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News items July 2017

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WuXi’s PDS Division Merges with STA
Shanghai, July 31, 2017: STA Pharmaceutical Co., Ltd. (STA) – a WuXi AppTec group company and the leading open-access capability and technology platform for small molecule pharmaceutical development and manufacturing – announces that it has merged with WuXi AppTec’s Pharmaceutical Development Services (PDS) division. The PDS division offers pre-formulation development, formulation development, as well as Clinical Trial Material (CTM) manufacturing, packaging and labeling of oral solid dosage forms including tablets, capsules, sachets and oral solutions/suspensions. PDS also established various enabling technology platforms for low soluble drugs including spray dried dispersion, hot melt extrusion, micro or nano suspension and liquid-filled hard gelatin capsules. Two commercial-scale drug product manufacturing facilities currently under construction are expected to become operational later this year and early next year, respectively. STA Pharmaceutical, after
31-07-2017  |  218x  |  News in brief
CPhI Annual Reports - how accurate were they 5 years on?
The CPhI predictions foresaw advancement in QbD and continuous processing Since this is the 5th edition, CPhI Worldwide has decided to look back at previous Annual Reports to see how accurate the predictions were. These included the expanded use of PAT, QbD, serialization, green chemistry and R&D improvements, as well as the rise of strategic relationships between pharma and CMOs (or CDMOs as they are now called). However, a potential hindrance to the industry was the predicted rise in the number of FDA warning letters. The 2013 Annual Report forewarned of the rapid increase of FDA warning letters as a result of a tightening regulation environment and a lagging industry. This prediction proved entirely accurate with FDA warning letters tripling over the past few years, from 4882 in 2012 to 14,590 in 2016. Another bold prediction from the first report was an expected boom in pharmaceutical R&D and improvements in development cycles. Interestingly, this was true in 2014 and 2015, stellar years for NME (New Molecular Entities) and BLA (Biologics
27-07-2017  |  198x  |  News in brief
Teklad Diets recertified to new ISO standard
Princeton, NJ, July 27, 2017 – Envigo has announced that its Teklad Diets sites in Madison, WI received recertification to the new ISO9001:2015 standard. ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. The ISO9001:2015 revision has re-focused on performance by combining the process approach with risk-based thinking and employing the Plan-Do-Check-Act cycle at all levels within an organization. Received in June, this certification gives Envigo’s customers’ confidence about the oversight and quality of the products they purchase for their research needs. In mid-May, SGS North America Inc., the world’s leading inspection, verification, testing and certification company, conducted an intensive four-day audit of the Envigo Madison site. The audit revealed Envigo
27-07-2017  |  208x  |  News in brief
STA Signs Supply Agreement with TESARO
SHANGHAI, July 24 2017 – STA Pharmaceutical Co., Ltd. (STA) – a WuXi AppTec subsidiary and the leading open-access capability and technology platform for small molecule pharmaceutical development and manufacturing – announces it has signed a supply agreement with the oncology-focused biopharmaceutical company, TESARO, Inc. (TESARO) for certain starting and intermediate materials for ZEJULA™ (Niraparib). Under the five-year agreement, STA will provide supplies of certain starting and intermediate materials for the recently launched ZEJULA – an orally active and potent poly(ADP-ribose) polymerase (PARP) inhibitor for the treatment of ovarian cancer. ZEJULA was approved for epithelial ovarian, fallopian tube or primary peritoneal cancer by the U.S. Food and Drug Administration (FDA) on March 27th 2017, and is now available to patients in the USA. This agreement follows a successful multiple-year development and clinical manufacturing arrangement with TESARO, and assisting
24-07-2017  |  283x  |  News in brief
Royal approval for MR Solutions with Queens Award win MR Solutions receives prestigous award by Her Majesty the Queen for oversees success
Royal approval for MR Solutions with Queens Award win
MR Solutions receives prestigous award by Her Majesty the Queen for oversees success MR Solutions, the Surrey-based manufacturer of preclinical MRI imaging systems, was received by the Queen at Buckingham Palace on July 11 in celebration of their Queen’s Award for Enterprise which is awarded in recognition of their outstanding success in growing overseas sales. This is the second Queen’s Award that MR Solutions has won, the previous one was for innovation in 2016. MR Solutions developed the world’s first range of commercially available superconducting, helium-free compact preclinical MRI scanners. These scanners are used for research purposes such as in cell visualisation for drug discovery. The winner’s reception was hosted by Her Majesty the Queen and His Royal Highness the Duke of Edinburgh. Dr David Taylor, CEO and Dr Vera Zhang, Director of MR Solutions’ international office based in Boston, stood in the receiving line for the Queen who congratulated the winners. MR Solutions is the only company in the world to offer a range of scanners
19-07-2017  |  413x  |  News in brief  | 
South Korean pharma becoming manufacturing export hub
Overseas buyers at CPhI Korea double in the past 2 years CPhI Korea returns to Seoul COEX Convention and Exhibition Centre for its fourth edition from 22nd-24th August 2017. The show will co-locate with ICSE, P-MEC, BioPh and Health Ingredients Korea. Reflecting the global interest in the South Korean pharma market, CPhI Korea 2017 will see a 13% rise in the number of exhibitors, in addition to a more than doubling of overseas buyers since 2015. This surge in international companies wanting to partner in Korea reflects a flourishing South Korean pharma economy, which, in recent years, has become the 3rd largest pharma region in Asia, with a forecasted growth from $18.6 billion in 2016 to $20.4 billion in 2020. The domestic biopharmaceutical market has also observed a notable surge over the last fives years with a compound annual growth rate (CAGR) of 9%. One of the main factors for this growth stems from government incentives such as the ‘Incheon Free Economic Zone’, with the intent of becoming one of the future top 3 economic
