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The 6th annual conference will gather the growing freeze drying community, filled with industry thought leaders and principle scientists involved in: manufacturing, material sciences, bio-therapeutics and pharmaceutical engineering.

SMi are delighted to have interviewed our speaker Maxime Gaillot, Senior Device Engineer, Roche, for Injectable Drug Delivery!

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 EU FMD Express – a cost-effective, simplified solution designed specifically to address the needs of smaller pharmaceutical companies complying with the EU Falsified Medicines Directive (FMD.)

Bio industry which is linked closely with pharmaceutical industry comes into the spotlight as new growth power in globally. KOREA PHARM recreate under the name of “Korea Int’l Pharmaceutical & bio-Pharma Exhibition”. 

AstraZeneca announced that the EC has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia.

Are you looking for new business partners, extendingyour distributor network or sourcing specific products on the Chinese pharma market?

GlaxoSmithKline plc  announces that it has reached an agreement with Novartis for the buyout of Novartis’ 36.5% stake in their Consumer Healthcare Joint Venture for $13 billion (£9.2 billion).

With Tuberculosis (TB) estimated to infect around 781 out of every 100 000 South Africans, people living with HIV/AIDS (PLHIV) are currently at the highest risk of both contracting and dying of this condition.

Bosch Packaging Technology pools knowledge with Bosch Center for Artificial Intelligence and Corporate Research.
Schopfheim / Frankfurt, Germany – At Achema, Bosch Packaging Technology presents its new data mining service, which has recently been added to the range of pharma services for solid dosage forms.
The service is offered by the Bosch subsidiary Hüttlin. The aim is to evaluate existing machine data more effectively to identify and eliminate root causes. “So far, about 50 percent of deviations have been classified as ‘human error’,” says Dr Marc Michaelis, expert for continuous production and process verification at Hüttlin. “Yet we assume that this is true for no more than ten percent. The rest is often misinterpreted due to missing information. As a matter of fact, there is already enough data available to get to the bottom of the causes. However, there is a lack of knowledge and time to read this data correctly.” First projects have shown that new patterns and failure causes can be defined and remedied in the production process thanks to data mining, and can help to achieve a more stable product quality in the long run.

 Correct interpretation of machine data
Thanks to Bosch’s data mining tool, it is now possible to examine large amounts of data for the smallest effects using statistical methods. In general, the data from two production batches is already sufficient to draw first conclusions. The more data is available for evaluation over a longer period, the more details can be identified. All it takes is machine sensors, which already collect data on almost all historical machines, as well as the right tool to disclose the data. “Large investments are not required to use the existing data more effectively. The key to success lies in merging knowledge from different disciplines,” says Michaelis. “Bosch not only has the necessary technical expertise, but also extensive process knowledge in customers’ product manufacturing. To identify reasons for process deviations, which are not obvious at first sight, we teamed up with the statistics experts from our Bosch Center for Artificial Intelligence in Germany and the U.S. Together we will raise the data treasure.”

 

 

The potential of this approach has already been demonstrated successfully in different customer projects. For instance, when a customer suddenly produced a
“out of specification” (OOS) batch, the Bosch experts systematically got to the bottom of things. The recorded data showed that a particular valve wasresponsible for the deviation. However, the valve had been excluded beforehand since it was considered uncritical in terms of product quality. Thanks to the data analysis, deeper correlations and an undetected cascade of connections could be identified. “Eventually, we found out that the valve provided an indirect indication of a false gas flow in the system, which was not visible at first sight. The problem could then be easily solved by recalibrating the system,” Michaelis explains.

Maintaining consistently high quality Consistently high product quality is a critical factor in the pharmaceutical industry, since authorities such as the FDA and EMA have strict guidelines for process understanding, monitoring and validation. “To make successful root cause analyses and process improvements, or to develop a control strategy as part of continuous process verification, we offer customers our new data mining service,” Michaelis says. “We are looking forward to further projects to pursue the
path of industry 4.0 together with our customers.”



Cologne (DE) / Walkersville, MD (USA), 26 March 2018. On 24 April 2018, Lonza is hosting a free 60-minute webinar on what are the best practices for connecting and integrating devices and systems in QC and production and how can the data captured be used to make better, more informed decisions.

