At POWTECH 2019 in Nuremberg, the plant manufacturing and process development specialist, Glatt, is presenting a groundbreaking waste-free process that recycles the phosphorus from ash to produce ready-to-use high-quality fertilisers.
Sharp has announced a $650,000 investment into enhancing its Interactive Response Technology (IRT) solution. Sharp’s IRT solution is used to manage patient interactions and drug supplies during clinical trials and perform a range of functions for sponsors, drug depots and investigative sites.
Takeda Pharmaceutical Co. announced that the EC extended the current marketing authorization of ADCETRIS to include treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).
Lonza announces the launch of DonorPlex Hepatocytes, a new line of high-quality cryopreserved pooled donor suspension hepatocytes, which are the first of their kind to be produced using Lonza’s novel patented manufacturing process.
MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases.
Silgan Dispensing, a global leader in the design, development and manufacturing of highly engineered pumps and sprayers in the pharmaceutical, home and beauty markets, will highlight its newest ophthalmic dispensing solution, Iridya™, at this year’s Pharmapack, Europe’s dedicated Pharmaceutical Packaging and Drug Delivery event.
Marken announced the expansion of its facilities in Philadelphia to include more space for logistics operations as well as a new GMP-compliant storage and distribution center to meet the growing demand for services in the area.
Daiichi Sankyo Company, Limited announced that the U.S. FDA has accepted a New Drug Application (NDA) and granted Priority Review for pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT).
Dotmatics and TetraScience announced that they have formed a strategic partnership. The partnership is designed to bring R&D labs an improved relationship with their scientific data. Dotmatics is a leading provider of scientific informatics solutions and services; TetraScience is an R&D data integration platform.
Clariant, a world leader in specialty chemicals, is introducing new polymer compounds specially formulated to limit or even eliminate hydrolytic degradation, which is known to affect certain materials commonly used in catheters.
The FUSE conference will be held April 8-10, 2019 at the Radisson Blu Aqua in Chicago, IL. FUSE is the marquis platform for creating powerful dialogue between business and creative leaders around brand and design’s intent, investment, and impact.
Contract development and manufacturing organization (CDMO), Particle Sciences, a Lubrizol LifeSciences company, has announced its partnership with leading Indian contract manufacturing organization (CMO), Encube Ethicals.
Neovasc Inc. ,a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina.
Horizon Discovery Group plc, a global leader in gene editing and gene modulation technologies, announces that it has entered into an exclusive strategic partnership with Rutgers, The State University of New Jersey , to develop and commercialise a novel gene editing technology, known as base editing.
Zenith Technologies, a world leader in delivering manufacturing software solutions to the life sciences industry, has seen a 150% rise in demand for its consultancy arm services.
Powder containment and sterile transfer solutions provider, ChargePoint Technology has achieved HazLoc (Hazardous Area) certification for VERIFI to further support customers in North America.
CRISPR Therapeutics , a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and ProBioGen.
The US FDA has granted approval for Samsung Bioepis to use Ontruzant (trastuzumab-dttb) to treat a range of cancers.
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry announced the launch of the BIOSTAT® RM TX single-use bioreactor, a new wave mixed system developed specifically for closed, automated expansion of consistent quality cell products such as ex vivo cellular immunotherapies.
Quanticate, a leading global data-focused clinical research organisation (CRO) has launched QVigilance to provide dedicated pharmacovigilance (PV) and risk management services.
Eisai Co., Ltd. and Purdue Pharma L.P. announced that a new drug application has been submitted to the U.S. FDA for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment of insomnia, a sleep-wake disorder.
As the pharmaceutical industry has changed and grown in the last two decades, there are increasing concerns about the safe handling of active pharmaceutical ingredients (APIs)– particularly in the process of removing catalysts from API slurries which has a direct impact on the quality of pharmaceutical products.
As China continues to advance from a big country in pharmaceuticals to a power in pharmaceuticals, and the global economy maintains good trends, the main business income of API manufacturing in China has reached RMB499.1 billion, growing by 14.68% year on year; and the export of APIs has reached USD29.1 billion, growing by 13.7% year on year.
The bio-pharma industry has entered the new stage of rapid development in recent years with the continuous development of the cutting-edge biological technology and the emerging and marketing of new targeted drugs and cell therapies, etc.
Lonza will unveil PyroTec™ PRO, the first-ever fully automated, plate-based robotic solution for endotoxin detection at SLAS2019 International Conference and Exhibition (2-6 February, Washington, DC, USA).
