-Thermostable rotavirus vaccine ROTASIIL® now available for procurement by UN and Gavi
SEATTLE, Sept. 28, 2018 /PRNewswire/ — PATH welcomes the World Health Organization’s (WHO’s) prequalification of the thermostable rotavirus vaccine, ROTASIIL®, manufactured by Serum Institute of India. The vaccine, which prevents severe rotavirus-induced diarrhea in infants, provides an innovative and affordable option to the global market as it is the first rotavirus vaccine that does not require constant refrigeration and will help meet the critical public health goal of improving vaccine supply worldwide.
A mother in India holds her infant. Photo: PATH/Richard Franco.
Achieving WHO prequalification means that ROTASIIL will now be available for procurement by United Nations agencies and Gavi, the Vaccine Alliance, for use in low- and middle-income countries. This will help accelerate availability of the vaccine in countries experiencing the highest burden of rotavirus-induced diarrhea by providing a practical and affordable option for vaccine introduction.
Rotavirus is the most common cause of severe diarrheal disease in children worldwide, and vaccination is the best way to prevent severe rotavirus illness. According to a recent study, 37 percent of global childhood diarrheal deaths in 2013 were due to rotavirus, a total of 215,000 rotavirus deaths. More than 90 percent of these deaths occurred in low-resource settings.
ROTASIIL was licensed by the Drugs Controller General of India in January 2017. Subsequently, data analysis from a Phase 3 study that gathered additional information required for WHO prequalification was completed and submitted in September 2017. The study found no interference with the immune response to childhood vaccines when co-administered with ROTASIIL and confirmed the consistency of three different and independent lots of the vaccine produced by Serum Institute. India began using ROTASIIL in its national immunization program starting in April 2018 in Jharkhand state, with further roll-out expected. ROTASIIL is also currently available for sale in India’s private market.
The international nonprofit PATH partnered with Serum Institute on evaluating ROTASIIL in the Phase 3 studies conducted in India and assisted with their applications for local licensure and WHO prequalification. PATH is continuing to work with Serum Institute on additional studies on ROTASIIL effectiveness (disease reduction in the population) and cost-effectiveness of the vaccine in India.
“PATH congratulates our partner, Serum Institute of India, for achieving the critical milestone for global access, WHO prequalification, of their oral rotavirus vaccine, ROTASIIL. PATH looks forward to contributing to the ongoing evaluation of this vaccine, and seeing a thermostable product added to the global supply of rotavirus vaccines in the fight against diarrheal disease,” said Dr. David C. Kaslow, PATH’s vice president for Essential Medicines and global head of the Center for Vaccine Innovation and Access.
Médecins Sans Frontières and Epicentre also evaluated the efficacy and safety of ROTASIIL in a separate Phase 3 study in Niger. The ROTASIIL used in the Niger study was stored at less than 25°C and transported for vaccination at ambient temperature, thus bypassing the typically challenging and costly cold-chain requirements that apply to most other vaccines. These data were included in the WHO prequalification dossier that led to the approval of the vaccine as a thermostable product.
ROTASIIL is an oral vaccine administered to infants in a three-dose course at 6, 10, and 14 weeks of age, at the same time as routine vaccinations. The WHO-prequalified ROTASIIL formulation is a lyophilized (freeze-dried) presentation packaged in single-dose vials alongside a diluent. ROTASIIL contains bovine-human reassortant rotaviruses against the most common rotavirus serotypes (G1, G2, G3, G4, and G9). The bovine-human reassortant rotaviruses were developed by the US National Institutes of Health and licensed to several emerging-country manufacturers and one US company for further development. Serum Institute was one of the licensees and developed it as ROTASIIL, a pentavalent (five-strain) vaccine product.
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For more than a decade, PATH has been working with a number of vaccine manufacturers on the development of new rotavirus vaccines, as well as increasing access to and improving the performance of existing rotavirus vaccines.
About PATH: PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. For more information, visit: http://www.path.org.
SHANGHAI, Sept. 28, 2018 /PRNewswire/ — On September 21, 2018, the CSCO precision medicine international session with the theme of “All-Round Research by Experts for Further Study”, hosted by the Chinese Society of Clinical Oncology (CSCO) and organized solely by OrigiMed Co., Ltd., was successfully held in Xiamen. At the conference, Beijing Xisike (CSCO) Clinical Oncology Research Foundation, East Clinical Center of Ontology and OrigiMed Co., Ltd jointly launched the Special Chinese Big Data Platform for Cancer Genomics Informatics, with the aim of establishing a special oncology genetic information database for the Chinese population and accelerating the innovation and development of precision diagnosis and treatment.
