In The Spotlight
Clinerion announces that data integration to its Patient Recruitment System platform can now also process electronic medical records made available by hospitals using the Fast Healthcare Interoperability Resources (FHIR) standard.
Janssen Biotech, Inc., announced that the U.S. FDA has approved an expanded indication for STELARA® (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Kaleido Biosciences, a clinical-stage biotechnology company developing novel chemistries to unlock the power of the human microbiome, today announced an agreement with CoreBiome, a genomics platform company focused on accelerating microbiome innovation with expert genomics and big-data analytics, to provide high-scale and high-content microbiome data to increase the speed and productivity of Kaleido’s clinical development and discovery programs.
CRF Health, a leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, has made two senior appointments to support the continuing growth of the global business.
Catalent Pharma , the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, welcomed Symbiomix Therapeutics’ announcement that the U.S. FDA has approved Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. 
Lonza is hosting a free 60-minute webinar on 24 October 2017, titled “Challenges and Strategies for Paperless Product Release – Bringing the Pieces Together.”
SIRION Biotech GmbH and Vibalogics GmbH, have signed a strategic partnership agreement designed to meet demand from gene therapy companies for a start-to-finish Adeno-Associated Virus (AAV) service.
Copenhagen, Denmark: Albumedix has announced that it has signed a strategic research agreement with Oslo University Hospital and University of Oslo. The three
organisations will work together to improve understanding of the interaction between bioengineered albumin variants and the neonatal Fc receptor (FcRn).
Worldwide Clinical Trials Experts to ExploreEmerging Trends in Cardiovascular Research in Webinar Commemorating World Heart Day.
Worldwide Clinical Trials will host the next in its series of ‘Eavesdropping on the Experts’ webinars titled, Five Emerging Trends in Cardiovascular Research”on September 28th at 11am ET in commemoration of World Heart Day (September 29th).
Quanticate, a global data-focused clinical research organisation (CRO), is further expanding its service offering into India with the opening of a new office.
In 2015, 29 million people in the United States had type 2 diabetes, according to the American Diabetes Association. Type 2 diabetes is generally a result of a decline in beta cell function, however this indicator is rarely measured because of flaws in the current method of assessment that can lead to inaccurate results.
CRF Health, the leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, will today officially open their Romania office and welcome to the helm a new VP of Global Services, Adina Tapalaga.
Aplagon Oy (“Aplagon”) and Cadila Pharmaceuticals Sweden AB today announced a development and commercialization agreement for Aplagon’s lead APAC product. APACs are proprietary, locally acting, potent antithrombotic products, which target blood vessel wall injury.
Worldwide Clinical Trials has been announced as a finalist for a second year in the 2017 “Best Contract Research Organization – Full Service Providers” category of the Scrip awards.
A new early-phase contract development and manufacturing organisation (CDMO), Ardena, has launched following the merging of Pharmavize and Crystallics.
The two companies came together in 2016 with backing from investor Mentha Capital. The new brand name, Ardena, reveals the increased service offering and complementary capabilities of Pharmavize in Belgium and Crystallics in the Netherlands.The new company will deliver integrated services that include a.o. solid-state chemistry, analytical and formulation development, and early-phase clinical supply manufacturing.With a team of 85 employees, the new Belgium-headquartered company is supporting customers across the globe in reaching important milestones.
Commenting on the announcement, Harry Christiaens CEO of Ardena, said: “We made the decision to combine the specialist capabilities of both Pharmavize and Crystallics last year so that we would be better placed to help our customers navigate the hurdles and pitfalls of early phase drug development.
“The launch of Ardena as a new brand is the next step in this journey and solidifies our collaboration; we are now one company, operating under one name. Looking to the future, we plan to continue this ‘buy and build’ strategy to further strengthen our service offering to customers. New acquisitions will follow soon.”
With facilities in Ghent, Belgium and Amsterdam, the Netherlands, Ardena has particular expertise in bioavailability enhancement and modified drug release and takes a dossier-centric approach to drug development.
Harry continued: “Drug developers need clinical materials on time in order to generate valuable clinical data and reach their next milestone, yet many face formulation challenges or lack the in-house infrastructure or regulatory knowledge required. Quite simply, our focus is to create strong formulations and regulatory-compliant drug products for clients planning early phase clinical trials.
“With product and dossier developed together, quality and regulatory compliance can be ensured from the start of a project. With drug developers under increasing time and cost pressures, this helps to streamline the drug’s progress to clinic and eventually to commercial production.”
Ardena will be exhibiting for the first time at CPhI Worldwide in Frankfurt, 24 – 26 October 2-17. Visit stand 40B12 to find out more.
