Today Stories

Prothena is eligible to receive development and sales milestone payments totalling up to 1.2 billion US dollars , including 100 million dollars in upfront and near-term clinical milestone payments Novo Nordisk will develop the phase 2 ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy Prothena Corporation plc and Novo Nordisk A/S today announced that the companies have entered into a definitive purchase agreement under which Novo Nordisk has acquired Prothena’s clinical stage antibody PRX004 and broader ATTR amyloidosis programme. PRX004 is a phase 2ready anti-amyloid immunotherapy designed to deplete the amyloid deposits that are associated with the disease pathology of ATTR amyloidosis. ATTR amyloidosis is a rare, progressive and fatal disease characterised by the abn…

Thermo Fisher Scientific, the world leader in serving science, today announced a collaboration with Ortho Clinical Diagnostics to promote and distribute Thermo Scientific MAS Quality Controls and LabLink xL Quality Assurance Software for use with Ortho Clinical Diagnostics VITROS analyzers. Through this agreement, Ortho Clinical Diagnostics customers will have complete access to MAS third-party quality controls as well as the LabLink xL web-based quality assurance program that provides real-time quality control monitoring with automatic data entry upload and audit-friendly reports. Customers will also have access to additional features, including support, service and quality control ranges for specific reagent lots, unique features that are not currently available through any other quality…

The EMPEROR-Preserved Phase III trial met its primary endpoint and demonstrated significant risk reduction with empagliflozin for the composite of cardiovascular death or hospitalization for heart failure in patients with heart failure with preserved ejection fraction (HFpEF) HFpEF has been classified as “the single largest unmet need in cardiovascular medicine”1 based on prevalence, poor outcomes and the absence of clinically proven therapies to date2 With approval, empagliflozin would become the first and only clinically proven therapy to improve outcomes for the full spectrum of heart failure patients regardless of ejection fraction  The EMPEROR-Preserved Phase III trial met its primary endpoint, establishing empagliflozin as the first and only thera…

Alzheimer’s Research UK has been selected as the official 2021 charity partner of Hertfordshire-based company, Innovative Trials.  The company, which specialises in clinical trial patient recruitment and community engagement, is aiming to raise at least £5,000 for the charity over the next 12 months. The funds raised will support groundbreaking dementia research for a world free from the fear, harm, and heartbreak of dementia. In the UK, almost one million people are thought to be living with dementia and this is expected to rise to two million by 2050. Alzheimer’s Research UK is the UK’s leading dementia research charity committed to developing life-changing treatments and cures - a mission shared by Innovative Trials. Kate Shaw, founder and CEO of Innovative Trials, said: “Dementia is a…

BioMed X Institute expands its collaboration with Merck KGaA, Darmstadt, Germany to a total of eight research programs. Call for application of the new research program ‘Extrachromosomal DNA in Cancer’ to open now. Heidelberg, Germany, July 5, 2021 – BioMed X, a leading independent research institute, announced today the start of its eighth joint research program with Merck KGaA, Darmstadt, Germany. The new program will explore the role of extrachromosomal DNA in cancer and it will complement the research of two ongoing oncology programs at BioMed X in the fields of DNA damage response and RNA splicing. Extrachromosomal circular DNA (ecDNA) was recently found to be particularly abundant in multiple human cancer cells, although its frequency varies among different cancer types. Elevated l…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Recipharm (STO: RECI-B), a leading contract development and manufacturing organization (CDMO), today confirmed that following the European Medicines Agency’s (EMA) Committee for Human Medicines (CHMP) approval of the Recipharm Monts site on June 11, 2021, drug product manufacture of the Moderna COVID-19 vaccine at the site in France has now begun. “We are proud to be working with Recipharm to build industrial production capacity in France in support of Europe’s vaccination campaign,” said Stephane Bancel, Chief Executive Officer of Moderna. “France is at the heart of European innovation in healthcare and will play an important role in Moderna’s strategic growth plan.” “Our c…

Publication comes alongside new ABPI Principles to help companies operate to high ethical standards The Association of the British Pharmaceutical Industry (ABPI) 2021 Code of Practice comes into force from 1 July, alongside new ABPI Principles to help companies operate to high ethical standards.   The ABPI Code of Practice is the industry’s commitment to operate in a professional, ethical, and transparent manner, for the benefit of patients and the public. It is independently administered by the Prescription Medicines Code of Practice Authority (PMCPA). The 2021 Code has been updated to make the Code easier for companies to use in their day-to-day activities, to reflect changes in the environment companies operate in and to reflect updates to the European Code.  Some new elements increase…

Approximately €400million investment annually to accelerate end-to-end R&D of next-generation vaccines, fully financed through resource reallocation Focus on innovating mRNA vaccines beyond pandemic to routine use in diseases with high unmet need Expected minimum of six clinical candidates by 2025 PARIS – June 29, 2021 - Sanofi will invest approximately €400 million annually in a first-of-its kind vaccines mRNA Center of Excellence. The Center will work to accelerate the development and delivery of next-generation vaccines by bringing together approximately 400 dedicated employees integrating end-to-end mRNA vaccine capabilities with dedicated R&D, digital, and chemistry, manufacturing and controls (CMC) teams across sites at Cambridge, MA (US) and Marcy l’Etoile, Lyon (France). …

As part of Sanofi’s ongoing efforts to reduce the complexity of its Consumer Healthcare portfolio and accelerate its growth trajectory, the company has signed an agreement with STADA for the divestiture of 16 Consumer Healthcare products commercialized in Europe. The transaction with STADA ensures that these products will continue to be available to consumers. "As discussed during our Capital Markets Day in February, simplifying the CHC product portfolio is an important part of our strategy to focus our resources and efforts where we can bring the most value, especially to consumers. We are pleased these products will continue to be available for consumers as we focus on becoming a fully integrated standalone business” said Julie Van Ongevalle, Executive Vice-President, Sanofi and Head of…

Leonard Award program recognizes innovation and positive achievements in the diabetes community Lilly to give $100,000 to Life for a Child in recognition of five Award winners In honor of the 100th anniversary of the discovery of insulin, Eli Lilly and Company (NYSE: LLY) today launched the Leonard Award to recognize diverse champions dedicated to advancing diabetes management through innovative thinking and novel approaches. Nominations are being accepted now until August 31, 2021 at Lilly.com/LeonardAward. The Leonard Award is inspired by the life of Leonard Thompson, the first person with diabetes to be treated with insulin in 1922, and looks to celebrate ongoing achievements in the diabetes community. The Award is open to eligible participants from the following categories: Teen/yo…

Aleta Biotherapeutics (‘Aleta’) and Cancer Research UK today announced a collaboration to advance the early phase clinical development of Aleta’s CAR-T cell engagercandidate, ALETA-001. Aleta is a privately held immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, and Cancer Research UK is the world’s leading cancer charity dedicated to saving lives. Under the terms of the clinical development partnership, Cancer Research UK’s Centre for Drug Development will fund, sponsor and conduct the first-in-human Phase 1/2a clinical trial of ALETA-001, which will be led by Dr Amit Patel’s Cellular and CAR-T therapies team at The Christie NHS Foundation Trust in Manchester, UK. ALETA-001 has been developed to benefit peo…

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…