Signing Ceremony
This year is the 21st year of the CSCO conference. As an academic extravaganza of Chinese clinical oncology, the conference has drawn nearly 30,000 experts and scholars in the field of clinical oncology both domestically and internationally to gather in Xiamen, for the purposes of exchanging new research and catching up with peers – a truly fruitful event. The launch of the Special Chinese Big Data Platform for Cancer Genomics Informatics, as one of the most important pieces of news released at CSCO this year, marked that precision prognosis and treatment have entered the era of big data, representing CSCO and OrigiMed Co., Ltd‘s responsibility and commitment to the continuous promotion of the “Healthy China” national strategy.
Signing Ceremony
In response to the national health big data strategy, precision medicine, as a new model of medical care, has been established as the direction of future development of oncotherapy. However, information analysis and interpretation of genetic testing must be supported by powerful cancer genomic data for both oncology and clinical diagnosis and treatment. Clinical oncology’s demand for a complete and standardized collection of Chinese population genetic samples is growing stronger. However, special Chinese oncology genomics related information databases are still at the exploration stage and regional databases are far from perfect, lacking key bioinformatics analysis to rely on, which has been a bottle neck of the industry.The initiative of theSpecial Chinese Big Data Platform for Cancer Genomics Informaticsis targeting this bottle neck to make breakthroughs. The powerful OrigiMed bioinformatic algorithms and unique OrigiMed technologies of the future will safeguard the accuracy and reliability of bioinformatic analysis and provide database support for the rapid development of cancer precision medicine.
The Special Chinese Big Data Platform for Cancer Genomics Informatics was jointly initiated by Beijing Xisike (CSCO) Clinical Oncology Research Foundation, East Clinical Center of Ontology and OrigiMed Co., Ltd and proposed by Prof. Qin Shukui and Prof. Li Jin. Clinical oncology experts from nearly 40 large domestic A-grade tier 3 hospitals jointly participated in the building of the genomics informatics platform. The aim of the platform is to search for the driver genes of high incidence cancers specific to the Chinese population and also genetic information related to clinical data such as metastasis, relapses, efficacy and treatment toxicity, in order to carry out comprehensive cancer assessments and provide informational and technological support, accurate diagnosis, and treatment references for domestic oncology clinical research and practice.
Prof. Li Jin, Chairman of CSCO and Chief Physician of the oncology department at the Shanghai East Hospital, an affiliate of Tongji University, pointed out, “We are grateful to the support provided by OrigiMed Co., Ltd. In the past several years, China has placed great importance in several directions of development in the medical field including big data analysis, gene bioinformatics and artificial intelligence. We hope that the Special Chinese Big Data Platform for Cancer Genomics Informatics will help us collect genetic data of 5,000 patients for comprehensive analysis of cancers and to provide fast and accurate diagnosis and treatment references for clinical research. Finally, we sincerely hope that the cooperation between CSCO and OrigiMed Co., Ltd will be a successful one.”
Wang Kai, CEO of OrigiMed Co., Ltd, said, “We would like to express our gratitude for the trust shown by CSCO in OrigiMed Co., Ltd. We have stayed true to our original intention of dedicating our effort to helping Chinese cancer patients. After the Special Chinese Big Data Platform for Cancer Genomics Informatics is launched, nearly 40 hospitals will participate during the first stage and OrigiMed Co., Ltd will provide more than 2,000 cancer patients of different types of cancers with WES whole exome sequencing and some deep sequencing of 450+ cancer core genes using the company’s Yuan Su 450+ series products, plus targeted clinical treatment plans. In the future, OrigiMed Co., Ltd will continue to contribute dedicated effort toward advancing R&D of China’s cancer gene testing and clinical diagnosis in order to further the development of the clinical testing of cancer genes in China.
This year’ CSCO precision medicine international session was for the first time, organized by OrigiMed Co., Ltd with the theme of “All-Round Research by Experts for Further Study.” The conference attracted nearly 600 cancer clinical experts from all corners of China. There were four major segments, including Sino-U.S. Dialogues, Multi-dimensional perspectives, Exploration and Discoveries and the ceremony to launch the clinical project. Many domestic and international top experts were invited to the conference and gave presentations, including Prof. Martin J. Murphy, Prof. Matthew Meyerson, Prof. Patrick Ott, Prof. Zhang Jianjun, Prof. Qin Shukui, Prof. Li Jin, Prof. Shi Yuankai, Prof. Zhou Caicun, Prof. Shen Lin, Prof. Xu Binhe, Prof. Liao Nin, Prof. Zhu Bo, Prof. He Yong, Prof. Fang Wenfeng, Prof. Li Li, Prof. Cai Xiuyu, Prof. Shi Weiwei and other domestic and international eminent guests. The guests shared their latest research and engaged in animated and in-depth discussions on cutting-edge topics from tumor heterogeneity to personalized new antibody vaccines and investigations of precision treatments of lung cancer, breast cancer and gastric cancer; from the single-target drug design era to the era of pathways and multi-dimensional biomarkers, and new discoveries fromthe Chinese population and the exploration of multi-dimensional biomarkers.
