In The Spotlight
Gilead Sciences, Inc. announced that Norbert Bischofberger, PhD, has decided to step down from his role as Executive Vice President, Research and Development and Chief Scientific Officer, effective at the end of April 2018.
Novartis announced changes to its senior leadership team to support the implementation of its strategic priorities. Bertrand Bodson, Chief Digital Officer, Steffen Lang, Global Head Novartis Technical Operations, and Shannon Klinger, Chief Ethics, Risk and Compliance Officer, have been appointed to the Executive Committee of Novartis (ECN).
Recipharm, the contract development and manufacturing organisation (CDMO), announces its new Blow-fill-seal machinery is now operational following a substantial investment last year at its facility in Kaysersberg, France.
An expert judging panel of IndustryWeek editors and advisors has selected the Thermo Fisher Scientific Auburn manufacturing site in Alabama as one of seven 2017 Best Plant winners.
Recipharm has announced that its 2017 International Environmental Award will be presented to Karen Kidd, Professor in Biology, and Geography & Earth Sciences at McMaster University in Hamilton, Ontario and Jarislowsky Chair in Environment and Health.
Powder containment and aseptic transfer valve specialist ChargePoint Technology has obtained the highest level of quality accreditation at its Liverpool, UK facility, to enable future product development for use in hazardous environments.
The pharma major will distribute Tocilizumab and Syndyma -- the second brand of Roche's cancer therapy bevacizumab -- in India.
The Regulatory Affairs Professionals Society (RAPS) continues its support of medical device professionals in Europe with the launch of a workshop focused on 510(k) premarket submissions to the US Food and Drug Administration (FDA).
A small specialist British engineering company called Priorclave celebrates 30 years in the design, manufacture and world-wide supply of an extensive range of laboratory and research grade autoclaves.
Lonza has announced a panel of top endotoxin experts to present at the 4th Global Endotoxin Testing Summit from 12-14 June 2018, in Annapolis, MD (USA).
Haverford Trust Co. lifted its position in shares of Eli Lilly and Co by 16.3% during the fourth quarter, according to the company in its most recent filing with the SEC.
Bristol-Myers Squibb Company announced that its Board of Directors has elected José Baselga, M.D., Ph.D., to the Board, effective March 1, 2018. Dr. Baselga will serve as a member of Science & Technology Committee of the Board of Directors.
Novartis shareholders today agreed to the Board of Directors' recommendations for all proposed resolutions at the Group's Annual General Meeting (AGM). A total of 1,731 shareholders were present at the meeting held in Basel, representing approximately 62.6% of the issued shares of Novartis.
Laboratory scientists across the globe can now benefit from a software system that helps them manage the entire lab, designed to support process adherence, data integrity and complete regulatory compliance.
A month has gone by since the last earnings report for AbbVie Inc. ABBV . Shares have added about 9.7% in that time frame, outperforming the market.
According to the study published in the Journal of Clinical Endocrinology and Metabolism, the presence of gut flora may be healthy for some people, while it may increase the risk of obesity in others.
On average its rare disease patients – around half of whom are children – have to wait for five years before they receive the correct diagnosis for their condition.
GPs and general practices are under serious pressure through increasing workloads not least due to more complex cases and the health challenges of an aging population.
In December, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the treatment for abnormal bleeding in women with uterine fibroids after four cases of serious liver injury - three resulting in a liver transplant - were reported among users of the drug.
Richard Wolf, answering strong global demand for its high-performance endoscopic technology services, today announced plans to expand in Southeast Asia by opening its 15th subsidiary to be located at the heart of Southeast Asia – Singapore.
Bayer and Loxo Oncology, Inc., , a biopharmaceutical company from Stamford announced the publication in The New England Journal of Medicine (NEJM) of larotrectinib data for the treatment of pediatric and adult patients whose tumors harbor Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusions.
Envigo, a leading provider of nonclinical contract research services and research models, announced the appointment of Lynn Lewis to the position of Senior Vice President, Global Sales.
