SeaPRwire

GIC-backed clinical trial firm WCG withdraws US IPO plans

elean
2 minutes

BENGALURU (REUTERS) - WCG Clinical, a clinical trial solutions company backed by Singapore's sovereign wealth fund GIC, on Wednesday (Oct 13) filed to withdraw its initial public offering (IPO), joining a list of companies that pulled the plug on their offerings in recent weeks. The company did not give a reason for the withdrawal in its paperwork with the US securities regulator, but adverse market conditions have forced exercise equipment maker iFIT Health & Fitness, AEON Biopharma and others to abandon their IPO plans recently. Inflation concerns and worries surrounding cash-strapped property developer China Evergrande Group have spooked investors and fueled wild gyrations in global equities in recent weeks. On Wednesday, data from the Labor Department showed US consumer prices increased solidly in September and are set to rise further in the coming months. However, despite some hiccups, the market for IPOs remains robust, with a slew of high profile companies like Amazon.com-backed electric vehicle maker Rivian and chipmaker GlobalFoundries lined up for stock market listings by the end of the year. In a filing with the US Securities and Exchange Commission in July, WCG Clinical...

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Honda: Toni Bou Wins 15th Consecutive FIM Trial World Championship Title

ruth
3 minutes

TOKYO, Sep 20, 2021 - (JCN Newswire via SEAPRWire.com) - HRC (Honda Racing Corporation) contract rider and Honda factory team(1) (Repsol Honda Team) rider Toni Bou has won the 2021 FIM(2) Trial World Championship. He has clinched his 15th consecutive title by winning the final round in Portugal, held on September 18.Toni Bou (Portuguese GP)This year's Trial World Championship is contested over six rounds (nine trials). In the opening double-header round held in June, Bou finished 1st / 2nd. He then won the next round in France, marking his 120th career win in the competition. After the summer break, he was 1st / 3rd in Andorra, won the next round (again in France), and won both trials at the Spanish double-header. Going in to the final round at Portugal as championship favorite, Bou won the round giving him his 15th consecutive championship title.Since clinching his first world championship title in 2007 on HRC's Montesa COTA 4RT factory bike, Bou has increased his unparalleled consecutive championship titles to 15. He has also won his 14th consecutive X Trial World Championship, an indoor competition raced on artificially prepared sections, taking his total tally of championship t...

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Honda: Takahisa Fujinami to End 26-Year Trial World Championship Career

ruth
4 minutes

TOKYO, Sep 15, 2021 - (JCN Newswire via SEAPRWire.com) - Honda announced that Honda Racing Corporation (HRC) contract rider Takahisa Fujinami (Repsol Honda Team), the first Japanese rider to win the FIM* Trial World Championship in 2004, will be retiring from the championship at the end of this season. Honda is truly grateful for all of the support given to the Japanese rider throughout his career.Born 1980 in Mie, Japan, 41-year-old Takahisa Fujinami began riding motocross at age 3, and after experiencing bicycle trials, started competing in the All Japan Trial Championship at age 13 in 1993, in which he became the youngest champion at age 15 in 1995.The following year, he began his career on the world championship stage, winning his first trial in the 1997 German round, becoming the youngest world championship trial winner at 17 years and 237 days old. In 1998 he was ranked fifth overall, and from the next year to 2003, was ranked second for five consecutive years. In 2004 he became the first Japanese champion in the series. From there on to 2017, he has been in the top five for 21 consecutive years, an astounding record. In the 2021 season-opener in Italy, he won Day 2, not only...

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ClinTex (CTi) Launches CTi-OEM Blockchain Clinical Trial App

indie
4 minutes

LONDON, Aug 3, 2021 - (ACN Newswire via SEAPRWire.com) - The ClinTex (CTi) tokenized platform (clintex.io) will be the first of its kind to utilize blockchain-based clinical data analytics to address the main causes of clinical trial inefficiency, helping to drive down the cost of new medicines and expediting their delivery to patients.ClinTex (CTi) launches 'Operational Excellence Module' (CTi-OEM) - a blockchain clinical trial application to tackle clinical trial inefficiencies and high costs. (ClinTex)The initial spark of an idea that would eventually become ClinTex started in 2014, at the DIA Forum in Vienna. By 2018, Clintex was formally working on the Clinical Trials Intelligence (CTi) platform. CTi's purpose is to deliver data analysis at scale, to drive collaboration and insights across clinical trials.With large pharma companies like Merck and Novartis already testing blockchain as a technology of the future to support their clinical trial strategy for patient information and to manage clinical trial medication, this paves the way for ClinTex CTi to partner with the industry to deliver more innovative and impactful uses of blockchain to increase clinical trial efficiency.T...

