PharmiWeb.com - Global Pharma News & Resources

Today Stories

Trial will evaluate potential of next generation of influenza vaccines with combined mRNA technology and flu vaccine development expertise Positive preclinical safety and immunogenicity data for mRNA influenza vaccine candidates support initiation of Phase 1 clinical trial Interim data anticipated by the end of 2021; outcomes from this clinical trial will inform next steps of our mRNA-based influenza vaccine program and strategy Sanofi Pasteur, the vaccines global business unit of Sanofi and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, have initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate co…
Updated version of highly sensitive and accurate COVID-19 PCR kit accounts for known and future viral mutations Thermo Fisher Scientific, the world leader in serving science, today announced the launch of a new CE-IVD-marked COVID-19 test. The TaqPath COVID-19 Fast PCR Combo Kit 2.0. expands Thermo Fisher's menu of highly accurate tests that detect active SARS-CoV-2 infections. The kit uses an advanced assay design which compensates for current and emerging variants by using eight total targets across three genomic regions of the virus. This approach helps to ensure the test provides accurate results even as the virus that causes COVID-19 continues to mutate. "COVID-19 variants can be more transmissible and potentially impact efficacy of diagnostics, vaccines and therapies, threatening to…
NEW YORK & LONDON, June 21, 2021 — Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases, is pleased to announce the appointment of Dr. Kevin Schutz, PharmD, as Vice-President of Regulatory Affairs. Dr. Schutz will lead regulatory interactions related to clinical studies in the United States, Europe and Asian countries. Dr. Schutz has over 19 years of pharmaceutical industry experience including 14 years of Regulatory Affairs experience. He has focused on disease indications with high unmet medical needs, in Neurology (including multiple sclerosis), Pulmonology (including infectious disease), and other potential disease indications, which the Company is currently deve…
Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC). MORAb-202 is Eisai’s first ADC and combines Eisai’s in house developed anti-folate receptor alpha (FRα) antibody, and Eisai’s anticancer agent eribulin, using an enzyme cleavable linker. It is a potential best-in-class FRα ADC with a favorable pharmacology profile and demonstrated single agent activity in patients with advanced solid tumors. Eisai is currently investigating MORAb-202 in FRα-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Pha…
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today the creation of the Kenneth C. Frazier Award for Maternal Health Equity, a grant award that will be bestowed annually to one organization in recognition of its commitment to and progress toward more equitable, high-quality maternal health care. The award will be granted by Merck for Mothers, Merck’s global initiative to help create a world where no woman has to die while giving life. The Kenneth C. Frazier Award for Maternal Health Equity is named in recognition of the legacy and commitment to maternal health by Kenneth C. Frazier, chairman and chief executive officer, Merck. Merck for Mothers flourished under his leadership following its creation nearly a decade ago and serves as only one of many example…
Novo Holdings A/S, a leading global life sciences investor, today announced it has acquired BBI Group (“BBI”), a leading supplier of products and services to the global diagnostics and life sciences industries, from Exponent for an enterprise value of over GBP 400 million. Novo Holdings will be the majority shareholder of the company. Founded in 1986, BBI provides critical reagents and immunoassay development, lateral flow development, diagnostic manufacturing services, and smartphone reader technologies to a global blue-chip customer base that includes Thermo-Fisher, Merck and Siemens. The company’s market-leading brand, BBI Solutions, provides a range of products, including antibodies, antigens, labels, complementary reagents and point of care tests. BBI is headquartered in South Wales a…
INTEGRATED PLATFORM APPROACH TO RESPOND TO THE CHALLENGES OF PANDEMIC PREPAREDNESS, RAPID RESPONSE AND DELIVERABILITY PRROTECT COMBINES FIRST-IN-CLASS PROGRAMMES ACROSS THERAPEUTIC MODALITIES, ACCELERATED R&D TIMELINES FOR HIGHLY EFFECTIVE NEUTRALISING ANTIBODIES WITH AI/ML PREDICTION TOOLS (J.HAL℠) AND MANUFACTURING PLATFORM (J.POD®) Hamburg, Germany, 15 June 2021: Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that the Company has launched an initiative for pandemic preparedness (“PRROTECT”). PRROTECT leverages a comprehensive set of novel projects and technologies to be better prepared for and respond faster to viral pandemics of the future. Virus outbreaks that can develop into dynamic pandemics are a permanent global threat. Besides p…
