to 100 million mRNA respiratory vaccine doses annually CAMBRIDGE, MA / ACCESSWIRE / March 23, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the finalization of a strategic partnership with the Australian Federal Government to establish a state-of-the-art, domestic mRNA vaccine manufacturing facility in Australia. This finalizes the agreement in principle with the Australian Federal Government announced in December 2021. "We are delighted to reach this milestone with the Australian Government and finalize our first on-shore manufacturing agreement," said Stéphane Bancel, Chief Executive Officer of Moderna. "The Austral…

mRNA-1230 is a combination respiratory vaccine candidate against SARS-CoV-2 virus, influenza virus and respiratory syncytial virus (RSV) mRNA-1287 is a vaccine candidate against the four endemic human coronaviruses (HCoV-229E, -NL63, -OC43 and -HKU1) CAMBRIDGE, MA / ACCESSWIRE / March 22, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it is expanding its mRNA pipeline with two new development programs. This announcement reflects the Company's commitment to expanding its portfolio by building on Moderna's experience with Spikevax®, its COVID-19 vaccine. The development programs include a combination respiratory vaccine candidate and a new program against all four of the endemic human coronaviruses…

SUZHOU, China, March 22, 2022, Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has established a global clinical collaboration with Bristol Myers Squibb to evaluate the combination of TST001, an investigational humanized monoclonal antibody targeting Claudin18.2 developed by Transcenta, with Opdivo® (nivolumab), Bristol Myers Squibb's anti-PD-1 therapy, for the treatment of patients with unresectable locally advanced or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ). This collaboration includes two global phase I/II open-label, multi-center studies, one to be held in the U.S. an…

- Creation of new company combines strengths of three leading value-based care specialists- Execution on strategic expansion along the renal care continuum significantly expands Fresenius Medical Care's total addressable market in the U.S. from around $50 billion to around $170 billion- Establishing independent and integrated value-based care offering in-line with FME25 plan of refining and further growing future Care Delivery segment in the U.S. Fresenius Medical Care, the world's leading provider of products and services for individuals with kidney diseases, announced today it has entered into a binding agreement to create an independent new company that combines Fresenius Health Partners, the value-based care division of Fresenius Medical Care North America, with InterWell Health, the l…

Jointly fund and develop up to three antibody-drug conjugate programs for the treatment of cancer Paris, March 16, 2022. Sanofi and Seagen Inc. (Nasdaq:SGEN) today announced an exclusive collaboration agreement to design, develop, and commercialize antibody-drug conjugates (ADCs) for up to three cancer targets. The collaboration will utilize Sanofi’s proprietary monoclonal antibody (mAb) technology and Seagen’s proprietary ADC technology. ADCs are antibodies engineered to deliver potent anti-cancer drugs to tumor cells expressing a specific protein and Sanofi currently has one ADC in development. John Reed, M.D., Ph.D.Global Head of Research and Development, Sanofi“This collaboration will enable the synergistic combination of molecules and platforms to produce candidate medicines with th…

NORTH CHICAGO, Ill., March 15, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Scripps Research, an independent, non-profit biomedical research and drug discovery institute, today announced a global collaboration to develop potential novel, direct-acting antiviral treatments for COVID-19. "Constant change is something we've experienced throughout the COVID-19 pandemic, with the emergence of many new variants and the evolving needs of treatment options to combat more contagious, aggressive and severe strains of the virus," said Tom Hudson, M.D., senior vice president, R&D, chief scientific officer, AbbVie. "We are committed to bringing differentiated, next generation oral antiviral treatments to patients and ensuring broad access to address the diverse treatment needs around the world." Th…

Investment will accelerate the overall Sarclisa® development program Sanofi will continue to fully manage the clinical program and retain full rights and control of Sarclisa® (isatuximab) PARIS, March 15, 2022. Sanofi and Blackstone (NYSE: BX) today announced a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences (BXLS) will contribute up to €300 million to accelerate the global pivotal studies and the clinical development program for the subcutaneous formulation and delivery of the anti-CD38 antibody Sarclisa®, to treat patients with multiple myeloma (MM). If successful, BXLS will be eligible to receive royalties on future subcutaneous sales. The pivotal study for the subcutaneous formulation is expected to begin in the second half of 2022. For the…

