Pharmaco - Today Stories

Donanemab significantly slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer's disease patients, lowering their risk of disease progression; nearly half of participants at earlier stage of disease on donanemab had no clinical progression at 1 year Additional subpopulation analyses presented live showed that those study participants at earliest stage of disease had even greater benefit, with 60% slowing of decline compared to placebo Furthermore, treatment effect continued to increase relative to placebo over the course of the trial, even though many participants completed their course of therapy at 6 or 12 months, supporting limited duration dosing FDA submission completed in Q2; regulatory action expected by end of year INDIANAPOLIS, July 17, 2023 /PR…

INDIANAPOLIS and NEW YORK, July 14, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Versanis Bio today announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical company focused on the development of new medicines for the treatment of cardiometabolic diseases. Versanis' lead asset is bimagrumab, a monoclonal antibody that binds activin type II A and B receptors to block activin and myostatin signaling. Bimagrumab is currently being assessed in the BELIEVE Phase 2b study alone and in combination with semaglutide in adults who are overweight or obese. Combining incretins with bimagrumab has the potential to further reduce fat mass while preserving muscle mass and may lead to better outcomes for people living with obesity and obesity-…

Supporting You with UC Provides Patients with Resources to Help Manage Their UC and Tips on Ways to Communicate with Their Doctor PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) has launched Supporting You with UC, an ulcerative colitis (UC) educational campaign with patient ambassador* Rosie White. The Supporting You with UC website includes White’s personal UC diagnosis and treatment journey, along with a collection of practical resources for people living with the disease to help manage symptoms on the go and in their everyday lives. There are approximately 600,000 to 900,000 people in the United States living with UC — a chronic, immune-mediated inflammatory bowel disease (IBD).1,2,3 UC presents as a range of symptoms that can be unique to each patient, hard to pr…

Agreement Will Expand Access to Labcorp's Diagnostics Capabilities and Improve Services BURLINGTON, N.C., July 11, 2023 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced that it has entered into an agreement with Legacy Health to acquire select assets of its outreach laboratory business, including laboratory facilities and equipment. Labcorp will also manage Legacy's inpatient hospital laboratories through a long-term agreement to provide staffing, leadership, scientific knowledge, analytics, supply chain services and laboratory support. Legacy will maintain ownership and licensure of its hospital laboratories as well as retain ownership of its central lab building at Holladay Park in Northeast Portland.  Legacy is a si…

EVOTEC AND BRISTOL MYERS SQUIBB ENTER EXCLUSIVE GLOBAL LICENCE AGREEMENT FOR SELECTED PROGRAMMES DEVELOPED AND PROGRESSED IN THE COLLABORATION SELECTED PROGRAMMES FURTHER STRENGTHEN THE PROGRAMME PIPELINE OF NEURODEGENERATION ASSETS EVOTEC RECEIVES $ 40 M PAYMENT AND IS ELIGIBLE TO EARN PERFORMANCE MILESTONE PAYMENTS, AS WELL AS TIERED ROYALTIES UP TO LOW DOUBLE-DIGIT PERCENTAGES ON PRODUCT SALES Hamburg, Germany, 11 July 2023:Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today announced that Bristol Myers Squibb Company (NYSE:BMY) has exercised its option to enter into an exclusive global licence agreement. The licence covers selected late-stage discovery programmes that were developed and progressed within the collaboration.Evotec and Bristol M…

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…

-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…

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…

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…

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…

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…

Clinically validated lipid nanoparticle (LNP) delivery technology will further strengthen Bayer’s gene therapy portfolio / High potency ionizable lipid technology and LNP carriers allow for efficient, targeted, and transient delivery of gene editing RNA components to the liver  Berlin, June 5, 2023 – Bayer AG is joining forces with Acuitas Therapeutics, Inc., a biotechnology company specializing in the development of lipid nanoparticle (LNP) delivery systems for molecular therapeutics. Acuitas’ LNP technology will support Bayer’s in vivo gene editing and protein replacement programs by specifically delivering RNA payloads to the desired target organ, the liver. LNPs are spheric drug delivery bodies which can be equipped with therapeutic payloads for intracellular deliver…

Basel, Switzerland, May 31, 2023 – The Consumer Health Division of Bayer has launched a business unit focused on developing new Precision Health products across its range of everyday health categories. Bayer will prioritize developing products that enable people to take greater control of their own personal health through digital solutions that facilitate more informed choices based on personal insights and novel delivery mechanisms. The shift in the healthcare industry is clear, people need better self-care with the ability to predict, prevent and better manage their health. In fact, an analysis conducted for Bayer found over 80% of consumers globally already demand greater healthcare personalisation. Technology advancements have enabled a wave of new digital products such as diagnostics,…

New GMP facility to complete eXmoor’s transition from consultancy to one-stop global cell and gene therapy partner Bristol, UK, May 30, 2023 – eXmoor pharma, the end-to-end cell and gene therapy (CGT) manufacturing partner, today announced the close of a USD 35 million Series A financing round, from new investor Kineticos Ventures and existing investor MVM Partners. The funding will help launch eXmoor’s Cell and Gene Therapy Centre, a 65,000 sq ft GMP manufacturing facility, purpose-built to develop and manufacture autologous and allogeneic cell therapies, as well as viral vectors. In doing so, eXmoor will leverage nearly two decades of in-house facilities design, strategic CGT process development and translation consultancy experience to officially complete its expansion into a full-servi…

Life Edit will receive an upfront cash payment and is eligible to receive milestone payments of 250-335 million US dollars for each of seven development programmes, as well as tiered royalties on global net sales. Life Edit has the option to a global profit share on one programme. Novo Nordisk will make an equity investment in ElevateBio, Life Edit’s parent company, as part of ElevateBio’s 401 million US dollars Series D financing. Bagsværd, Denmark and Durham, NC, US, 24 May 2023 – Novo Nordisk and Life Edit Therapeutics, Inc., an ElevateBio company focused on next-generation gene editing technologies and therapeutics, today announced a research and development collaboration to discover and develop gene editing therapies against a select set of therapeutic targets. With a focus on advan…

Healthcare Businesswomen’s Association Spotlights Jennifer Sozio and Caitlin Purinai for Biopharma Industry Impact MORRISVILLE, N.C., May 17, 2023 (GLOBE NEWSWIRE) -- Syneos Health® (Nasdaq: SYNH), a leading fully integrated biopharmaceutical solutions organization, today announced that Jennifer Sozio, SVP Clinical Operations, FSP360, and Caitlin Purinai, Senior Director, Human Resources Business Partner, have been recognized by the Healthcare Businesswomen’s Association (HBA) as admirable female leaders in the healthcare industry. “I am thrilled to see Jennifer Sozio and Caitlin Purinai recognized by the HBA for their outstanding performance and commitment to excellence,” said Michelle Keefe, CEO, Syneos Health. “Jennifer and Caitlin are role models for employees across the organization,…