19-07-2017  |  252x  |  News in brief
CFDA, US FDA & Industry leaders collaborate at MAH summit
Discussions showed a positive outlook with the pilot program STA Pharmaceutical Co., Ltd. (STA) – a WuXi AppTec subsidiary and a leading open-access capability and technology platform for small molecule pharmaceutical development and manufacturing – co-organized a summit along with the Shanghai Municipal Food and Drug Administration and the local government of the Jinshan District of Shanghai on the current state of the China Marketing Authorization Holder (MAH) system, currently being piloted in ten provinces and municipalities across China. Discussions ran for several hours and were centred on the progress of the new MAH system in streamlining drug approvals for the China market. The system coordinates with international standards for drug safety to keep patient risk low, while stimulating innovation, and speeding patient’s access to life saving therapies. A leader from the Shanghai Food and Drug Administration explained that the idea of the approval system reform was first conceived in 2015 in Shanghai, one of China’s
18-07-2017  |  230x  |  News in brief
Concept Life Sciences appoints Dr Andrew Clifton
Concept Life Sciences appoints Dr Andrew Clifton
Dr Andrew Clifton joins Concept Life Sciences as Head of Bioassay Development and Screening Technologies. Concept Life Sciences offers tailored preclinical services including integrated drug discovery programs providing its international client base with world class integrated services. Dr Clifton will be responsible for providing assay development and screening capabilities to support preclinical drug discovery projects from hit finding through to candidate selection. Andrew has over eighteen years’ experience in both large pharma and biotech through his roles at AstraZeneca and Redx Pharma. Andrew’s expertise is in biochemistry and pharmacology with experience across major drug target classes including a wide variety of enzymes and GPCRs. He has extensive experience of assay development and screening applied to hit finding, hit to lead and lead optimisation and has contributed to the delivery of multiple clinical candidates. His therapy area experience includes
11-07-2017  |  282x  |  News in brief  | 
Precision NanoSystems to host nanomedicines symposium
Precision NanoSystems to host nanomedicines symposium
Join Precision NanoSystems for its second annual nanomedicines symposium, entitled Nanomedicines: enabling new therapeutic modalities, on the 15th of July in Boston, MA. Following the success of last year’s inaugural event, the symposium will bring together distinguished researchers and drug developers from across the nanomedicines industry, and will precede the Controlled Release Society’s Annual Meeting and Exposition from the 16th to 18th of July. The symposium schedule has been designed to provide an overview of the latest developments in nanomedicine research, including strategies for overcoming in vitro and in vivo barriers to effective and targeted drug delivery. It will cover a diverse range of applications, with the keynote address – To target or not to target: lessons from RNAi-based targeted lipid nanoparticles – being provided by Professor Dan Peer from the Department of Cell Research and Immunology at Tel Aviv University. Other topics covered during
10-07-2017  |  237x  |  News in brief  | 
NL42 interviews Accenture & LabAnswer on the recent announce PLA2018, an opportunity for Accenture & LabAnswer to share their message in Europe
NL42 interviews Accenture & LabAnswer on the recent announce
PLA2018, an opportunity for Accenture & LabAnswer to share their message in Europe The recently announced Accenture agreement to acquire LabAnswer, a leading US-based scientific and laboratory informatics consulting firm, has led to some reflections on the new coming lab informatics consulting landscape in Europe. As organizer of the European Congress Papeless Lab Academy , Roberto Castelnovo (Owner at NL42 Consulting) had the opportunity to discuss with Brad Michel Managing Director – Life Sciences at Accenture and with Mark Everding, CEO and Managing Partner, and Patrick Pijanowski, Partner, Pharma & Life Sciences Practice, both from LabAnswer. By combining LabAnswer’s industry knowledge and experience in scientific and laboratory informatics consulting with Accenture’s business consulting expertise, industry platforms, innovation capabilities and global scale, the acquisition will enhance Accenture’s ability to apply digital technologies to assist clients in transforming their scientific and laboratory processes across a variety of industries. To
10-07-2017  |  415x  |  News in brief  | 
CPhI Worldwide opens entries for largest ever Pharma Awards
The 2017 awards include 8 new categories - celebrating outstanding achievements Full list of categories: • Excellence in Pharma: API Development • Excellence in Pharma: Formulation • Excellence in Pharma: Manufacturing Technology and Equipment • Excellence in Pharma: Bioprocessing • Excellence in Pharma: Analysis, Testing, and Quality Control • Excellence in Pharma: Drug Delivery Devices • Excellence in Pharma: Packaging • Excellence in Pharma: Supply Chain, Logistics, and Distribution • Excellence in Pharma: Contract Services and Outsourcing • Excellence in Pharma: Regulatory Procedures and Compliance • Excellence in Pharma: Corporate Social Responsibility • Excellence in Pharma: CEO of the Year • NEW! Excellence in Pharma: Excipients • NEW! Excellence in Pharma: Pharma Company of the Year- Large • NEW! Excellence in Pharma: Pharma Company of the Year- SME • NEW! Excellence in Pharma: Sustainability Initiative of the Year • NEW! Excellence in Pharma: Export Promotion • NEW! Excellence in Pharma: OTC • NEW! Excellence in Pharma:
10-07-2017  |  209x  |  News in brief
Eppendorf acquires a majority share in Bio-ITech B.V.