BioLIVE – the UBM bioprocessing and manufacturing event opening in October (9-11) in Madrid – announces that it is to build on the success of last year’s global small molecule country rankings by introducing a biologics manufacturing and processing league table.

At ACHEMA,the leading international trade fair for the process industries in June in Frankfurt am Main, market leading supplier of fluidizedbed and spouted bed systems, Glatt, will showcaseseveral new developments, including a compact system for continuous agglomeration and a modular control system that’s easy to customize.

The Tredegar facility is our development and manufacturing Center of Excellence with specialist expertise in the processing of highly potent molecules. The site has undergone significant investments over recent years; this latest project ensures analytical capacity and capability to service increasing customer demand.


The investment will see the laboratory increase its analyst headcount by approximately 60 percent and increase its High-Performance Liquid Chromatography (HPLC) capacity in excess of 20 percent, in addition to tripling its capacity for sample receipt. The layout design of the facility incorporates state-of-the-art Lean philosophies and optimized safety, combined with leading ergonomic principles, to deliver enhanced throughput and additional efficiency improvements.


Since launching the contained manufacturing facility, utilizing the latest in containment technology at Tredegar; the site has seen significant growth in its global customer base. This latest project will ensure that we are able to service both existing and potential new clients, as well as offering a project initiation in terms of analytical transfer within 4-6 weeks.


The site offers a true Center of Excellence for the development and manufacturing of pharmaceutical products in a variety of dosage forms and has over 30 years of experience in the specialist handling of potent molecules. Investment in state-of-the-art contained equipment, combined with the creation of a ‘Potent Passport’ philosophy to identify the specific handling requirements for every Highly Potent Active Pharmaceutical Ingredient (HPAPI) project, defines PCI as a market leader within this space. Contained technology includes Xcelodose® micro-dosing for early stage development drug-in-capsule (DIC), fluid bed granulation and roller compaction for products sensitive to heat and moisture.
Commenting on the expansion, PCI Senior Vice President, International, Richard Yarwood said: “Expansion of our laboratory services is an important program for the Tredegar site. Speed to market is of critical importance to our clients. We pride ourselves on continually improving our service for both existing and potential new clients and our analytical service is integral from the early stages of analytical development through to commercial launch and the associated annual stability testing.”
He continued “Among our many key strengths is our ability to on-board projects faster than our competitors. This additional footprint will ensure we are able to continue to offer this speed of project initiation addressing customer need.“

Micell® Technologies, Inc., a privately-held, development-stage biomedical company, today provided an update on its recently expanded intellectual property portfolio. With the granting of 24 patents in 2017, including eight that issued in the fourth quarter, Micell's extensive intellectual property portfolio comprises 186 patents (166 issued and 20 allowed) protecting the company's novel drug-eluting stent, its enabling technologies, and future biomedical and other applications.


Micell's technology platform uses unique surface modification and polymer science to allow for precisely and consistently controlled drug elution. This technology made possible the successful development of Micell's drug-eluting stent, the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent). The device is designed to optimize clinical performance and healing compared to other currently available drug-eluting coronary stents.


"Patents issued throughout the past year represent external validation of Micell's innovative approach to controlled drug delivery. Beyond MiStent, this platform technology potentially allows for diverse and broadly based biomedical applications that could address unmet clinical needs.

To date, there are more than 8,410 claims -- issued, allowed and pending -- associated with Micell's patents, and additional patent applications currently are pending," said Arthur J. Benvenuto, Micell's Chairman and CEO.
Editor's Note: For detailed information related to Micell's intellectual property portfolio, please contact Micell Technologies.

Envigo is investing in an expansion of its surgical facility at its Livermore, California site in response to large market demand from West Coast customers.

Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces that its next-generation sequencing (NGS)-based MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping Kit is now CE marked, enabling the Company to commercialize the device in Europe.

SMi Group are delighted to announce the 6thannual Pharmaceutical Freeze Drying Technology conference, being held this June 2018! Read on for a massive £400 off.

Drug Safety 2018 aims to discuss the latest findings and current thinking on pharmacovigilance. Importantly, it will address the newest regulatory updates and interpretations of them, including the impact of the vital and much awaited Clinical Trial Regulations.