For more information, please visit http://ardena.com/
International Pharmaceutical Expo the premier event dedicated to pharmaceutical and biotechnology innovation, technology and knowledge from development through commercialization, today announced FormulationX will debut at INTERPHEX 2018 featuring exhibits, technical conference and networking focused on drug substance.
KemPharm, Inc. , a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced preliminary results of KP415.109.
Selvita S.A. and The Leukemia & Lymphoma Society (LLS) announced a partnership to co-fund further preclinical and clinical development of a targeted therapy to treat patients with acute myeloid leukemia (AML).
Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, announced that it is now actively enrolling patients in a global pivotal study of Aerucin®, the Company’s broadly reactive monoclonal antibody being developed to treat acute pneumonia caused by Gram-negative bacteria Pseudomonas aeruginosa.
Thermo Fisher Scientific, the world leader in serving science announced that the U.S. FDA has issued an Emergency Use Authorization for the company's new TaqPath Zika Virus Kit.
Vertex Pharmaceuticals Incorporated announced that the U.S. FDA has approved KALYDECO® (ivacaftor) for use in more than 600 people with CF ages 2 and older who have one of five residual function mutations that result in a splicing defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Eisai Co., Ltd. announced that it has submitted applications to the US FDA and the EMA for its in-house discovered and developed anticancer agent lenvatinib mesylate (lenvatinib) for the treatment of hepatocellular carcinoma (HCC).
More than one third (40 per cent) of pharmaceutical industry professionals are not confident that they will meet serialization deadlines in the US and Europe, according to new industry research.
BRITISH biotech business TopiVert has recently initiated clinical trials with two of its narrow spectrum kinase inhibitor (NSKI) drug candidates following support from Onyx Scientific.
Zenith Technologies has strengthened its global workforce, recruiting 100 people over the past year in response to growing demand for manufacturing execution system (MES) and automation technology in the pharma sector.
Alere Inc , a global leader in rapid diagnostics announced the availability of its point-of-care Alere iCup® Rx Drug Screen, a rapid urine test that detects five of the most commonly misused and abused prescription drugs.
Leading British autoclave specialist Priorclave is delighted to announce their appointment of Barbra Wells as President and CEO to head up its American operation.
Eiger BioPharmaceuticals Inc , announced an agreement to sell to Theragene Pharmaceuticals, Inc., a private biotechnology company, a non-strategic asset, Mydicar®.
BioGeneration Ventures (BGV), the early stage life sciences venture capital firm with funds focussed on European biotechnology companies, announces an investment by the European Investment Fund (EIF) and other new investors in BGV III, taking the total capital commitments to EUR 66m, out of a maximum EUR 75m.
New industry research explores the greatest barriers to serialization success as companies across the pharmaceutical supply chain prepare for new regulations in the US and Europe.
Juniper Pharma Services , a subsidiary of Juniper Pharmaceuticals, Inc. , has broadened its manufacturing capabilities bringing on-line its new spray dryer following the successful installation and validation of the advanced manufacturing equipment at its UK-based site.
Compounded Sodium Bicarbonate PF 8.4% 50mEq per syringe is expected to help alleviate chronic drug shortage impacting the nation’s hospitals.
Greenphire, the global leader in clinical trial payment automation, has established an Advisory Group for the growing CRO community. The goal of this group is to empower CROs to play a more active role in shaping the rapidly evolving payment automation market.
TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, announced Automated Validation Manager (AVM) – a revolutionary web-based offering that automates the entire validation lifecycle of the TraceLink Life Sciences Cloud on an ongoing basis.
West Pharmaceutical Services, Inc. , a global leader in innovative solutions for injectable drug administration, today announced that it will deliver a presentation on best practices for improving patient outcomes through integrated containment and delivery systems on June 1, 2017 at the 6th Annual InnoPack Pharma Confex in Mumbai, India.
Specialty chemicals company LANXESS has appointed a new head of Corporate Development. Dr. Jens-Christian Blad (39) will assume responsibility for the group function by September 1, 2017, at the latest.
Recipharm, the contract development and manufacturing organisation (CDMO), has invested in its UK & Ireland presence with the appointment of Shabbir Mostafa to its Business Management team.
The eighth HKTDC Hong Kong International Medical Devices and Supplies Fair opened today at the Hong Kong Convention and Exhibition Centre (HKCEC).
This year’s edition of MEDICAL FAIR THAILAND is set to be its biggest yet with more than 700 international exhibitors expected. 17 national and country pavilions will present more than 5,000 state-of-the-art medical and healthcare products, equipment and solutions to a targeted audience of 10,000 medical and healthcare professionals.
Neurocrine Biosciences, Inc. announced that the U.S. FDA has approved INGREZZATM (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD).
The European Aluminium Foil Association (EAFA) has awarded Amcor's Frangible Formpack® Blister an Alufoil Trophy for Technical Innovation.
