SQN Clinical Launches the Most Advanced Real-time Analytics Tool for Clinical Research

DISS, England, July 17, 2018 /PRNewswire/ —

SQN Clinical launches SQN Health Analytics, providing clinical professionals with a clear picture of the entire trial process and all collected data, whenever and wherever they need it.  

With high-level summary information, advanced filtering options and the ability to drill down to individual patient records, SQN Health Analytics marks the end of manual, complex and time-consuming data exploration. Sponsors now have greater control, identifying potential issues before they arise and allowing for more robust trial management and in-trial decision making.  

This cloud-based suite is the latest addition to SQN Health, the electronic data capture (EDC) system that incorporates the recently launched, patient-centric, electronic patient reported outcomes (ePRO) app. 

“Reliable data is the cornerstone of clinical research and thanks to recent advances in technology we can now collect more meaningful and usable information than ever before,” explains Tony Rees, Director at SQN Clinical. “The challenge is to maximise the use of data to better support the clinical trial process and patient oversight. Our advanced data analytics, incorporating artificial intelligence (AI) components, now delivers some of the most advanced project and clinical oversight capability within the industry.”  

Sponsors have to demonstrate effective oversight of their clinical trials and increasingly have the need to explore data relationships and various clinical parameters. SQN Clinical Analytics delivers this in real-time allowing for data review, patient profiling and exploratory analysis in dynamic ways not previously seen. This adds significant value to the management of patients and trials and is of particular benefit in supporting data safety monitoring boards (DSMB).

Responsive and flexible analytics that evolve with each trial 

Joseph Jameson, Data Analyst at SQN, explains the concept behind SQN Health Analytics: “We recognised our clients’ needs to improve clinical oversight and efficiency within clinical research. They need an analytics suite that is flexible, responsive and reflects the real-time fluctuations and unique evolution of their particular trials. Each trial is unique and we are now able to rapidly deploy bespoke analytics reports that specifically meet their needs.  

“We can display any trial data in a clear and uncluttered way, real-time, anytime and anywhere. Reports and snapshots can still be generated for any point in the trial, providing reliable data for review meetings and to support decision making. The system allows for comparative analytics between or within trials, providing the opportunity to explore relationships and patterns that weren’t easy to see before.

“Our analytics suite is fully integrated with our EDC and ePRO systems providing a seamless data ecosystem. It gives sponsors access to information according to their role and the predefined access rights given to them. Senior teams can view high-level data for oversight management, comparing multiple sites and tandem trials. Dashboards with user-defined KPIs provide an instant snapshot of any element of the trial, and the data can be sorted and filtered in multiple ways to show any combination of factors.

“By cross-comparing data from both the EDC and ePRO systems we can clearly see the impact of patient-reported outcomes on clinical trial data, supporting the Food and Drugs Administration (FDA) focus on the importance of this information.

“Our analytics does not use generic software adapted from another unrelated industry but has been specifically designed and built to support the complexity of clinical trial designs and their unique underlying data needs. It brings the data to life in a way not previously seen and includes a dynamic option to export selected data for further review, analysis and reporting.  

Keeping trials on track 

“This development adds value for our clients and represents a significant step forward in the management of clinical trial data,” states Rees. “SQN Health Analytics will enhance the ways in which our clients interact with and use their data and. With their input, we are already developing innovative new ways in which we can extend the analytics functionality.”

“Future phases will include machine learning and further artificial intelligence to provide predictive modelling and forecasting capabilities. Our aim is to help professionals anticipate issues and events before they arise and enable them to take proactive steps to keep their trials on track.

“SQN Health Analytics gives clinical teams the ability to interrogate trail audit data in a way not previously possible, delivering a new standard in supporting trial integrity. Our goal is to help pharmaceutical and biotech companies to get their products to market in a safer, more effective way. We do that by giving them the insight and control they’ve long been looking for.”

Aurigene Announces First in Human Dosing with RoRγt Inverse Agonist AUR-101

BOSTON, July 12, 2018 /PRNewswire/ —

– Phase 1 data from the study expected to be available by December 2018

Aurigene, a biotechnology company focused on discovering and developing drugs for oncology and inflammatory disorders, announced today that it has commenced dosing in INDUS, a Phase 1 trial of AUR-101 in healthy volunteers. The study is designed to evaluate the safety signals, pharmacodynamic modulation, and recommended dosage for Phase 2 studies (RP2D).