Building on the success of SMi's 10th Annual Flagship Conference Pre-Filled Syringes, SMi are thrilled to present the launch of their Injectable Drug Delivery conference being held at Holiday Inn, Kensington Forum, London, on the 16th – 17th May 2018.

Novartis announced the launch of two new Joint Working Projects with National Cancer Vanguard sites, which aim to identify ways to improve cancer patient care pathways and access to services. The projects will be based at The Christie in Greater Manchester and within the UCLH Cancer Collaborative region (north and east London), covering a catchment population of 6.9 million people. The two projects are part of Novartis' ongoing commitment to combine resources, time, and expertise with the NHS, with the aim to significantly improve cancer patient outcomes.


With one in two people born after 1960 expected to develop cancer at some point in their lifetime[1], optimising working practices and addressing variations in care is essential to ensure the best outcomes for cancer patients. Central to both Joint Working Projects is the use of data analytics to generate insights, which will be used to improve cancer patients' experiences, one of the six key priorities of the NHS cancer strategy.


The Joint Working Project with UCLH Cancer Collaborative will adopt the use of Multi-Disciplinary Team (MDT) level balanced scorecards to capture service outcomes data for breast, lung, lymphoma, melanoma, and prostate cancer patient pathways. This service level data will include information on cancer patients' waiting times versus targets, the number of patients diagnosed with cancer, and the proportion of patients being prescribed chemotherapy and receiving it at home. Patient or clinical information will not be disclosed as part of the project.


Decisions on clinical practice are informed by data, however, information from these pathways is not currently captured under one source, and varies across different types of cancer and hospitals. The NHS and Novartis are jointly funding two project analysts to manage the project and to compare data from the MDT scorecards to service standards in the National Institute for Health and Care Excellence (NICE) treatment guidelines. Insights will be used by staff to improve MDTs' effectiveness and enhance patient care pathways, to develop care levels that are tailored to individual patient needs and provide a better quality of service for patients.
"Through the use of the MDT scorecards, we will be able to gather data on service outcomes across multiple cancers to identify areas for improvement," said Professor Kathy Pritchard-Jones, chief medical officer for UCLH Cancer Collaborative. "Reducing variations in cancer treatment pathways is vital to ensuring our patients receive the highest level of care we can provide them, regardless of the staging or type of cancer they have."


The Joint Working Project with The Christie NHS Foundation Trust will work to address care pathway inconsistencies in breast cancer, the most common cancer in the UK accounting for 31% of all new cancer diagnoses in women[3]. The project includes a partnership with IQVIA, a leading global provider of information and innovative technology solutions, to analyse current breast cancer pathways and identify opportunities to enhance care. This will involve examining relevant anonymised healthcare data including Public Health England's Cancer Analysis System (CAS) and NHS Hospital Episodic Statistics (HES) to establish the current state of the breast cancer treatment pathways across Greater Manchester so that variations in access to care can be better understood. The project will also evaluate patient journeys by enabling patients to record their experiences of treatment pathways through the use of innovative technology provided by the app, uMotif. It is anticipated that findings from the project will lead to improvements in the timeliness of treatment interventions for patients, and provide clarity on where to focus resource efforts, subsequently helping to address any variation in access to treatment.


"At The Christie we are committed to improving treatments and pathways for our patients, and this partnership will allow us to harness the power of data analytics to improve care for patients with secondary breast cancer," said Professor Andrew Wardley, clinical director of NIHR Manchester Clinical Research Facility at The Christie. "We are hopeful that the success in this project could lead to advancements in care for breast cancer patients across the country."


If the two initiatives are successful, the models and recommendations could be implemented more widely in their respective regions and potentially rolled out nationally, providing a standard for best practice. Mari Scheiffele, Oncology General Manager, Novartis UK & Ireland, said: "Our partnerships with the NHS are of paramount importance as we work towards our shared goal of improving treatment pathways and care for cancer patients. Pooling resources to identify areas for improvement and possible solutions helps to ensure patients receive the best possible outcomes."


