PharmiWeb.com - Global Pharma News & Resources

Today Stories

*         ICARIA (Isatuximab in Combination with pomalidomide And low-dose dexamethasone veRsus pomalidomide and low dose dexamethasone in patients with refractory or relapsed And refractory Multiple Myeloma), study evaluated the benefit of isatuximab in combination with standard of care in prolonging progression free survival as compared to standard of care in patients with relapsed/refractory multiple myeloma *         Multiple myeloma is the second most common haematological cancer1 *         First randomised Phase 3 trial to evaluate the benefit of adding a monoclonal antibody to pomalidomide and dexamethasone for treatment of relapsed/refractory multiple myeloma I…
Merck, a leading science and technology company, and GSK, a science-led global healthcare company, today announced that the companies have entered into a global strategic alliance to jointly develop and commercialize M7824 (bintrafusp alfa*). M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers. This includes a Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC).   M7824 is designed to simultaneously target two immuno-suppressive pathways, transforming growth factor-β (TGF-β) trap and an anti-programmed cell death ligand-1 (PD-L1…
Torque, an immuno-oncology company developing first-in-class Deep Primed™ T Cell Therapeutics to direct immune power deep within the tumor microenvironment, and Thermo Fisher Scientific Inc. (NYSE: TMO), today announced a collaboration to build a dedicated Slipstream™ manufacturing facility for high-efficiency production of Torque's Deep-Primed T cell immunotherapies. Buildout of the Torque/Thermo Fisher manufacturing facility has begun, and the companies anticipate processing patient cells by the end of 2019. The Slipstream platform will initially be used in the clinical development of Torque's lead Deep-Primed T cell candidate, TRQ-1501, in solid and hematologic tumors; followed by TRQ-1201, also for solid and hematologic tumors. "Torque's cell manufacturing technology platform is crit…
Neuraxpharm Group, a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders (CNS), announces the acquisition of Farmax, a CNS specialty pharmaceutical company, from SVUS Pharma.   Farmax, located in Hradec Králové, Czech Republic, was the commercial division of SVUS Pharma, and has a strong distribution presence in the Czech Republic, Slovakia as well as a small presence in Hungary. Farmax is a leader in sales and marketing both branded and non-branded generics pharmaceuticals for CNS disorders such as Zolpinox®. It also commercializes well-known OTC nutraceuticals such as Preventan® and Maxicor®. Farmax has been renamed Neuraxpharm Bohemia and will commercialize its products under the Neuraxpharm brand. Leveraging its proprie…
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced a worldwide collaboration and license agreement with MeiraGTx Holdings plc (NASDAQ: MGTX), a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio, including leading product candidates for achromatopsia (ACHM) caused by mutations in either CNGB3 or CNGA3, and X-linked retinitis pigmentosa (XLRP). Further, the companies have formed a research collaboration to explore new targets for other inherited retinal diseases and further develop adeno-associated virus (AAV) manufacturing technology. "Janssen is excited to expand our portfolio with the addition of innovative assets that have the potential to improve sight or prevent the progressi…
Beckman Coulter Life Sciences today announced its acquisition of Labcyte, a privately held, acoustic liquid handling company based in San Jose, California. Labcyte is best known for its Echo® acoustic droplet ejection technology, which uses sound waves to transfer tiny amounts of liquid with unequalled speed and accuracy. This technology—the centerpiece of Labcyte's Echo Liquid Handlers—enables walkaway convenience and integration capabilities. Labcyte technology enables faster and more cost-effective laboratory workflows in applications such as drug discovery and genomics. "Labcyte's unique product portfolio complements our existing liquid handling and laboratory automation business. It provides new opportunities to develop and enhance time-saving solutions for customer workflows,"…
UPMC Health Plan and AstraZeneca today announced the initiation of a pioneering value-based contract effective Jan.1, 2019 for UPMC for Life Medicare members who are prescribed BRILINTA® (ticagrelor), a medication used to lower a patient's chances of having another heart attack or dying from one in the 12 months following a heart attack. The goal of the contract is to align the incentives of the manufacturer, AstraZeneca, with UPMC Health Plan by connecting reimbursement for BRILINTA® to clinical outcomes in a real-world population. Specifically, reimbursement for the medication will be linked to cardiovascular outcomes for people treated with BRILINTA® following a recent hospitalization for heart attack or unstable angina. This value-based contract is groundbreaking in two way…