AUR-101 is a selective, potent inverse agonist of the receptor RoRγt, designed as an oral agent for the treatment of IL17-driven immunological conditions, including psoriasis. Aurigene expects data from the INDUS study to be available by December, 2018.

Commenting on the trial, CSN Murthy, CEO of Aurigene said “This is the first study of the planned global clinical development for AUR-101; we are excited to have started the clinical evaluation of the compound and expect to mirror the excellent results seen in established pre-clinical disease models”.

About AUR-101 

AUR-101 is a potent, oral RORϒt inverse agonist, with high selectivity across other ROR isoforms and nuclear hormone receptors and expected to confer a superior safety profile. AUR-101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients and also very significant reduction in ear swelling and histopathology scores in two separate pre-clinical psoriasis models. In addition, AUR-101 has been found to be safe in preclinical toxicology evaluations, at several fold of anticipated efficacious doses in humans.

About Aurigene 

Aurigene is a development stage biotech company, engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases. Aurigene is focused on oral immune checkpoint inhibitors, precision-oncology and the Th-17 pathway. Aurigene currently has three programs from its pipeline in clinical development. Aurigene’s oral PD-L1/ VISTA antagonist CA-170 is currently in Phase 2 clinical development in India. Additionally, Aurigene’s selective CDK7, CDK12 inhibitors, CD47 immune checkpoint inhibitor, and SMARCA2/ 4 degraders are at different stages of pre-clinical development. Aurigene has partnered with several large- and mid-pharma companies in the United States and Europe and has delivered over 15 compounds currently in clinical development. For more information, please visit Aurigene’s website at http://aurigene.com/

FARO® Announces Acquisition of Open Technologies

Extends 3D Capabilities Into Dental and Across a Variety of Design Driven Industries

LAKE MARY, Fla., July 16, 2018 /PRNewswire/ — FARO® (NASDAQ: FARO), the world’s most trusted source for 3D measurement and imaging solutions for factory metrology, construction BIM, product design, public safety forensics, and 3D machine vision applications announces the acquisition of Opto-Tech s.r.l. and its subsidiary Open Technologies, s.r.l.

Located in Brescia, Italy, Open Technologies offers a rich portfolio of compact, 3D structured light scanning solutions that specifically enable dentists, dental technicians and orthopedics to leverage the 3D world for the creation of crowns, implants and prosthesis.

Additionally, Open Technologies offers an integrated suite of industrial products that dramatically reduce time and effort across a variety of product design and inspection applications that include reverse engineering, heritage preservation, product visualization and dimensional measurement. These solutions comprehensively address a variety of market segments including Automotive, Aerospace, Computer Graphics, Furniture, Fashion Design and Public Safety.

“Open Technologies proven core competency in compact, 3D structured light scanning solutions aligns perfectly with our strategic direction,” stated Dr. Simon Raab, FARO’s President and CEO.  “We continue to take a leadership position in the integration of visionary 3D technology as a core solution requirement across the breadth of industries where design or reconstruction is considered critical.”

About FARO

FARO is the world’s most trusted source for 3D measurement, imaging and realization technology. The Company develops and markets computer-aided measurement and imaging devices and software for the following vertical markets:

  • Factory Metrology – High-precision 3D measurement, imaging and comparison of parts and complex structures within production and quality assurance processes
  • Construction BIM – 3D capture of as-built construction projects and factories to document complex structures and perform quality control, planning and preservation
  • Public Safety Forensics – Capture and analysis of on-site real world data to investigate crash, crime and fire, plan security activities and provide virtual reality training for public safety personnel
  • Product Design – Capture detailed and precise 3D data from existing products permitting CAD analysis and redesign, after market design and legacy part replication
  • 3D Machine Vision – 3D vision for both control and measurement to the manufacturing floor through 3D sensors and custom solutions