MedPharm Ltd has announced the expansion of its US Center of Excellence in Durham, North Carolina in response to increasing service demand for its topical and transdermal formulation development and performance testing services.
Hong Kong International Airport (HKIA) and Brussels Airport announced the launch of an airport-to-airport (A2A) pharma corridor, offering services catering to the specific needs of pharmaceutical shipments.
Omya, a leading manufacturer of mineral ingredients, has developed two new tablet concepts which were introduced at Health ingredients Europe 2018.
PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, introduced a new, dedicated division to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost-effectively.
Medigene AG reported that an additional European Patent was granted for its dendritic cell (DC) vaccine platform.
Aptar Pharma is pleased to announce the co-organization and diamond sponsorship of the Respiratory Drug Delivery (RDD®) Europe 2019 scientific conference, which will connect pulmonary and nasal drug delivery experts from around the world in Estoril, Portugal, May 7-10, 2019.
The US FDA has approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for the manufacturing process of second generation Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo].
Eisai Co., Ltd. announced that its in-house discovered and developed antiepileptic drug (AED) perampanel , for which a NDA was submitted for review as an adjunctive treatment for partial onset seizures in epilepsy patients 12 years of age and older in China in October 2018, has been designated for Priority Review by the NMPA due to perampanel's significant clinical benefit compared to existing treatments.
North Estonia Medical Centre (NEMC) consists of seven clinics and 32 specialist centers, and is the most important caregiver in the capital of Estonia, Tallinn, as well as in the northern part of the country.
Monoclonal antibodies (MAbs) have been extraordinary tools in the field of bioscience due to their high level of specificity and selective binding ability.
Swedish life science company, OnDosis, and global contract development and manufacturing organisation (CDMO), Recipharm, have entered into an agreement for the formulation development of an ADHD treatment for the US market.
Axol Bioscience, the human cell culture specialist, is launching a new line of Human induced Pluripotent Stem Cells (iPSC)-derived Microglia for the consistent and reproducible study of neuroglia and their involvement in neurodegenerative diseases, including Alzheimer’s disease, multiple sclerosis and Parkinson’s disease.
Genoscience Pharma, a clinical-stage biotechnology company dedicated to discovering and developing anticancer drugs, is delighted to announce that it received the Most Innovative European Biotech SME Award for 2018 in the Healthcare category at EuropaBio.
Labviva, an AI-powered digital marketplace for life science reagents, instrumentation and services announces its launch to create scientifically informed purchasing decisions.
AstraZeneca announced a new collaboration with Cancer Research UK to launch a centre of excellence in genetic screening, cancer modelling and big data processing aimed at accelerating the discovery of new cancer medicines.
Recipharm has announced that its proprietary molecule Erdosteine has been officially recognised by the GOLD (Global Initiative for Chronic Obstructive Lung disease) Scientific Committee as one of the commonly used maintenance medications in COPD (Chronic Obstructive Pulmonary Disease).
The Santa Casa da Misericordia hospital of Porto Alegre, Brazil, will expand Clinerion’s network of partner hospitals in Brazil. Patients from the hospital’s seven clinics will gain access to leading-edge, innovative medical treatment via Clinerion’s Patient Network Explorer platform.
UBM India, India's leading B2B exhibition organizer, is all set to bring in the third edition of the widely appreciated India Pharma Week, a week-long celebration packed with avant-garde events from 9th – 14th December, alongside the 12th edition of its flagship expo CPhI and P-MEC India.
The new VACUETTE® branded SAFELINK tube holder facilitates quick and easy blood collection. The tube can be used in combination with all medical products that have a standard female luer lock connection, such as winged cannulae. Above all, it stands out thanks to its simple handling.
DuPont Nutrition & Health (DuPont) will offer ingredients to enable the design of patient-centric, speed-to-market solutions to advance consumer health at CPhI India, Dec. 12-14 in Delhi, India.
The EORTC Brain Tumor Group and Protagen AG today announced a collaboration to utilize Protagen’s Cancer Immunotherapy Array to identify autoantibody biomarkers that investigate the immunological profile and immuno-competence of long-term Glioblastoma survivors.
Cios Fit-a multidisciplinary mobile C-arm ready for demanding environments, was introduced at the 63rd Annual Indian Orthopaedic Association Conference, Coimbatore, on November 28th, 2018; setting a benchmark in mobile C-arms.
It was inaugurated by Dr.S Rajasekaran, Chairperson of AOSpine (International community of Spine Surgeons, headquartered in Switzerland).
