PharmiWeb.com - Global Pharma News & Resources

Today Stories

With a commitment to listen to women to understand their health needs and provide the solutions that are so urgently needed Organon, London, UK, 3 June 2021 – Organon (NYSE: OGN) has today launched as the only global health company of its size, with a singular vision: to make a better and healthier every day for every woman. With a majority-female Leadership Team, the company will be headquartered in the US, with offices across the globe including one in Shoreditch, London. Organon has more than 60 products across an international footprint that will serve people in more than 140 countries, with nearly 80% of its approximately $6.5 billion in annual revenue generated outside the U.S. “It’s exciting to take the helm in a new and vibrant company with such a strong purpose; a commitment to i…
New agreement with Lonza will increase drug substance production in Europe by the fourth quarter 2021 Lonza Geleen will support the production of an additional 300 million doses per year Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has entered into an additional agreement with Lonza (SIX: LONN) to support drug substance manufacturing for its global supply chain. The agreement will establish a new production line at Lonza’s Geleen site in the Netherlands, contributing to the supply of an additional 300 million doses of Moderna’s updated booster variant vaccine candidate, if authorized, per year, at a 50 µg dose. In addition to previously announced investments in drug substance manufacturing with RO…
Bagsværd , Denmark and Tokyo, Japan, 1 June 2021 – Heartseed Inc. and Novo Nordisk A/S today announced that they have entered into an exclusive worldwide collaboration and licence agreement for development, manufacturing and commercialisation of Heartseed’s lead asset HS-001. HS-001 is an investigational cell therapy using purified cardiomyocytes derived from induced pluripotent stem cells (iPSC), which is currently under development by Heartseed for the treatment of heart failure. Heartseed is planning to initiate a phase 1/2 clinical trial in Japan (LAPiS Study) in the second half of 2021 evaluating the safety and efficacy of HS-001 for the treatment of heart failure caused by ischemic heart disease. Japan’s Pharmaceutical and Medical Devices Agency has approved Heartseed’s Clinical Tria…
Geneva, Switzerland, May 28, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company"), a biopharmaceutical company with its lead compound RLF-100™ (aviptadil) in advanced clinical development to treat COVID-19 induced respiratory disorders, today announced the appointment of Taneli Jouhikainen, M.D., MBA, to the newly created position of Chief Operating Officer (COO), effective June 1, 2021. The position was created to stay abreast with Relief’s strategic transition from a clinical-stage company to a diversified, fully integrated product-driven entity. Dr. Jouhikainen will oversee all internal product development and intellectual property activities and will be an important contributor to the Company’s growth strategy and corporate development efforts. He…
Two-stage design will evaluate vaccine formulations targeting original D.614 virus as well as B.1.351 variant, in diverse geographies with multiple circulating variants A booster study program will begin in the coming weeks to complement Phase 3 trial Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved in Q4 2021 PARIS and LONDON – May 27, 2021 – Today, Sanofi and GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa, and Latin America. The prim…
Baxter International Inc. (NYSE:BAX), a global leader in acute care, today announced the global launch of PrisMax 2, the latest version of the company’s next-generation platform. PrisMax 2 is designed to help simplify delivery of continuous renal replacement therapy (CRRT) and other organ support therapies, while providing hospitals the flexibility to meet the unique demands of the intensive care unit (ICU). The PrisMax 2 system features new solutions within the company’s TrueVue digital health portfolio, as well as the PrismaLung+ blood-gas exchanger that delivers extracorporeal carbon dioxide removal (ECCO2R) therapy to support the management of acute respiratory dysfunction. PrisMax 2 and TrueVue will soon be available in more than 20 countries across the United States and Europe. Prism…
Johnson & Johnson Limited is pleased to announce the appointment of Charmaine England as Area Managing Director for Consumer Health Northern Europe, effective 17 May 2021.  England will oversee the Northern Europe business, which includes the UK, Ireland, Norway, Sweden, Denmark and Finland. She will manage a portfolio of iconic Johnson & Johnson Consumer Health brands, including AVEENO®, JOHNSON’S®, LISTERINE®, NEUTROGENA®, OGX®, CALPOL® and NICORETTE®. In her new role, England joins the company’s Europe, Middle East and Africa (EMEA) Consumer Health Leadership team, where she will focus on meeting fast-evolving consumer needs, deepening partnerships with customers, and building an empowered team. England previously served as Managing Director for Johnson & Johnson’s Consumer…