FARO’s global headquarters is located in Lake Mary, Florida.  The Company also has a technology center and manufacturing facility consisting of approximately 90,400 square feet located in Exton, Pennsylvania containing research and development, manufacturing and service operations of our FARO Laser Tracker and FARO Cobalt Array Imager product lines.  The Company’s European regional headquarters is located in Stuttgart, Germany and its Asia-Pacific regional headquarters is located in Singapore. FARO has other offices in the United States, Canada, Mexico, Brazil, Germany, the United Kingdom, France, Spain, Italy, Poland, Turkey, the Netherlands, Switzerland, India, China, Malaysia, Thailand, South Korea, Japan, and Australia.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, such as statements about demand for and customer acceptance of FARO’s products, and FARO’s product development and product launches. Statements that are not historical facts or that describe the Company’s plans, objectives, projections, expectations, assumptions, strategies, or goals are forward-looking statements. In addition, words such as “is,” “will” and similar expressions or discussions of FARO’s plans or other intentions identify forward-looking statements. Forward-looking statements are not guarantees of future performance and are subject to various known and unknown risks, uncertainties, and other factors that may cause actual results, performances, or achievements to differ materially from future results, performances, or achievements expressed or implied by such forward-looking statements. Consequently, undue reliance should not be placed on these forward-looking statements.

Factors that could cause actual results to differ materially from what is expressed or forecasted in such forward-looking statements include, but are not limited to:

  • development by others of new or improved products, processes or technologies that make the Company’s products less competitive or obsolete;
  • the Company’s inability to maintain its technological advantage by developing new products and enhancing its existing products;
  • declines or other adverse changes, or lack of improvement, in industries that the Company serves or the domestic and international economies in the regions of the world where the Company operates and other general economic, business, and financial conditions; and
  • other risks detailed in Part I, Item 1A. Risk Factors in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 and in Part II, Item 1A. Risk Factors in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018.

Forward-looking statements in this release represent the Company’s judgment as of the date of this release. The Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, unless otherwise required by law.

More information is available at http://www.faro.com

Logo – https://mma.prnewswire.com/media/95369/faro_technologies__inc__logo.jpg

Source: FARO Technologies, Inc.

Editor’s Note: Ideal Body

Everybody has their own ideal body shape that they want to achieve. Some want their body to be muscular, lean, toned and much more. There is no one ideal shape that will fit all of us.

Science has stated that there are essentially three body types: Ectomorph, Endomorph, and Mesomorph. The gist of each type is as follows:

Ectomorph: Lean and long, difficulty building muscles

Endomorph: Big, with a tendency to store body fat

Mesomorph: Muscular, high metabolism

I had always thought of myself as an Endomorph, and I’m not wrong. But years of doing sports I worked so hard on myself just so I could catch up with my team members. I honestly never thought I was good enough, hence the extra work. I went to the gym to build up muscles and strength. I walked almost everywhere for cardio. I didn’t run because running was already incorporated in most of the sports I did (and I really hated running at the time).

I know you’re thinking “What does this have to do with having an ideal body?” Bear with me for a little while longer.

Now, throughout my life of doing sports and gaining the flab (right after I stopped), I had the type of body where a waist did not exist. I learned to hide or fake one with my clothes. I got used to this and was not embarrassed at my lack of a waist. It was nothing to be ashamed of. Supermodel Gisele Bundchen does not have a waist and nobody cares. Look at her career!

Now, in my late 30s I was diagnosed with a disease and the doctor advised was for me to take 3 x 10 minutes walk daily. No exceptions. I was lucky I had friends who supported me and accompanied me on my walks. I began the prescribed exercises in the month of August, had surgery in September and by October I realized my body had changed.

I had more energy, could lift heavier stuff, and had a healthier mindset about food. I also noticed that my legs changed shape to the point a friend exclaimed they were “amazeballs”. Next thing I realized was when a male friend asked why I was hiding my waist. I had a waist!

I realized then that was my natural body shape. It was a stark contrast to the lean possibly Ectomorph body I was striving to achieve in my younger years. This is my ideal body shape. It had always been but I didn’t think I was built like this naturally.

I have to point out that when I decided to go back to the gym at this time, my personal trainer told me that he will train me so I will have THE ideal body. He pointed to one of the female members who was training at the time and I was shocked. There is nothing wrong with her but she was lean, packed with muscles and no hint of a waist. A musclier version of my younger self. When I told my trainer that wasn’t my goal, he told me to stop thinking so negatively and, of course, that’s the body all women want.

 

The Editor a few years ago. Image is from her personal collection.

That got me thinking and I’ve been asking friends about this ever since – What is your ideal body shape? Everyone has a different answer. But the reasons remain somewhat similar – to be lean, stronger, and fitter. Ok, some of my male friends said to attract girls, but I digress.