This was based on the evaluation by US FDA of its preclinical and clinical data of Phase I establishing safety and clinical scope of efficacy for the drug.
TraceLink Inc, the World’s Largest Track and Trace Network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace.
TV spot showcases the science behind the ultimate breathability and comfort of DAILIES TOTAL1® contact lenses
Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc announced that the U.S. FDA granted approval for Basaglar 100 units/mL. BASAGLAR is a long-acting insulin with an identical amino acid sequence to Lantus®, another U-100 insulin glargine.
Bayer AG and its development partner Janssen Pharmaceuticals, Inc announced results from a new real-world study, REVISIT-US.
World pharma today/Drug Research/-Biogen unveiled new TECFIDERA® (dimethyl fumarate) research that reinforces its strong and sustained efficacy in newly diagnosed relapsing-remitting multiple sclerosis (RRMS) patients and further supports its long-term, well-characterized safety profile. These data were presented today at the 68th annual meeting of the American Academy of Neurology (AAN) in Vancouver, Canada.
Chugai Pharma and TWO CELLS Co Ltd announced that on April 25, 2016, both companies concluded a licensing agreement regarding gMSC®1, a regenerative cellular medicine for chondrogenesis in the knee, created by TWO CELLS.
AbbVie GK announced that EA Pharma and AbbVie will commence the co-promotion of fully human anti-TNF-α monoclonal antibody HUMIRA® for indications in the field of gastrointestinal disease.
US ingredients conglomerate announces new partnership to distribute specialty lipids into the pharmaceutical and nutritional markets in Asia and South America.
SBI Pharmaceuticals Co., Ltd. , a subsidiary of SBI Holdings, Inc., engaged in the research and development of medicines using 5-ALA*.
CordenPharma, a full-service Contract Development & Manufacturing Organization , will be awarded 2017 CMO Leadership Awards presented by Life Science Leader magazine across all 6 Core Award Categories and all 8 Specialty Award Categories.
Patheon N.V. ,a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharma sectors, announced that the company was selected as the winner of the “Supply Chain Resiliency Partner of the Year” award by the Global Supply Chain Resiliency Council.
Clintec announces the launch of its new brand identity – reflected in their newly created website. This in part marks Clintec’s 20th anniversary and the achievement of significant milestones following another year of substantial growth, together with a succession of key appointments that have enhanced the global leadership team.
GW Pharmaceuticals plc , a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform.
Intarcia Therapeutics, Inc. announced that the U.S. FDA has accepted for active review its NDA for ITCA 650, an investigational therapy for the treatment of type 2 diabetes (T2D).
Kraig Biocraft Laboratories , the leading developer of spider silk based fibers announced it had secured a long term property lease in Texas for the Company’s domestic mulberry production.
Clinerion announces new services for market access which give pharmaceutical companies insight into patient populations based on its health data analytics tools.
Fresenius Medical Care, the world’s largest provider of dialysis products and services, today announced a leadership change in North America.
Alexion Pharmaceuticals Inc announced that the U.S. FDA has granted orphan drug designation (ODD) to ALXN1210, a highly innovative, longer-acting anti-C5 antibody that inhibits terminal complement, which is being evaluated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
Hologic, Inc announced that the U.S. FDA has granted PMA approval for the Company's HIV-1 viral load monitoring assay. The Aptima® HIV-1 Quant assay is a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens.
Sanofi and its vaccines global business unit Sanofi Pasteur confirmed today the end of their vaccine joint-venture with MSD (known as Merck & Co. Inc., in the United States and Canada), Sanofi Pasteur MSD (SPMSD).
OSE Immunotherapeutics SA announced that the company has entered into a worldwide license option agreement with Servier, an independent international pharmaceutical company, for the development and commercialization of OSE Immunotherapeutics’ Effi-7, an antagonist of the interleukin-7 receptor.
Takeda Pharmaceutical Company Limited and Lightstone Ventures announced the launch of Cerevance, a neuroscience company focused on discovering and developing novel therapeutics for neurological and psychiatric disorders.
WIN INDIA 2016, India’s leading industrial and engineering trade fair will bring together 3 key industrial trade fairs - CeMAT INDIA, Industrial Automation INDIA (IA India) and Motion Drive & Automation INDIA (MDA India).
Sun Pharma announced the launch of BromSite™ (bromfenac ophthalmic solution) 0.075% in the US market.A nonsteroidal anti-inflammatory drug indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
Contract development and manufacturing organization (CDMO) Saneca Pharma is driving forward with new research and development initiatives for the manufacture of active pharmaceutical ingredients (APIs) following a €1.5 million grant from the Slovak Ministry of Education, Science, Research and Sport.
Gilead Sciences Inc announced that the U.S. FDA has approved Vemlidy® (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.