Purdue Pharma L.P. (“Purdue”) and Alivio Therapeutics today announced that they have entered into a partnership to advance one of Alivio’s product candidates through clinical development with an option exercisable by Purdue to collaborate on a limited number of additional compounds utilising Alivio’s inflammation-targeting technology. ALV-107 is a non-opioid treatment being developed for interstitial cystitis/bladder pain syndrome (IC/BPS).   Alivio will receive up to $14.75 million in upfront and near-term license exercise payments and is eligible to receive royalties on product sales and over $260 million in research and development milestones. Purdue also has an option to invest in Alivio’s next equity financing.   “This collaboration with Alivio is an important milestone…
United Therapeutics Corporation (Nasdaq: UTHR) today announced the closing of the transactions contemplated by its license agreement with Arena Pharmaceuticals, Inc. (Nasdaq: ARNA). Under the agreement, United Therapeutics acquired exclusive, worldwide rights to develop and manufacture the Phase 3 investigational drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension (PAH).  Upon closing, United Therapeutics paid Arena $800 million. Arena is also entitled to potential milestone payments of up to $400 million based on the achievement of certain regulatory events as well as low double-digit tiered royalties on annual net sales of ralinepag products.   &n…
Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced positive top-line results from a Phase 1/ Phase 3 study evaluating the pharmacokinetics, efficacy and safety of biosimilar candidate ABP 798, a biosimilar candidate to RITUXAN® (rituximab), compared to rituximab in patients with moderate-to-severe rheumatoid arthritis. The results demonstrate that the study met its primary endpoint of pharmacokinetic (PK) similarity. Additionally, equivalent efficacy was established and a similar safety profile was demonstrated. The primary objective of the study was PK similarity comparing ABP 798 to rituximab. The PK endpoints of the study were area under the serum concentration–time curve (AUC) and maximum serum concentration (Cmax), both of which were within the pre-specified equi…
B-MoGen Biotechnologies, Inc. and CytoSen Therapeutics announced today a research collaboration to develop the next generation of gene-modified Natural Killer Cell (NK) therapies.  B-MoGen will utilize its expertise in genetic design and its patented non-viral gene delivery platform in conjunction with CytoSen's nanoparticle expansion platform to improve efficacy and reduce cost of NK cell therapeutics.  "We are very excited and look forward to teaming up with CytoSen to utilize our scientific expertise and engineering work with CARs and TCRs to help develop NK treatments in the human therapeutics space," said Jeff Liter, President and CEO of B-MoGen.  "CytoSen's innovation, science and pioneering technology is a perfect fit with B-MoGen's genome engineering experience and…
LunaPBC, founder of LunaDNA, the first community-owned genomic and health data platform, announced today its partnership with Genetic Alliance, a non-profit dedicated to providing ordinary people with powerful tools to transform research. Over the course of 2019, the organizations will merge Genetic Alliance's Platform for Engaging Everyone Responsibly engagement platform with LunaDNA to provide individuals and communities with more resources to support health management while maximizing research opportunities. The partnership enables LunaPBC and Genetic Alliance to unite their shared mission and technologies to create seamless solutions to support individuals, disease foundations, and patient advocacy organizations while also powering disease research at scale. Shared values across…
Medline, a global manufacturer and distributor of medical and laboratory products with patient-centered solutions, services and expertise across the continuum of care, today announced it has been awarded a group purchasing agreement for laboratory distribution services with Intalere, effective January 1, 2019 for two years.  Intalere members already have access to competitive pricing through Medline as their primary medical distributor through a 4-year agreement renewed in February 2018.  This new laboratory contract complements what is in place by extending this negotiated pricing to Intalere members that also select Medline to be their primary laboratory distributor.  With more than 40 distribution centers strategically located across the country, Medline offers Intalere…
The US Food and Drug Administration (FDA) recently approved pharma giants Sanofi and Merck's Vaxelis, a new pediatric vaccine against six diseases. The vaccine will help to bolster vaccination rates across the US by reducing the shot burden on infants and children, according to GlobalData, a leading data and analytics company.  Vaxelis, which is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type b, was developed as part of a joint-partnership between Sanofi and Merck, known as MSD outside the US and Canada. James Mather, Pharma Analyst at GlobalData, says: “Vaxelis’ approval in the US is a major regulatory breakthrough, as the FDA has been more hesitant than the European Medi…