SeaPRwire

GIC-backed clinical trial firm WCG reveals revenue jump in IPO filing

elean
1 minute

BENGALURU (REUTERS) - WCG Clinical, a clinical trial solutions company backed by Singapore's sovereign wealth fund GIC, filed for an initial public offering (IPO) in the United States on Thursday and revealed a jump in its quarterly revenue. The company, which also counts buyout firm Leonard Green & Partners LP among its investors, plans to list on the Nasdaq. WCG was valued at US$3.1 billion when Leonard Green took a stake in the company in 2019, Reuters reported at the time. Private equity firm Arsenal Capital Partners is also an investor in the firm which helps clients reduce the time and cost of enrolling patients in clinical trials. The company's revenue jumped by a third to US$137.6 million in the three months ended March 31, its filing showed. Net loss came in at US$20.6 million from US$30.1 million last year. Princeton, New Jersey-based WCG is looking to issue into an IPO market which has been on a record run, helped by the US. Federal Reserve's easy money policy and unprecedented government stimulus. Goldman Sachs, Morgan Stanley and BofA Securities are among the underwriters for WCG's IPO.

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Avance Clinical’s USA Biotech Survey Finds 21% Not Aware Australian Clinical Data is Accepted by the FDA and Other Major Regulatory Authorities

indie
3 minutes

ADELAIDE, AUS, Jun 4, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical announced the results of their Australian Clinical Trials Knowledge Survey with Endpoints News as part of their presence at BIO Digital 2021.Results from the survey found:- 21% were not aware Australian data is accepted by the FDA and other major regulatory authorities- less than half of respondents were aware of Australia's 43.5% rebate on clinical research spend- only 52% knew that studies could achieve regulatory approval in under 5 weeks in AustraliaThe survey was sent to Endpoints News subscribers in biotech hubs on the USA east and west coasts.The Avance Clinical team is attending BIO Digital 2021 virtually and is available on the BIO One-on-One Partnering(TM) platform to discuss the benefits of conducting trials in Australia.Avance Clinical CEO Yvonne Lungershausen, said the survey was designed to determine awareness levels among biotech companies around the key benefits of conducting clinical trials in Australia. "Sponsors are well aware of the quality of research from Australia ho...

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Avance Clinical Releases Industry Survey Results at BIO Korea 2021

indie
3 minutes

ADELAIDE, AUS, May 27, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical shared results of a recent industry survey conducted by the company that found data quality to be the most important criteria for selecting a CRO for Phase ll studies in Australia.Results from the survey found 63.64% of respondents selected data quality as the Key operational consideration when planning Phase II, followed by access to patients, then CRO therapeutic area expertise, cost, and access to KOLs.Avance Clinical is attending BIO Korea 2021 virtually and is available via the Partnering platform to discuss the benefits of conducting trials in Australia. Avance Clinical has extensive experience in conducting trials in oncology, CNS, cardiovascular, infectious diseases and dermatology.Avance Clinical CEO, Yvonne Lungershausen, said South Korea is recognised globally for its thriving biotech sector and the CRO is keen to connect with companies wanting regional alternatives for their clinical development. "As Australia's CRO for biotechs, we are seeing an increasing number of South Kor...

