PharmiWeb.com - Global Pharma News & Resources

Recruitment - Today Stories

Alcami, a leading provider of custom end-to-end development and manufacturing services for the pharmaceutical and biotechnology industries, today announces it has finalized manufacturing and quality agreements with Solasia Pharma, K.K. (TSE: 4597) for the clinical supply manufacture of the active pharmaceutical ingredient (API) darinaparsin, a novel mitochondrial-targeted agent developed for the treatment of various hematologic and solid cancers. Solasia is a Japan-based specialty pharmaceutical company dedicated to the development of innovative oncology medicines. In March 2011, Solasia acquired the rights to darinaparsin from ZIOPHARM Oncology, Inc. for the potential treatment of Peripheral T-Cell Lymphoma (PTCL). The agent is currently in Phase II pivotal trials in Asia. "We are pleas…
Health education startup MedCircle today announced a partnership with the accrediting organization Annenberg Center for Health Sciences at the Eisenhower to offer Annenberg CME/CE learners a new digital networking platform that facilitates greater engagement between healthcare providers and patients, family members and others interested in a specific health topic. "MedCircle was created to give those seeking information on health topics a way to tap into content they can trust," said Dr. Kapil Gupta, chief executive officer and founder of MedCircle. "With our partnership with the Annenberg Center, we provide an easy, secure way for Annenberg clinician-learners and other credentialed healthcare providers to engage with patients, patient advocates and interested consumers." The Annenberg C…
EpiSwitch™ technology to identify new targets and biomarkers relating to fibrotic mechanisms   Fibrosis associated with chronic inflammation is a serious unmet clinical need   Oxford BioDynamics Plc (AIM: OBD), a biotechnology company focused on the discovery and development of epigenetic biomarkers based on regulatory genome architecture, for use within the pharmaceutical and biotechnology industry, is pleased to announce that it has entered into an initial collaboration with a major US biopharmaceutical company to advance the discovery and development of novel treatments to address patients with abnormal wound healing response, leading to fibrosis. Fibrosis is a pathological feature of most chronic inflammatory diseases, which can affect nearly every tissue in the body. If…
Diplomat Pharmacy, Inc. (NYSE: DPLO), has entered into a definitive agreement to acquire Pharmaceutical Technologies, Inc., doing business as National Pharmaceutical Services. The transaction is expected to close in 30 days. National Pharmaceutical Services (NPS) is a full-service pharmacy benefit manager (PBM) based in Omaha, Nebraska. It features a proprietary claims-processing system and offers mail-order service under its Integrated HMO Pharmacy. "Industry dynamics and the evolution of our payor strategy have accelerated our push to add PBM-like services," said Phil Hagerman, CEO and chairman of Diplomat. Hagerman said small and midsize payors, self-funded employers, and unions are seeking flexible solutions to improve health care outcomes and reduce costs. Partnering with NPS, he s…
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that the company submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for inotersen, based on the phase 3 NEURO-TTR study in patients with hereditary TTR amyloidosis (hATTR). The MAA for inotersen will be reviewed under the EMA's Accelerated Assessment program, which is intended to expedite access to drugs that the EMA considers to be of major therapeutic interest. "The submission of the inotersen MAA to the EMA represents a critical milestone for Ionis and for European patients suffering from ATTR. We are pleased that we met the last deadline for Accelerated Assessment in the EU for 2017. Next week, we also plan to submit the NDA to the FDA. Today's submission to the EMA puts us one step cl…
Amgen (NASDAQ: AMGN) and Novartis today announced an expanded collaboration with the Banner Alzheimer's Institute (BAI) to initiate a new trial – the Alzheimer's Prevention Initiative (API) Generation Study 2. This trial follows the launch of the Generation Study 1, and will determine whether the BACE1 inhibitor CNP520 can prevent or delay the onset of Alzheimer's disease symptoms in a high-risk population. BACE1 is an enzyme that plays an important role in the production of Amyloid β, a protein which accumulates in the brains of individuals with Alzheimer's disease years before clinical symptoms begin. More information on the sites participating in Generation Study 2 can be found at ClinicalTrials.gov and in the website www.GenerationProgram.com. "As a leader in the challenging fight to…