Luye Pharma has announced it has entered an agreement with AstraZeneca China, the terms of which grant AstraZeneca China exclusive rights to promote Luye Pharma's Xuezhikang Capsules in mainland China. This is the first time that a multinational pharmaceutical company has gained exclusive authorization in China to promote an innovative drug independently developed by a Chinese pharmaceutical company. According to the agreement, AstraZeneca will be responsible for the exclusive promotion of Xuezhikang Capsules in mainland China, while Luye Pharma will retain asset rights, commercial sales rights, the registration permit, all intellectual property rights and other product-related rights aside from product promotion. As a widely acknowledged product both at home and abroad, Xuezhikang is th…
JOLT Advantage Group, a leading North American IT consulting firm, specialized in Intelligent Automation, Business Transformation and Performance, announced today its partnership with UiPath, the global leader in Robotic Process Automation (RPA) software, to join forces to democratize RPA and help organizations attain long term success with end-to-end support on their digital transformation journey. JOLT recently completed a large assets acquisition from Everpace, a pure-play, purpose-built RPA boutique firm, that carried a vast amount of custom process automation frameworks, deployment accelerators, and unique RPA operational models to strengthen JOLT's existing intelligent automation portfolio with a scalable automation design across multiple verticals, including healthcare, finance, ba…
Following its completed acquisition of Aetna, CVS Health (NYSE: CVS) today announced a $100 million commitment to making community health and wellness central to the newly combined company's charge for a better world. The new Building Healthier Communities initiative, which will be funded over five years through the combined company as well as the CVS Health Foundation and Aetna Foundation, builds upon the outstanding tradition of community investment by both organizations and mobilizes their scale, combined capabilities and resources behind a unified strategy to deliver a measurable impact on the health of communities across the United States. "We believe the path to better health and a better world can be reached by creating a whole new health care model that's more local, affordable, a…
Collaboration will initially support nine new phase I/II clinical trials with Nanobiotix’s first-in-class agent NBTXR3 for use in treating six cancer types - head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers - involving around 340 patients Most of the trials are expected to be launched in 2019 Collaboration includes a $12M total investment from Nanobiotix NANOBIOTIX and The University of Texas MD Anderson Cancer Center today announced a large-scale, comprehensive clinical research collaboration to evaluate innovative strategies for treating patients with head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers. The collaboration will expand clinical development of NBTXR3, a first-in-class agent designed to physically destro…
AbSci, a global leader in biotherapeutic discovery and manufacturing technologies, today announced a collaboration with Sanofi.  Under the terms of the agreement, AbSci will apply its breakthrough E.coli manufacturing platform, SoluProTM, and its novel optimization assay system, to two of Sanofi's biotherapeutic molecules. AbSci's proprietary technology platform is designed with the ability to rapidly achieve optimized, scalable, high-quality, high-titer production of any class of biotherapeutic molecule, including traditionally difficult to manufacture molecules and next-generation scaffolds. The collaboration will take place at AbSci and be funded by Sanofi. "It is exciting to partner with a renowned company like Sanofi," said Sean McClain, CEO of AbSci. "This collaboration illustr…
CytoReason, a leader in machine learning for drug discovery and development, announced today that it has entered into a collaboration agreement with Pfizer Inc. (NYSE:PFE) that will leverage CytoReason’s cell-centered models of the immune system.   CytoReason will receive from Pfizer payments potentially equaling up to low double digit millions of US$ for technology access fees, research support and certain success-based payments.   CytoReason’s proprietary platform helps rebuild lost cellular information from gene expression data and associates genes to specific cells. This information is then integrated with additional omics and literature data to create a cell-based model of the trial-specific immune response. Integration with the CytoReason disease model empowers the stud…