 

Point is to have your ideal body shape in mind and work towards it. It doesn’t matter if it’s different from your friends’ ideal. I have since been jaded about exercising but have recently starting to pick it up again. I am nowhere near my ideal body but my current body can be seen here.

CStone’s PD-1 inhibitor CS1003 receives clinical trial approval in China

SUZHOU, China, July 12, 2018 /PRNewswire/ — CStone Pharmaceuticals (SuZhou) Co. LTD (CStone), a privately-held biopharmaceutical company devoted to developing next-generation innovative drugs, announced today that the China National Drug Administration (CNDA) has approved the first clinical trial application (CTA) in China for CS1003, a self-developed and wholly-owned anti-programmed death-1 (PD-1) monoclonal antibody (mAb). CS1003’s CTA filing was entered into the new process by the CNDA and approved after less than four months of review by the Center for Drug Evaluation. CStone will initiate a multi-center Phase I clinical trial to assess the safety, tolerability and preliminary anti-tumor activity of CS1003 in Chinese patients with advanced cancers.

“We are pleased to begin the development of CS1003 in China, which follows a first-in-human dose escalation trial initiated in Australia in May this year,” said Dr. Frank Jiang, Chief Executive Officer at CStone. “The start of clinical evaluation for CS1003 in China is an important step in the development path for this molecule, which is a key component of CStone’s immunotherapy strategy and will form the backbone of combination therapies. Alongside the programmed death-ligand 1 (PD-L1) mAb CS1001, CS1003 is the second CStone pipeline candidate to be tested in Chinese patients.”

“PD-1 and PD-L1 immunotherapies have demonstrated significant clinical benefits for patients with various cancers, and we look forward to assessing the safety and efficacy of this high-quality PD-1 candidate in Chinese cancer patients,” commented Dr. Jason Yang, Chief Medical Officer at CStone. “CS1003 is cross-reactive with both human and mouse PD-1, which enables pre-clinical proof-of-concept experiments to quickly determine its anticancer activity, especially  in combination with various anticancer modalities. The results of these early experiments have demonstrated that CS1003 has strong potential as a monotherapy and in combination with multiple anticancer agents.”

About CS1003 and the PD-1/PD-L1 pathway

CS1003 is a humanized anti-PD-1 IgG4 monoclonal antibody developed by CStone using an internationally leading hybridoma platform. CS1003 has shown good tolerability and efficacy profile in preclinical in vivo studies. In contrast with other anti-PD-1 mAbs, CS1003 recognizes both human and murine PD-1, providing a unique competitive advantage during efficacy testing in syngeneic mouse tumor models particularly for development of effective combination therapies.

PD-1, or programmed death-1, is an inhibitory checkpoint receptor expressed on T cells. Under normal circumstances, it binds with its ligands, programmed death ligand-1 or ligand 2 (PD-L1/PD-L2), inhibiting T cell and cytokine activation, serving to dampen the immune response and prevent damage to healthy tissues. However, studies have shown that PD-L1 can be abundantly expressed on the surface of many solid tumors as well as hematological malignancies. Cancer cells can therefore make use of the PD-1/PD-L1 pathway to avoid immune system recognition and attack. Targeting of the PD-1/PD-L1 checkpoint by anti-tumor drugs can block the “tumor immune evasion mechanism” and restore anti-cancer immune ability in patients.

Currently, there are two anti-PD-1 antibodies approved globally: Opdivo® (nivolumab) from Bristol-Myers Squibb and Keytruda® (pembrolizumab) from Merck, Sharp & Dohme. Opdivo® became the first PD-1 mAb to gain marketing approval in China in June 2018. 

About CStone Pharmaceuticals

CStone Pharmaceuticals is a clinical stage biopharmaceutical company devoted to the development of innovative drugs. With a broad pipeline, the company engages in the development of cancer therapeutics with a special focus on immuno-oncology based combination therapies. All members of the management team are seasoned executives from top multinational pharmaceutical companies. CStone has successfully built up its core competency in clinical development and translational medicine. The company is backed by prestigious VC/PE funds via two financing rounds to date, raising $150 million in a Series A round in July 2016, followed by $260 million in a Series B round in May 2018. With an experienced team, a rich pipeline, a robust R&D model, and substantial funding, CStone is well positioned as the partner of choice for multinational pharmaceutical and biotech companies to develop drugs in China and the Asia-Pacific region. For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com.

