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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…
MeiraGTx, a London and New York-based gene therapy company, has established a new collaboration with Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery, development and delivery. The collaboration will enable MeiraGTx and Oxford Genetics to develop novel adeno-associated virus (AAV) vectors, as well as packaging and producer cell lines to support the manufacturing needs of MeiraGTx's pipeline of gene therapy product candidates. The companies aim to create a fully scalable AAV production system that can satisfy the requirements for increased viral vector yields, process robustness and product efficacy. As part of the agreement, MeiraGTx gains exclusive, worldwide research and manufacturing rights to novel serotype specific AAV vectors, along…
Candor, a technology and marketplace company specializing in pairing consumers with top health plans, announces the acquisition of Tenex, a comprehensive software development company. Candor is strengthened by the transaction and now has the ability to enhance technological support. Candor enables access to truly flexible benefits and wellness solutions based on the specific needs of consumers and offers Prosper Benefits™ at the True Cost of Care™. The Candor app simplifies the enrollment process and automates the user experience. John Good, COO of Candor, explains, "We demonstrate the True Cost of Care. In other words, there are healthcare plans that have higher negotiated rates for the same procedures. These plans, which we eliminate, are masked by similar copays, deductibles and out-o…
Rimidi, a digital health company that provides software and clinical analytics for chronic disease management, and Eli Lilly and Company (NYSE: LLY), a leader in diabetes care for more than 90 years, are coming together to develop provider-focused tools that will integrate personalized solutions for people who use insulin to manage their diabetes, the companies announced today. Rimidi will integrate its diabetes management software platform with Lilly's integrated insulin management system in development. The non-exclusive agreement between Rimidi and Lilly will strive to make diabetes management easier for approximately 30 million Americans with diabetes and the health care providers who care for them by helping people use insulin more effectively while optimizing diabetes management wit…
Ablynx NV [Euronext Brussels and Nasdaq: ABLX] today announced additional results from the Phase III HERCULES study with caplacizumab, the Company's anti-von Willebrand factor (vWF) Nanobody® being developed for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). These new data relate to additional pre-specified secondary endpoints and demonstrate that treatment with caplacizumab resulted in a clinically meaningful reduction in the use of PEX and length of stay in the ICU and the hospital.   The number of days of PEX during the overall treatment period was 38% lower in the caplacizumab group compared to the placebo arm (5.8 days versus 9.4 days) resulting in a 41% reduction in the volume of plasma used (21.3L on caplacizumab compared to 35.9L in the placebo group).…
Almirall, S.A (ALM), a global skin-health focused pharmaceutical company, today announced an agreement with Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, to further develop and commercialize KX2-391 for the treatment of actinic keratosis and other skin conditions. Subject to the terms and conditions of the License Agreement, Athenex will grant to Almirall an exclusive license under the Athenex IP to research, develop and commercialize KX2-391 in the United States of America and European countries, including Russia. KX2-391, also known as KX-01, is a first-in-class dual Src kinase and tubulin polymerization inhibitor in Phase III devel…
As the rate of diabetes continues to escalate in the United States, health care payers are looking for solutions to help manage the cost of treating this serious disease while helping to ensure quality health care for their members. This has led Prime Therapeutics LLC (Prime), a leading pharmacy benefit manager (PBM), and Novo Nordisk, a global health care company and leader in diabetes care, to establish a value-based contract for the type 2 diabetes drug, Victoza®, as part of Prime's CareCentered Contract™ program. Since signing its first outcomes-based contract in 2010, CareCentered Contracting has served as one arm of a multi-pronged strategy to help control costs for Prime's clients, employers and members. This new contract with Novo Nordisk for Victoza aligns to Prime's strategy by…
