Clinical research - Today Stories

Boston Scientific Corporation (NYSE: BSX) today announced it has closed an investment and entered into an acquisition option agreement with Millipede, Inc., a privately-held company that has developed the IRIS Transcatheter Annuloplasty Ring System for the treatment of severe mitral regurgitation (MR). Under the terms of the agreements, Boston Scientific has purchased a portion of the outstanding shares of Millipede along with newly issued shares of the company for a total consideration of $90M. Boston Scientific has the option to acquire the remaining shares of the company at any time prior to the completion of a first in human clinical study that meets certain parameters. Upon the completion of the clinical study, Millipede has the option to compel Boston Scientific to acquire the remain…

Elanco Animal Health, a division of Eli Lilly and Company (NYSE: LLY), is pleased to announce a new global in-licensing agreement with Ab E Discovery to further develop and bring to market an egg antibody focused on supporting gut health, and thereby the growth and welfare, of poultry. Developed at the University of Wisconsin-Madison by Drs. Mark Cook and Jordan Sand, this unique innovation targets anti-nutritional challenges found in an animal's gut. This technology, when fully developed, will focus on the natural ability of hens to pass antibodies to their offspring through eggs. Adding egg proteins to the diets of young birds passes on antibodies to improve gut health. A healthy gut can decrease susceptibility to certain pathogens, such as Eimeria spp., which is known to cause coccidi…

Mylan N.V. (NASDAQ, TASE: MYL) today announced the launch of Brabio (glatiramer acetate injection) 40 mg/ml,[1] the first available therapeutically equivalent version of Teva’s Copaxone® indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system.[2]   It is expected that Brabio will be available at a lower acquisition cost to the NHS, which is currently seeking to expand its use of best value medicines following the launch of its ‘Medicines Value Programme’. This initiative aims to improve health outcomes by diverting budget to other areas of need without compromising on treatment.   Mylan Europe President Jacek Glinka commented, “Bringing a more affordable, more accessible treatment op…

Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas" ) today announced that it has completed the acquisition of Mitobridge, Inc. ("Mitobridge"), and Mitobridge has become a wholly owned subsidiary of Astellas as of January 23, 2018 (U.S. Eastern Time). By exercising the option right to acquire Mitobridge, Astellas paid $225 million1 to acquire 100% of the equity in Mitobridge. In addition, Mitobridge shareholders will be eligible for additional payments from Astellas that total up to $225 million2 depending on the progress of various programs in clinical development. The transaction accelerates Astellas' research and development in diseases associated with mitochondrial dysfunctions and will enable the delivery of innovative new treatment options to pat…

Blue Mesa Health Inc., New York, NY, today announced a partnership with Merck KGaA, Darmstadt, Germany to pilot its CDC-recognized Diabetes Prevention Programs in territories outside of the United States. Founded in 2015, Blue Mesa Health has designed and commercialized two chronic disease prevention programs based on the CDC's landmark National Diabetes Prevention Program. Transform is a year-long lifestyle change program that integrates remote health coaching from dieticians, a peer support group, and the integration of smartphone app technology with connected bathroom scales and activity trackers. Transformemos is a Spanish-language program currently available in the US market for Spanish speakers. "We are thrilled to partner with a leading science and technology company like Merck KG…

Paris (France) and Waltham, Mass. - January 22, 2018 - Sanofi and Bioverativ Inc., a biopharmaceutical company focused on therapies for hemophilia and other rare blood disorders, have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Bioverativ for $105 per share in cash, representing an equity value of approximately $11.6 billion (on a fully diluted basis).  The transaction was unanimously approved by both the Sanofi and Bioverativ Boards of Directors. "With Bioverativ, a leader in the growing hemophilia market, Sanofi enhances its presence in specialty care and leadership in rare diseases, in line with its 2020 Roadmap, and creates a platform for growth in other rare blood disorders.  Together, we have a great opportunity…

Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the European Commission (EC) has granted marketing authorization for MVASI® (biosimilar bevacizumab). MVASI is the first biosimilar bevacizumab approved by the EC and is approved for the treatment of certain types of cancers, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alfa-2a for advanced and/or metastatic renal c…