Mallinckrodt Pharmaceuticals a leading global specialty pharmaceutical company, will present on Wednesday, Nov. 30, 2016, at the 28th Annual Piper Jaffray Healthcare Conference at the Lotte New York Palace, 455 Madison Ave, New York.
Cipla Limited announced that it has received Establishment Inspection Report (EIR) from the US FDA for its Indore facility indicating formal closure of the US FDA inspection conducted in July/August, 2015.
GEA was awarded for best manufacturing technology and equipment at the CPhI Pharma Awards, which took place this week during the leading trade fair CPhI Worldwide in Barcelona, Spain.
Global pharmaceutical companies lose an estimated $75 billion annually to counterfeit, gray market and stolen product. Impending regulations aimed at protecting public health, intellectual property and national security will require pharmaceutical, medical device and consumer packaged-goods manufacturers to track and trace products across the supply chain.
Almac Group’s Diagnostics business unit announced its partnership with ArcherDx to provide FusionPlex® and VariantPlex NGS assays as part of their CDx partnership solutions.
Japanese scientist whose experiments explored the machinery by which cells recycle their dilapidated or unwanted contents won the Nobel Prize in physiology or medicine on Monday.
Zuellig Pharma and TopRidge Pharma Limited have signed a deal that will see Zuellig Pharma distribute Imdur, a mature medicine for the prevention of angina in patients with heart disease, in eight markets across the region.
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry announced its polyethersulfone membrane (PESU) is now integrated into two new, sterile Sartocon® benchtop and production scale filtration assemblies. Using these assemblies guarantees rapid and safe ultrafiltration of biologics and vaccines.
Amgen will present at the Morgan Stanley Global Healthcare Conference at 10:30 a.m. ET on Wednesday, Sept. 14, 2016, in New York City. Robert A. Bradway, chairman and chief executive officer at Amgen, will present at the conference.
Teva Pharmaceutical Industries Ltd. announced that it will host a conference call and live webcast along with a slide presentation on Friday, September 9, 2016 at 8:00 a.m. ET to communicate an overview of the future prospects of Teva Generics business following the close of the Actavis generics deal.
Teva Pharmaceutical Industries Ltd will host a live audio webcast at the Wells Fargo Healthcare Conference. Eyal Desheh will present on Wednesday, September 7, 2016 at 1:10 PM ET.
TG Therapeutics, Inc. announced that the U.S. FDA has granted orphan drug designation for TG-1101 (ublituximab) the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, for the treatment of patients with neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD).
The United States Food and Drug Administration (FDA) has granted Orphan Drug Designation in the United States for Biotie's BTT1023 drug candidate for the treatment of primary sclerosing cholangitis (PSC). PSC is a chronic and progressive fibrotic liver disease for which there are currently no FDA-approved treatments.
Mylan N.V. announced that the U.S. Patent and Trademark Office (PTO) has ruled in favor of Mylan in its inter partes review (IPR) proceeding and found all claims of two related Copaxone® 40 mg/mL patents to be unpatentable. The U.S. Patent Nos. are 8,232,250 and 8,399,413, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. A decision by the PTAB on Mylan's third petition seeking inter partes review of U.S. Patent No. 8,696,302 is expected on or before September 1, 2016.
Bristol-Myers Squibb Company and Pfizer Inc announced that 19 abstracts (late-breaking, rapid-fire, oral and poster presentations) will be presented at ESC Congress 2016, to be held August 27–31 in Rome, Italy. These new data from post-hoc analyses from ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) and retrospective real-world data analyses continue to underscore the Alliance’s commitment to the evaluation of Eliquisfor patients with nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). Of note, several of the real-world data analyses are part of ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies), a global real-world data research program designed to further evaluate the effectiveness and safety of apixaban in routine clinical practice.
Aphena Pharma Solutions is pleased to announce the relocation and major expansion of our chocolated pharmaceutical manufacturing operations.
Offerings include brand-equivalent formulations of senna OTC laxatives (compare to Ex-Lax ®) marketed as private-label products. All production has been transferred out of our previous site in Sherburne, New York, to new production suites at Aphena's FDA-registered, cGMP facility in Easton, Maryland, where we have on-site analytical and microbiological laboratories that support the production operation.
At Easton, we have implemented several improvements to significantly increase capacity and throughput of the manufacturing and packaging operations via debottlenecking. Also, several process modifications have been implemented for a more continuous and highly efficient production operation. These improvements provide for up to a fourfold annual capacity increase, and additional space at the facility is available for further expansion.
Aphena has continued to develop new, improved laxative formulas to meet consumer preferences, and we actively assist customers with process development and scale-up services for new chocolate-based nutritional supplement formulas as well as for pharmaceuticals in other therapeutic categories.