About OrigiMed Co., Ltd
OrigiMed (Shanghai) Co., Ltd focuses on R&D of international new technologies and their application in oncology and dedicates itself in pushing forward the clinical testing of hundreds of cancer genes and providing every patient with comprehensive and accurate molecule level information to assist doctors with their precision treatments and advance the reform of clinical treatment methods for Chinese patients. The company’s headquarters are located in Shanghai Pujiang Hi-Tech Park and it has set up branches and medical testing facilities in Shanghai, Shenzhen, Jinan and Fuzhou, covering a total area of 12,000 square meters. OrigiMed Co., Ltd has developed gene testing products of tissue DNA, RNA and plasma ctDNA, targeting different clinical stages, using second generation high-throughput sequencing technology, featuring the testing of hundreds of cancer related genes and covering all types of solid tumors. The company has also developed the industry’s first precision treatment data sharing and patients follow-up APP, namely, Dr. Ground Hog and its service network covers more than 200 core hospitals in all five major regions nationally.
ISNES, Belgium, Sept. 26 2018 /PRNewswire/ — VolitionRx Limited (NYSE American: VNRX) (“Volition”) today released a video featuring members of its Scientific Advisory Board (SAB). The video was taken at Volition’s laboratories in Belgium during the last SAB meeting and features members of the SAB discussing their involvement with Volition and support of its mission to significantly improve cancer diagnostics.
The SAB is a multi-disciplinary international board with expertise in broad areas of technology and convenes at least twice a year to give high level advice and counsel to Volition’s scientific team. Chaired by Dr. Alan Colman, the Board has seven other members, all highly-respected leading experts in their individual fields.
Dr. Colman commented “The role of the SAB is to review and advise the Volition team on the development of its scientific program. Every member provides invaluable insight and input which helps drive scientific rigour.”
 
About Volition
Volition is a multi-national life sciences company focused on developing simple, easy to use, cost effective blood tests designed to help diagnose a range of cancers. The tests are based on the technology platform of Nucleosomics®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.
As cancer screening programs become more widespread, Volition’s products aim to help to diagnose a range of cancers quickly, simply, accurately and cost effectively. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life.
Volition intends to expand the application of its technology beyond cancer by exploring other disease applications. The company’s research and development activities are currently centered in Belgium, with additional offices in London, Texas and Singapore, as it focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide.
For more information about Volition, visit Volition’s website https://volitionrx.com/ or connect with us via:
The contents found at Volition’s website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document. The addresses for Volition’s website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only.
Nucleosomics® is a trademark of VolitionRx Limited and its subsidiaries.
Merieux Equity Partners, a management company created by Merieux Developpement,announcesthefirst closingof itsthird generation fund, Merieux Participations 3,focusing on growth capital within the healthcare and nutrition sectors.
Dedicated to partnering with fast-growing companies in the health and nutrition sectors, Merieux Participations 3 was launched in July 2018 with a fundraising goal of more than 300 million euros. Only two months after the commercial authorization by the French Market Authorities (AMF), a first closing has been completed with an initial amount of 200 million euros (or 235 million USD). In addition to the Merieux family holding, this 3rd generation fund is backed by renown investors, such as the Dassault Holding (GIMD), Credit Agricole Centre-Est, Credit Agricole Assurances and Compagnie Financière La Luxembourgeoise, representing more than 60% of the commitments to-date.
Merieux Participations 3 will focus on growth equity investments, in support of small- to mid-cap companies operating within the healthcare and nutrition sectors and located in Western Europe or North America. With a typical ticket size ranging from 20 to 40 million euros per company, this new fund will operate MBO / LBO transactions as well as traditional growth equity deals, targeting fast growing companies with a clear potential to become market leaders at a global level.
Merieux Equity Partners has already completed its first majority investment into STIplastics Healthcaring. The investment will allow this fast-growing company, located near Grenoble (France) and specialized in the development and manufacturing of plastic solutions for laboratories within the pharmacy and nutrition sectors, to strengthen its industrial platform and broaden its product offering over the coming years.
Through Merieux Participations 3, Merieux Equity Partners also intends to broaden its scope of activity into the nutrition sector. The firm recently took a minority equity position in Biobest, a Belgian company commercializing a range of integrated biological control solutions for the pollination and natural crop protection market. Merieux Equity Partners will help Biobest become the global leader in this rapidly growing market segment.