The Independent Cancer Taskforce outlined their cancer strategy following on from the publication of the NHS Five Year Forward View, which identified a focus on improving outcomes across the whole cancer pathway[2],[4]. Initiatives such as these Joint Working Projects demonstrate Novartis' commitment to supporting this goal.

Novartis announced the launch of two new Joint Working Projects with National Cancer Vanguard sites, which aim to identify ways to improve cancer patient care pathways and access to services. The projects will be based at The Christie in Greater Manchester and within the UCLH Cancer Collaborative region (north and east London), covering a catchment population of 6.9 million people. The two projects are part of Novartis' ongoing commitment to combine resources, time, and expertise with the NHS, with the aim to significantly improve cancer patient outcomes.


With one in two people born after 1960 expected to develop cancer at some point in their lifetime[1], optimising working practices and addressing variations in care is essential to ensure the best outcomes for cancer patients. Central to both Joint Working Projects is the use of data analytics to generate insights, which will be used to improve cancer patients' experiences, one of the six key priorities of the NHS cancer strategy.


The Joint Working Project with UCLH Cancer Collaborative will adopt the use of Multi-Disciplinary Team (MDT) level balanced scorecards to capture service outcomes data for breast, lung, lymphoma, melanoma, and prostate cancer patient pathways. This service level data will include information on cancer patients' waiting times versus targets, the number of patients diagnosed with cancer, and the proportion of patients being prescribed chemotherapy and receiving it at home. Patient or clinical information will not be disclosed as part of the project.


Decisions on clinical practice are informed by data, however, information from these pathways is not currently captured under one source, and varies across different types of cancer and hospitals. The NHS and Novartis are jointly funding two project analysts to manage the project and to compare data from the MDT scorecards to service standards in the National Institute for Health and Care Excellence (NICE) treatment guidelines. Insights will be used by staff to improve MDTs' effectiveness and enhance patient care pathways, to develop care levels that are tailored to individual patient needs and provide a better quality of service for patients.
"Through the use of the MDT scorecards, we will be able to gather data on service outcomes across multiple cancers to identify areas for improvement," said Professor Kathy Pritchard-Jones, chief medical officer for UCLH Cancer Collaborative. "Reducing variations in cancer treatment pathways is vital to ensuring our patients receive the highest level of care we can provide them, regardless of the staging or type of cancer they have."


The Joint Working Project with The Christie NHS Foundation Trust will work to address care pathway inconsistencies in breast cancer, the most common cancer in the UK accounting for 31% of all new cancer diagnoses in women[3]. The project includes a partnership with IQVIA, a leading global provider of information and innovative technology solutions, to analyse current breast cancer pathways and identify opportunities to enhance care. This will involve examining relevant anonymised healthcare data including Public Health England's Cancer Analysis System (CAS) and NHS Hospital Episodic Statistics (HES) to establish the current state of the breast cancer treatment pathways across Greater Manchester so that variations in access to care can be better understood. The project will also evaluate patient journeys by enabling patients to record their experiences of treatment pathways through the use of innovative technology provided by the app, uMotif. It is anticipated that findings from the project will lead to improvements in the timeliness of treatment interventions for patients, and provide clarity on where to focus resource efforts, subsequently helping to address any variation in access to treatment.


"At The Christie we are committed to improving treatments and pathways for our patients, and this partnership will allow us to harness the power of data analytics to improve care for patients with secondary breast cancer," said Professor Andrew Wardley, clinical director of NIHR Manchester Clinical Research Facility at The Christie. "We are hopeful that the success in this project could lead to advancements in care for breast cancer patients across the country."


If the two initiatives are successful, the models and recommendations could be implemented more widely in their respective regions and potentially rolled out nationally, providing a standard for best practice. Mari Scheiffele, Oncology General Manager, Novartis UK & Ireland, said: "Our partnerships with the NHS are of paramount importance as we work towards our shared goal of improving treatment pathways and care for cancer patients. Pooling resources to identify areas for improvement and possible solutions helps to ensure patients receive the best possible outcomes."


The Independent Cancer Taskforce outlined their cancer strategy following on from the publication of the NHS Five Year Forward View, which identified a focus on improving outcomes across the whole cancer pathway[2],[4]. Initiatives such as these Joint Working Projects demonstrate Novartis' commitment to supporting this goal.

