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Authorisation will help protect adults 60 years of age and older in the UK from RSV disease for the first time In the UK, RSV leads to an estimated 14,000 hospitalisations and an estimated 8,000 deaths in adults 60 years of age and older each year The authorisation is based on phase III efficacy data in older adults GSK plc (LSE/NYSE: GSK) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been authorised for use in Great Britain by the MHRA. Neale Belson, Senior…
Advances World-Class Clinical Research Capabilities with Leading Regulatory-Grade Registries Platform Expected to Be Immediately Accretive to Adjusted Earnings Per Share 1 WALTHAM, Mass.--(BUSINESS WIRE)-- Thermo Fisher Scientific Inc. (NYSE: TMO) (“Thermo Fisher”), the world leader in serving science, today announced it has entered into a definitive agreement to acquire CorEvitas, LLC (“CorEvitas”), a leading provider of regulatory-grade, real-world evidence for approved medical treatments and therapies, from Audax Private Equity (“Audax”), for $912.5 million in cash. Real-world evidence is the collection and use of patient health outcomes data gathered through routine clinical care. This is a high growth market segment as pharmaceutical and biotechnology customers, as well as regulatin…
Abbott's breakthrough technology enables the world's first beat-to-beat, wireless communication and synchronization between two leadless pacemakers, which are smaller than a AAA battery Leadless pacemakers provide a new minimally invasive option that will revolutionize care for more people in the U.S. who need pacing to treat a variety of slow or abnormal heart rhythms Approval comes on the heels of recent late-breaking clinical trial data showing that the AVEIR™ DR leadless pacemaker system is safe and effective at treating abnormal heart rhythms ABBOTT PARK, Ill., July 5, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the AVEIR™ dual chamber (DR) leadless pacemaker system, the world's first dual chamber leadless pac…
-Nearly 300 children with cystic fibrosis and two copies of the F508del mutation are now eligible for the first time for a medicine that can treat the underlying cause of their disease- LONDON--(BUSINESS WIRE)--Jul. 5, 2023-- Vertex Pharmaceuticals today announced that the European Commission has granted approval for the label extension of ORKAMBI® (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) ages 1 to <2 years old who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common form of the disease. “This approval will offer some of the youngest children with cystic fibrosis the chance of improved outcomes, by treating their disease at a young age,” said Carmen Bozic, M.D., Executive Vic…
BURLINGTON, N.C., July 3, 2023 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced that it has completed the spin-off of Fortrea, the newly formed independent Contract Research Organization providing Phase I-IV clinical trial management, patient access and technology solutions to pharmaceutical and biotechnology organizations around the world. Fortrea will begin trading on the NASDAQ Stock Market under the symbol "FTRE" effective at the market opening today. "I want to thank our teams for their tireless work in creating two strong, independent companies through the Fortrea spin," said Adam Schechter, chairman and chief executive officer. "The transaction is intended to better meet customer needs, enable appropriate value-…
First Phase III results for AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody drug conjugate demonstrated statistically significant improvement in progression-free survival vs. standard chemotherapy in previously treated locally advanced or metastatic disease Trial will continue to assess the dual primary endpoint of overall survival  Positive high-level results from the TROPION-Lung01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy. For the dual primary endpoint o…
GSK plc (LSE/NYSE: GSK) and BELLUS Health Inc. (TSX/NASDAQ: BLU) today announced GSK has completed the acquisition of BELLUS, a biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC), by way of a plan of arrangement in accordance with Section 192 of the Canada Business Corporations Act (the “Arrangement”). The Arrangement was approved by BELLUS’ shareholders on 16 June 2023. As previously announced, the acquisition of BELLUS includes camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the first-line treatment of adult patients with RCC. In connection with the closing of the Arrangement, BELLUS also announced the cancellation of its annual shareholder meeting, which was sc…