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Agilex Biolabs Partners with Endpoints News on Deconvoluting Inflammation and Immunology for Clinical Trials

indie
4 minutes

ADELAIDE, AUS, May 21, 2021 - (ACN Newswire via SEAPRWire.com) - Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials is partnering with Endpoints News to share the latest on deconvoluting inflammation and immunology for clinical trials, in a webinar hosted by Endpoints News Editor Arsalan Arif.Agilex Biolabs' Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM) said:"Inflammation is a complex biological process involving a host of resident and recruited immune cells which are mobilized to infiltrate tissues in response to invading pathogens. These immune cells boast elevated numbers and heightened activation as they churn out inflammatory mediators, which act in unison to coordinate and modulate the immune response. Choosing the right bioanalytical platform for your immunology clinical trial is critical to data collection. But navigating the intricate inflammation process can be difficult."In this webinar Dr Sales will examine what these platforms look like in use, and how should you go about selecting the right one. It will also identify the most common bioanalytical platforms used ...

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Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

indie
3 minutes

ADELAIDE, AUS, May 7, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).In Australia, dealings with GMOs in clinical research requires authorisation under the Gene Technology Act 2000. The OGTR administers the Gene Technology Act 2000, and has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating dealings with GMOs.The global market for genetic modification therapies is expected to grow from $2.3 billion in 2018 to reach $17.4 billion by 2023, gro...

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Agilex Biolabs Congratulates Bionomics Limited on BNC210 PK Results

indie
5 minutes

ADELAIDE, AUS, Apr 30, 2021 - (ACN Newswire via SEAPRWire.com) - Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.Liz Doolin, Bionomics' Vice President Clinical Development commented that "We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning. We look forward to continuing this partnership into the future."Bionomics (ASX: BNO, OTCQB: BNOEF, Germany: AU000000BNO5), is a global, clinical stage biopharmaceutical company. Bionomics said in their announcement:"BNC210 is a novel, negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor in development for the treatment of anxiety and stressor-related disorders, and in November 2019 was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of Post-Traumatic S...

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Avance Clinical Invited to Present “Decentralized Trials – No Going Back” for Oracle Health Sciences Connect

indie
4 minutes

ADELAIDE, AU, Apr 22, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been invited to present on the future of decentralized clinical trials at the Oracle Health Sciences Connect conference.Title: Decentralized Trials - No Going BackLink: https://www.oracle.com/in/industries/life-sciences/health-sciences-connect/sessions/ Time: 23 April, 2021 - 3.05 pm (Australia/Adelaide ACST).Avance Clinical CEO Yvonne Lungershausen, shared the company's insights on the future of Decentralized Clinical Trials (DCTs) and the technology and patient factors that will determine success. Avance Clinical uses the full range of eClincial technologies to support clients wanting DCTs or a site-based approach while still leveraging advance technology including ePro, eSource and eConsent."DCTs are fast becoming the new norm and this is an incredible opportunity for the drug development sector as well as the diverse and remote patient populations that will now have access to clinical trials," said Lungershausen. "The pandemic has been the catalyst in speeding up the adoption of decen...

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Eisai: 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer’s Disease

ruth
3 minutes

TOKYO, Apr 20, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer's Disease with Lecanemab, an Anti-Abeta Protofibril Antibody, in the peer-reviewed journal Alzheimer's Research and Therapy. The manuscript describes results from Study 201, a Phase 2b proof- of-concept clinical trial that explored the impact of treatment with lecanemab (BAN2401) on reducing brain amyloid beta (Abeta) and clinical decline. The manuscript concluded that the pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the Phase 3 clinical trial Clarity AD aims to confirm. The results of Study 201 were presented at the Alzheimer's Association International Conference and Clinical Trials on Alzheimer's Disease in 2018.The lecanemab Clarity AD Phase 3 clinical trial completed enrollment last month with 1,795 symptomatic patients with early Alzheimer's disease (AD). Clarity AD is a placebo-controlled, double-blind, parallel-group, 18-month study with an open-label ext...