INVICTUS MD STRATEGIES CORP. is pleased to announce that , Gene Simmons, Chief Evangelist Officer for the company and its management team opened the trading day at the TSX Venture Exchange (TSXV). The appearance coincides with the company changing its share ticker from IMH to GENE.

"To have a cannabis company like Invictus open the trading at TSXV, one of the world's best trading communities, is truly inspiring," said Invictus Chairman and CEO Dan Kriznic. "With our footprint in Ontario and Alberta on track for full production over the next 12 months, and poised to help supply Canada's dynamic consumer marketplace with a wide variety of strains and extracts."

Invictus changed its TSX Venture symbol from IMH to GENE, effective immediately for trading commencing on March 20, 2018, to reflect the importance of the company's new partnership with rock icon and branding genius Gene Simmons, anticipating that Simmons will play a vital role as the company marches into this historic year for Canada and cannabis.

Simmons will be involved on a variety of different areas. His key focus will be on helping the company forge its public awareness strategy. Additionally, he will make appearances at the annual general meeting, investor meetings, and trade shows, and will serve as a media spokesperson. His efforts will be performed in accordance with the strict regulations of Health Canada's Access to Cannabis for Medical Purposes Regulations (ACMPR), the Food and Drugs Act (FDA) and the Narcotic Control Regulations (NCR).

Simmons explored a number of potential cannabis partnerships before deciding to work with Invictus.
"As I learned more about the changing sentiment of the public and investors, I was enthusiastic to invest in the Cannabis space. I did my due diligence with the available information on the top 10 Licensed Cannabis Producers in Canada, including a number of face-to-face interviews," said Simmons. "They have a leadership that has the potential to change that and a solid plan for growth."

Sarepta Therapeutics, Inc , a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases.

Bristol-Myers Squibb Company and Pfizer Inc. will present findings from a real-world data (RWD) analysis titled, Comparison of Effectiveness, Safety, and the Net Clinical Outcome between Different Direct Oral Anticoagulants in 162,707 Non-Valvular Atrial Fibrillation Patients Treated in US Clinical Practice.

Nanologica AB (publ) has entered into a service agreement with global contract development and manufacturing organisation (CDMO) Sterling Pharma Solutions for the large-scale production of silica particles. 

Cell-based assays have become an important application in the life science sector, from basic to top-level research. They are widely used in biotech companies and academic research institutions to monitor cell health in real-time.

Bio-Techne has released MimEX™ GI, a new product line for generating 3-dimensional (3-D) gastrointestinal tissue on a 2-D surface.

Abbott announced the U.S. FDA approved the Masters HP™ 15mm rotatable mechanical heart valve, the world's smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement.

Globally, about 800 women die every day of preventable causes related to pregnancy and childbirth; 20 per cent of these women are from India,1 and Postpartum Haemorrhage (PPH) is the leading cause of maternal mortality in India.

Roche announced that the European Commission has approved Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors.

Recipharm, the contract development and manufacturing organisation (CDMO), has signed a licensing agreement with Altus Formulation Inc., a Canadian drug development company, to allow its customers to access new drug delivery technologies and products.

Eli Lilly and Company announced that the U.S. FDA has approved Verzenio™ in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

Novo Nordisk announced the submission of a Biologics License Applications (BLA) to the US FDA and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for N8-GP, an extended half-life factor VIII for treatment of people with haemophilia A.

RBC analyst Brian Abrahams said the decision will have "zero material impact" on Biogen as Zinbryta was expected to bring in about $400 million in 2027 revenue for the company, or less than 3% of total sales.

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted positive opinions recommending that two Pfizer hematology medicines be granted marketing authorizations in the European Union (EU).

As global interest in traditional and alternative medicine grows, Elsevier, the global information analytics business specializing in science and health, announced that it is working with Beijing University of Chinese Medicine (BUCM) to create a new taxonomy for traditional Chinese medicine (TCM) in Embase, the world’s most comprehensive biomedical literature database.

Semiconductor wafer fabrication plants and ultra-high purity chemical suppliers can now strengthen their monitoring of trace elements within challenging sample matrices with a new triple quadrupole inductively coupled plasma mass spectrometer (ICP-MS), offering sub-parts-per-trillion detection—making it an ideal solution for ultraclean applications.