Cios Fit is designed to help in improving quality of care, achieve efficient workflows, and profit from high uptime; thereby reducing avoidable costs. It is built for the tough job in the Operation Room (OR) where the equipment needs to deliver high quality imaging, be simplified in its usage and robust to last for long; while ensuring price point is not exceeded.
With Cios Fit-powerful imaging technology, the surgeons are able to maintain consistency with crystal clear images of anatomical structures, implants, screws and devices resulting in accurate treatment and thus improving patient experience.
Dr. Nanjappa K.M. of Cauvery Uroderm Center, at Kalyan, near Mumbai, where Cios Fit was recently tested shared his experience while performing an Endo-urology procedure. He mentioned, “Cios Fit has an exceptional image quality, which is the best I have experienced so far. The touch screen display and the printer with the machine is a good add on feature for documentation.
Moreover, the pulse mode of the machine is so well integrated with the software, that the dynamic images in this mode are very smooth, without any ghosting and lags. The best part of the machine is its radiation dose per case, significantly lower than any of the other machines available today. Overall, it’s a good, compact, sleek, feature-rich asset”. In an OR set up where surgeries need to be performed with minimum assistance, the Cios Fit can be easily used and maneuvered with its light weight design by a single assistant.
It has a built-to-last design, which aims to enable consistent performance and high uptime, no matter how intensely it is used. In order to improve the machine’s durability, sensitive elements are replaced with a shock resistant SD card that helps to handle the intense OR environment; thereby cutting down on avoidable costs. Smart radiation dose management with dedicated pediatric mode and smart power management for patients with diverse needs, ensure safety in the OR not only for patients but also for the surgeon and other OR staff. Imaging gets simplified with the unique touch and play concept of Cios Fit, where the image and dose both can be optimized with just one button push.
Free movements with 380° C-arm angulation with no need to lock it after each movement, simplifies the entire process for the OR team. Moreover, its small footprint and light weight design eases the Door-to-Door transfer for the OR staff. Fast boot time, dynamic and high quality imaging, ease of documentation of the procedure with a USB port and an instant connection to the printer and easy maneuverability are the key features of Cios Fit.
Sanjay David, Business Area Head – Advanced Therapies, Siemens Healthineers, India said, “The Cios Fit mobile C-arm is designed for the tough environment in an OR, where there are multiple procedures in a day to be performed; keeping in mind the high patient load at the medical institutions. Cios Fit addresses many concerns of all the stakeholders, right from healthcare professionals to operators and patients, as part of our endeavor in transforming care delivery”.
About Siemens Healthineers
Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalizing healthcare. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services. In fiscal 2018, which ended on September 30, 2018, Siemens Healthineers generated revenue of €13.4 billion and adjusted profit of €2.3 billion and has about 50,000 employees worldwide. Further information is available at www.siemens.co.in/healthineers
IQV announced that Napo Pharmaceuticals, Inc. , a wholly-owned subsidiary of Jaguar Health, Inc., has selected Orchestrated Customer Engagement , IQVIA Technologies’ innovative commercial solutions suite, to support Napo’s growing commercial organization and enable it to work more closely with healthcare providers.
Yposkesi, a leading CDMO for gene therapy viral vector manufacturing, today announces an agreement in principle governing the terms of a strategic partnership with Axovant Sciences, a company developing innovative gene therapies for neurologic and neuromuscular diseases.
Zenith Technologies, a world leader in delivering GMP manufacturing software solutions to the life sciences industry, recently conducted an industry survey that suggests the digitalisation of manufacturing is a top priority.
IQVIA announced that Adhera Therapeutics Inc. has selected Orchestrated Customer Engagement (OCE), IQVIA Technologies’ transformational commercial platform, to build its commercial infrastructure and bring the company’s specialty drug innovations to patients.
Clinerion has added a live heatmap to its homepage indicating prevalence of searchable disease indications by ICD10 code according to the global patient network in its Patient Network Explorer.
Sygnature Discovery a leading independent integrated drug discovery and pre-clinical services company, is continuing the expansion of its operations with the opening of its first US office, located in Harvard Square, Cambridge, Massachusetts.
The Bridging Clinical Research & Clinical Health Care Collaborative, a forum where health care professionals, patients, physicians, academics, clinical researchers, service and technology providers, and regulatory authorities convene to advance clinical research and its integration with health care, has released a preliminary list of its 2019 agenda topics.
Analytical scientists and laboratory managers seeking high-performing, multi-functional instruments with low cost of ownership can now benefit from a new FTIR spectrometer designed to analyze complex samples quickly and deliver fast, accurate results.