“We are confidentaboutthe success of our investment platform,in response of thegrowingdemand fromentrepreneursforstrongerand more specialized investors,offeringtailor-madefinancing solutions.“ said François Valencony,CEOof Merieux Equity Partners.“The commitment of prestigiousinvestorsto Merieux Participations 3,alongsidetheMerieux family,reflects the growing interest inour value proposition, both entrepreneurial and sector-specific,supported by a uniqueteam.”
“Investing in tomorrow‘s medicineandsupportingemerging market leadersinternationally,areprioritiesforInstitut Merieux anda genuine component ofthe entrepreneurialapproachof our family”. said Alexandre Merieux, President of Merieux Developpement.Alongsidethe creation of Merieux Equity Partners andwiththe support of familyholdingsthat share our long-term vision, weintend tostrengthen our action in areas with major public health challenges.“
TOKYO, Sept. 25, 2018 /PRNewswire/ — AGC, a world-leading manufacturer of glass, chemicals and high-tech materials, will be establishing a cGMP (*1)-compatible mammalian cell culture facility at its Chiba Plant designed to take on contracts for antibody biopharmaceutical development and production. This is made possible through the technology of CMC Biologics acquired in 2017, and will be the first high-quality mammalian cell culture-based services with proven track record in the U.S. and Europe to be made available in Japan. As a large portion of antibody biopharmaceutical products currently depends on overseas production, the company looks forward to better serving its Japanese customers and neighboring regions through this new domestic capability. The facility is scheduled to begin operations in the third quarter of 2019.
AGC entered the bioscience business in 1985, and launched its biopharmaceutical CDMO (*2) business in 2000, with primary focus on the Japanese market using microorganisms. Biomeva was acquired in 2016 and CMC Biologics in 2017, allowing AGC to realize full-scale entry into the Western biopharmaceutical CDMO market, not only using microorganisms, but mammalian cells as well. As of January 2018, the biopharmaceutical CDMO businesses at the bases in Japan, the U.S. and Europe have been integrated under the umbrella of AGC Biologics for globally unified management.
Under the management policy “AGC plus,” the AGC Group will continue to position life sciences as one of its strategic businesses. It will continue to actively invest so that it can provide globally unified high-quality services to customers of all regions in the synthetic drug and biopharmaceutical businesses, areas expected to see great growth in demand. In addition, by maximizing the synergies of each location, AGC will enhance its technical capabilities and contribute to pharmaceutical companies, patients and wider society.
Notes:
(*1) cGMP: Production and quality management standards for pharmaceuticals and quasi-drugs (current Good Manufacturing Practice) (*2) CDMO: Contract Development & Manufacturing Organization
*The company changed its name from Asahi Glass Co., Ltd. to AGC Inc. on July 1, 2018. *Handling of personal information is governed by the company’s privacy policy.
Survey shows high fear of cancer, heart attacks and diabetes, with many Singaporeans pessimistic about their health status and unsure of the best place to turn for advice. Demand for personal medical case management, new cancer treatment technologies and personalised diagnosis is high across every demographic.
Majority of Singaporeans are worried about their health, with only 42% stating they consider themselves quite or very healthy. A significant majority of Singaporeans are worried of one day being diagnosed with cancer.
Singaporeans are keen to understand more about their health and take proactive measures to prevent developing serious medical conditions, but only 58% believe their GP is providing them with sufficient information about possible preventative measures.
60% undergo some general physical examinations, yet only 26% actually undergo any tests that are related to the prevention and/or early diagnosis of cancer, despite this being their biggest fear. For example, of female respondents, only 37% undergo Pap smear and breast examination tests which are known to save lives.
Disturbingly, when it comes to defining the cancer and choosing the most appropriate cancer treatment, only 20% consider undergoing a biopsy the most important step in the cancer journey, alongside even less (12%) who see staging as a crucial first step, despite both being crucial to improving medical outcomes and survival rates. 92% are likely to use new and advanced technologies that enable targeted and personalised cancer care if made available.
42% combine traditional Chinese medicine with Western medicine, and from our experience are doing so without consulting their primary specialist on the potential negative effects of combining both.
Almost half of Singaporeans believe the choice of a specialist equals in importance to the hospital they will be treated at.
Most Singaporeans are equally satisfied with the public and the private healthcare system (67% vs. 68%), with lowering costs being their main concern.
There is a strong interest (78%) in obtaining Personal Medical Case Management services, and 86% would be interested in a multi-disciplinary approach to treatment.