The only U.S. contract manufacturer of chocolate-based pharmaceuticals, Aphena provides a full range of solid and semisolid packaging solutions. Call us at 866-465-4506 to find out more about what Aphena can do for you!
The Thermoforming Hub Open House of Marchesini Group is one of the most long-awaited events of next Autumn for the Italian pharmaceutical industry. The event starts officially on 15th October when authorities, citizens and all of the employees of the Group will attend the inauguration of the biggest national thermoforming hub in Carpi (in the province of Modena, Emilia-Romagna). Once it is up and running, this Hub - which is rising brick upon brick thanks to the work of 300 people, on a site of 14 thousand square meters and in which Marchesini Group has invested 10 million Euro - will host the top experts of the sector and will employ over 150 workers of the Group. The end result will be one large industrial complex where the two current factories of Carpi specialising in the production of stand-alone machines and complete lines for packaging pharmaceutical blisters will merge.
After the inauguration, the Open House will take place from 17th to 21st October: this type of event has now become a consolidated formula for Marchesini Group, which has always enjoyed opening the doors of its factories to show customers the “world” of Marchesini, directly and without hiding anything, to give them the opportunity to talk directly with the designers and to take a close look at the working methods, technological novelties and the whole business system generally speaking.
On these dates, journalists and experts will be able to visit the production facilities and participate in workshops during which the topics of serialization and Made-in-Italy technology for the pharmaceutical market will be discussed. Guests will also be able to do a bit of sightseeing: in the city of Carpi, a Renaissance pearl of Emilia Romagna, as well as some landmarks, such as the Ferrari Museum or local textile factories that behold the industrial secrets that make this region a production district known across the whole world.
Optima has expanded its machine range to include new entry-level solutions. These solutions currently include the flexible and completely attuned filling and closing machines OPTIMA FM1 and CM1. These new systems can also be used as stand-alone units. Turnkey solutions such as the MODULINE, designed and manufactured by Optima Consumer, are leading technology. Optima’s presentation at FachPack will also include the InlineCan – the cardboard can that is manufactured on site.
The new OPTIMA FM1 for liquid to pasty products is ideal for the food, cosmetics and chemical industries. Two different pump systems ensure a wide range of applications, high filling accuracy and very gentle product handling. The OPTIMA FM1 processes a filling volume capacity of up to 1,000 ml, at a maximum output of 90 containers/min.
The OPTIMA CM1 pairs perfectly with the FM1 in terms of closing technology, with the flexibility to be configured or expanded for a range of closure types, such as stoppers, droppers, screw caps, snap-on caps and crimp seals. The machine can be expanded with a second workstation. All controls are located beneath the machine plate in accordance with GMP compliance. The output is up to 45 containers/min. Installation, format change and operation via the HMI is quick and easy. The entry-level machines are built in serial production, to minimize lead-time while maintaining the highest quality standards.
Taking flexibility to a new level: At FachPack, the Optima Moduline is equipped with the multi-carrier transport system from Siemens. Transport systems driven by linear motors move adaptably to the individual process steps such as filling, closing, labelling and more. The carriers are loaded and unloaded from the system on demand, and can be fitted with magnetically connected format pucks. The system is excellent for small batches as it can be quickly converted for different formats, product types or seasonal requirements. The Moduline platform offers a wide range of functions: using a tablet, visitors at FachPack are able to personalise labels for individual bottles; these will then be applied directly by the Moduline.
Optima will also present the new InlineCans. These cardboard cans are manufactured, filled, closed and, if required, processed through final packaging, all in one continuous process and therefore, have substantial storage and logistic benefits. The high quality and custom design present a prestige package at the point of sale. The InlineCan, a unique and innovative machine concept, was designed in cooperation with Hörauf. The SoftCan also follows a similar principle. For this film can, the package is also produced and filled directly “inline”, i.e. from roll-stock.
The OPTIMA SD €co auger doser is the company’s semi-automatic entry-level solution for powder products, with a dosing range of 50 g to 5,000 g. The machine achieves very accurate dosing results using shut-off scales.
Optima Consumer will also be at FachPack to provide detailed conversations regarding packaging solutions for food, cosmetics and chemicals.
Kyowa Hakko Kirin Co Ltd has completed the construction of the HB6 Plant in the Takasaki Plant (Takasaki city, Gunma, Plant Manager: Hitoshi Arai) in August 2016.
The new HB6 facility is equipped with one of the largest bioreactors for recombinant animal cells (12,000 L bioreactor) to produce commercial active pharmaceutical ingredients. The purpose of this facility is to meet the needs of production capacity with the increasing demand of antibody drug and items in the future.
The design concept of this facility includes multiproduct production with high productivity to be compliant with the Good Manufacturing Practices (GMP) for Japanese, U.S., and European drug products. Mainly monoclonal antibody drug substances will be produced, and the products will thus be supplied globally. The facility is planned to start its operations in 2016, and to begin commercial production after 2019.
