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STRATEGIC PARTNERSHIP LEVERAGES EVOTEC’S PROPRIETARY PLATFORM CAPABILITIES IN THE FIELD OF PROTEIN HOMEOSTASIS Hamburg, Germany, 14 June 2022:Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) announced today that the Company has entered a drug discovery collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”). Evotec’s innovative TargetAlloMod platforms will be evaluated to discover first-in-class novel mode of action therapeutic candidates. The agreement was facilitated by Johnson & Johnson Innovation.Under the agreement, Evotec and Janssen will jointly conduct screens on the identified targets and collaborate with hit identification and lead optimisation of the most promising…
Next-generation booster vaccine candidate delivers immune boost in adults primed with mRNA vaccines; with a stronger immune response compared to Pfizer-BioNTech’s Comirnaty booster vaccine Next-generation booster vaccine candidate demonstrates potential to protect against COVID-19 variants of concern, including Omicron BA.1 and BA.2, with a favorable safety and tolerability profile Paris – June 13, 2022 – Sanofi today reports data from two trials, VAT02 Cohort 2 and COVIBOOST VAT013, conducted with its new next-generation COVID-19 booster vaccine candidate modelled on the Beta variant antigen and including GSK’s pandemic adjuvant. In the Phase 3 VAT02 Cohort 2 study, the Sanofi-GSK next-generation vaccine candidate induced (at day 15 post-immunization) a significant boost in antibody tit…
Coave Therapeutics and ABL enter into strategic collaboration to develop gene therapy manufacturing processes and create joint capabilities for process development of AAV-based gene therapy Two-stage collaboration aims to accelerate development of high-capacity manufacturing processes for AAV-based products and secure Coave’s infrastructure needs to set up its process development capabilities Paris and Strasbourg, France, June 9, 2022 - Coave Therapeutics (‘Coave’), a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, and ABL, a pure play contract development and manufacturing organization (CDMO) specialized in the development and manufacturing of viruses for vaccine candidates, gene and cancer therap…
WILMINGTON, N.C., June 08, 2022 - The PPD clinical research business of Thermo Fisher Scientific has been named Clinical Research Company of the Year at the 2022 PharmaTimes Clinical Researcher of the Year International competition held recently in London. In addition to the business winning the highest honor again this year, 50 clinical researchers from the company were named finalists within all nine eligible team and individual competition categories. "For the third year in a row, our colleagues have made their presence known by winning multiple recognitions, including the top title, in this highly regarded competition," said Amber Lee, senior vice president, clinical operations, clinical research, Thermo Fisher Scientific. "The unwavering dedication, expertise and passion our colleague…
Innovative Trials, a UK-based clinical trials patient recruitment company, has today (Monday 6 June) announced its intention to help fund research into multiple sclerosis (MS) and contribute towards the MS Society's vision of a world free from the effects of MS. The company, which works with some of the world’s biggest pharmaceutical companies to accelerate the development of life-changing treatments, has chosen the MS Society as its official 2022-23 charity partner and is aiming to raise at least £3,000 for the charity over the next 12 months.  MS is a neurological condition that affects nerves in the body. More than 130,000 people in the UK are living with the condition and around 7,000 people are diagnosed every year [1]. MS is unpredictable and different for everyone, but common sympto…
Expansion will create more than 250 additional high-skilled manufacturing jobs at Pfizer’s Kalamazoo site NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment, PAXLOVIDTM (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). The investment will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which will create more than 250 additional high-skilled jobs at Pfizer’s Kalamazoo site.…
Cambridge, UK, June 6, 2022 – SMC Ltd., a leading solutions provider in the manufacturing of pharmaceutical and medical devices, announces the opening of Cambridge Pharma, a new business offering pharmaceutical development services, including sterile fill-finish. The new 20,000 sq ft facility, located at the Cambridge Research Park, UK, includes a purpose-built sterile fill-finish facility, a process development laboratory and an analytical laboratory. Services include process development and scale up, sterile fill finish for clinical trials, QC and stability testing and QP release of clinical trials supplies. Chetan N. Patel, Owner and CEO of SMC Group, has a strategic vision for the Company, “We value pharmaceutical partnerships and continue to expand services in development, manufacturi…
On 23 June 2021 at its Investor Update, GSK plc (“GSK” or the “Company”) confirmed its intention to separate its Consumer Healthcare business from the GSK Group to form Haleon plc (“Haleon”), an independent listed company. It is proposed that the separation will be effected by way of a demerger (the “Demerger”) of at least 80 per cent. of GSK’s 68 per cent. holding in the Consumer Healthcare business to GSK shareholders. The Consumer Healthcare business is currently a joint venture between GSK and Pfizer Inc (“Pfizer”), with GSK holding a majority controlling interest of 68 per cent. and Pfizer holding 32 per cent. GSK today confirms that the Circular in relation to the proposed Demerger, the consolidation of GSK shares (the “GSK Share Consolidation”) and certain new arrangements with Hal…