Analytical scientists and laboratory managers seeking high-performing, multi-functional instruments with low cost of ownership can now benefit from a new FTIR spectrometer designed to analyze complex samples quickly and deliver fast, accurate results.
PANTHERx® Specialty Pharmacy, The Rare Disease Specialty Pharmacy , and RxCrossroads by McKesson, the leading commercial solutions partner for life sciences companies, announced their collaborative program to simplify the channel for precision medicine therapies.
Regeneron Pharmaceuticals, Inc. and Sanofi announced that new analyses on mortality from the 18,924-patient ODYSSEY OUTCOMES trial were presented at the American Heart Association (AHA) Scientific Sessions 2018.
Quanticate, a data-focused clinical research organisation (CRO), has announced that it is partnering with Lancaster University to sponsor a STOR-i PhD project.
Zenith Technologies, a world leader in delivering GMP manufacturing software solutions to the life sciences industry, has launched a new virtual customised training service to tackle critical gaps in industry manufacturing software and process training.
Lonza announced that the recombinant Factor C Assay has been used for endotoxin testing of Eli Lilly’s Emgality™ , the first drug approved by the U.S. FDA to have been released using this method instead of traditional Limulus Amebocyte Lysate (LAL) - based methods. Emgality™ is a monoclonal antibody drug treatment for the prevention of migraine in adults.
The Lubrizol Corporation announces a proprietary nasal delivery formulation of diazepam for the treatment of epilepsy which was developed by contract development and manufacturing organization (CDMO), Particle Sciences, a Lubrizol LifeSciences company, has been submitted as a NDA to the U.S. FDA by San Diego-based Neurelis Inc.
Anaqua’s ideaPoint, a leading provider of innovation management solutions, announced the launch of new software that will simplify the identification and capture of key partnering opportunities and novel innovative ideas.
CRF Health, a CRF Bracket company, the leading provider of patient-centered eSource technology solutions for the life sciences industry, announced the awarding of two new contracts by top-20 pharma companies, which will see the company’s innovative eCOA solutions used to capture patient-reported outcomes in 15 global dermatology trials.
Aptar Pharma is pleased to announce the co-organization and its diamond sponsorship of the third Respiratory Drug Delivery (RDD®) Asia scientific conference, which will welcome internationally renowned speakers in pulmonary and nasal drug delivery.
A new report released unveils 50 female leaders in healthcare business in the UK. Produced by BioBeat, 50 Movers and Shakers in BioBusiness 2018 emphasises the current role of women in leading, inspiring and innovating to ensure new technologies and treatments continue to improve UK research, health and society.*
DefiniGEN Ltd are pleased to announce the commercial licensing of CRISPR-Cas9 gene-editing technology from Broad Institute of MIT and Harvard in the USA, to develop human cell disease models to support preclinical metabolic disease therapeutic programmes.
Shionogi & Co., Ltd. announced recently that, after completing a Priority Review, the USA FDA has approved XOFLUZA (baloxavir marboxil) for the treatment of acute, uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
Thermo Fisher Scientific, the world leader in serving science, and Symphogen, a clinical-stage antibody oncology-focused company, have entered into a two-year collaborative partnership to deliver validated, platform workflows for simplified characterization and quality monitoring of complex therapeutic proteins.
SPANISH contract development and manufacturing organisation (CDMO) Idifarma has begun its seventh project with Spanish biotechnology company, Palobiofarma.
Advarra, the premier provider of IRB, IBC and research quality and compliance consulting services in North America, has completed all integration activities. This includes harmonization of SOPs and the transfer of legacy study information into the Advarra Center for IRB Intelligence (CIRBI) Platform and the Advarra IBC Platform.
On 6 November 2018, Lonza is hosting a free 60-minute webinar presenting a new approach to Electronic Batch Records (EBR) and demonstrating how Lonza’s MODA™ Execution System is designed to address the data management challenges facing biopharmaceutical manufacturers.
CPhI Worldwide, closes its 29th edition with pre-audit figures showing the most international audience in the event’s history, with a total unique attendance of 44,500 – remarkably, over 39,000 of which were international.
GeNeuro , a biopharmaceutical company developing new treatments for neurological and autoimmune diseases, announced that following a successful collaboration in preclinical amyotrophic lateral sclerosis (ALS) models.
Clinerion and S4 Research announce a partnership to expand the global network of hospitals on the Clinerion’s Patient Network Explorer platform into India. International pharmaceutical companies will be able to match their leading-edge clinical trials to patients in India.