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada) has been selected for inclusion in the FTSE4Good Index Series of socially responsible investment (SRI).*1 The company has now been listed for 14 years in succession, starting in 2003.
The FTSE4Good Index Series is a leading series of SRI indices produced by FTSE Russell*2 in order to measure firms’ sustainability from the standpoints of environmental, social and governance practices. A number of distinctive standards are applied in order to select constituents, which numbered 160 firms in Japan and 823 worldwide as of the end of June 2016.
Our company’s inclusion in FTSE4Good is underpinned by especially high evaluations in 3 of the 14 areas assessed: Corporate Governance, Climate Change, and Customer Responsibility. We have also been selected for inclusion in the MSCI (Morgan Stanley Capital International) Global Sustainability Indexes, another globally-recognized SRI index series, for the last 6 years in succession.
Our responsibility to society, encapsulated in our Corporate Mission, is “to broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide,” and we define the implementation of this mission as our “CSR management.” We remain committed to the practice of CSR management and the sustainable enhancement of corporate value.
Eisai Co., Ltd and MAMORIO, Inc announced that they have entered into an agreement to collaborate on the development of the Me-MAMORIO1 tracking tool to support people with dementia going out. The two companies will conduct a demonstration experiment aiming for implementation as well as development of Me-MAMORIO under cooperation with various stakeholders including the government, healthcare professionals and care workers.
Me-MAMORIO is a small tag that utilizes the short-range wireless Bluetooth2 communication standard. When people with dementia who carry the Me-MAMORIO tag pass close to people in the community who have the corresponding application installed on their smartphones, positional data is automatically sent to a server. This positional data is then automatically transmitted to careworkers, family members and other designated people. People in the community are not notified when people with dementia carrying the Me-MAMORIO are near, however by just carrying a smartphone with Bluetooth switched on they can cooperate with community-wide support for people with dementia going out. The strengths of Me-MAMORIO are that it is small and lightweight compared with a Global Positioning System (GPS) device, and easy for dementia patients to carry. The aim of Me-MAMORIO is to enable people with dementia to preserve their individuality and allow them to go out freely in the areas they are used to with peace of mind and safety.
It is said that there are various reasons for people with dementia wanting to go outside the home including the patients themselves having a strong need or feeling anxiety. According to the Metropolitan Police Department, of the missing persons reported to the police in 2015, 12,208 of them were people with dementia. Ever since statistics were recorded in 2012, this number has been rising year after year. Among them, 150 people were still missing at the end of 2015. According to the Ministry of Health, Labour and Welfare, the number of patients with dementia was approximately 4.62 million in 2012, and is expected to increase to approximately 7 million by 2025.
Leveraging the experience gained from the development and marketing of treatments for Alzheimer's disease and dementia with Lewy bodies, Eisai has been working in cooperation with various stakeholders including the government, healthcare professionals and care workers to build communities where people can live safely even if they have dementia. With agreements signed with medical associations and local governments in approximately 65 locations nationwide, Eisai is realizing interprofessional collaboration among healthcare professionals, care workers and others. These kinds of dementia-related knowledge and capabilities built up will be utilized in the demonstration experiment and development for Me-MAMORIO.
Under its vision of “Forget about forgetting”, MAMORIO Inc. develops and manages a number of products and services including Japan's biggest lost and found portal site “Otoshimono.com” (http://otoshimono.com) as well as the world's smallest IoT product MAMORIO, a tag which utilizes Bluetooth that when simply attached to an important object, can be quickly located if lost by having an alert and map displayed on a smartphone receiving information from a user-based smartphone crowdtracking platform. MAMORIO will utilize the assets built up through these platforms in the demonstration experiment and development for Me-Mamorio.
Eisai and MAMORIO will work to advance the demonstration experiment and development for Me-MAMORIO aiming to realize the establishment of an environment where people with dementia can preserve their individuality and go out freely in the places they are used to living in with peace of mind and safety, as well as build an environment where the community as a whole can look out for people with dementia.
Valeant Pharmaceuticals International, Inc announced that it has entered into a licensing agreement with Norgine B.V. ("Norgine"); under which Valeant has obtained the rights to develop and commercialize NER1006 Powder for Oral Solution in the U.S. and Canada. NER1006 is a novel, low-volume (1L) polyethylene glycol-based bowel preparation for cleansing of the colon in preparation of colonoscopy, whose U.S. regulatory filing is anticipated in 2016.
Norgine is a European specialist pharmaceutical company focused on developing, manufacturing, and marketing its products in various therapeutic areas, including: gastroenterology, hepatology, and critical and supportive care.
