Clinical research - Today Stories

Johnson & Johnson Innovation LLC today announced a five-year alliance with Boston University, an internationally recognized research university and member of the Association of American Universities, that will help accelerate the vision of creating a world without lung cancer.   As part of the alliance, a Johnson & Johnson Innovation Lung Cancer Center at Boston University will be established, allowing close collaboration between Boston University investigators and members of the Lung Cancer Initiative within Johnson & Johnson to work together to develop solutions that prevent, intercept and cure lung cancer.  Avrum Spira, M.D., Professor of Medicine, Pathology and Bioinformatics, Boston University has joined Johnson & Johnson Innovation as Global Head, Lung…

Cyxone AB (publ) announced today that the company has decided to complete the acquisition of drug candidate Rabeximod and issue approximately 1.9 million shares to complete the payment to OxyPharma AB. Cyxone entered into an acquisition agreement with OxyPharma in June 2017 for the drug candidate Rabeximod and now chooses to complete the transaction. The deal has strengthened Cyxone's development portfolio with a candidate in clinical phase II program and broadened the company's portfolio in autoimmune diseases. Cyxone entered an agreement to acquire Rabeximod, a drug candidate in phase II development for rheumatoid arthritis (RA), in June 2017, with an arrangement that the company could choose to decide when the transaction would be completed, and payment will be paid under specific cond…

Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, and Nektar Therapeutics (Nasdaq: NKTR) today announced a non-exclusive, clinical collaboration to evaluate the safety and efficacy of Nektar's NKTR-214, a CD122-biased agonist, in combination with entinostat, Syndax's oral, small molecule Class 1 specific HDAC inhibitor, in patients with metastatic melanoma who have previously progressed on treatment with an anti-PD-1 (programmed death receptor-1) agent. Under the terms of the agreement, Syndax and Nektar will collaborate on a study to evaluate the combination. The Phase 1b portion of the trial aims to establish safety and a recommended dose for the combination regimen and will be followed by a Pha…

WellCare Health Plans, Inc. (NYSE: WCG) announced today that it has entered into a definitive agreement to acquire Meridian Health Plan of Michigan, Inc., Meridian Health Plan of Illinois, Inc., and MeridianRx, a pharmacy benefit manager (PBM), (collectively, "Meridian") for $2.5 billion in cash. The transaction is expected to close by the end of 2018, subject to customary closing conditions, including regulatory approvals. Meridian expects to generate more than $4.3 billion in total revenue in 2018. As a result of this transaction, WellCare will diversify its Medicaid portfolio through the addition of Michigan, where Meridian has the No. 1 Medicaid market position; deepen its Medicaid business in Illinois; and acquire an integrated PBM platform. Meridian is one of the largest privately…

HCTec, a leading provider of healthcare workforce optimization solutions, announced today a multi-year electronic medical record (EMR) application managed services support agreement with Adventist Health.  HCTec is providing technical and clinical support for Adventist's EMR needs in its Oregon facilities.  Adventist Health, which operates primarily on a Cerner clinical and revenue cycle platform, has more than 50 ambulatory clinics that also utilize Epic software in the Pacific Northwest.  This partnership transfers EMR support operations for the ambulatory clinics to HCTec.  "Our application managed services division is on the forefront of this innovative model for EMR support," said HCTec's Founder and President William Bartholomew.  "We are excited to begin th…

Avara Pharmaceutical Services, a world-class contract development and manufacturing organization (CDMO), today announced that it has agreed to acquire the largest sterile manufacturing facility for injectable medicines in Canada from a leading global pharmaceutical company, as part of a continuing expansion of its global footprint. "This acquisition represents our first entry into the Canadian market and further expands our sterile processing capability, which is in very high demand," said Timothy C. Tyson, Avara's Chairman and Chief Executive Officer. "It comes with a world-class development center and a dedicated team of experts that will support us in delivering high-quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements." The proposed acquisitio…

Eisai Inc. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental New Drug Application (sNDA) for lenvatinib for the potential first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The FDA has indicated that the extension of the Prescription Drug User Fee Act (PDUFA) date is needed to allow additional time for review of the application. The agency expects to complete the review on or before August 24, 2018, thus extending the target action date by a standard extension period of three months from the original PDUFA action date of May 24, 2018. Eisai, as the marketing authorization holder, is working closely with the FDA to suppo…