World Blood Donor Day takes place on 14 June each year. The aim is to raise global awareness of the need for safe blood and blood products for transfusion and of the critical contribution voluntary, unpaid blood donors make to national health systems. The day also provides an opportunity to call to action to governments and national health authorities to provide adequate resources and put into place systems and infrastructures to increase the collection of blood from voluntary, non-remunerated blood donors. Safe blood and blood products and their transfusion are a critical aspect of care and public health. They save millions of lives and improve the health and quality of life of many patients every day. The need for blood is universal, but access to blood for all those who need it is not.…
Ten leading German companies form this newly created Quantum Technology and Application Consortium Together, the members want to explore industrial applications for quantum computing Quantum computing has also great potential for pharmaceutical research and development Today, Boehringer Ingelheim joined the Quantum Technology and Application Consortium (QUTAC) as a founding member. This consortium unites ten of the leading German companies from the fields of chemistry and pharmaceuticals as well as from the insurance business and the automotive industry. Their aim is to take quantum computing to the level of large-scale industrial application. In doing so, the founding members want to make a significant contribution to advance this technology in the German and European market. “As part o…
Lifebit’s deep learning, Natural Language Processing and Artificial Intelligence platform automatically detects and tracks global infectious disease outbreaks using real-world evidence The captured insights can accelerate detection of the latest outbreaks including transboundary diseases and emerging pathogens Boehringer Ingelheim, a global leader in animal health, announces the beginning of a long-term partnership with Lifebit Biotech to utilize Artificial Intelligence (AI) for the detection and early-reporting of global disease outbreaks using real-world data harvested from scientific publications and other open sources. Utilizing the Lifebit REAL platform, insights into the latest infectious disease outbreaks allow R&D efforts to be prioritized…
Q2 Solutions, a wholly-owned subsidiary of IQVIA and a leading clinical trial laboratory services organization, today announced a transformative collaboration with Tasso Inc., a pioneer in clinical-grade, at-home, patient-centered blood testing, to develop diagnostic tests used in decentralized (virtual) clinical trials. These new laboratory-developed tests will use Tasso’s devices, enabling patients to collect their own blood using a virtually painless process from anywhere at any time. “The current COVID-19 pandemic has created a surge in demand for more virtual clinical trials and remote patient monitoring applications,” said Ben Casavant, PhD, CEO and Co-founder of Tasso. “Tasso is now poised to accelerate this paradigm shift in patient care through our clinical-grade and convenient bl…
Programs now available to support patients and families with their treatment journey Collaborations with Veterans Health Administration, CVS Health and NAFC focused on health disparities in underserved communities Value-based agreements in progress with Cigna and other payers Following today’s U.S. Food and Drug Administration’s (FDA) accelerated approval of ADUHELMTM (aducanumab-avwa) as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain, Biogen (Nasdaq: BIIB) and Eisai Inc., U.S. subsidiary of Eisai Co., Ltd., announced a range of programs intended to support access for all qualified patients, including traditionally underserved populations. These initiatives aim to help patients and their famili…
07-Jun-2021
This year, Carers Week takes place from 7th - 13th June. Carers Week is an annual awareness campaign that celebrates and recognises the vital contribution of the UK’s unpaid carers – supporting family members and friends who are older, have a disability, mental or physical illness or need extra help as they grow older. On behalf of the Carers Week charities, Helen Walker, Chief Executive of Carers UK, said: “Throughout the COVID-19 pandemic unpaid carers have played an essential role supporting older, disabled and seriously ill relatives and friends, doing so most of the year on their own behind closed doors. They have forgone breaks from caring and much of the support they would normally have relied on. “As restrictions ease it is vital that we acknowledge the enormous contribution that u…
- Abbott has the capacity and supply to support increased demand for mechanical circulatory support (MCS) devices following Medtronic's decision to stop the global distribution and sale of the Medtronic HeartWare™ ventricular assist device (HVAD) - Access to MCS devices are critical for advanced heart failure patients and can improve survival, clinical outcomes and quality of life - Abbott is working with physicians and health systems to ensure supply of left ventricular assist devices (LVADs) alongside training and education for implanting physicians now offering Abbott's HeartMate 3™ to their patients Abbott (NYSE: ABT) today announced the company has capacity and supply to effectively support the growing demand for mechanical circulatory support (MCS) devices for the effective treatment…
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…