NER1006 has been developed to provide overall bowel cleansing, with an additional focus on the ascending colon in adults. The NER1006 Phase III clinical trial program is now completed and includes three multicenter randomized parallel group studies: NOCT, MORA, and DAYB. The NOCT and MORA studies support efficacy, whereas the DAYB study contributes to the safety evaluation.
"We are excited to partner with Norgine to bring an innovative treatment to the patients that need it most," said Joseph C. Papa, chairman and chief executive officer of Valeant. "To date, NER1006's clinical results have been positive and it is an excellent strategic fit with the Salix portfolio that will enhance our gastrointestinal business. This agreement reflects our commitment to bolstering R&D and our commercial offerings as we continue to shape Valeant for the future."
Peter Stein, CEO at Norgine said, "We are extremely pleased to enter into this agreement with Valeant and build upon our successful partnership for MOVIPREP®. Valeant has an established presence in gastroenterology in the U.S. and Canada and a strong portfolio of products in this therapy area. As a European specialist pharma company, Norgine is entirely focused upon the development and commercialization of products in Europe. Valeant is therefore an excellent choice as our partner for the launch of NER1006 in the U.S. and Canada."
Norgine will manufacture and supply NER1006 for Valeant. Financial terms of the agreement have not been disclosed.
Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
Norgine is a European specialist pharmaceutical company that has been established for over 100 years. Norgine provides expertise and 'know how' in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients. Norgine's approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth. Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales, and one in Dreux, France. For more information, please visit www.norgine.com
Servier announces the launch of a bioproduction programme at its site in Gidy. First research batches in 2019 and first clinical batches in 2020.
Today, approximately 50% of the new anticancer treatments originate from biotechnologies, and the partnerships established by Servier in this field over recent years with Macrogenics, Cellectis, Pfizer, GeNeuro, Sorrento, and also the Institut Curie, are in keeping with this trend. Through their mechanism of action, which is more targeted and more accurate than those of chemical molecules, these biopharmaceuticals allow better efficacy and reduced side effects to be achieved in given patient populations.
In order to accelerate the availability of these new treatments for patients and healthcare professionals, to better control the development process for these candidate drugs, and to be able to reduce the costs of the end products, Servier has decided to complement its industrial expertise by building a bioproduction unit at its site in Gidy, near Orléans (France).
Christian Sauveur, Vice-President in charge of Industry for Servier, states: “it is essential for our Group to control the entire drug chain, in order to improve our efficiency and to guarantee the quality of our products. Our industrial commitment in France, and worldwide, is thus strengthened”.
While waiting for the premises in Gidy to be ready to accommodate this new production, the setting-up process and the development of the group’s expertise have already started, in partnership with the University of Dublin (Ireland) and the Servier R&D teams. At the same time, work will soon begin on the fitting out of production unit 3 in Gidy, covering an area of some 3000 m2, at an estimated budget of 35 million euros. The site should be able to produce its first research batches (non GMP) during the first semester of 2019, and the first clinical batches at the beginning of 2020. In 2020, the bioproduction team should include some thirty staff.
By investing in its site in Gidy to launch this new bioproduction unit, Servier is contributing towards the regional ecosystem, as well as to the national market in this field.
See the press kit for further information on topics of bioproduction and Servier’s project in Gidy.
Servier is an international pharmaceutical company governed by a non-profit Foundation and headquartered in France. With a strong international presence in 148 countries and a turnover of 3.9 billion euro in 2015, Servier employs over 21,200 people worldwide. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiology, oncology, metabolism, neuropsychiatry and rheumatology, as well as by its activities in high quality generic drugs. Being completely independent, the Group reinvests 25% of Servier’s products turnover in Research and Development, and all its profits in its growth.More information is available at: www.servier.com
Servier External Communications
Tel: +33 1 5572 6037
Allergan plc a leading global pharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for TRUBERZI® (eluxadoline) in the European Union.4 TRUBERZI® is an oral medication that relieves the main symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults.1 In two pivotal trials, TRUBERZI® significantly reduced two of the most bothersome symptoms of IBS-D, abdominal pain and diarrhoea, with sustained relief demonstrated over six months1,2. TRUBERZI® was generally well tolerated with the most common side effects being nausea, constipation, and abdominal pain1,2.
"With this positive decision for TRUBERZI®, Allergan is one step closer to bringing this innovative medication to IBS-D patients across Europe who are in desperate need of new treatment options," said David Nicholson, Chief R&D Officer, Allergan. "Once approved, TRUBERZI® will join CONSTELLA® (linaclotide) as the only licensed prescription medications proven to treat bothersome symptoms of IBS-D and irritable bowel syndrome with constipation (IBS-C) respectively. Offering these effective treatment options to physicians and their patients underscores Allergan's commitment to helping address unmet needs in gastrointestinal diseases."