Almac Group, the global contract development and manufacturing organisation, today announced the acquisition of 100% shares of BioClin Laboratories, an independent and privately owned organisation based in Athlone, Ireland. Established in 2002 and located in Garrycastle, just two hours away from Almac Group’s Headquarters in Northern Ireland, BioClin is internationally recognised for providing expert analytical services including cGMP pharmaceutical and biopharmaceutical analysis, GMP microbiology testing and GLP bioanalysis. The company also boasts Ireland’s leading GLP certified (INAB), cGMP certified (HPRA) and FDA registered contract laboratory. BioClin’s bespoke 14,000sq ft modern facility significantly increases Almac’s analytical capacity and perfectly complements its ex…
Novartis announced today, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Advanced Accelerator Applications (NASDAQ:AAAP) is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera® (177Lu-DOTATATE), a first-in-class RLT product for neuroendocrine tumors (NETs). Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. The transaction would strengthen Novartis' oncology presence with both near-term product launches as well as a new technology platform with pot…
Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into a settlement and license agreement with Celgene Corporation that resolves patent infringement litigation in the U.S. related to Celgene's Thalomid®.  The license agreement permits Lannett to manufacture and market in the U.S. its generic thalidomide product as of August 1, 2019 or earlier under certain circumstances.  As mandated by the U.S. Food and Drug Administration (FDA), Thalomid® is subject to Risk Evaluation and Mitigation Strategies (REMS) program, which is designed and implemented during the commercialization of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks. "I congratulate my staff and colleagues for showing the cour…
Tokyo, Japan, Basking Ridge, NJ, and Berlin, Germany – (October 30, 2017) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Glycotope GmbH (hereafter, Glycotope) have signed an option agreement for future strategic collaboration and licensing to develop an antibody drug conjugate (ADC) by combining Daiichi Sankyo’s proprietary ADC technology with Glycotope’s investigational tumor-associated TA-MUC1 antibody PankoMab-GEX®.   Under the terms of the agreement, once a feasibility study has been successfully completed, Daiichi Sankyo has the right to exercise its option for worldwide exclusive rights to develop and commercialize PankoMab-GEX ADC. If Daiichi Sankyo exercises these rights, Glycotope will receive an upfront payment as well as development and sales milestone…
ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, and the International Consortium for Health Outcomes Measurement (ICHOM), a non-profit organization with the mission of driving value based health care, shared the findings of a global patient outcomes benchmarking platform at this week’s ICHOM’s annual conference in Washington DC. The platform aims to catalyse physician driven learning and improvement of the outcomes that matter most to patients. ICON and ICHOM first partnered to advance value-based healthcare through the launch of a global healthcare outcomes benchmarking pilot program called GLOBE in March 2016.  The pioneering work of the GLOBE pilot program, through its collab…
Omnicell, Inc. (NASDAQ: OMCL) today announced that Hackensack Meridian Health has chosen the Company's automated medication management solutions and enterprise services to serve the health care network's pharmacy needs. Hackensack Meridian Health serves New Jersey residents spanning from Bergen to Atlantic counties through its 13 hospitals and more than 140 ambulatory care centers, fitness and wellness centers, home health services, rehabilitation centers, and skilled nursing centers. Hackensack Meridian Health recognizes that having cohesive medication management technology across its healthcare system can play an integral role in improving clinical operations, specifically by promoting patient safety, supply chain efficiencies, and overall standardization efforts. As a nationally accred…
Microsoft and PAREXEL form cloud technology alliance aimed at accelerating the pace of drug development Companies seek to drive digital transformation of the biopharmaceutical industry by combining PAREXEL’s drug development expertise with Microsoft Azure. REDMOND, Wash., and BOSTON — Oct. 24, 2017 — Microsoft Corp. and PAREXEL International Corp., a leading global biopharmaceutical services organization, on Tuesday announced a technology development alliance aimed at driving innovation across the life sciences industry with technology powered by Microsoft Azure. The collaboration between Microsoft and PAREXEL is designed to help the industry accelerate drug development and bring new therapies to patients sooner. The companies will combine Microsoft’s global cloud infrastructure, intell…