AbbVie Inc (ABBV.N) said on Thursday its board had approved a $10 billion stock repurchase program, and the drugmaker also increased its quarterly dividend, as it reaped the benefits of U.S. tax law changes.
AstraZeneca and Merck, known as MSD outside the U.S. and Canada, announced that the U.S. FDA has granted Orphan Drug Designation (ODD) for selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).
The drug, verubecestat, was being tested in patients who showed only a glimmer of the symptoms that eventually rob them of memories and basic functions. It’s another setback in a long list of experimental treatments that have had little or no effect on the neurodegenerative disease.
UK gene cell therapy designer Oxford BioMedica’s shares jumped as much as 11.2% to 12.30 pence this morning after announcing a $100 million collaboration and licence agreement with US hemophilia specialist Bioverativ , which last month agreed to be acquired by French pharma major Sanofi in a $11.6 billion deal.
Pfizer Inc. (NYSE:PFE) today announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD).
The world's largest pharmaceutical manufacturing plant is now 98,500 square feet larger.And that expansion -- the most visible part of an ongoing $147 million investment by Pfizer Inc. -- is a very good thing for Portage and Kalamazoo County, local leaders say.
Pimco is the largest bond investor, but it also manages quite a bit in equities. According to S&P Capital IQ, Pimco now oversees $5.1 billion in U.S. equities.
Merck KGaA and Pfizer received a setback on Thursday for their drug Bavencio, which is a late starter in the rapidly evolving field of cancer immunotherapies.
Vetter is one of the winners of the clean manufacturing award CLEAN! 2018. The pharmaceutical service provider was able to convince the independent expert jury of the Fraunhofer Institute for Manufacturing Engineering and Automation (IPA) with its innovative Vetter CleanRoom Technology V-CRT®.
Contract development and manufacturing organisation (CDMO) Recipharm has appointed Bernard Pluta to lead its new global development organisation.
The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life sciences R&D has today announced the launch of the User Experience (UX) for Life Sciences (LS) Toolkit, to help life science companies improve UX in line with other global industries.
The UXLS toolkit marks the culmination of a collaborative project involving more than 50 UX specialists from 20 different organisations across the world; including several top ten pharmaceutical companies, bioscience, and technology firms. The toolkit contains UX case studies, methods, and metrics – enabling life science companies to design better, more intuitive, more usable digital products, specifically for R&D in the life science and healthcare environment.
These issues and the benefits of UXLS for improving productivity will be discussed further at The Pistoia Alliance’s User Experience for Life Science conference on the 14-15th May 2018 in Boston, USA, featuring keynote speakers from companies including Novartis.
“In today’s world, software is the gateway to unlocking the many zettabytes of data that humans produce. When scientific software is poorly designed, it is frustrating and time-consuming to use, and adds yet another barrier to the acceptance and adoption of new digital technologies, such as automation and Artificial Intelligence. This has the cumulative effect of making drug discovery and development far less efficient and productive,” commented Dr Steve Arlington, President of The Pistoia Alliance.
“As we become more familiar in our personal lives with digital technologies that interact intuitively and respond to our needs, the desire for technology that ‘just works’ in our professional lives is also growing. The potential for good UX design to impact life science R&D is significant – from improving the UX of clinical trials and making it easier for patients to participate, to delivering cutting-edge UX design that supports the ‘laboratory of the future’. UX design should not be considered a remote or niche area, and we hope that our UXLS toolkit enables more companies to realise this potential.”
The UXLS project was formed by The Pistoia Alliance in recognition of the fact that many life science organisations are behind the curve when it comes to UX. Although UX principles are widely recognised and have been applied successfully in other industries, such as retail and financial services, adoption and use in life science is low. Members of The Pistoia Alliance communicated this issue, and the UXLS project began as a result in early 2017.
The project empowers life science professionals to realise the benefits that UX design can deliver through engagement with a wider audience, including stakeholders in senior management. The global UXLS project team worked collaboratively to develop the toolkit which provides a ‘how-to’ that helps businesses adopt UX principles and methods as they develop scientific software.