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Merck Announces Collaboration with Xian Janssen to Launch INVOKANA(R) (canagliflozin) for the Treatment of Type 2 Diabetes in China

BEIJING, July 12, 2018 /PRNewswire/ — Merck, a leading science and technology company, signed an agreement with Xian Janssen Pharmaceuticals Ltd. in Beijing on July 11, to launch INVOKANA® (canagliflozin), an innovative drug for adults with type 2 diabetes.


Merck and Xian Jassen Partnership Agreement Signing Ceremony

Invokana(R) for the Treatment of Type 2 diabetes China Launch Ceremony

“Our mission is to transform 40 million patients’ lives in China by 2025. We are very pleased to be collaborating with Xian Janssen, who shares our goal of helping improve the lives of people living with or at risk of type 2 diabetes. Merck has been making continued efforts to expand its portfolio with the aim of providing more high-quality medicines and better treatment options for millions of diabetic patients in China. The introduction of INVOKANA® to China reinforces our long-term commitment to China“, said Rogier Janssens, Managing Director and General Manager of Merck’s biopharma business in China.


Speech from Rogier Janssens, Managing Director and General Manager of Merck’s biopharma business in China

Through this agreement, the two companies will work closely together on future development, distribution, promotion, access, marketing and sales of INVOKANA® (canagliflozin) in the country and Merck will hold the exclusive rights for INVOKANA® (canagliflozin)’s promotion in China.

INVOKANA® (canagliflozin) is a member of a novel class of drugs known as sodium-glucose co-transporter 2 (SGLT-2) inhibitor and was approved in China in September 2017. INVOKANA® (canagliflozin) is approved for treatment of type 2 diabetes in combination with metformin or with metformin plus sulfonylurea in adults who have not achieved adequate glycaemic control on these oral therapies.

With a mechanism of action that is independent of insulin secretion and sensitivity, INVOKANA® (canagliflozin) helps reduce the reabsorption of filtered glucose in the kidneys and lowers the renal threshold for glucose(RTG)and thereby increases urinary glucose excretion through inhibition of highly selective SGLT-2.Besides its pronounced anti-hyperglycemic effects, INVOKANA® (canagliflozin) can also bring additional benefits to patients such as reductions in body weight, slowing the progression in albuminuria and lowering of blood pressure[1]. By adding INVOKANA® (canagliflozin), another novel therapy following Glucophage® (metformin hydrochloride), and other diabetes’ products, to its diabetes portfolio, Merck is committed to providing Chinese patients with better treatment options for their diabetes and complications, leading to better quality of life.

According to the 2017 International Diabetes Federation (IDF) Diabetes Atlas, China has more than 114 million people living with diabetes, the largest number of any country in the world. Additionally, data from the China Guideline for the Prevention of Type 2 Diabetes (2017 Edition)[2]shows that in China the prevalence of type 2 diabetes among the adult population is 10.4%. Research also shows that the number of people with diabetes is rising year on year, with patients often being diagnosed at a younger age and many still struggling to control their blood sugar level. Indeed, approximately half of adults with the disease do not achieve recommended levels of glucose control[3], which increases the risk of potentially life-threatening complications, such as heart disease, stroke, renal failure, and diabetic retinopathy.

Under the Healthy China 2030 Initiative, health of the Chinese people has been given strategic importance. The Chinese government has gradually introduced a shift of focus from disease treatment to disease prevention.

“With poor lifestyle choices, particularly in relation to exercise and diet, the number of diabetic patients is increasing rapidly all over the world. More effective treatment options are needed to help diabetic patients control the disease and improve their overall quality of life”, said Ji Linong, a professor from Peking University People’s Hospital and chairman of the International Diabetes Federation Western Pacific Region (IDF-WPR), speaking at the signing ceremony. Prof. Ji also emphasized the importance of seeking medical advice at certified hospitals as well as early diagnosis and early intervention to improve treatment outcomes. He highlighted that healthy diet and lifestyle change are an important way to help prevent diabetes.

Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to cancer treatment or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2017, Merck realized sales of EUR 15.3 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority stakeholder of the publicly listed group. Merck holds the global patent rights to the Merck name and brand, with the only exceptions of the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Merck China Healthcare

With nearly 2,000 employees and footprint throughout the country, Merck Healthcare is committed to serving China and markets with 16 medicines in 7 major therapeutic areas. Merck Healthcare China has broad expertise in fertility and thyroid therapeutic areas, and has strong presence in CV, endocrinology and oncology. The R&D Beijing Hub, established in November 2009, is an integrated R&D facility, aimed at stimulating innovation, introducing new medicines to China and the rest of Asia, and leading research and development into new treatment solutions for critical diseases in Asia.