Northwell Health and Cigna have reached agreement to continue their more than 20-year relationship, keeping all Northwell hospitals, physicians, laboratories, home health and other providers in the Cigna network.  On November 30, Cigna preemptively notified its members that Northwell was leaving the Cigna hospital network, but an agreement has been reached to continue the longstanding participation agreement.  Members and employers should disregard any communication from Cigna or others stating that Northwell providers will not participate with Cigna Health Plans.  The agreement will continue without change through 2018 and all Northwell patients who are insured through Cigna will continue to be welcomed and cared for by Northwell providers. "Northwell puts its patients fi…
Santhera Pharmaceuticals , Summit Therapeutics , Catabasis Pharmaceuticals  and Duchenne UK are pleased to announce a collaboration to host a Duchenne Muscular Dystrophy (DMD) Awareness Day today in London.   The half-day event will feature presentations by key opinion leaders representing clinical practitioners, industry professionals and the patient group Duchenne UK. Professor Dame Kay Davies FRS of the University of Oxford, Dr Rosaline Quinlivan MD of the National Hospital for Neurology and Neurosurgery and Professor Thomas Voit MD of Great Ormond Street Hospital and University College London will deliver keynote addresses focusing on the biology and aetiology of the disease, and the current treatment landscape.   The sponsoring companies will also present on their r…
Shire plc (LSE: SHP, NASDAQ: SHPG), the biotech leader in rare diseases, and Rani Therapeutics, an InCube Labs company, today announced a collaboration to exclusively conduct research on the use of the Rani Pill™ technology for the oral delivery of factor VIII (FVIII) therapy for patients with hemophilia A. The collaboration agreement grants Shire an exclusive option to negotiate a license to develop and commercialize the technology for delivery of FVIII therapy following completion of feasibility studies. As part of the collaboration, Shire has also made an equity investment into Rani Therapeutics.   Rani Therapeutics has developed a novel approach for the oral delivery of large molecules, including peptides, proteins, and antibodies, using the Rani Pill, a capsule that delivers an…
Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the signing of a companion diagnostic[1] (CDx) development agreement with Amgen, a leading biotechnology company (NASDAQ: AMGN), for the Idylla(TM) RAS biomarker tests. The aim of the agreement is to register the Idylla(TM) RAS biomarker tests with the US Food and Drug Administration (FDA) as a companion diagnostic test for Amgen's drug Vectibix® (panitumumab). Vectibix® is the first and only fully human monoclonal anti-epidermal growth factor receptor (EGFR) antibody indicated for certain metastatic colorectal cancer (mCRC) patients with wild-type RAS[2]. RAS testing is an essential predictive biomarker to determine the treatment plan for pa…
Alliance Pharma plc (AIM: APH), the specialty pharmaceutical company, announces that its wholly owned subsidiary, Alliance Pharmaceuticals Limited, has acquired all of the rights to Ametop from global medical technology business Smith & Nephew for a consideration of US$7.5 million.   Ametop is a topical anaesthetic gel product used for numbing the skin prior to intravenous injection or cannulation.   Smith & Nephew has been selling Ametop in the United Kingdom, Republic of Ireland (ROI), New Zealand and Canada for over 10 years. In the 12 months to 31 October 2017 the total sales of Ametop by Smith & Nephew were US$2.8 million with approximately 75% of sales derived from the UK and ROI.   The consideration is being funded from existing cash and bank facilit…
Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an agreement with Aralez Pharmaceuticals Trading DAC, an Irish designated activity company, to become the exclusive distributor in the U.S. of the authorized generic version of Toprol-XL® (Metoprolol Succinate) Extended Release Tablets in 25 mg, 50 mg, 100 mg and 200mg.  For the 12 months ended September 2017, total U.S. sales at Average Wholesale Price (AWP) of Metoprolol Succinate extended release tablets 25 mg, 50 mg, 100 mg and 200 mg were approximately $690 million, according to IMS.  Financial terms were not disclosed. "Metoprolol Succinate is a widely prescribed medication and will be an important addition to our cardiovascular product offering," said Arthur Bedrosian, chief executive officer of La…
Today at Veeva European Commercial & Medical Summit, one of the largest life sciences events for commercial and medical affairs professionals in Europe, Veeva Systems (NYSE: VEEV) announced a new digital asset management capability that makes it simple for brand managers to create portals that organize and showcase content within Veeva Vault PromoMats. With Veeva Vault PromoMats Brand Portal, marketing teams can share digital assets and campaigns in one place so employees, affiliates, and agencies can easily find and leverage existing content. “Veeva is expanding the digital asset management capabilities in Vault PromoMats to help organizations drive greater reuse of the growing volume of content they’re creating,” said David Bennett, Veeva vice president of strategy, commercial conte…