GAITHERSBURG, MD, March 14, 2022 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced a research and evaluation collaboration with The Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute designated Comprehensive Cancer Center and part of NYU Langone Health. The collaboration is centered around NexImmune’s artificial antigen presenting cells' (aAPCs) ability to expand neoantigen-specific CD8+ T cells in apheresis material provided by melanoma patients. Dr. Jeffrey S. Weber, Deputy Director of the Laura and Isaac Perlmutter Cancer Center will guide the research and evaluat…

NORTH CHICAGO, Ill. and BUDAPEST, Hungary, March 11, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Gedeon Richter Plc. ('Richter') today announced a new co-development and license agreement to research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. The collaboration is based on the results of preclinical research carried out by Richter and includes several new chemical entities selected for development. AbbVie and Richter have collaborated for 15 years on Central Nervous System (CNS) projects, including globally launched products such as cariprazine (VRAYLAR® / REAGILA®). "In collaboration with Richter, we will continue to build on our research that seeks to provide additional insights into our understanding of caripra…

Digital Diagnostics and Baxter International Inc. announced a long-term strategic partnership to help front line care providers deliver high-quality care and improve care outcomes. The partnership includes plans to offer Digital Diagnostics’ industry-leading IDx-DR® autonomous AI software as a diagnostic service combined with the Welch Allyn® RetinaVue® 700 Imager.  Digital Diagnostics created IDx-DR, the autonomous AI diagnostic system for the detection of diabetic retinopathy (including diabetic macular edema) at the point-of-care. Only 15% of people with diabetes receive the recommended annual diabetic eye exam.1,2 Access to effective diagnostic services is an obstacle, especially in rural or underserved areas. It leaves many with undiagnosed and untreated levels of disease, and a highe…

BioNTech and Regeneron plan to jointly conduct clinical trials evaluating FixVac candidate BNT116 in combination with Libtayo for the treatment of advanced non-small cell lung cancer (NSCLC) The development costs for the trials will be equally shared between the parties The companies advance clinical development of FixVac and Libtayo combination to third tumor type building on their existing agreements in melanoma and prostate cancer by combining their complementary immunotherapies to pave the way for new treatment options in high medical need indications MAINZ, Germany, March 8, 2022 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced the expansion of its strategic collaboration with Regeneron to advance the Company’s FixVac candidate BNT116 in co…

As the Covid-19 pandemic continues to have a disproportionate impact on women, Organon invites other organisations to join them in their mission to adopt initiatives which help women prioritise their health. LONDON, UK — Organon (NYSE: OGN), a global women’s health company, is designating International Women’s Day (IWD) on 8th March as a day to recognise the growing health disparities that women face that have been exacerbated by the COVID-19 pandemic. Since its inception, IWD has focused on accelerating gender parity. Organon recognises the need for a global effort to address her health and understands that it needs to start with its own employees by giving them paid time off to attend to their own health needs. The company is also inviting organisations in the UK and across the globe to…

Moderna announces commitment to advance vaccines targeting 15 pathogens identified as biggest public health risk by WHO and CEPI into clinical studies by 2025 Moderna launches mRNA Access, a new collaborative enabling researchers around the world to utilize Moderna's mRNA technology platform to pursue research in their own labs on emerging and neglected infectious diseases Moderna expands commitment to never enforce COVID-19 patents in the Gavi COVAX AMC for 92 low- and middle-income countries Moderna has entered into a Memorandum of Understanding with the Government of the Republic of Kenya to establish its first mRNA manufacturing facility on the continent of Africa CAMBRIDGE, MA / ACCESSWIRE / March 7, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RN…

Acquires Swiss-based multi-disciplinary consultancy SFL (Solutions for Life Sciences) to accelerate the development of and access to innovative treatments SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat, a scientific-minded global clinical research organization (CRO), announced today the expansion and strengthening of its service capabilities by acquiring SFL (Solutions for Life Sciences). With headquarters in Basel, Switzerland and several European affiliates, SFL brings unique capabilities and a highly credentialed team to support a growing number of biotech, pharmaceutical and medtech companies. Led by Founder and CEO Shayesteh Fürst-Ladani, the SFL team has longstanding experience in providing strategic advice and operational support for all stages of product development, with in-house…