Merck’s main therapeutic areas include fertility, oncology, cardiovascular, surgery and emergency, thyroid disease, diabetes, allergy. Product brands include Gonal-f® to treat infertility, the assistive reproduction products Ovidrel® , Luveris® , Cetrotide® , and Crinone® ; oncology product Erbitux® for the treatment of RAS WT mCRC; Concor® for high blood pressure, Stilamin® for acute gastrointestinal diseases, Euthyrox® for hypothyroidism and Thyrozol® for hyperthyroidism, Glucophage®, Glucophage XR® Glufast® for diabetes and Doxium® for diabetic ophthalmic complication, and NHD for allergies.

[1] Stenlof K,et al.Diabetes Obes Metab. 2013 APr;15(4):372-82

[2] Wang L, Gao P, Zhang M, et al. JAMA, 2017

[3] Bailey CJ, Kodack M. Patient adherence to medication requirements for therapy of type 2 diabetes. Int J Clin Pract. 2011;65:314–322.

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SK Holdings to Acquire AMPAC Fine Chemicals (AFC), a Leading Contract Development and Manufacturing Organization (CDMO)

– Combination significantly strengthens SK’s CDMO growth platform

– AFC provides entry into the US, the world’s largest CDMO market, positioning the combination as a global leading CDMO with a strong presence across the US, Europe and Asia

– Creates substantial market synergies by combining highly complementary assets and expertise of the two companies, further accelerating growth

– SK aims to grow the combined company into a global top-tier CDMO in the next 5 years

SEOUL, South Korea, July 12, 2018 /PRNewswire/ — SK Holdings, an investment-type holding company of SK Group, and AMPAC Fine Chemicals, a leading global provider of high-quality API development and manufacturing solutions to the pharmaceutical industry, today announced that their boards of directors have approved SK’s acquisition of 100% of the ownership interests in AFC.


AFC’s Petersburg (VA)

Established in the 1990s, AFC is a leading global supplier of high value-added APIs and intermediates in medical indications such as cancer, CNS, cardiovascular and anti-viral, having grown more than 15% a year over the past several years.  

AFC is strategically located with facilities on the west, east and south coasts of the United States, providing services to a large number of pharma and biotech companies throughout the entire life cycle of their products. Its relationships with major blue chip pharmaceutical companies span more than 20 years based on its strong capabilities to manufacture high-value added products that require innovative technology solutions and stringent quality control. Through its performance and reputation for reliability, it has secured sole/preferred supplier status for a number of products that have a strong potential for growth into blockbuster products.

With the rapidly aging population, the pharmaceutical industry is set to grow at 4% annually; however, leading CDMOs continue to grow at a much faster rate of approximately 16% annually. SK Holdings has identified pharmaceuticals as a growth engine. “Pharmaceuticals is one of SK Holdings’ key pillars of growth and the acquisition of AFC is an important step towards becoming a global player in the market,” said Donghyun Jang, President and Chief Executive Officer of SK Holdings. Mr. Jang added, “AFC’s development and manufacturing capabilities and outstanding regulatory track record, evidenced by the fact that the California plant is utilized by the FDA as a training site, are an excellent complement to SK.”

Aslam Malik, Chief Executive Officer of AFC, added: “We are excited to join SK Holdings. SK and AFC are highly complementary and together we will be able to offer our customers a much broader portfolio of offerings including a global supply chain. Together we will achieve SK’s goal of becoming a global top-tier CDMO.”

SK Biotek, a wholly-owned subsidiary of SK Holdings, has built a strong relationship with major global pharmaceutical companies since its inception in 1998 as an API manufacturer. Its portfolio of technologies includes the world’s first low-temperature continuous flow technology, which is considered best-in-class. The combination of SK Biotek’s presence in Europe and Asia and AFC’s robust presence in the US will create a powerful platform to become a global top-tier CDMO in the next 5 years.

*Simpson Thatcher & Bartlett LLP is acting as the legal advisor to SK Holdings for the acquisition

About SK Holdings

SK Holdings continues to enhance its portfolio value by executing long-term strategic investments with a number of competitive subsidiaries in various business areas, including energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Holdings is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information, please visit http://hc.sk.co.kr/en/.

