In The Spotlight
Batavia Biosciences announces its partnership with an international consortium coordinated by PATH aiming to develop and manufacture safer novel oral poliovirus vaccines (nOPV).
A new serialisation implementation partner has formed to assist the increasing number of companies needing to meet the data requirements of looming global regulation changes.
Innovative medical technology is an increasingly important driver for delivering efficiencies in the global healthcare system.
TFS is delighted to announce that Dr János Filakovský MD, PhD, MBA has accepted the position of CEO. János brings a wealth of experience to TFS from the Life Science Industry, including over 20 years serving in different leadership roles at Quintiles.
Amgen announced that the U.S. FDA has approved the supplemental Biologics License Application (sBLA) for XGEVA® (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
Supporting trace element analysis across the environmental, food safety, pharmaceutical and industrial markets, Thermo Fisher Scientific is showcasing its latest inductively coupled plasma mass spectrometry (ICP-MS) and inductively coupled plasma optical emission spectrometry (ICP-OES) solutions and techniques at the 2018 Winter Conference on Plasma Spectrochemistry in Amelia Island, Florida in booth 43-45.
Aptar Pharma, a leading drug delivery systems provider, will once again bea key exhibitor at Pharmapack 2018, Europe's dedicated pharmaceutical packaging and drug delivery event, which takes place on February 7-8 at Paris Expo, Porte de Versailles, France.
Juniper Pharma Services , a subsidiary of Juniper Pharmaceuticals, Inc, is proud to announce that its co-founder Martyn Davies has been appointed as a Commander of the Order of the British Empire (CBE) in Her Majesty’s 2018 New Year’s Honours List.
Industry experts from bioLIVE – the new UBM biomanufacturing and bioprocessing event taking place next year in Madrid (October 9-11).
UBM India celebrates the industry with a dazzling array of comprehensive, path-breaking events under the India Pharma Week umbrella.
Slovakia-based contract development and manufacturing organization (CDMO) Saneca Pharma has strengthened its team with the appointment of a new CDMO sales director as it continues to implement its global growth strategy.
With nearly 30 years’ experience in the industry, having held positions in a number of worldwide CDMO and contract research companies, Markus Saal joins the senior team at Saneca to head up its finished dosage form (FDF) sales and business development activity.
In addition to being a leading global contract development and manufacturing organization, Vetter is also a leader in the area of occupational health management.
Agendia, a world leader in personalized medicine and molecular cancer diagnostics, and University Hospitals Leuven (UZ Leuven) in Belgium have partnered to co-validate Agendia’s new in vitro diagnostic (IVD) MammaPrint® BluePrint® Breast Cancer Risk of Recurrence and Molecular Subtyping Kit.
In concert with its Brazilian partner, the iHealth Group, Clinerion has agreed with Bioserv SMO to add Bioserv’s trial sites to the PRS platform. The Hospital São Vicente de Paulo is the first implementation, bringing another 540 thousand patient lives to Clinerion’s coverage in Brazil.
Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery, development and delivery, has established a new agreement with clinical-stage gene therapy company, MeiraGTx.
Worldwide Clinical Trials (www.worldwide.com) has been recognized by Medidata , the leading global provider of cloud-based solutions and data analytics for clinical research, with the first annual Medidata Accelerator Award.
NBE Therapeutics AG, a biopharmaceutical company developing next-generation ADCs carrying highly potent, immune-stimulatory anthracycline toxins, announces the appointment of Dr. Nicole Onetto to its Board of Directors.
UBM India, India's leading B2B exhibition organizer saw the launch of the grand 11th edition of the signature event, CPhI & P-MEC India 2017, one of the world’s leading pharma networking expos.
Essentra, a global leader in healthcare packaging, will showcase its innovative pharmaceutical packaging, labels, serialisation and patient adherence solutions at CPhI India, 27-29th November 2017.
Tartu University Hospital, the only university hospital in Estonia and an e-Health pioneer, has joined the network of hospitals on Clinerion’s PRS platform.
UBM India, India's leading B2B exhibition organizer, is all set to bring in the second edition of the widely appreciated India Pharma Week, a week-long celebration packed with avant-garde events from 25th to 30th November alongside its flagship expo CPhI and P-MEC India.
The CPhI Pharma Awards are among the most prestigious recognitions within the pharmaceutical industry. MJR PharmJet, partner of leon-nanodrugs GmbH in drug development received one of this year’s awards for the highly innovative MicroJet Reactor Technology.
Eisai Co., Ltd. announced that the latest data on its oral dual orexin receptor antagonist lemborexant and its oral beta secretase cleaving enzyme (BACE) inhibitor elenbecestat(1) will be presented at the 10th Clinical Trials on Alzheimer's Disease (CTAD), taking place in Boston, the United States, from November 1 to 4.
Singapore Exchange-listed Singapore eDevelopment Limited ("SeD") announced that its U.S. biomedical subsidiary, Global BioLife Inc. ("Global BioLife") has completed development and testing of mosquito deterring technologies including fragrances, paints, and fabric.
Humane Society International, one of the world's largest animal protection organizations, is pleased to welcome The Lo & Behold Group, a Singaporean hospitality company, is joining the movement to improve animal welfare in its supply chain by committing to sourcing 100 percent cage-free eggs.
CRF Health, the leading global provider of patient-centered eSource technology and service solutions for the life sciences industry announced that its TrialMax Touch® solution has been selected by a top ten pharmaceutical company for a landmark global oncology trial.
Saltigo GmbH, a subsidiary of specialty chemicals company LANXESS, will be exhibiting at CPhI 2017 as a flexible service-provider and one-stop supplier for the life science industries and users of fine chemicals.
The Pistoia Alliance, a global, not for profit alliance that works to lower barriers to innovation in life sciences R&D, today announced the winners of its 2017 President’s Startup Challenge. The grand prize winner, selected by a panel of seven industry judges, is Medley Genomics.
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. 
Heptares Therapeutics (“Heptares”), a wholly owned subsidiary of Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), is delighted that one of its founders, Richard Henderson (MRC Laboratory of Molecular Biology, Cambridge, UK), was awarded the Nobel Prize in Chemistry 2017 together with Jacques Dubochet (University of Lausanne, Switzerland) and Joachim Frank (Columbia University, New York, USA) "for developing cryo-electron microscopy for the high-resolution structure determination of biomolecules in solution."
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).