In The Spotlight
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).
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).