Contract development and manufacturing organisation (CDMO) Saneca Pharma has renewed an agreement with Pharmascience Inc, one of Canada’s largest pharmaceutical companies, for the manufacture and supply of prescription medicines in tablet form.

CRF Health, the leading provider of patient-centered eSource for the life sciences industry, announced that its TrialConsent® electronic informed consent solution has been shortlisted for the ‘Best Patient-Focused Technological Development’ category in the 2018 Clinical & Research Excellence (CARE) Awards.

Despite significant technological advances in technology, cardiovascular diseases (CVDs) remain the number one cause of death globally. CVDs are a group of disorders of both the heart and blood vessels that can lead to heart attacks and strokes.

Alma Lasers, a subsidiary of Sisram Medical Ltd , the leading global innovator of laser light-based, radio frequency and ultrasound solutions for the aesthetic and surgical markets and the #1 rated leading provider of energy-based surgical and medical aesthetic solutions in the Peoples Republic of China announced the launch of the Soprano ICE Platinum.

On average, 1 in 10 children who enroll in pediatric phase I cancer trials are improved after the trial, and 1 in 50 die from drug-related complications, according to a new systematic review and meta-analysis published this week in PLOS Medicineby Jonathan Kimmelman from McGill University, Canada, and colleagues.

Allergan plc, a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, today announced that the U.S. FDA has accepted for filing Medicines360's supplemental New Drug Application (sNDA).

AbbVie , a global biopharmaceutical company, and Voyager Therapeutics, Inc. , a clinical-stage gene therapy company announced that they have entered into an exclusive strategic collaboration and option agreement to develop and commercialize vectorized antibodies directed against tau for the treatment of Alzheimer's disease and other neurodegenerative diseases.

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US FDA has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

The meeting will be held at the San Diego Convention Center and the scheduled times (noted in local Pacific Time) for the Allergan presentations, titles and authors are as follows:

Amgen announced that the Oncologic Drugs Advisory Committee of the U.S. FDA will review data supporting the BLINCYTO® (blinatumomab) supplemental Biologics License Application (sBLA) for the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL) at a meeting on March 7, 2018.

AbbVie  a global research and development-based biopharmaceutical company, today announced it will present new, late-breaking data across investigational medicines and HUMIRA® (adalimumab) at the 2018 American Academy of Dermatology (AAD) Annual Meeting (February 16-20, San Diego).

GSK announced the expanded indication for Fluarix Tetra (Quadrivalent Influenza Vaccine) has been approved in Europe to include adults and now children from six months of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.

GlaxoSmithKline plc and Innoviva, Inc. announced the submission of the landmark IMPACT data to the European Medicines Agency as part of a type II variation to support an expanded label for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) in Europe for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD) (for the relief of symptoms and reduction of exacerbations, see section 5.1).

Vertex Pharmaceuticals Incorporated announced that the U.S. FDA approved Symdeko (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor.

The U.S. FDA approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).

CRF Health, a leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, announced that its electronic informed consent solution, TrialConsent®, has won the 2018 Best Practices Award at this year’s Clinical Informatics News Awards.

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, today announced financial and company results for the fourth quarter and  full year of 2017.

CRF Health, a leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, has announced the appointment of Bill Byrom as Vice President of Product Strategy & Innovation.

Lonza announced the latest addition to its cell-culture product portfolio – the Quasi Vivo® System. The Quasi Vivo® Device consists of an advanced, interconnected fluidics system to create more physiologically relevant cell-culture conditions, helping researchers improve the predictive value of their studies.

The Children’s Emergency Hospital "Louis Turcanu" brings over 90,000 patients in the Timișoara area to the PRS network of hospitals, expanding Clinerion’s global footprint into Romania.

Pharmapack Europe (#PharmapackEU), organised by UBM, announced the winners of the much celebrated 2018 Pharmapack Awards. Due to the outstanding quality of entries, six worthy winners were chosen across two categories, ‘Exhibitor Innovation’ and ‘Health Products’.