GSK to pay $2.1 billion upfront and up to $1.2 billion in potential development milestones Proposed acquisition provides access to next-generation 24-valent pneumococcal vaccine candidate in phase II development and highly innovative, MAPSTM technology Supports development of a strong portfolio of innovative vaccines and specialty medicines GSK plc (LSE/NYSE: GSK) today announced that it has entered into a definitive agreement to acquire Affinivax, Inc. (Affinivax), a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts, for a $2.1 billion upfront payment and up to $1.2 billion in potential development milestones. Affinivax is pioneering the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines. Pneumo…
Alistair Macdonald to Retire After 20 Years in Variety of Leadership Roles Michael Brooks Named Chief Operating Officer Company Reports First Quarter 2022 Results and Updates Full Year Guidance MORRISVILLE, N.C., April 29, 2022 (GLOBE NEWSWIRE) -- Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, today announced the appointment of Michelle Keefe as CEO and a member of the Company’s Board of Directors. Keefe, currently President, Medical Affairs and Commercial Solutions, succeeds Alistair Macdonald, who will retire after 20 years at Syneos Health. Macdonald will remain an advisor to Syneos Health through March 2023. Keefe brings more than 30 years of life sciences industry experience to the role. Since joining Syneos Health in 2017, her lead…
London, 25th May 2022 — Novartis UK has today announced the launch of a new heart failure Health Inequalities Insights Tool (HIIT) that draws on a range of health datasets to build a greater understanding of the relationship between heart failure and socioeconomic deprivation in England. The HIIT utilises data on heart failure prevalence and outcomes from Hospital Episode Statistics, the Quality and Outcomes Framework, the National Cardiac Audit Programme, NHS Digital and Referral to Treatment data. The data is presented in relation to the Office for National Statistics Index of Multiple Deprivation, which is the official measure of relative deprivation in England. The tool is intended to act as an interactive resource for healthcare systems with a view to supporting local planning and dec…
Pfizer will provide all its current and future patent-protected medicines and vaccines available in the U.S. or EU on a not-for-profit basis to 45 lower-income countries. Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to commit to join the Accord. Health officials in these countries will help identify and resolve hurdles beyond supply to inform the roll out in all 45 lower-income countries. Pfizer calls upon global health leaders and organizations to join the Accord, bringing their expertise and resources to close the health equity gap and help create a healthier world for 1.2 billion people. DAVOS, Switzerland--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today launched ‘An Accord for a Healthier World.’ This groundbreaking initiative aims to provide all of Pfizer’s…
ICON kick starts the first half of 2022 with a string of prestigious industry awards recognising healthcare intelligence work and staff, as independently judged by peers worldwide Dublin, Ireland – 23 May 2022 – ICON plc, (NASDAQ: ICLR) a global provider of drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device, and government organisations, has been recognised with a number of prestigious business and industry awards in April 2022, including Company of the Year at the 2021 Business & Finance Irish Business Awards and Pharma Contract Services Company of the Year at the Pharma Industry Awards 2021. This is the second time the healthcare intelligence company has received the prestigious Company of the Year accolade from the Business an…
18 May 2022. Geneva, Switzerland. The Union for International Cancer Control (UICC) and multiple partners* are establishing the Access to Oncology Medicines (ATOM) Coalition, a new global partnership to increase access to quality-assured essential cancer medicines in low- and lower middle-income countries (LLMICs) and to help countries develop the capacity for their proper use. It is estimated that less than 50% of the cancer medicines on the WHO Model List of Essential Medicines (WHO EML) are currently available in LLMICs. In 2020, more than 3.5 million new cancer cases were diagnosed in LLMICs and an estimated 2.3 million premature deaths were caused by cancer. If left unchecked, deaths from cancer in LLMICs are expected to rise to 4 million by 2040.1 Prof. Anil D’Cruz, President of UICC…
Today is Clinical Trials Day 2022 – a day dedicated to recognising the people who conduct clinical trials and thanking them for their commitment to improving public health. Lead by the Association of Clinical Research Professionals (ACRP) and powered by Sanofi, Clinical Trials Day raises awareness of clinical trials and of clinical research as a career option. It is celebrated globally on the day that James Lind began what is widely regarded as the first randomised clinical trial aboard a ship on May 20th, 1947. Visit the ACRP website for sharable resources and more information on how you can get involved. Are you looking for a job in Clinical Research? Take a look at the latest vacancies in Clinical Research on PharmiWeb.Jobs here.