IBS is common worldwide, with an estimated global prevalence of around 11%.5,6 Around one third of IBS patients are estimated to have IBS-D.7 In a pan-European survey, it is estimated that approximately 3.5 million people (1.4% of the population) across western European countries have IBS-D (France, Germany, Italy, Spain, and the UK).8 IBS is associated with a high economic burden in terms of direct medical costs and intangible social costs.9 In the European Union, total costs (direct and intangible social costs) are estimated to be between €700–€1600 per person per year,10 but the true economic and human impact of managing IBS is widely underestimated.11-14
"IBS-D can severely affect patient quality of life and in some cases it can be very debilitating. In the absence of effective medications, doctors and patients have had few options available beyond over-the-counter medicines, as well as diet and lifestyle modifications," said Prof. Jan Tack, Professor of Internal Medicine at the University of Leuven, Belgium. "TRUBERZI® has the potential to become the only licensed treatment for IBS-D in Europe providing a valuable, evidence-based treatment option for patients."
The CHMP is the scientific committee of the European Medicines Agency (EMA) and recommends medicines for Marketing Authorisation across the 28 member states of the European Union. The final decision from the European Commission is expected within a few months. If approved, Allergan anticipate launching this new product in Europe during 2017, following successful negotiations with the relevant national payer and reimbursement groups.
TRUBERZI® (eluxadoline) is a twice daily, oral medication indicated for use in adults suffering from irritable bowel syndrome with diarrhoea (IBS-D).1 TRUBERZI® has a novel dual mechanism of action and acts on both agonist-antagonist opioid receptors in the gastrointestinal tract.1 TRUBERZI® effectively targets multiple symptoms of IBS-D, such as pain, diarrhoea, urgency and bloating.1,2 TRUBERZI® is already licensed in the U.S. as VIBERZI™.
About Irritable Bowel Syndrome with Diarrhoea (IBS-D)
IBS-D is a functional bowel disorder characterised by chronic abdominal pain and frequent diarrhoea. The exact causes of IBS-D are unknown but symptoms are thought to result from a disturbance in the way the gastrointestinal tract and nervous system interact.
IBS-D can be debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-D is associated with economic burden in direct medical costs and intangible social costs, such as work absenteeism and lost productivity, along with decreased patient quality of life.8,12-15
Allergan plc headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercialising innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Truberzi® Summary of Product Characteristics, July 2016
Lembo AJ, et al. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med 2016; 374:242-253
European Medicines Agency website. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000219.jsp [last accessed: July 2016]
Committee for Medicinal Products for Human Use (CHMP) Meeting. European Medicines Agency, London, UK 22 July 2016. Positive opinion decision available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002571.jsp&mid=WC0b01ac058004d5c1
Canavan C, et al. The epidemiology of irritable bowel syndrome. Clin Epidemiol 2014;6:71-80.
Lovell RM, et al. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol 2012;10(7):712–21.
Spiller R, Aziz Q, Creed F, Emmanuel A, Houghton L, Hungin P, et al. Guidelines on the irritable bowel syndrome: mechanisms and practical management. Gut. 2007;56(12):1770-98.
Allergan Data on File INT/0207/2016d June 2016
Canavan C, et al. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther 2014;40(9):1023–34.
Ricci, J-F. Irritable bowel syndrome: a comparison of the economic (direct and indirect) burden in four European countries. Gut 2002;51(Suppl 3):Abstract 107.
Lacy BE, et al. Bowel Disorders. Gastroenterology 2016;150:1393–1407
Camilleri M, et al. Economic burden of irritable bowel syndrome proposed strategies to control expenditures. Pharmacoeconomics 2000;(17)4:331–8.
Cash B, et al. Total Costs of IBS: Employer and Managed Care Perspective. Am J Manag Care 2005 Apr;11(1 Suppl):S7–16.
Volmer T, et al. Cost of illness studies may largely underestimate the cost of diseases with unmet medical need such as irritable bowel syndrome (IBS). Value Health 1999;2(5):399–399.
Janet Kettels (Int'l)
Mark Marmur (U.S.)
Mylan N.V. announced the U.S. launch of Dextroamphetamine Sulfate Extended-release Capsules, 5 mg, 10 mg, and 15 mg, a generic version of Amedra Pharmaceuticals LLC's Dexedrine®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in narcolepsy and attention deficit disorder with hyperactivity as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome.(1)
Dextroamphetamine Sulfate Extended-release Capsules, 5 mg, 10 mg, and 15 mg, had U.S. sales of approximately $101.3 million for the 12 months ending May 31, 2016, according to IMS Health.
Currently, Mylan has 245 ANDAs pending FDA approval representing $101.6 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $30.8 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.
(1) Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependency and must be avoided. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
For further information:
Nina Devlin (Media),
Kris King (Investors), 724.514.1813