Expansion of AZ Forest programme raises commitment to plant 200 million trees across six continents by 2030 New reforestation projects in Brazil, India, Vietnam, Ghana and Rwanda in addition to existing projects including in Australia and Indonesia AstraZeneca has announced a $400 million investment in its global AZ Forest programme, raising its commitment to plant 200 million trees by 2030 and ensure their long-term survival. This includes new or expanded projects in Brazil, India, Vietnam, Ghana and Rwanda that will contribute to the Company’s climate action, restore nature, promote biodiversity and build ecological and community resilience, spanning over 100,000 hectares worldwide. The investment builds on AstraZeneca’s initial AZ Forest commitment, announced in 2020, to plant and mai…
- Following positive Phase 1/2 results in Vertex’s VX-880 program, Vertex and Lonza announce strategic manufacturing collaboration - - Dedicated large-scale facility will support commercial production of Vertex’s T1D cell therapy portfolio - - Approximately 300 new jobs anticipated at Lonza Portsmouth, New Hampshire Site - BOSTON & BASEL, Switzerland--(BUSINESS WIRE)--Jun. 26, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Lonza (SIX: LONN) today announced a strategic collaboration to support the manufacture of Vertex’s portfolio of investigational stem cell-derived, fully differentiated insulin-producing islet cell therapies for people with T1D, currently focusing on the VX-880 and VX-264 programs that are currently in clinical trials. Vertex’s first clinical program, V…
Innovations created by the 24 semi-finalists include an app that helps people living with dementia communicate, high-tech facial recognition glasses to identify familiar faces, and an augmented reality map to help people safely find their way around their area. Semi-finalists will each receive £80k grants as part of the overall £4m Longitude Prize on Dementia driving the co-creation of personalised technologies to help people living with dementia enjoy independent and fulfilled lives. The Longitude Prize on Dementia is funded by Alzheimer’s Society and Innovate UK and delivered by Challenge Works. 20 June 2023 - An app that repairs “broken” speech, high-tech glasses that can help those with dementia recognise others, and a “Yellow Brick Road” map to help people navigate their community a…
Acquisition delivers industry-leading research capability, and strengthens pipeline with a novel candidate for ulcerative colitis, Crohn’s disease and other autoimmune conditions RAHWAY, N.J.--(BUSINESS WIRE)--$MRK #MRK--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the Prometheus Biosciences, Inc. (“Prometheus”) (NASDAQ: RXDX) acquisition. Prometheus is now a wholly-owned subsidiary of Merck and the common stock of Prometheus will no longer be listed or traded on the Nasdaq Global Market. “The Prometheus acquisition accelerates our growing presence in immunology, augments our diverse pipeline and increases our ability to deliver patient value. This transaction is another example of Merck acting strategically and decisively when…
Vaxxas opens 5,500 square meter (60,000 square feet) state-of-the-art biomedical manufacturing facility in Brisbane, Queensland, which will support the production of millions of Vaxxas’ high-density microarray patches (HD-MAPs) per year for future late-stage clinical trials and first commercial vaccine products. Funded by the Queensland Government and Vaxxas, the facility showcases world-class and first-of-a-kind biomedical manufacturing capabilities. The facility contains two independent Good Manufacturing Practice (GMP), qualified aseptic cleanrooms, a medical device manufacturing space, a device assembly cleanroom, and supporting infrastructure including laboratories and office space. The facility is Vaxxas’ new global headquarters and home to 130 employees including highly-skilled an…
Sanofi Consumer Healthcare launches new portal to unlock science and solve key challenges in self-care Paris, France – June 14, 2023 – Sanofi’s Consumer Healthcare Business Unit has today launched a new Open Innovation Portal, allowing the wider supply chain community to submit their creative, disruptive, and game-changing solutions to meet the challenges of an ever-evolving consumer healthcare landscape. Startups, entrepreneurs, research institutions, accelerators, universities and more can now respond online to challenge areas that have been identified by Sanofi Consumer Healthcare, from creating sustainable packaging to developing new products and technologies. The healthcare landscape is evolving rapidly and, post-COVID, with an ever-increasing recognition of the importance of self-car…
WiLD is a new and fast-growing professional network for women in senior positions across industry and academia in Danish life science A key objective is to provide professional, tailored mentoring programs for women in the life science business – from young talents to executives - in critical career transitions and WiLD has received a grant from the Lundbeck Foundation to build a mentorship programme, which will be launched in September 2023 13 June 2023, Denmark: Women in Life Science Denmark (WiLD) is pleased to announce that is has been awarded a grant of EUR 63.800 from The Lundbeck Foundation to advance its mentoring program for women working in life sciences in Denmark. WiLD’s Female Leadership Mentoring Program aims to inspire the next generation of female leaders and entrepreneurs…