Strata Oncology, a precision oncology platform company, today announced the close of a $26 million USD Series B funding round.  New investors Pfizer Ventures, Merck Global Health Innovation Fund, Deerfield Management and Renaissance Venture Capital Fund were joined by existing investors Arboretum Ventures and Baird Capital. Strata Oncology will use the new funding to: Expand the Strata Precision Oncology Network, a group of leading health systems adopting Strata's platform to systematize tumor molecular profiling and precision therapy trials. Further develop the company's clinical-genomic data and software solutions to streamline health system precision oncology workflows and catalyze new clinical research opportunities. Submit the company's tumor molecular profiling assay, StrataNG…

Amgen (NASDAQ: AMGN) today announced a groundbreaking collaboration with the National Cancer Institute (NCI), the Federal Communications Commission (FCC) Connect2Health Task Force, the University of Kentucky (UK) Markey Cancer Center and the University of California, San Diego (UCSD) Design Lab to support the improvement of cancer outcomes. The L.A.U.N.C.H. (Linking & Amplifying User-Centered Networks through Connected Health) program will use human-centered design methodologies to identify the needs of patients, caregivers and healthcare providers. The program will use these insights to develop and deliver a connected solution for patients to be able to better manage their cancer symptoms. While the project will initially be focused on underserved populations in rural, Appalachian Ken…

Aptinyx Inc., a clinical-stage biopharmaceutical company developing transformative therapies for challenging neurologic disorders, today announced Allergan plc (NYSE: AGN) has exercised its option to acquire drug candidate AGN-241751, an oral small-molecule N-methyl-D-aspartate (NMDA) receptor modulator. Aptinyx discovered AGN-241751 utilizing its proprietary chemistry platform and the compound was selected for further development by Allergan under its ongoing research collaboration with Aptinyx. Allergan was granted option rights to a limited number of small molecules from the Aptinyx discovery platform under a research collaboration initiated in conjunction with its 2015 acquisition of Naurex, the predecessor company from which Aptinyx and its platform were spun out. Through that transa…

A unique non-estrogen prescription therapy, Intrarosa™, has been approved by the US Food and Drug Administration (FDA) and by the European Medical Agency (EMA), for the treatment of the most bothersome symptom of vulvovaginal atrophy, due to menopause, known as dyspareunia.  Mundipharma has been granted the commercial rights to Intrarosa™ (Prasterone) in the Middle East and Africa as part of an agreement signed between Mundipharma and Endoceutics, Inc.  Intrarosa™ (Prasterone) has been developed for the treatment of women experiencing moderate to severe dyspareunia, which is an outcome of vulvovaginal atrophy, that occurs due to menopause. Intrarosa™ is a unique non-estrogen product that is administered locally in order to exert an action limited to the vagi…

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, Kyowa Hakko Kirin Co. Ltd (Kyowa Hakko Kirin), and Kyowa Kirin International PLC (Kyowa Kirin International) today announced that the Phase 3 study of Crysvita® (burosumab) met its primary endpoint demonstrating that Crysvita was superior to oral phosphate and active vitamin D (conventional therapy) in improving rickets in children with X-linked hypophosphatemia (XLH) after 40 weeks of treatment (LS Mean treatment difference  of +1.14, p<0.0001). The study also showed improvement in important metabolic and functional measures with Crysvita treatment, and a safety profile similar to that observed in other Crysvita pediatric XLH stu…

Advicenne (Euronext: ADVIC), a specialist pharmaceutical company focused on the development of pediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases, announces it has entered into a partnership with the European Society for Paediatric Nephrology (ESPN). This partnership, which will initially last for 3 years, will enable data collection on distal Renal Tubular Acidosis (dRTA) in Europe. This collaboration will be marked by the opening of a survey on the management of dRTA in Europe (mainly covering the 5 largest European countries). The database will gather real-life data on health evolution and care process of 400 dRTA patients with primarily the genetic form of the disease in Europe. The database will be used to provide compelling information on pat…