The agreement will further enable global supply of mRNA-1273, Moderna’s COVID-19 vaccine with Samsung Biologics’ fill and finish manufacturing service May 22, 2021-- Moderna (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing a fully integrated end-to-end contract development and manufacturing service, today announced a Manufacturing Services and Supply Agreement in which Samsung Biologics will provide large scale, commercial fill-finish manufacturing for mRNA-1273, Moderna’s COVID-19 vaccine. Upon execution of the deal, technology transfer will commence immediately at Samsung Biologics’ facilities in Incheon, South Korea, utilizing a state-of-the-art production line equip…
New agreement to supply 900 million doses to the European Commission (EC), with option to request up to an additional 900 million doses Additional dose deliveries beginning December 2021 through 2023 Pfizer and BioNTech have now committed a total of up to 2.4 billion doses of COMIRNATY® to the EC since the beginning of the pandemic Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the European Union (EU), with an option for the EC to request up to an additional 900 million doses. This new agreement is in addition to the 600 million doses that have already been committed to the EU through 2021. The additional 900 million agreed doses are exp…
COVID-19 made 2020 the most challenging year in decades – but clinical researchers rose to the challenge. Thanks to clinical trials, millions of doses of life-saving vaccines have been developed and administered around the world, giving hope for a better year ahead. Hope. That’s what clinical researchers provide. Every day, they rise to a new challenge and give patients and families hope for a healthier, more promising tomorrow. On this Clinical Trials Day, the Association of Clinical Research Professionals (ACRP) thanks clinical researchers around the world for continuing to rise to the challenge and give us hope. Hope in the battle against infectious disease. Hope in the battle against cancer. Hope in the battle against anything that challenges our pursuit of a better tomorrow. Why May 2…
- American Heart Association and Abbott announce new initiative to advance health equity, fight high blood pressure and chronic conditions in greater Austin area The American Heart Association, the world’s leading nonprofit organization focused on heart and brain health for all, and the global healthcare company Abbott, today announced a new multi-year initiative to reduce high blood pressure and chronic diseases affecting historically underserved local communities in Austin, Texas. The initiative is made possible through a generous financial contribution from Abbott, and will support three Federally Qualified Healthcare Clinical Systems (FQHCs) in Central Texas in providing educational resources, support and self-monitoring devices necessary for high-risk hypertensive and diabetic patient…
Merck to support up to six additional research projects at the BioMed X Institute in Heidelberg within the next six years Call for application for a global crowdsourcing project, ‘Regulatory T Cell Dysfunction in Autoimmunity and Inflammaging’ Merck, a leading science and technology company, today announced the extension of its ongoing collaboration with BioMed X, Heidelberg, Germany. Under the new agreement, Merck will start up to six additional research projects at the BioMed X Institute, building on ongoing research projects in the fields of oncology (DNA damage response and RNA splicing) and autoimmunity (intestinal epithelial barrier in autoimmune diseases). The next joint global crowdsourcing project will explore mechanisms of immune senescence and mitochondrial dysfunction in regu…
Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups High immune response after a single dose in patients with prior infection shows strong booster potential Global Phase 3 study expected to start in the coming weeks The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks. The Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerab…
As part of the agreement, Biogen will leverage Envisagenics’ AI platform with the goal of better understanding Central Nervous System diseases Biogen Inc. (Nasdaq: BIIB) and Envisagenics today announced a new collaboration to advance ribonucleic acid (RNA) splicing research within central nervous system (CNS) diseases. As part of the collaboration, Biogen will leverage Envisagenics’ proprietary artificial intelligence (AI)-driven RNA splicing platform, SpliceCore®, to define and understand the regulation of different RNA isoforms in CNS cell types. Genetic information encoded in the human chromosome is converted into RNA molecules which is then used as the template to make proteins. RNA splicing is the process that trims out extra information embedded in the intermediate RNA molecules, a…