SINGAPORE, Sept. 25, 2018 /PRNewswire/ — A new survey commissioned by Medix has uncovered a range of attitudes towards the diagnosis and treatment of health conditions in Singapore. Across every demographic there is a pessimism towards personal heath and fear around being diagnosed with cancer. Many Singaporeans are proactive with seeking second opinions and undertaking physical examinations, but there is a strong desire for more personalised advice and treatment options.
The study reveals men (53%) are more worried about strokes than women (32%), while cancer is the biggest worry for both, with heart attacks (51%) and diabetes (44%) the next highest concerns. Worryingly, only 58% feel their GP is providing them with sufficient information to prevent diseases. In the case of receiving a severe medical diagnosis, 87% would seek a second opinion.
Residents from all demographics show a strong understanding of the importance of genetic testing (78%) and regular physical check-ups (60%), yet there remains a strong desire for further information and services to prevent serious, medical conditions. 78% state that they would be interested in personal medical case management in the case of a serious illness, and 86% would like a multi-disciplinary approach to treatment. An overwhelming 91% would look for information on new technologies that treat cancer.
When it comes to seeking advice around specialists, less than half (41%) ask their GP for advice, with 14% looking online for recommendations. In regards to the value of specialists, 3 in 4 are confident of the answers provided by them. Surprisingly, 46% feel that the choice of specialist and hospital are of equal importance for the medical outcome. When it comes to satisfaction of healthcare service provision, both the public (67%) and private (68%) sectors are seen of equal importance.
“There is a clear demand for more information around the options available when it comes to healthcare in Singapore. One of the most important steps when tackling health problems is to be as prepared as possible, so preventative measures, regular relevant check-ups, additional medical opinions, and consultations with the right range of specialists is the ideal approach,” said Sigal Atzmon, CEO of Medix. “Knowledge is power, and making educated, objective choices should be Singaporeans priority. Everyone from insurers to doctors to government should be offering the necessary resources to provide these options and ensure that everyone is confident about being able to access them.”
While the survey shows a widespread fear of cancer diagnosis, less than half undergo cancer related prevention and early diagnosis tests. For example, only a worrisome 37% of female respondents undergo breast examinations and/or Pap smears, which are known to save lives. Only 29% of respondents undergo liver function tests, alongside 21% undergoing thyroid function tests.
In terms of the actual treatment of cancer, 42% combine traditional Chinese medicine and Western medicine.
“This is quite worrying as medical literature and research has indicated there can be potentially negative side-effects for the cancer patient when combining conventional Western treatments with traditional Chinese medicine without obtaining appropriate advice,” said Professor David Zeltser, Global Medical Director at Medix. “For example, Asian Ginseng is used in Chinese medicine to prevent cancer and restore strength. However, this induces the activity of CYP3A in the liver, which in turn reduces the effectiveness of many proven chemotherapy drugs. Physicians should be more proactive in obtaining a complete medication history, including herbal medicine use, when advising on suitable courses of treatment.”
Ms. Atzmon, CEO of Medix, added: “The fear of cancer is one of the most striking findings of this survey, especially when you consider it alongside the lack of tests being carried out to diagnose it. The fact that just over half of respondents stated that their cancer was managed by an oncology specialist, despite the clear benefits of doing that is a cause for concern. Another significant concern is around the lack of understanding on which are the most important steps to be undertaken to define your cancer and make an educated choice of treatment. Only 20% understand that undergoing a biopsy is the most important step before treatment, alongside only 12% who see staging as a crucial step, despite both being critical to improving medical outcomes and survival rates. There are some positives when it comes to seeking second opinions, and interest by Singaporeans to use new and advanced technologies in cancer treatment, but clearly more education needs to be done.
Professor Zeltser said the survey results, coupled with Medix’ deep understanding of specialised personal medical case management services, pointed to a very clear set of guidelines to better help Singapore people deal with cancer. These include:
Conduct screening tests based on your risk profile and family history.
Insist on a biopsy and staging before starting treatment.
Seek Oncologist advice and, go for additional medical opinions and apply a multidisciplinary approach. When going for additional medical opinion, or medical case management, retrieve your medical information, as this is crucial for ensuring a quality driven process
Ask about new treatment options and genetic testing of your tumour to personalise your treatment plan.
Consult an oncologist before combining TCM with Western Medicine.
Further, Ms. Atzmon called on the Singapore Government to take additional steps to better educate Singaporeans about cancer prevention and treatment, improve accessibility to subsidised cancer screening tests and implement tools to generally reduce cost of treatment in private hospitals, for example, by applying packaged pricing. “There is a pressing need for greater transparency and reporting on treatment provided by the private sector as well,” she added.