AMRA, the international leader in body composition analysis, and BioTelemetry Research (“BTR”), a leading global imaging and cardiac core lab, announced today the formation of an exclusive alliance for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) clinical trials. This first-to-market partnership will advance imaging science and benefit clinical trial sponsors in several musculoskeletal and metabolic therapeutic areas. In clinical studies, muscle and fat fractions have traditionally been measured by scanning individual organs such as the liver, or particular body regions such as the abdomen. Commonly, researchers would prefer to scan the entire body in order to learn exactly where study participants are losing or gaining muscle or fat mass. However, un…
Micro Interventional Devices, Inc.™ (MID) announced today the second successful implantation of its MIA (Minimally Invasive Annuloplasty) technology.  The patient was enrolled in the first arm of the STTAR (Study of Transcatheter Tricuspid Annular Repair) clinical trial studying the safety and efficacy of MID's MIA device designed to eliminate or greatly reduce tricuspid regurgitation.  This is the second patient enrolled in the surgical arm of the STTAR study utilizing a bicuspidization approach.  The procedure took less than 14 minutes.  The rapid, reproducible deployment of the MIA implant resulted in a 24% reduction in annular area and a reduction in tricuspid regurgitation from moderate regurgitation pre-procedure to trace regurgitation post-procedure.  As wi…
Cardax, Inc. (OTCQB:CDXI) announced today that it has entered into a mutual exclusivity agreement with General Nutrition Corporation ("GNC") for ZanthoSyn, the Company's premium astaxanthin dietary supplement for inflammatory health and longevity.* The exclusivity agreement builds on the Company's recently announced national rollout of ZanthoSyn across GNC's more than 3,200 US corporate stores and now designates GNC as the exclusive "brick-and-mortar" retailer of ZanthoSyn in the United States. ZanthoSyn will also continue to be available online at gnc.com, amazon.com, and zanthosyn.com. The exclusivity agreement covers the use of ZanthoSyn as a human dietary supplement, with an initial term of two years and provides for automatic renewals. The exclusivity obligation is subject to GNC c…
GIMDx, Inc. (hereinafter referred to as "GIMDx") announced today that it has concluded an exclusive OEM and International Distribution agreement for IncellDx, Inc. (hereinafter referred to as "IncellDx") single cell immune-oncology and oncology diagnostic products in China. GIMDx will supply its parent company, Guangzhou Improve Medical Instruments Co., Ltd. (hereinafter referred to as "Improve Medical"), with IncellDx component products which will be kitted and co-labeled for the Chinese IVD market. Products included in the agreement are IncellDx's proprietary single cell quantification of Programmed Death Ligand 1 (PD-L1) on tumor cells and immune cell subtypes, single cell HPV E6/E7 mRNA detection for cervical cytology, and the IncellPREP® tissue single cell suspension system for solid…
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that it has entered a collaboration with Seventh Sense Biosystems, Inc. (7SBio), a private medical device company developing TAP™, a novel, push-button, blood collection device to make blood testing more convenient and virtually painless. As part of its commitment to the collaboration, Ionis has made a strategic investment of $2 million in 7SBio as part of a Series C financing that will also include other investors. 7SBio aims to create a new standard for blood collection that increases patient compliance with blood testing by improving patients' experience with blood collection, leading to faster diagnoses and better outcomes. The U.S. Food and Drug Administration (FDA) recently approved TAP for the collection of blood by a healt…
Plasticell, the biotechnology company specialising in stem cell screening and cell therapy development, has entered into a collaboration with GSK to use its combinatorial stem cell screening technology, CombiCult®, to optimise the directed differentiation of induced pluripotent stem cells (iPSCs) to specific blood cell lineages for use by GSK in its therapeutic research. In the collaboration, Plasticell will use its CombiCult® technology to screen combinations of molecules provided by GSK to identify and optimise iPSC differentiation protocols. Plasticell’s proprietary technology will allow the simultaneous screening of multiple iPSC lines, facilitating the development of a robust protocol that is applicable across lines. Commenting on the collaboration, Plasticell’s founder and Executiv…
CASI Pharmaceuticals, Inc. (the "Company") (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced that it has entered into definitive agreements with certain institutional and accredited investors, including existing shareholders, to purchase approximately $23.8 million of securities in a registered direct offering.  CASI expects to receive net proceeds of approximately $23.3 million after deducting agent's fees and other offering expenses.  CASI has agreed to sell an aggregate of approximately 7,951,868 shares of its common stock and warrants to purchase shares of its common stock. …