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TOT BIOPHARM Announces A Number of Key Anti-Tumor Drugs Have Entered the Pivotal Clinical Stage in 2020

indie
10 minutes

HONG KONG, Mar 24, 2021 - (ACN Newswire via SEAPRWire.com) - TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Company"; stock code: 1875.HK), a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, announced today its audited annual results for the year ended 31 December 2020.Milestones of 2020 Annual Results TOT BIOPHARM's core products including mAb drug TAB008 and ADC drug TAA013 have achieved key milestones. The Company actively promoted the development of and collaboration relating to innovative drugs and have established a R&D and commercialization platform integrating mAb and ADC drugs. The Company will rapidly expand its CDMO/CMO business to create new momentum for the future development of the Company.Key milestones of pipeline products: -- TAB008 (anti-VEGF mAb): Phase III clinical results were published. The clinical results show that TAB008 has similar efficacy, safety, immunogenicity and pharmacokinetics profiles with the brand-name formulation of bevacizumab. The new drug application under the new version of the Administrative Measures for Drug Registration was submitted, and...

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Fujitsu Embarks on Joint Research with National Cancer Center Japan to Create New Services for Drug Development and Clinical Trials

ruth
6 minutes

TOKYO, Mar 18, 2021 - (JCN Newswire via SEAPRWire.com) - Fujitsu today announced it has concluded a comprehensive collaborative research agreement with National Cancer Center Japan. The joint research will center on exploring ways that real-world data(1), including medical information from electronic records, can be leveraged to contribute to the development of new drugs, clinical trials, and preventive medicine in pharmaceutical companies.Through its joint research with the National Cancer Center, Fujitsu aims to create new value through a wide range of information and analysis services by creating an anonymized personal health record scheme(2) (PHR), which includes case study information and health information on patients visiting the National Cancer Center Hospital East. Fujitsu additionally seeks to create a platform for providing pharmaceutical companies with data that can be used for drug development and preventive medicine. Fujitsu will establish a new model to process medical information from electronic medical records into highly secure statistical data to improve the efficiency of clinical trials and supports active participation in international joint clinical trials by ...

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Avance Clinical and Medidata Celebrate Strategic Partnership and Inhouse Expert Accreditation Milestones

indie
4 minutes

ADELAIDE, AU, Feb 26, 2021 - (ACN Newswire) - The leading Australian CRO for biotechs, and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical continues to celebrate their strategic partnership with Medidata, and the accreditation of seven Medidata inhouse experts.The two organizations have been working together to deliver world-class clinical research services to Avance Clinical's biotech customers via the Medidata Rave Clinical Cloud™.Avance Clinical, Chief Strategy Officer, Ben Edwards said "We look forward to many more years working with Medidata as we continue to grow the business and support the development needs of our clients."Mr Edwin Ng, Senior Vice President, General Manager for Medidata APAC, said, "We are pleased to be supporting Avance Clinical's exceptional growth in Australia. Avance Clinical accreditation signifies the importance of Medidata's portfolio of products in ensuring the success of our partners' programs, and our continued commitment to helping our partners streamline and enhance the clinical research process."Avance Clinical, Director Business Development Operations, Sandrien Louwaars said, "The Medidata Rave Clinical Cl...

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O2 and NEC jointly conduct Open RAN trial

ruth
3 minutes

TOKYO, Feb 2, 2021 - (JCN Newswire) - O2 (Telefonica UK) and NEC Corporation (TSE: 6701) have announced a successful Open RAN trial on O2's network with NEC and its ecosystem of partners that includes virtualized RAN software from Altiostar and hardware from GigaTera Communications and Supermicro among others.NEC helped to define a customized Open RAN architecture, optimized and adapted to the requirements of the O2 mobile network. Given its role as the system integrator for this trial, NEC coordinated the overall design of the system, which delivered a solid end-to-end solution and was conducted in collaboration with the aforementioned industry leaders. NEC's role included end-to-end testing and interoperability verification by leveraging its recently established Center of Excellence in the UK, which is where the trial with O2 was conducted, running via O2's core network. The trial builds on O2's progress in developing Open RAN technologies over the past 12 months. In January 2020, new windowO2 announced a range of Open RAN projects to help its customers better utilize its network, and its parent company, Telefonica, is playing an active role in Open RAN networks. Telefonica annou...