GC Incentives continues to expand its global reach in the incentives and recognition industry, including wellness rewards, through its new partnership with CoreHealth Technologies, a wellness technology company. GC Incentives will leverage its experience and global partnership with UK-based Ovation Incentives to simplify the administration and fulfillment of wellness rewards for global customers on the CoreHealth corporate wellness portal. "Our technology powers wellness programs for health providers, and their global clients, located around the world. These providers are looking for a one-stop solution that makes it easy to incent and reward employees for their participation and success in wellness programs – no matter where they are located in the world," says Anne Marie Kirby, CEO of…
Express Scripts (NASDAQ: ESRX) and Avista Capital Partners, a leading private equity firm, announced today that Avista has signed a definitive agreement to acquire United BioSource (UBC), a wholly-owned subsidiary of Express Scripts Holding Company. Founded in 2003 and headquartered in Blue Bell, Pennsylvania, UBC is a leading provider of pharmaceutical and patient support services, partnering with life science companies to make medicine and medical products safer and more accessible. The company has 13 locations in the U.S., Europe, and Canada. A core strength of UBC is generating, analyzing, and communicating real-world evidence throughout a medical product's lifecycle. Patrick Lindsay, UBC president, said, "Our team of clinical and commercial experts understands the many facets of dru…
PMD Solutions, an industry leading medical technology company based in Cork Ireland, today announced its successful enrolment in the NHS Innovation Accelerator (NIA) Programme as part of the NIA's official kick-off launch event which took place in London this week.  Now entering its third year, the NIA is an NHS England initiative delivered in partnership with England's 15 Academic Health Science Networks (AHSNs) and focused exclusively on identifying and partnering with only the top leading healthcare pioneers in the market. Since its launch in July 2015, the NIA has supported the uptake and spread of 25 high-impact, evidence-based innovations across 799 NHS organisations. This recruitment process follows an international call and robust selection process, including review by a coll…
At the 5th Canton Nucleic Acids Forum (CNAF) in Guangzhou, China, Guangzhou RiboBio Co., Ltd. ("RiboBio") and GE Healthcare Life Sciences ("GE") held a strategic partnership signing ceremony. The strategic partnership agreement is aimed at establishing a deep alliance to jointly build Asia's largest oligonucleotide drug development and manufacturing facility in China.  The goal of this partnership is to provide a total solution for oligonucleotide drug companies worldwide. Dr. Biliang ("Bill") Zhang, President of RiboBio, and Mrs. Shufang ("Sofia") Lim, the Chief Commercial Director of GE Healthcare Life Science China, executed this strategic partnership agreement. The signing was witnessed by three Nobel Laureates including: Dr. Tomas Lindahl from Francis Crick Institute,…
Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; hereinafter "Sumitomo Dainippon Pharma") and Angelini S.p.A. (Head Office: Rome, Italy; CEO: Gianluigi Frozzi; hereinafter "Angelini") announced today that the companies have formed a partnership (entering into a license and distribution agreement) with the goal to expand availability in Europe of Latuda® (generic name: lurasidone hydrochloride; hereinafter "LATUDA"), an atypical antipsychotic which was created by Sumitomo Dainippon Pharma. Under the terms of the agreement, Sunovion Pharmaceuticals Europe Ltd., a subsidiary company of Sumitomo Dainippon Pharma Group, (hereinafter "Sunovion Europe") has granted Angelini exclusive commercialization rights for LATUDA in 29 European countries[*] and in Tur…
WuXi AppTec (WuXi), a leading global pharmaceutical, biotechnology and medical device open-access capability and technology platform company, announced that its Advanced Therapy Unit based in Philadelphia has been selected as a manufacturing partner for advanced therapies through the California Institute for Regenerative Medicine (CIRM) funded IQVIA (formerly QuintilesIMS) Stem Cell Center. In collaboration with its partners, the Stem Cell Center aims to accelerate the preclinical/clinical development, and commercialization of stem cell, cellular and gene-modified therapies via end-to-end solutions and targeted services to advance assets from candidate identification through market authorization and improve the probability of clinical and commercial success. WuXi AppTec Advanced Ther…