“At EMBL-EBI, we have a mandate to share data from life science experiments, and put a lot of energy into helping people make the best possible use of it,” says Professor Ewan Birney, Director of the European Bioinformatics Institute. “We experienced a big change when we re-focussed the development of our services and started to adopt a user-centred design process. We benefited from doing user research, prototyping, design and testing to get to the heart of the problem and deliver products and services that are intuitive for researchers. I was initially sceptical, but then I was impressed to see the results across our organisation.”
The UXLS toolkit so far contains six case studies from organisations such as Novartis, EMBL-EBI, and AstraZeneca; 10 published methods, such as interactive prototyping and usability testing; meaningful principles that will assist and explain activities to better a system or process. The toolkit will be beneficial for UX practitioners, bioinformaticians, software developers, and technical and IT managers. The UXLS conference will be hosted by Novartis at the Novartis Institutes for BioMedical Research (NIBR). Pat Keller, Global Head of User Experience at NIBR will deliver a keynote speech at the conference, which will also feature several ‘hands on’ UX workshops.
About The Pistoia Alliance
The Pistoia Alliance is a global, not-for-profit members’ organization made up of life science companies, technology and service providers, publishers, and academic groups working to lower barriers to innovation in life science and healthcare R&D. It was conceived in 2007 and incorporated in 2009 by representatives of AstraZeneca, GSK, Novartis and Pfizer who met at a conference in Pistoia, Italy. Its projects transform R&D through pre-competitive collaboration. It overcomes common R&D obstacles by identifying the root causes, developing standards and best practices, sharing pre-competitive data and knowledge, and implementing technology pilots. There are currently over 80 member companies; members collaborate on projects that generate significant value for the worldwide life sciences R&D community, using the Pistoia Alliance’s proven framework for open innovation.
About the European Bioinformatics Institute (EMBL-EBI)
The European Bioinformatics Institute (EMBL-EBI) is a global leader in the storage, analysis and dissemination of large biological datasets. We help scientists realise the potential of ‘big data’ by enhancing their ability to exploit complex information to make discoveries that benefit humankind. We are at the forefront of computational biology research, with work spanning sequence analysis methods, multi-dimensional statistical analysis and data-driven biological discovery, from plant biology to mammalian development and disease. We are part of EMBL and are located on the Wellcome Genome Campus, one of the world’s largest concentrations of scientific and technical expertise in genomics. Website: www.ebi.ac.uk
Aptar Pharma, a leading provider of innovative drug delivery systems, will host a live educational webinar on the benefits of connected drug delivery devices, with a particular focus on improving patient regimen compliance and outlining the benefits to the whole healthcare ecosystem.
Clariant, a world leader in Specialty Chemicals, and its Healthcare Packaging business unit, is introducing a new brand name to encompass all of the products and technology related to equilibrium relative humidity (ERH) stabilization.
Sandoz, a Novartis division and the global leader in biosimilars, announced a global partnership with Asia's premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide.
Cmed, an innovative technology-led CRO, will demonstrate the eSource and live data analytics capabilities of encapsia®, a next generation clinical data suite, at Summit for Clinical Operations Executives 2018 this month.
TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, announced two key new senior leadership appointments: John Hogan hired as senior vice president of engineering and Bob Sturim promoted as Chief Technology Officer.
CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has been honoured in this year’s Biotechnology Awards with the CluePoints® solution being named the “Best Risk-Based Monitoring Solution”.
CRF Health, a leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, has announced the appointment of former Novartis veteran and eClinical Quality Assurance and Data Integrity Specialist, Tom Haag, as Vice President, Quality Assurance.
Global API developer and manufacturer, Sterling Pharma Solutions, has experienced growth in the Japanese market as a result of its technical capabilities and innovation strategy.
Porex Corporation will showcase advanced solutions for laboratory and medical professionals that speed fluid transfer of diagnostics, improve accuracy and purity in liquid handling, and enhance wound management and improve clinical outcomes.
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.