New Assay for Patient Care and Use in Clinical Trials Could Lead to Expanded Treatment Options for Melanoma BURLINGTON, N.C.--(BUSINESS WIRE)--May 18, 2022-- Finding treatment options for skin cancer may become easier with the launch of a new test by Labcorp (NYSE: LH), a leading global life sciences company. The new test measures Lymphocyte-activation gene 3 (LAG-3) expression levels by immunohistochemistry (IHC) in tumor tissue. LAG-3 is an immune-oncology target with demonstrable clinical benefit in patients with melanoma. The test is available for use in both clinical trials and for the care and treatment of patients. “Our goal is to provide diagnostic solutions that can help guide the clinical application of new cancer treatments, improving the lives of those living with cancer,” Pras…
-New 344,000 square foot cell and genetic therapies research and manufacturing facility to be built- -Facility to support continued R&D growth- BOSTON--(BUSINESS WIRE)--May 17, 2022-- At a dedication today of the new Jeffrey Leiden Center for Cell and Genetic Therapies in Boston’s Seaport, Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced plans to build another 344,000 square foot facility in the Seaport to support the company’s continued rapid growth, in particular the expansion of its cell and genetic therapies programs. With the completion of this new site expected in 2025, Vertex will occupy 1.9 million square feet of real estate in the Seaport across five sites, making it the largest biotech in Boston in terms of square footage. Jeffrey Leiden Center for Cell and Geneti…
- AbbVie receives the option to license worldwide rights to CUG252 from Cugene, a clinical-stage and potential best-in-class Treg-selective IL-2 mutein, building on AbbVie's commitment to developing novel therapies in immunology - Cugene to complete a Phase 1a study in healthy volunteers and to conduct a Phase 1b study in patients with autoimmune/inflammatory disease during the option period NORTH CHICAGO, Ill. and WALTHAM, Mass., May 16, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Cugene Inc., a clinical-stage biotechnology company focused on developing next-generation precision immunology and oncology medicines to treat autoimmune disease and cancer, today announced an exclusive worldwide license option agreement for CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well…
Arimoclomol is an NDA-stage, revenue-generating investigational drug candidate being developed for the treatment of Niemann-Pick disease type C (NPC), a rare progressive neurodegenerative disease KemPharm plans to refile the New Drug Application (NDA) for arimoclomol in NPC with the U.S. Food and Drug Administration (FDA) as early as the First Quarter of 2023 Conference call and live audio webcast with slide presentation is scheduled for tomorrow, May 16, 2022, at 8:30 a.m., EDT  CELEBRATION, Fla., May 15, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, today announced a definitive agreement with Orphazyme A/S…
WILMINGTON, N.C., May 12, 2022 - The PPD clinical research business of Thermo Fisher Scientific, the world leader in serving science, has been distinguished for industry leadership in digital and decentralized clinical trial solutions by Information Services Group (ISG), a leading global technology research and advisory firm. The business was recognized as an ISG Provider Lens Leader for its digital transformation services, including customer solutions for clinical development and patient engagement. This marks the second consecutive year the business has been acknowledged by ISG. In its 2021 ISG Provider Lens Life Sciences Digital Services Global Report, ISG recognized Thermo Fisher's clinical research business with a clinical development leader designation for its skill and dexterity in…