The survey was carried out with 600 respondents from diverse backgrounds in regards to income, age and gender. A presentation deck outlining the results in detail can be provided on request.
Medix Medical Monitor Survey Uncovers Singapore’s Health Concerns & Perceptions
About Medix Medical Services
Established in 2006, Medix is a global and leading provider of innovative, high quality, medical management solutions. With offices in London, Hong Kong, Shanghai, Singapore and Tel Aviv, and a client base exceeding 3 million members in over 90 countries, Medix offers its clients — primarily global health and life insurers, financial groups, large corporations and government institutions — significant value-added services in the world of healthcare. Medix’ team comprises 300 in-house doctors, as well as nurses, research experts, medical admin teams and an accredited global network of over 3,000 specialists and 1,500 leading hospitals.
Medix is proud to provide its customers with proven better medical outcomes. On global yearly average, Medix has changed the initial diagnosis in over 20% of the cases and improved treatment choices in over 43% of those cases. In Asia, these numbers are even higher. By doing so, Medix provides its customers with fast-track solutions to the right diagnosis and optimised treatment pathways. In over 55% of the cases, unnecessary consultations, tests, treatments and procedures were avoided, which led to significant improvement in overall medical quality, efficiency and cost-management.
Further, Medix also provides disease prevention management services, digital health solutions and medical governance services to insurers, large corporates and government institutions.
Medix is a Shared Value company that strives to enable people around the world to receive the best medical care possible while eliminating unwarranted healthcare variations and helping to control medical cost inflation. Medix believes accessibility, quality and sustainability of medical care are important components of social rights, and is fully dedicated to these activities globally.
The Medix Medical Monitor Research was structured to investigate Singapore consumers’ awareness and behaviour towards health issues and cancer. The research data was collected through computer-assisted web interviews of 600 people, who are health insurance policy holders aged 26 to 59 with average or above average personal income. The quotas on gender, age, personal income applied reflect the representation of Medix’ target consumers in Singapore. The research was conducted in August, 2018 by Kantar Millward Brown, a leading multinational market research firm.
NANJING, China, Sept. 20, 2018 /PRNewswire/ — PharmaBlock Sciences (Nanjing), Inc. (SZSE: 300725), a global leader in providing innovative chemistry products and services throughout the pharmaceutical R&D process, recently announced the appointment of Dr. Shijie Zhang as Chief Technology Officer. Shijie joins the company from Agios Pharmaceuticals, Inc., where he was Director of Process Chemistry and API Manufacturing, CMC.
Dr. Shijie Zhang brings over 20 years of combined experience in medicinal chemistry, process chemistry, and API manufacturing. Before joining PharmaBlock, he led the CMC API team at Agios for the two FDA-approved therapies (Idhifa®, Tibsovo®), by managing and overseeing API development programs and manufacturing activities spanning from preclinical stage to commercial stage, and preparing API sections of regulatory filing documents, including IND, IMPD, NDA, and briefing documents.
“We are thrilled to welcome Shijie on board, and he is truly a key addition to our leadership team,” said Dr. Minmin Yang, Chairman of PharmaBlock. “His unparalleled knowledge and intimate experience in bringing drugs from preclinical stage to commercialmakes him the best person to lead our rapidly growing CDMO business, and critical to our future strategies.”
PharmaBlock started its business by providing lab-scale building blocks and medicinal chemistry services to support drug discovery. With more pharmaceutical R&D projects adopting its products advanced from discovery to preclinical and clinical research, even into commercialization, PharmaBlock sensed great demand in expanding process and manufacturing capabilities. Since the joining of Dr. Jing Li, former Associate Director at Merck & Co., Inc., as Vice President of Process Chemistry two years ago, PharmaBlock has made great progress in expanding process chemistry and implementing process technologies. Bringing Dr. Shijie Zhang to the team will get a step further to improve the QA system, and extend competence in process development and manufacturing to support clients’ late phase and commercial programs, thus strengthening the company’s competitiveness in CDMO business.
“I am delighted to join PharmaBlock, and I have witnessed its remarkable and rapid growth. With its strong leadership role in building blocks business, and impressive progress in process chemistry capabilities, PharmaBlock has a solid foundation to win in CDMO business,” said Dr. Shijie Zhang, “I look forward to working with the tremendous team, helping fulfill its commitment to accelerating pharmaceutical innovation from research, to development, to commercial.”