Every year, over 600,000 women worldwide are diagnosed with cervical cancer and over 340,000 die from this preventable disease, caused by infection with human papillomavirus (HPV). Nine out of 10 women who die from cervical cancer live in low- and lower-middle income countries (LMICs).1 WHO prequalification enables LMICs to use the cobas® HPV test in their national cervical cancer elimination programs, increasing access to the patients who need it most. Establishing screening programs helps prevent and detect cervical cancer, which is especially important in areas with limited healthcare resources where patients are often diagnosed with the disease at late stages. Basel, 13 June 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the cobas® HPV test for use on the cobas® 6800/…
Bagsværd, Denmark, 12 June 2023 - Novo Nordisk today announced plans to invest 15.9 billion Danish kroner starting in 20231 to expand an existing Active Pharmaceutical Ingredient (API) production facility in Denmark for the future portfolio within serious chronic diseases. The investment comes as Novo Nordisk marks the 100th anniversary of its founding in Denmark, where 21,000-plus employees – approximately half of the company's global workforce2 - still work today. The majority of these employees work at various production sites. The investment in Hillerød, Denmark will create additional production capacity and increase Novo Nordisk’s ability to meet future market demands and be a key enabler for Novo Nordisk to develop its future clinical late-phase product portfolio. “This important inv…
The company’s third commercial CAR T manufacturing facility in the U.S. further extends Bristol Myers Squibb’s leadership in cell therapy PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved commercial production at the company’s newest cell therapy manufacturing facility in Devens, Massachusetts. The Devens site is a critical component of BMS’ expanding global cell therapy manufacturing footprint for long-term supply of the company’s cell therapy portfolio. “The Devens facility integrates the latest state-of-the-art technology in the industry with top talent in the Boston area that will take us into the next phase of our cell therapy journey,” said Karin Shanahan, executive vice president, Globa…
Lynparza (olaparib) receives a positive recommendation from NICE for maintenance treatment of BRCA-mutated relapsed, platinum-sensitive high-grade ovarian, fallopian tube or peritoneal cancer Following today’s decision from the National Institute for Health and Care Excellence (NICE) to recommend Lynparza (olaparib) for the maintenance treatment of BRCA-mutated relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, following 2 or more courses of platinum-based chemotherapy, please see below for commentary from AstraZeneca UK and MSD spokespeople. 1 Tom Keith-Roach, President, AstraZeneca UK, said: “Olaparib was discovered and developed in the UK, which makes today’s positive recommendation for BRCA-mutated platinum-sensitive relapsed, high…
Now in its 11th year, MedTech Innovator continues to identify the best medical device, diagnostic and digital health startups developing innovative tools to improve patient care LOS ANGELES--(BUSINESS WIRE)--#innovator--MedTech Innovator, the world’s largest accelerator of medical technology companies, today announced the 2023 Accelerator Cohort. After a competitive selection process, 61 companies were chosen to participate in the MedTech Innovator’s flagship four-month MedTech Accelerator program. Featuring medical device, diagnostic, and digital health companies from around the globe, the 2023 Cohort members will get unparalleled visibility and access to leading medtech manufacturers, providers, investors, and other industry stakeholders. MedTech Innovator will additionally award $800,00…
Thermo Scientific Orbitrap Astral mass spectrometer combines high resolution and speed to accelerate the discovery of new proteins and advance precision medicine WALTHAM, Mass.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today unveiled the Thermo Scientific™ Orbitrap™ Astral™ mass spectrometer, one of the most significant advancements in mass spectrometry in 15 years. The new Astral analyzer combines fast throughput, high sensitivity and deep proteome coverage to allow researchers worldwide to uncover proteins that previously evaded detection and make breakthrough discoveries more efficiently than ever. Researchers can use this information to identify new clinical biomarkers, reveal diseases earlier and develop new interventions for eve…