Today, the National Institute for Health and Care Excellence (NICE) has issued its Final Appraisal Determination (FAD) recommending the use of four out of six disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis. Rebif® (interferon β-1a), Avonex®  (interferon β-1a), Extavia® (Interferon β-1b) and Copaxone® (glatiramer acetate) have been recommended, within their marketing authorisations, as options for treating relapsing-remitting multiple sclerosis in the NHS provided the companies provide the drugs with the discounts agreed in the patient access schemes.1 NICE does not recommend Betaferon® (interferon beta-1b), concluding that it would not be a good use of NHS resources. NICE has also stated it is not in a position to recommend pegylated interferon β-1a (Pleg…

Sanofi (Euronext: SAN; NYSE: SNY) and Ablynx (Euronext Brussels and Nasdaq: ABLX) today announced the results of the initial tender offer period of Sanofi's previously announced tender offers to acquire all of the outstanding shares (including shares represented by American Depositary Shares ("ADSs")), warrants and convertible bonds (together, the "Securities") of Ablynx.    The tender offer is made pursuant to the Heads of Agreement, dated January 28, 2018 between Sanofi and Ablynx, and is comprised of two separate but concurrent tender offers: (i) a tender offer under the laws of Belgium for all of the outstanding shares, warrants and convertible bonds of Ablynx (the "Belgian Offer") and (ii) a tender offer under the laws of the U.S. for all of the outstanding shares held by…

Eli Lilly and Company (NYSE: LLY) and ARMO BioSciences, Inc. (NASDAQ: ARMO) today announced a definitive agreement for Lilly to acquire ARMO for $50 per share, or approximately $1.6 billion, in an all-cash transaction. ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary product candidates designed to activate the immune system of cancer patients to recognize and eradicate tumors. The acquisition will bolster Lilly's immuno-oncology program through the addition of ARMO's lead product candidate, pegilodecakin, a PEGylated IL-10 which has demonstrated clinical benefit as a single agent, and in combination with both chemotherapy and checkpoint inhibitor therapy, across several tumor types. Pegilodecakin is currently being studied in a P…

Today Change Healthcare announced its plans for a collaboration with Adobe and Microsoft that will bring providers a more effective way to give patients the exceptional experience they want. By uniting engagement orchestration proven to work in consumer marketing with industry leading healthcare IT across the continuum of care, providers can compete on the strength of their patient relationships, beyond their existing quality and cost effectiveness capabilities. This new, visionary approach to consumer engagement is needed because existing methods aren't working. An ORC International study concluded healthcare stakeholders are investing heavily in engagement strategies and technologies, but only one-fifth of consumers said their experiences improved, and another fifth said their…

Akili Interactive (“Akili” or “Company"), a leading prescription digital medicine company developing novel treatments for cognitive dysfunction, today announced that it has successfully closed a $55 million Series C financing led by Temasek. Other participating institutional and strategic investors included Baillie Gifford, Amgen Ventures, M Ventures (the CVC fund of Merck KGaA, Darmstadt, Germany), JAZZ Venture Partners, Canepa Advanced Healthcare Fund, and Brooklands Capital Strategies. The financing follows the positive top-line results in December 2017 from Akili’s multicentre randomised controlled pivotal study of AKL-T01, the Company’s flagship investigational product designed to treat paediatric attention deficit/hyperactivity disorder (ADHD). Akili is planning to file AKL-T01 for…

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today its co-development agreement with ai4gi, a commercial joint venture between Satis Operations and Imagia. Their Artificial Intelligence (AI) solution for real-time clinical decision support during screening and surveillance colonoscopy procedures will be exclusively offered by Olympus America Inc. (OAI). This co-development agreement is intended to raise the bar for all physicians to ultimately improve clinical outcomes, reduce overall costs and enhance quality of life for patients. The integration of AI into the colonoscopy procedure holds great promise for the future of GI screening for physicians and patients. Ai4gi initia…

Dolomite Bio, a leading provider of high throughput single cell technology, and Partek Incorporated, a recognized leader in the development of powerful genomic data analysis tools – today announced a collaboration to combine Partek’s single cell data analysis capabilities with Dolomite Bio’s microfluidic droplet-based single cell technology. Single cell data analysis enables researchers to gain useful insights into the diversity and state of single cells in a particular sample, which is fundamental for research into many diseases and immunity. However, analyzing single cell data can be challenging without prior advanced bioinformatics skills or in-house capabilities. To solve this challenge, Dolomite Bio and Partek Incorporated are collaborating on the development of an analysis pipeline…