About PharmaBlock
PharmaBlock Sciences (Nanjing), Inc. (SZSE:300725) is a leading provider of innovative chemistry products and services throughout the pharmaceutical R&D process. Officially operated in 2008, PharmaBlock has rapidly gained recognition for its outstanding capability in the design, synthesis, and supply of novel building blocks for drug discovery use. With more drug R&D projects adopting the company’s products advance from discovery to preclinical and clinical research, even into commercialization, PharmaBlock moved on to build up top notch process R&D capabilities, and is providing scale-up synthesis and manufacturing of key intermediates/RSMs. The company is now committed to a more comprehensive and long-term service to valued customers.
Over the past years, PharmaBlock has partnered with over 80% of the top 20 pharmaceutical companies, and hundreds of small to medium-sized biotechs around the world. In 2012, the company opened a facility in the San Francisco Bay Area, and set up the United States headquarters in Pennsylvania in 2017, expanding the inventory, customer service and lab functions for more efficient and timely services to local customers in the United States and Europe.
New family of drug candidates inhibit the ‘master switch’ involved in inflammation and autoimmunity
Able to cross the blood-brain barrier and blood-nerve barriers
Opens development of treatments of inflammatory and autoimmune diseases of the brain and peripheral nerves
Multiple sclerosis and peripheral neuropathies identified as potential clinical targets
Patent applications lodged
Development being fast-tracked.
Noxopharm (ASX: NOX) (the ‘Company’) and its majority-owned subsidiary, Nyrada, have discovered a way to inhibit IRAK4, a protein widely regarded as the ‘master switch’ in the development of many forms of chronic inflammation including autoimmune diseases.
Nyrada Inc is a US incorporated biotechnology company, two-thirds owned by Noxopharm and consolidated within the NOX Group, to hold the Noxopharm non-oncology drug development programs: (i) a PCSK9 inhibitor; (ii) an anti-inflammatory drug; (iii) a neuroprotectant drug.
IRAK4 has emerged in recent years as a key switch in the cells that form the body’s innate immune system. Faulty IRAK4 behaviour in these innate immune cells is widely regarded as playing a key role in the development of many forms of chronic inflammatory and autoimmune diseases. This has led to IRAK4-inhibitors being widely hailed as the next generation of anti-inflammatory drugs for the treatment of autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease (including ulcerative colitis and Crohn’s Disease), lupus and psoriasis.
The Company has discovered a compound that is a potent inhibitor of IRAK4. And while this provides an opportunity to treat the same broad range of conditions being pursued by others, the Company believes that the future of its IRAK4 program lies in the treatment of inflammatory diseases of the central nervous system (brain and spine) and the body’s peripheral nerves. This belief comes from the ability of this compound to cross the barriers that exclude the great majority of drugs from entering the brain and peripheral nerves. This ability provides what Noxopharm believes is a major opportunity to pursue drug development for inflammation associated with diseases such as Alzheimer’s Disease, Parkinson’s Disease, multiple sclerosis, amyotrophic lateral sclerosis (motor neurone disease) and peripheral neuropathies (particularly diabetic peripheral neuropathy).
The Company is able to make today’s announcement with the recent lodgement of a US provisional patent application and a Patent Cooperative Treaty (PCT) patent application.
James Bonnar, Nyrada Vice-President, Research & Development, said, “A lot of attention currently is being given to developing IRAK4 inhibitors for diseases such as rheumatoid arthritis and gouty arthritis and lupus, but we see our discovery as a breakthrough in providing the tools needed to address inflammatory and autoimmune diseases of the nervous system.”
Graham Kelly, Noxopharm CEO, added, “I see this as a major development. At a strategic level it adds an important plank to the Group’s ambitions to evolve into a global biotech company. But importantly at the patient level, it represents a realistic prospect for finally being able to provide treatment for a number of insidious diseases affecting the nervous system which have defied successful management to date.”
“Neuroinflammation has long been known to be associated with diseases such as Alzheimer’s, Parkinson’s and multiple sclerosis. But recent evidence now shows that neuroinflammation is associated even with psychiatric conditions such as depression, bipolar disorder and schizophrenia.”
“Having a drug that blocks IRAK4 and all its downstream pro-inflammatory cytokine effects, combined with its ability to reach the brain in sufficient levels, is an exciting breakthrough that has resulted from a lot of hard work by a team of Australian chemists and scientists,” Kelly added.
Pre-clinical programs now are being undertaken to identify the most appropriate therapeutic indication(s), with human studies likely in 2020.
Forward Looking Statements
This announcement may contain forward-looking statements. You can identify these statements by the fact they use words such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “plan”, “should”, “target”, “will” or “would” or the negative of such terms or other similar expressions. Forward-looking statements are based on estimates, projections and assumptions made by Noxopharm about circumstances and events that have not yet taken place. Although Noxopharm believes the forward-looking statements to be reasonable, they are not certain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond the Company’s control that could cause the actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statement. No representation, warranty or assurance (express or implied) is given or made by Noxopharm that the forward-looking statements contained in this announcement are accurate and undue reliance should not be placed upon such statements.