CHICAGO and ABBOTT PARK, Ill., May 12, 2021 – United and Abbott today announced a first-of-its-kind collaboration to use Abbott’s BinaxNOW™ COVID-19 Home Test and Abbott’s NAVICA app to help make the international travel experience more seamless. Recently updated CDC guidelines permit travelers to self-administer a rapid antigen test under the real-time supervision of a telehealth service and use the verified negative test result to board an international flight to the U.S. if they test negative. “We appreciate the private sector proactively helping travelers have access to easy, reliable COVID-19 test options,” said CDC Director Rochelle P. Walensky, MD, MPH. “Comprehensive testing that is easy, rapid, accurate and trusted is a fundamental strategy for preventing the spread of COVID-19.” …
AberInnovation’s BioAccelerate has been incubating some of the most promising bioscience companies in Wales for three years now. Previous successes have included sugar industry disrupters ARCITEKBio and high-end mead producers Shire Meadery, both now resident at the AberInnovation Incubator building on the outskirts of Aberystwyth.   With the second phase of this year’s BioAccelerate now underway, let’s take a look at some of the brightest ideas coming out of the new hub for collaborative R&D and innovation in west Wales.   Amigrow   At the cutting edge of several emerging technologies, Amigrow aims to leverage artificial intelligence (AI), satellite imagery, Internet of Things (IoT) and crowdsourced data to transform the way food is grown worldwide.   Through effectively harnessing t…
Collaboration aims to identify novel AAV capsids with enhanced properties to facilitate the development of new gene therapies for CNS and neuromuscular disorders Capsigen’s screening technology is designed to produce dose optimized, fit for purpose vectors that may have applicability across Biogen’s gene therapy pipeline Capsigen to receive a $15 million upfront payment and is eligible to receive potential research, development and commercial milestone payments Biogen Inc. (Nasdaq: BIIB) and Capsigen Inc. announced today that they have entered into a strategic research collaboration to engineer novel adeno-associated virus (AAV) capsids that have the potential to deliver transformative gene therapies that address the underlying genetic causes of various CNS and neuromuscular disorders. A…
Lupus is a global health problem that affects people of all nationalities, races, ethnicities, genders, and ages. Lupus can affect any part of the body in any way at any time, often with unpredictable and life-changing results. Important Facts to Know about Lupus: It is a serious and potentially life-threatening autoimmune disease. It can damage any organ or tissue from the skin or joints to the heart or kidneys. It develops in response to factors both inside and outside of the body; however, the exact cause of Lupus is unknown. Symptoms of Lupus come and go and change over time which makes it difficult to diagnose. Common symptoms include joint pain, skin rashes, overwhelming fatigue, and fevers that last for days or weeks. Lupus is not contagious. Whilst there isn’t a cure for Lupus, it…
- A new, first-of-its-kind study known as TAP-CHF leverages expertise across Abbott's cardiovascular portfolio to optimize treatment for patients suffering from both AFib and heart failure - The trial will utilize Abbott technology including cardiac ablation and sensors to monitor for both pulmonary artery pressure and abnormal heartbeats - Historically, treating patients with both AFib and heart failure has been challenging, with few effective treatments or options to adequately manage both conditions simultaneously Abbott (NYSE: ABT) today announced a new trial focused on improving the treatment for people simultaneously battling both atrial fibrillation (AFib) and heart failure. The first-of-its-kind trial aims to provide new insights into more effective treatment for patients with AFib…
Projects led by collaborating researchers from the two organizations will focus on autoimmune diseases and inflammatory conditions PARIS and Palo Alto, CA – May 6, 2021 – Sanofi has entered into a three-year research collaboration with Stanford University School of Medicine. Together, the two organizations and their scientists will work to advance the understanding of immunology and inflammation through open scientific exchange. Additionally, Sanofi will provide funding and scientific inputs into projects of mutual interest, crossing multiple therapeutic areas including autoimmune diseases and inflammatory conditions. “We look forward to working with some of the most innovative scientists in the human immunology community. Together we will explore groundbreaking concepts and obtain deepe…