In an event at its new branch office attended by key customers and business associates, Vetter’s senior management representatives presented the company’s service portfolio along with its growth strategy for South Korea and the Asia Pacific (APAC) region.

Cobra Biologics (Cobra), an international contract development and manufacturing organisation (CDMO) of biologics and pharmaceuticals, and Symbiosis Pharmaceutical Services (Symbiosis), a contract manufacturing organisation (CMO) specialising in sterile Fill Finish, announced that they have been awarded a 16-month collaborative grant of £1.9m from Innovate UK.

Novartis AG announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US FDA approval of its NDA for Lutathera® (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.

During the Society of Toxicology Meeting from 11-15 March 2018 at the Henry B. González Convention Center in San Antonio, TX (USA), Lonza will present two posters highlighting its latest research into developing more physiologically relevant in vitro cell-culture models for ADME-Tox testing.

UPM Raflatac's pharmaceutical and healthcare labeling experts will be present at Pharmapack exhibition on 7-8 February 2018 in Paris, France.

Elsevier, the global information analytics business specializing in science and health,announced that six start-up companies have been selected from more than 150 global applicants for The Hive, Elsevier's innovation initiative for biotech and pharmaceutical start-ups.

NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced new lateral solutions that enable surgeons to perform lateral single-position surgery and expand the Company’s comprehensive lateral portfolio.

FuturaGene, a wholly owned subsidiary of Suzano Pulp and Paper, and Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO), are pleased to announce that a patent has been issued in Brazil to CSIRO, which covers the downregulation of the expression of plant target genes or other target genes, including genes of insect pests and disease agents.

Ziath announced it will showcase its new, cost-effective 2D barcode rack scanner, the DataPaq™ Mirage, at SLAS2018 (3–7 February 2018, San Diego, CA).

Orchard Therapeutics, a biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, today announced the appointment of Frank Thomas to the newly created position of chief financial officer and chief business officer.

Whether for use in research or general laboratory applications, the performance and build quality of the Priorclave QCS range of front loading autoclaves has made it a global success. 

CRF Health, the leading global provider of patient-centered eSource technology solutions for the life sciences industry, announced that it has been recognized as a leading HealthTech Innovator in the 2017 Global Digital Health 100 Awards.

Orchard Therapeutics, a biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, announced the completion of an oversubscribed $110 million (£85 million) Series B financing.

HealthCarePoint (HCP), a Texas-based health care and clinical research networking-technology company founded by patient-survivors, announced its mutual collaboration with Clinerion.

Thrombolytic Science, LLC (TSI), a clinical stage vascular health and biotechnology company announced the appointment of Annalisa Jenkins, MBBS, FRCP, formerly President and CEO of Dimension Therapeutics, Inc. , as a non-executive board member.  Dr. Jenkins brings over 25 years of global pharmaceutical industry experience to TSI’s Board of Directors.

Scientists and doctors from Singapore institutes are collaborating with Samsung Medical Center (SMC), a leading academic medical centre in Seoul, Republic of Korea, to develop the world's first clinically reliable and robust platform that will significantly improve the treatment of hepatocellular carcinoma (HCC) or liver cancer.

Envigo, a leading provider of nonclinical contract research services and research models, announced today the implementation of a first-in-class surgical model tracking system, designed to track and monitor the entire spectrum of surgical model development – enabling critically required efficiencies while enhancing animal welfare.

Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has introduced a new version of its SIMCA® and SIMCA®-online data analytical solutions, which are offered by its subsidiary Sartorius Stedim Data Analytics, formerly known as Umetrics.

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 unveiled FutureLink.

ADC Biotechnology – a specialist ADC contract services company with proprietary conjugation technology designed to overcome process and aggregation challenges during the development of new ADCs – announces the signing of a partnership agreement with multi-disciplined engineering specialists, WHP.

CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has announced two new strategic appointments to strengthen its business development team.

Akili Interactive , an affiliate of PureTech Health (PRTC.L) announced top-line results from the Company’s STARS-ADHD pivotal study of its lead investigational digital medicine, AKL-T01, in paediatric attention-deficit/hyperactivity disorder (ADHD).

To help hospital pharmacists prepare for and provide cutting edge innovation in service delivery and patient care, five Synergy Satellites will be organised during the 23rd Congress of the EAHP which will take place from 21st to 23rd March 2018 in Gothenburg, Sweden.