SQI Diagnostics Inc. ("SQI" or the "Company") (TSX-V: SQD; OTCQB: SQIDF), today announced it has signed a revenue-producing agreement with a global biotechnology company to provide assay development and future sample testing and analysis services.  This customer has contracted test development to SQI to create an immunogenicity assay utilizing SQI's multiplexing technology. After completing test development, SQI anticipates it will be engaged to provide contract research services to provide analytical sample testing. This testing will be done at SQI's state-of-the-art facility in Toronto.  This contract research service augments SQI's product offerings enabling pharma and biotech customers to outsource their multiplexed assay development, validation, and testing services to SQI.…

Applied BioMath (www.appliedbiomath.com), the industry-leader in applying mechanistic modeling to drug research and development, today announced a collaboration with Compass Therapeutics for the semi-mechanistic pharmacokinetic and pharmacodynamic (PK/PD) modeling of a therapeutic targeting solid tumors.  Semi-mechanistic PK/PD models will be developed for mouse, cynomolgus monkey, and human species and will help answer strategic questions such as the target coverage required for efficacy and dose regimen selection for the clinical study. "We will use these models to help guide experiments and narrow down critical dosing and target coverage ranges to support an Investigational New Drug (IND)," said Michael Schmidt, Vice President, Antibody Discovery and Engineering at Compass Therape…

Biotage AB (Biotage), (NASDAQ OMX Stockholm: BIOT.ST) today announces the closing of the acquisition of all outstanding shares in the privately held company Horizon Technology, Inc. (Horizon) based in New Hampshire, US, in accordance with contract and public announcement of December 6th, 2017. The purchase price adjusted for actual net cash at the closing date is approx. USD 17.9 million, corresponding to approx. SEK 143.4 million[1], based on an enterprise value of approx. USD 16.4 million and cash of approx. USD 1.5 million. This information was submitted for publication, through the agency of the contact persons set out above, at 17.00 CET on January 16, 2018. [1] Based on an exchange rate USD/SEK of 0.1247. This exchange rate has been used throughout this press release for the conver…

CGT Catapult and CombiGene today announced that they will be collaborating on a project to develop manufacturing processes for CombiGenes drug candidate CG01, a novel gene therapy for treatment of epilepsy. The collaboration aims to develop a complete and final manufacturing process which will allow CombiGene to progress to commercial GMP production and thereafter clinical trials.   CombiGene is pioneering a new therapy with the potential of dramatically improving the quality of life for a group of epilepsy patients for whom there currently is no effective treatment available. CombiGene’s unique platform uses gene therapy vectors to deliver a combination of neuropeptide y (NPY) and NPY receptors into brain cells which has shown to inhibit epileptic seizures, in a series of preclinic…

NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced it will begin a pre-clinical collaboration with Providence Cancer Institute to study Nanobiotix's lead product, NBTXR3, a first-in-class nanoparticle designed for direct injection into cancerous tumors and activation by radiotherapy.   The collaboration with Providence Cancer Institute, located at the Robert W. Franz Cancer Center in Portland, Ore., one of the world's leading oncological research centers, will provide essential preclinical data on the ability of NBTXR3 activated by radiotherapy to induce an antitumoral immune response. This is an in-depth study into the early immunologic mechanisms, triggered by nanopartic…

- In Europe, there are approximately 3,400 children ages 6-11 who have two copies of the F508del mutation -   - Existing reimbursement agreements in countries like Ireland will enable rapid access to ORKAMBI; country-by-country reimbursement processes will now begin in other countries-   LONDON – January 10, 2018 –Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted extension of the Marketing Authorization for ORKAMBI® (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people with two copies of the F508del mutation, to include children ages 6 through 11. In Europe, there are approximately 3,400 children ages 6 through 11 with two copies of this mutation. Existing reimbursem…