About AMPAC Fine Chemicals

AFC is a U.S.-based company with demonstrated capabilities in process development, scale-up, and cGMP-compliant commercial production of active pharmaceutical ingredients and registered intermediates for pharmaceutical and biotechnology customers. Its specially engineered facilities and experienced staff allow AFC to safely produce highly energetic compounds at commercial scale. In addition, AFC’s other technology platforms include production of highly potent compounds, continuous processes and industrial-scale chromatographic separation using simulated moving bed chromatography and Analytical Services to the Pharmaceutical Industry. AFC’s operations are located in Rancho Cordova & El Dorado Hills CA, in La Porte, Texas and in Petersburg, VA. For more information, please visit www.ampacfinechemicals.com.

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PureCircle Has Vastly Increased Its Capacity To Supply Reb M to the Beverage and Food Industries

Enough to Sweeten 500 Million Cases of Carbonated Soft Drinks or the Equivalent

Cost Comparable to Sugar

CHICAGO, July 13, 2018 /PRNewswire/ — PureCircle (LSE: PURE), the world’s leading producer and innovator of stevia sweeteners, announces that its recent advances in expanding capacity now enable it to supply significantly more Reb M to global beverage and food companies.  Using beverage sweetening as an equivalized example, PureCircle can now supply enough Reb M to sweeten about 500 million cases of zero-calorie carbonated soft drinks.  PureCircle continues to build production capacity, and it estimates that three years from now, it could supply enough Reb M to sweeten 1 billion cases of zero-calorie carbonated soft drinks or the equivalent in beverages and foods using Reb M as the sweetener.


Various soft drinks sweetened with PureCircle stevia

PureCircle further estimates that, depending on amounts purchased and terms of purchase, companies buying Reb M from PureCircle will find the cost of using it to sweeten a beverage or food, equivalent to their cost of using sugar to achieve the same level of sweetening.

Reb M is the variant of stevia sweetener which has the most sugar-like taste and which is most sought after by beverage and food companies.  

Until now, a challenge has been that Reb M is present only in relatively small amounts in conventional stevia plants.  PureCircle has developed a proprietary strain of the stevia plant that it calls Starleaf ™ stevia. It contains greater amounts Reb M than conventional stevia plants. PureCircle is massively ramping up its planting of Starleaf. 

PureCircle produces Reb M both directly from the Starleaf stevia plant and from other stevia sweeteners in the plant.  In the latter case, PureCircle starts with purified stevia leaf extract with low Reb M content and by adding an enzyme, the maturation to Reb M is completed, just as the leaf does naturally.  Enzymes play a similar role in various products including baby food, cheese, other dairy products and chocolate.

The Reb M produced from the two processes are both from the stevia leaf and are identical in great taste. 

All of PureCircle’s stevia sweeteners – produced using either of the above-cited processes — are non-GMO. 

In addition, they all are “GRAS.”  “GRAS” is a U.S. Food and Drug Administration designation meaning “generally recognized as safe” by experts. 

Beverage and food companies are already using PureCircle’s Reb M in their products.  PureCircle’s expansion in production of Reb M will help companies obtain supplies of an ingredient they need, as they respond to their consumers’ desires for more zero- and low-calorie products using plant-based sweeteners.

Our website: www.purecircle.com

OrigiMed Collaborates with Illumina to Further Develop and Promote its Advanced Clinical Molecular Tumor Applications

SHANGHAI, July 13, 2018 /PRNewswire/ — OrigiMed announces an agreement with Illumina in Shanghai, China. It will develop and promote its advanced molecular clinical tumor applications to the public based on the Next Generation Sequencing (NGS) technology of Illumina. This marks further cooperation between Illumina and Chinese enterprises. It also signals that genomics technology will play an increasingly important future role in the fast-developing market of precise diagnosis of cancer.


Signing Ceremony (PRNewsfoto/OrigiMed)

Recently, NGS has emerged as the key technology in precision medicine. The Chinese market has huge potential to apply NGS technology because of its large cancer patient population – more than 4 million new cancer patients identified in China each year. The cooperation between OrigiMed and Illumina means that the world’s leading NGS technology will cover more widely the Chinese market. As an important part of the cooperation, Illumina will provide NGS instruments and related reagents, and OrigiMed will focus on the clinical applications in tumor molecular diagnosis and provide self-developed and a patterned bioinformatics solution to the medical institutions. In the future, OrigiMed plans to develop a total sequencing solution for clinical applications.