ACN Newswire

China Biotech Services LY007 Cell Injection Obtained Clinical Trial Approval Letter

indie
2 minutes

HONG KONG, Jan 28, 2021 - (ACN Newswire) - China Biotech Services Holdings Limited ("CH BIOTECH SER" or "Company", stock code: 8037.HK) non-wholly-owned subsidiary Shanghai Longyao Biotechnology Co., Ltd. ( "Shanghai Longyao") received an approval letter from the National Medical Products Administration for a clinical trial of the Company's LY007 Cellular Injection on January 21, 2021, which is registered as a Class I new drug. LY007 Cellular Injection is mainly used for the treatment of non-Hodgkin lymphoma. It is currently the first and only CD20-targeted CAR-T product whose application for a registered clinical trial has been approved in China.LY007 Cellular Injection is a chimeric antigen receptor T-cell (CAR-T) injection and is mainly used in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and metastatic follicular lymphoma. LY007 Cellular Injection has beenwas developed independently by Shanghai Longyao and incorporates its patented OX40 co-stimulatory signal design. Experiments have proved that the design enhances the efficacy of the Product without compromising safety. According to the clinical trial ap...

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SinoMab Dosed First Healthy Subject in Phase I Clinical Trial of SN1011 in China

indie
4 minutes

HONG KONG, Jan 18, 2021 - (ACN Newswire) - SinoMab BioScience Limited ("SinoMab" or the "Company", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that the first healthy subject was successfully dosed in the Phase I clinical trial of SN1011, an innovative third-generation covalent reversible Bruton's tyrosine kinase ("BTK") inhibitor drug candidate, today in Shuguan Hospital in Shanghai, China. The subject is currently in a normal condition.Medical staff from Shuguan Hospital in Shanghai conducted the Phase I clinical trial of SN1011.SN1011 is the third generation, covalent reversible Bruton's tyrosine kinase ("BTK") inhibitor designed for higher selectivity and superior efficacy for the long-term treatment of systemic lupus erythematosus, rheumatoid arthritis, pemphigus, multiple sclerosis and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of selectivity and affinity. The Phase I clinical trial was conducted in...

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Jobless man of unsound mind ordered to be detained after trial for murdering 75-year-old father

aseanpr
3 minutes

SINGAPORE - A 46-year-old man of unsound mind was ordered to be detained at the President's pleasure on Tuesday (Nov 30) after the High Court found, following a trial, that he had killed his 75-year-old father. Justice Valerie Thean concluded that Tan Kok Meng, who was left alone for three hours with his father at their Bedok North flat, had caused the death of the older man on Nov 13, 2015. Although Tan was found to have committed the alleged acts, under the law, he was acquitted of murder due to his mental incapacity. Two psychiatrists from the Institute of Mental Health had diagnosed him with schizophrenia and found that he was probably of unsound mind during the killing. One of them said Tan was also in a state of acute drug intoxication during the incident as he had taken methamphetamine then. Tan will be confined in a psychiatric institution, prison or some other place of safe custody. There is no minimum period of detention and the mental state of the detainee is reviewed regularly until he is suitable for discharge. After the verdict, Tan appeared to be in good spirits and was allowed by the court to speak to a few family members. He was on trial for murder and was accused ...

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Avance Clinical Wins MasterControl 2020 Innovation Excellence Award

indie
4 minutes

ADELAIDE, AU, Oct 30, 2020 - (ACN Newswire) - The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical today accepted the MasterControl 2020 Innovation Excellence Award in a virtual ceremony.L-R: Priyanka Chamoli, Director Quality Assurance, Emma Woolman, Senior Compliance and Training Officer, Yvonne Lungershausen, Avance Clinical's CEO, and Lisa Eglinton, Director Compliance and Training.Avance Clinical made the announcement today at AusBiotech 2020 (28 - 30 October, 2020).https://www.ausbiotechnc.org/Avance Clinical CEO Yvonne Lungershausen said the company was very pleased to be awarded such recognition by MasterControl, a leader in the clinical digital management technology. The MasterControl Clinical Excellence solution streamlines eTMF management and helps clients achieve real-time visibility into critical clinical processes across operational teams - all on one centralized platform. https://www.mastercontrol.com/clinical/"The award acknowledges our leadership as Australia's biotech CRO and it provides further confidence to our clients that we are serious about delivering quality clinical research...