The 2nd edition of the celebrated India Pharma Week, a UBM India initiative introduced last year to celebrate a decade of CPhI & P-MEC, UBM’s flagship engagement platform, and the world’s leading Pharmaceutical networking event -- witnessed one of its most significant events, the CEO Round Table.

Recipharm, a leading contract development and manufacturing organisation (CDMO) has equipped three more of its facilities with serialisation capabilities in line with the US regulatory requirements in time for today’s introduction of the Drug Supply Chain Security Act (DSCSA).

Orchard Therapeutics Limited (“Orchard”), a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies.

Quanticate, a data-focused clinical research organisation (CRO), has launched its centralised statistical monitoring service (https://www.quanticate.com/centralized-statistical-monitoring) as an extension of its statistical consultancy offering in response to recent amendments to the International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) E6(R2) guidelines.

Implandata Ophthalmic Products GmbH (Implandata) is a privately held, ISO 13485 certified medical device company founded in 2010 in Hannover/Germany.

Swisslog, a global provider of robot and data-driven intralogistics solutions, has been awarded contracts to optimize the storage and handling of medical devices from two world-leading brands in Japan.

The Mehmet Akif Ersoy Göğüs Kalp Damar Cerrahisi Eğitim Araştırma Hastanesi (IMAEH) hospital in Istanbul has joined the network of hospitals on Clinerion’s PRS platform.

CPhI Worldwide, organised by UBM, closes its 28th edition with pre-audit figures indicating a record-breaking attendance of over 44,500* and 2,598 exhibitors. Held in Frankfurt (Germany), the heart of Europe’s biggest pharmaceutical market (24-26th October, 2017), the world’s largest pharma event saw attendees from 169 countries – 25% of which are CEO or board level.

Aquila BioMedical Ltd., an innovative preclinical contract research organisation (CRO) now part of Concept Life Sciences group, has secured an extended agreement with UK-based biotech firm Macrophage Pharma Ltd. to support its preclinical immuno-oncology programmes.

Following its CPhI Europe banner headline “Enlighten your formulation”, Omya has shown how its calcium carbonates can be used to develop tailor-made products in response to specific consumer or patient needs in a variety of pharmaceutical forms.

CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has further expanded its Late Phase work in Japan by entering into two new partnerships with global top 20 pharmaceutical companies.

Pharmapack Europe 2018 announced the comprehensive event programme for Europe’s dedicated pharmaceutical packaging and drug delivery conference and exhibition taking place on 7–8 February at Paris Expo Porte de Versailles, Paris.

Toyota Motor Corporation (Toyota) announces that it has signed an agreement with Kazusa DNA Research Institute, Eurofins Genomics K.K., and GeneBay Inc. on October 30 to license Toyota's unique GRAS-Di(1) DNA analysis technology that can dramatically accelerate selective breeding.

The largest and most recent export contract won by Priorclave is for shipment to the USA of nine research grade autoclaves which will be destined for the campus of California State University, Fullerton and will be used by faculty and students in the Department of Biological Science and Department of Chemistry and Biochemistry.

Cristal Therapeutics, a clinical stage biopharmaceutical company developing targeted nanomedicines for the treatment of cancer and other diseases with high unmet patient need, announced that it has begun a Phase 1b clinical program of its lead nanomedicine candidate CriPec®-docetaxel in patients with solid tumours.

Clinerion has expanded its geographic coverage to include over 60 million patients in the USA, via a strategic partnership with Provisio Inc.

NeoGenomics, Inc. , a leading provider of cancer-focused genetic testing services in the United States, announced that it has opened its first international laboratory facility in Rolle, Switzerland, in the Canton of Vaud, just outside of Geneva as a separate subsidiary, NeoGenomics Europe, S.A.

Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, received the prestigious Frost & Sullivan’s 2017 European Customer Service Leadership Award for Bioanalytical Contract Testing Services.

CorFlow Therapeutics AG announced that the company has completed the CHF 2.6M 1st close of its Seed+ financing round led by experienced private medical device investors who over the last decades have supported breakthrough interventional cardiology technologies.