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- 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…
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) announced on teh 27th December the exclusive launch of a generic version of Reyataz®1(atazanavir) capsules in the U.S. Atazanavir sulfate capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg. “The exclusive launch of our generic version of Reyataz marks our fifth generic product offering for the treatment of HIV-1 infection,” said Brendan O’Grady, Executive Vice President, North America Commercial at Teva. “Antiviral medications continue to be a focus for Teva Generics, and this is an important addition to our portfolio.” With nearly 600 generic medicines available, Teva has the largest p…
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…
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…