– New facility will include comprehensive mammalian process development and manufacturing capabilities
BOTHELL, Washington, and CHIBA, Japan, Sept. 20, 2018 /PRNewswire/ — AGC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, announced today that as part of its ongoing program to expand its production capacities globally, it will establish a new state of the art process development and manufacturing facility at its CDMO facility in Chiba, Japan. The new facility, which is expected to be operational in the second half of 2019, will contain single-use bioreactors at the 500 and 2000L scale and will be ideally suited for the production of monoclonal antibodies (MAbs), fusion proteins and other types of therapeutic proteins.
AGC Biologics currently provides mammalian protein process development and manufacturing services from its facilities in Bothell, WA; Berkeley, CA; and Copenhagen, Denmark, as well as microbial process development and manufacturing services from its facilities in Heidelberg, Germany; Copenhagen, Denmark; and Chiba, Japan. The Company will leverage its extensive experience and expertise with mammalian production systems to rapidly establish these services at its site in Japan.
“This is a key investment for AGC Biologics that will expand our capabilities and reinforce our leadership position in the Japanese CDMO marketplace,” said Gustavo Mahler, PhD, Chief Executive Officer of AGC Biologics. “Our new mammalian capabilities will represent a unique and convenient option for companies in Asia seeking mammalian production services nearby and for US and European companies seeking production in Asia.”
About AGC Biologics
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a strong commitment to deliver the highest standard of service to our clients. AGC Biologics has an extensive network of cGMP facilities in the US, Europe and Asia. We offer deep industry expertise, innovative solutions and technologies, and customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial, for mammalian and microbial. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver reliable and compliant drug substance supply, on time. For more information, visit www.agcbio.com.
AGC Biologics Media Contact Information: Robert J. Broeze, PhD Chief Business Officer Email: rbroeze@agcbio.com
ZEISS announces two new milestones in refractive technology, with 1.5 million SMILE treatments and the production of its 1000th VisuMax femtosecond laser
JENA, Germany, Sept. 21, 2018 /PRNewswire/ — Today, the Medical Technology business group of ZEISS announced two milestones in refractive technology after the recent completion of 1.5 million treatments with SMILE® and the production of its 1,000th VisuMax® femtosecond laser.
“We are delighted that doctors worldwide have applied the minimally invasive laser correction procedure over 1.5 million times for the treatment of ametropia,” says Jim Mazzo, Global President Ophthalmic Devices at Carl Zeiss Meditec. “We offer surgeons one of the most comprehensive portfolios for refractive laser surgery and the production of the 1,000th ZEISS VisuMax® is another testament to our leadership in this field.”
ZEISS is setting performance benchmarks in corneal surgery with VisuMax®, the only approved femtosecond laser on the market to treat ametropia using the minimally invasive procedure. The VisuMax® creates a thin, lenticular disc (lenticule) in the cornea, which is extracted by the surgeon through a small incision in the corneal surface also created by the laser. The virtually intact corneal surface minimizes disruption to the biomechanics of the cornea.
“Procedures and technologies developed by ZEISS help doctors to improve the vision of many people, and we are determined to protect our intellectual property from any infringement,” emphasizes Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG. “We firmly believe that the patents we hold are critical and necessary to continue to ensure the quality of SMILE® in its application and further development.”
With over thirty years of experience in refractive laser technology, ZEISS has successfully launched numerous innovations in the market, boosting a portfolio of 85 patent families, over 240 granted patents – a number that is steadily rising due to ongoing applications. Patents include developments in several areas of corneal femtosecond laser technology, methods to achieve focus quality, patient interface design, shape and sequence of certain laser incisions, and innovative illumination methods.
The basic intellectual property for SMILE® technology is exclusively owned by ZEISS.
Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another. For country specific product information, see the appropriate country website. Product specifications are subject to change in design and scope of delivery as a result of ongoing technical development.
Brief profile
Carl Zeiss Meditec AG (ISIN: DE 0005313704), the Medical Technology Business Group of ZEISS, is listed on SDAX and TecDAX of the German stock exchange and one of the world’s leading medical technology companies. The Company supplies innovative technologies and application- oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With approximately 3,000 employees worldwide, the Group generated revenue of € 1,189.9 million in fiscal year 2016/17 (to 30 September).
The Group’s head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company’s presence in these rapidly developing economies. Around 41 percent of Carl Zeiss Meditec AG’s shares are in free float. The remaining approx. 59 percent are held by Carl Zeiss AG, one of the world’s leading groups in the optical and optoelectronic industries.