About OrigiMed

OrigiMed is a medical science and technology transforming company which focuses on developing new technologies and clinical applications for all types of cancer patients. By carrying out more comprehensive and high-throughput methods, leveraging wholesome bioinformatics analysis and clinical annotation, we identify cancer specific molecular markers and genomic features to guide targeted or immuno-therapy, ultimately aim to fortify the evolution of cancer precision medicine in China.

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ROHTO Exhibits Concept Models of Eye-drops for Four Extreme Conditions at Art Gallery in Daikanyama, Tokyo

– SPECIAL EVENT: OUR EYES ARE EXPERIENCING MUCH HARSHER CONDITIONS THAN WE IMAGINE –

OSAKA, Japan, July 13, 2018 /PRNewswire/ — On Sunday, July 8, 2018, celebrating 110 years in the manufacture and sales of eye-drops, ROHTO Pharmaceutical Co., Ltd. (hereinafter ROHTO) held an exhibition titled, OUR EYES ARE EXPERIENCING MUCH HARSHER CONDITIONS THAN WE IMAGINE – 4 EXTREME SITUATIONS, 4 EYE-CARE CONCEPTS, at an art gallery in Daikanyama, Tokyo.

Event website: https://www.rohto.co.jp/company/vision/event/

Artifact-like concept models were exhibited in the gallery, demonstrating how eye-drops can take on the challenges of extreme conditions often encountered in the four featured countries.

This exhibition featured innovative and unprecedented concept models in eye-care product development. ROHTO is currently proceeding with plans to take these concepts to the production stage.

(Logo: https://kyodonewsprwire.jp/img/201807115896-O1-17kq4455)
(Photo1: https://kyodonewsprwire.jp/img/201807115896-O2-xrFk7p5d)

In the exhibition, four harsh environments for eyes were selected from different parts of the world and four concept models of eye-drops for each of the harsh conditions were displayed.

(Photo2: Top left: Japan, top right: Kazakhstan, bottom left: Australia, bottom right: Iceland
https://kyodonewsprwire.jp/img/201807115896-O3-20OVI2a2)

The following four countries were selected:

(1) A country covered with deserts: Kazakhstan
(2) A country exposed to strong ultraviolet rays: Australia
(3) A country with harsh cold climate: Iceland
(4) A country suffering from blue light: Japan

Description of Concept Models Displayed:

(1) A country covered with deserts: Kazakhstan
For Kazakhstan, where nearly 70% of the land is covered with deserts, eye-drops were developed with a gyroscope function to maintain balance even on unstable ground. The image was to come up with eye-drops that can be applied, even in shaky conditions such as during camel rides or minor landslides.

(2) A country exposed to strong ultraviolet rays: Australia
The levels of exposure to direct sunlight and ultraviolet rays are high in Australia, and for this area, the concept is eye-drops which can be applied even while facing down. The image adopted was to convert eye-drops to steam using ultrasonic waves for application.

(3) A country with harsh cold climate: Iceland
Eye-drops for Iceland, a cold district, were created with a concept incorporating a car defroster to prevent the liquid from freezing even at severe low temperatures. In addition, the eye-drops also feature a phosphorescent (light-storing) function that makes it easy to find even during short daylight time.

(4) A country suffering from blue light: Japan
Japan is a country suffering from frequent exposure to blue light, and a concept model was developed pursuing the pleasure of pressing acupressure points and applying eye-drops, both at the same time. Visitors were able to experience this concept model for Japan in a designated area in the gallery. Many of the visitors were enjoying a totally new way of applying eye-drops.

About the Production Partner

The production partner for this concept model is secca inc., a design firm based in Kanazawa on the Japan Sea coast. secca created completely new designs for eye-drops utilizing their unique perspective of integrating traditional craft techniques with cutting-edge 3D digital technology.

About ROHTO

ROHTO Pharmaceutical Co., Ltd. celebrates the 110th anniversary of the manufacture and sales of eye-drops. Committed to the spirit of exceeding what is common sense, and taking into consideration the diversity of eye conditions, ROHTO strives to contribute to the health of eyes all over the world.

Official website: https://www.rohto.co.jp/global/

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Source: ROHTO Pharmaceutical Co., Ltd.

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