Specializing in the design and production of premium medical electronic equipment, LED SpA has added an innovative handpiece for use in high-frequency surgery to its portfolio.
Global contract packaging and supply chain organisation (CPO), Tjoapack and UK-based technology company, Veratrak, have launched the European Platform on Changing Healthcare (EPOCH) as part of their ongoing partnership dedicated to improving pharmaceutical supply chain operations.
Plasticell Ltd, a developer of stem cell technologies and regenerative medicines, has announced that the Advanced Stem Cell Training Network (ASCTN), a European research consortium in which the company is a partner organisation, has successfully bid for over €3,700,000 in funding from the EU to create and exploit advanced cellular models of neurological disorders – notably Parkinson´s, Huntington´s and Demyelination disease - which are caused by acute or progressive loss of cells in the brain.
Sandoz, a Novartis division and the global leader in biosimilars, announced a global resolution of all intellectual property (IP) related litigation with AbbVie concerning the proposed Sandoz biosimilar Hyrimoz® (adalimumab) for reference medicine Humira®** (adalimumab).
Almac Diagnostic Services, a global stratified medicine company specialising in biomarker driven clinical trials, has made a significant investment in a new Illumina NovaSeq 6000 sequencer which will benefit Biopharma clients’ biomarker discovery and clinical trial projects.
Roche announced that the US FDA has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with haemophilia A without factor VIII inhibitors.
United Cargo announced it will enhance its TempControl service and expand the options it offers shippers of pharmaceuticals and other life science products by approving the new CSafe RAP active container.
Aptar Pharma, a leading provider of innovative drug delivery systems, in combination with Schott Glass and EMA Pharmaceuticals, has announced that it will launch Aptar Pharma QuickStart™ for injectable drug development at CPhI Worldwide 2018, in Madrid, Spain, October 9th.
apceth Biopharma GmbH, a leading company for the development and manufacturing of cell and gene therapeutics, congratulates its partner bluebird bio on the acceptance and validation of its market authorization application by the European Medicines Agency (EMA).
MetP® Pharma, focusing on the nasal delivery of drugs to the systemic circulation and especially to the brain, presents its Nascum®-Plus nasal gel.
Orchard Therapeutics, a leading commercial-stage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, announced that the EMA has granted Priority Medicines (PRIME) designation to OTL-300, an investigational autologous ex vivo lentiviral gene therapy for the treatment of transfusion-dependent beta-thalassemia (TDBT), the most severe form of beta-thalassemia.
Piramal Pharma Solutions (PPS), a global leader in Contract Development and Manufacturing Solutions, announced the launch of its Xcelerate Integrated Solutions™ platform to address a rapidly growing market need.
RayDyLyo® a breakthrough innovation with multiples benefits
RayDyLyo® is an all-plastic capping solution designed to work with all ISO stopper configurations (serum and lyo).
Aptar Pharma, a leading drug delivery systems provider, continues its commitment to meeting new market trends with the release of an industry first, PureHale, a new portable and ready-to-use drug delivery solution designed for upper respiratory care.
Liver4Life is a project of Wyss Zurich, a joint research and development center of the ETH Zurich and the University of Zurich in the fields of Regenerative Medicine and Robotics.
Protagen AG, the National Center for Tumor Diseases (NCT) and NEC Laboratories Europe GmbH have announced a collaboration to improve the in silico prediction of immunotherapy response in malignant melanoma.
CPhI Worldwide, organised by UBM (part of Informa PLC), announces the finalists of the eagerly anticipated 2018 CPhI Pharma Awards.
SYMBIOSIS Pharmaceutical Services, a fast-growing specialist sterile manufacturing CDMO, has reported FDA approval for its viral vector manufacturing fill/finish process at its biologics manufacturing facility located in Scotland, UK.
Videojet Technologies has launched a brand new application - the Videojet Pharma Line App – to provide instant information and guidance for customers looking to code or mark onto pharmaceutical and medical device packaging.
CPhI Worldwide the world’s largest pharma event – taking place in Madrid (9-11, October 2018) and organized by UBM (part of Informa plc) – has released the second part of its annual report, which evaluates the effects of regulatory divergence, trade agreements and IP rights over the next 5-years.
Neurimmune announced the achievement of a key preclinical milestone in the ongoing collaboration with Ono Pharmaceutical Co., Ltd. In November 2017, the parties entered into a collaboration focused on the development of human-derived antibodies against a novel therapeutic target for neurodegenerative diseases.