Eppendorf acquires a majority share in Bio-ITech B.V.
Bio-ITech B.V., leading supplier of software for life science laboratories,is proud to announce that Eppendorf acquired a majority share in the company. After closely collaborating for over one year, the participation of Eppendorf in Bio-ITech is a key milestone in the company history and an important step to enable further growth. As the market interest for Electronic Lab Notebooks and Sample Management solutions intensifies, Bio-ITech will be able to scale up its current activities by offering its software solutions across the globe. The collaboration between Bio-ITech and Eppendorf will further strengthen and lead to natural integration of Bio-ITech software solutions with products such as those of the Eppendorf portfolio. With the acquisition of Bio-ITech shares, early investor SquareOne BV exited the company as shareholder. The management board would like to thank SquareOne BV for their commitment and support over the past years. Eppendorf Chief Technology Officer
10-07-2017  |  302x  |  News in brief  | 
EBSD microstructure examination using SEM A powerful tool to study microstructures
EBSD microstructure examination using SEM
A powerful tool to study microstructures The electron backscatter diffraction (EBSD) technique –a powerful tool to study microstructures by SEM (scanning electron microscopy) In the field of scanning electron microscopy (SEM) the electron backscatter diffraction (EBSD) technique has developed into a powerful tool for the crystallographic analysis of materials. In particular, the emergence of computer algorithms for the fully automated analysis of diffraction patterns have pushed the technique to develop into a new kind of scanning microscopy technique, known as “orientation imaging microscopy, OIM*” [1] or “crystal orientation microscopy/mapping, COM”. It uses computer algorithms for the automated analysis of the diffraction patterns. The COM technique is based on the consecutive acquisition of electron diffraction patterns obtained from every point of a scan grid on a flat surface of a steeply inclined sample in the SEM.
10-07-2017  |  455x  |  White paper  | 
Ubm emea pharma events reach over 100,000 attendees in Asia
CPhI shows in Japan, China, South East Asia, India and Korea to drive growth in 2017 Amsterdam, 4th July 2017: Ubm emea announces that its CPhI events, the largest dedicated pharma exhibition series in the world, will welcome over 100,000 attendees to Asia in 2017. UBM hosts five CPhI events in the region – including industry flagships CPhI & P-MEC China, CPhI & P-MEC India, and CPhI Japan, as well as high growth events, CPhI South East Asia and CPhI Korea. UBM’s strategy in Asia is to serve the largest pharma industries by creating locally tailored events that maximize opportunities for exhibiting companies to meet with potential partners, both from the domestic market, but also new customers regionally and internationally. These events act as a hub to help businesses grow in new markets, whilst also providing bespoke content programmes, with new learnings, practical solutions, industry trends and developments. CPhI South East Asia closed its sixth edition in late March 2017 with over 5,000 attendees and 260 exhibitors. The 2017 event
04-07-2017  |  218x  |  News in brief
DiaSorin and Tecan to collaborate in new platform developmen
DiaSorin and Tecan Group have announced that they have agreed to collaborate in a development under which DiaSorin will make use of Tecan’s Fluent® Laboratory Automation Solution as its nucleic acid extraction platform. The new platform will be used in combination with the DiaSorin Liaison® Mdx pcr system to provide the customer with a complete sample to result system for molecular diagnostics. The Fluent platform, to be supplied through Tecan Partnering, will be optimized for use with DiaSorin extraction chemistry and automated PCR set up of the Liaison MDX 96-well disc. Fluent breaks new ground, delivering more capacity and increased speed. The platform provides exceptional precision, throughput and walkaway time. Dr David Martyr, CEO of Tecan, commented: “We are delighted that DiaSorin has chosen the Fluent Laboratory Automation Solution as the basis for this new platform. The precision, speed and low volume liquid handling accuracy offered by the Fluent are
03-07-2017  |  210x  |  News in brief
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