Syapse, a leading precision medicine company, announced today it has entered into a multi-year strategic collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY) to make precision medicine a reality for more cancer patients and their healthcare providers. Syapse and Roche will work jointly to develop software products and analytics solutions that empower healthcare providers with the tools and insights they need to practice precision medicine at scale, with the goal of improving patient outcomes and health-related quality of life. Under the terms of the agreement, Roche will fund the development of these products, which will benefit oncologists and their care team, health systems, and ecosystem stakeholders including payers. Building on the Syapse Platform, Syapse will develop and deploy the…

Cypralis and Gilead Sciences, Inc. (“Gilead”) have agreed that Cypralis will have exclusive development and commercialization rights to certain macrocyclic inhibitors of peptide bond isomerases, in all fields except for oncology and virology. This is a further step in the collaboration between the parties which follows a multi-year drug discovery collaboration between Selcia Ltd (Ongar, Essex) and Gilead (Foster City, California) under which Selcia’s chemists and biologists provided integrated drug discovery services to support Gilead’s liver disease research programmes. The research phase ended in 2013 and Selcia’s rights under the agreement have been subsequently transferred to Cypralis. During the research collaboration, Selcia and Gilead generated four jointly owned patents…

TiGenix NV ("TiGenix") (Euronext Brussels and NASDAQ: "TIG"), an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop novel therapies for serious medical conditions, today confirms that Takeda Pharmaceutical Company Limited ("Takeda") has announced its intention to launch a voluntary conditional takeover bid on TiGenix.   Takeda intends to acquire 100% of the securities with voting rights or giving access to voting rights of TiGenix not already owned by Takeda or affiliates at a price of EUR 1.78 per share in cash and an equivalent price in cash per American Depositary Share, warrant and convertible bond.   Takeda intends to launch the proposed takeover bid shortly after the appro…

Arecor Limited,  a leader in developing superior biopharmaceuticals through the application of an innovative formulation technology platform, and JDRF, the leading global organisation funding type 1 diabetes research, are pleased to announce the successful completion of their partnered programme and the pre-clinical development of an ultra-concentrated, rapid-acting insulin product (“the product”) for the significantly enhanced treatment of insulin-requiring diabetes, particularly type 1 diabetes.     The product, which is scheduled to progress into a first-in-human clinical study in people with type 1 diabetes in 2018, is a significant step toward enabling miniaturization of next-generation insulin delivery technologies that are promising to transform…

Arvinas LLC, a private biotechnology company focused on creating a new class of drugs based on protein degradation, announced today a research collaboration and license agreement with Pfizer Inc. (NYSE: PFE) for the discovery and development of drug candidates using Arvinas' proprietary PROTAC (PROteolysis TArgeting Chimeras) Platform, a novel technology used to create small molecule therapeutics aimed at degrading disease-causing cellular proteins. The multi-year agreement covers the discovery and development of potential PROTAC clinical candidates designed to degrade several key disease-causing proteins in multiple therapeutic areas. Arvinas will drive discovery efforts, and Pfizer will be accountable for clinical development and commercialization of any products that may result from th…

Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant" or the "Company") today announced that its affiliate has completed the divestiture of the Sprout Pharmaceuticals subsidiary ("Sprout") to Sprout2 Inc., an entity affiliated with certain former shareholders of Sprout, in exchange for a 6% royalty on global sales of ADDYI® (flibanserin) beginning in May 2019. In connection with the sale, Valeant has provided a $25 million loan to fund initial operating expenses. In connection with the completion of the sale, Valeant has been released from the ongoing obligations of the original transaction to split future profits related to the sale of ADDYI® (flibanserin) with the former shareholders of Sprout, as well as certain related provisions, including the obligations to…

Timely reporting of results from pharmaceutical company-sponsored clinical trials for newly approved medicines has reached the highest recorded level of 93%, according to a new study published in the peer-reviewed journal Current Medical Research and Opinion (CMRO). The ABPI-sponsored study – Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014 – is the latest in a series covering all trials in patients associated with all 142 new medicines approved by the European Medicine Agency (EMA) over a continuous six-year period (2009-2014). This research, coupled with assessments of the previous five years, indicates that the disclosure rate of industry-sponsored clinical trials at 12 m…