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1028
AVROBIO Receives Orphan-Drug Designation from the U.S. FDA for AVR‑RD‑02 for the Treatment of Gaucher Disease
AVROBIO Receives Orphan-Drug Designation from the U.S. FDA for AVR‑RD‑02 for the Treatment of Gaucher DiseaseFRIDAY, OCTOBER 25, 2019AVROBIO, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the Company’s investigational gene therapy, AVR-RD-02, for the treatment of Gaucher disease. AVR-RD-02 consists of the patient’s own hematopoietic stem cells, genetically modified to express glucocerebrosidase (GCase), the enzyme that is deficient in Gaucher disease. The Company is actively recruiting in Canada for its Phase 1/2 clinical trial of AVR-RD-02, which seeks to evaluate the safety and efficacy of the therapy in patients with Type 1 Gaucher disease.“Under the existing standard of care, patients with Gaucher disease are bound to a lifelong infusion schedule of enzyme replacement therapies, and still experience painful and progressive symptoms such as debilitating musculoskeletal pain and fatigue,” said Birgitte Volck, MD, PhD, President of Research and Development at AVROBIO. “Orphan-drug designation recognizes the unmet need of populations with rare diseases like Gaucher where AVROBIO strives to transform lives by addressing the underlying cause of the disease with a single dose of gene therapy.”Orphan-drug designation is granted by the FDA to drugs and biologics which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan-drug designation provides certain incentives, which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers.information source:pharma focus AsiaThe original link:https:https://www.pharmafocusasia.com/news/avrobio-receives-orphan-drug-designation-from-the-us-fda-for-avrrd02-for-the-treatment-of-gaucher-disease2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact：AnnPhone: 021-65650305Email：Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934 -
1029
HistoIndex Announces Global Partnerships To Expand AI-Based Digital Pathology Platform
HistoIndex Announces Global Partnerships To Expand AI-Based Digital Pathology PlatformMONDAY, OCTOBER 28, 2019HistoIndex announces the expansion of its AI-based digital pathology platform towards large-scale NASH preclinical programs for pharmaceutical and biotech companies to achieve quantifiable and reproducible data on therapeutic responses in NASH animal models, and to aid CROs as well as research agencies in validating new models mimicking the NASH disease.Published preclinical studies have demonstrated the use of HistoIndex's fully quantifiable Second Harmonic Generation (SHG) technology as a highly accurate stain-free method that can monitor the efficacy of various therapeutic agents, by quantifying more than 450 NASH-associated parameters in fibrosis, inflammation, ballooning and steatosis. The information of these NASH-associated parameters gathered from the entire liver tissue, provides comprehensive insights on the mechanism of action of the therapeutic agent. As a drug discovery tool, HistoIndex's SHG-enabled digital pathology platform will allow pharmaceutical and biotech companies to select promising lead candidates for further optimization and make informed decisions in the management of their NASH drug development pipeline.In addition to ongoing NASH clinical trials, HistoIndex is currently involved in multiple preclinical studies, most of which are conducted by major pharmaceutical and biotech companies, medical universities, CROs and research agencies. Notably, HistoIndex has recently entered into a collaboration with the A*STAR's Genome Institute of Singapore (GIS) to validate their in vivo and in vitro NASH models based on Asian-centric clinical data. Says Professor Patrick Tan, Executive Director of the Genome Institute of Singapore (GIS), "At GIS, we conduct our preclinical studies on fatty liver involving data from animal models based on patient-derived transcriptomic data. This has a high translational potential as it helps us to pinpoint new therapeutic targets and their validation. Therefore, using a fully quantitative, reliable and objective pathological evaluation such as HistoIndex's AI-based digital pathology platform is essential to the success of our efforts in therapeutic target discovery."HistoIndex is also a partner with globally-renowned CRO, WuXi Apptec, in advancing their NASH preclinical programs with advanced R&D and smart imaging analysis capabilities. Published study data will be available for discussions during networking opportunities throughout AASLD's The Liver Meeting® in November 2019. "We are very excited to extend our AI-based SHG platform to preclinical studies to help companies with drug discovery programs select promising lead candidates for further optimization and subsequent clinical development," says Dr Poon Thong Yuen, Chief Executive Officer of HistoIndex. "Our SHG image analysis platform has already been used to analyze the efficacy of a series of promising drug candidates for NASH within various animal models commonly-used by the industry, and we believe these preclinical partnerships will help drive the adoption of our platform significantly."information source:pharma focus AsiaThe original link:https:https://www.pharmafocusasia.com/news/histoindex-announces-global-partnerships-to-expand-ai-based-digital-pathology-platform2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact：AnnPhone: 021-65650305Email：Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934 -
1030
Gilead and Glympse Bio Announce Strategic Collaboration for Use of Biomarker Technology in NASH Clinical Development
Gilead and Glympse Bio Announce Strategic Collaboration for Use of Biomarker Technology in NASH Clinical DevelopmentTUESDAY, OCTOBER 29, 2019Gilead Sciences Inc. and Glympse Bio, Inc., today announced that the companies have entered into a strategic collaboration in nonalcoholic steatohepatitis (NASH) clinical development. Glympse Bio’s proprietary synthetic biomarkers – bioengineered to identify stage and progression of disease as well as early detection of treatment response – will be used to determine clinical trial participants’ stage of disease at initial screening and to determine responses to study treatment in Gilead’s NASH clinical program.“We are excited about the opportunity to partner with Glympse Bio to help inform our NASH development program,” said Mani Subramanian, MD, PhD Senior Vice President, Liver Diseases, Gilead Sciences. “By utilizing this innovative technology, we hope to better characterize this complex disease and improve our understanding of how our compounds impact disease progression.”Glympse Bio’s proprietary technology, Glympse Inside™, combines synthetic biomarkers with machine learning approaches to identify the stage and monitor progression of important, complex diseases such as cancer, fibrosis, inflammation, and infections, in real time.“We are very excited about partnering with Gilead, a leader in drug development, to help drive earlier and more favorable outcomes for patients,” said Caroline J Loew, President and CEO, Glympse Bio. “Gilead’s commitment to developing innovative medicines in areas of high unmet medical need aligns with our mission of transforming disease detection and measuring treatment response, all with the goal of helping improve the lives of patients.”information source:pharma focus AsiaThe original link:https:https:https://www.pharmafocusasia.com/news/gilead-and-glympse-bio-announce-strategic-collaboration-for-use-of-biomarker-technology-in-nash-clinical-development2019 Asia-pacific pharma IP Leader Summit:http://en.zenseegroup.com/p/510934/ will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact：AnnPhone: 021-65650305Email：Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934 -
1031
Gotham Therapeutics Establishes Advanced Oncology Profiling Cascade with ProQinase to Progress its Portfolio of Epitranscriptomic Drug Candidates
Gotham Therapeutics Establishes Advanced Oncology Profiling Cascade with ProQinase to Progress its Portfolio of Epitranscriptomic Drug CandidatesWEDNESDAY, OCTOBER 30, 2019Gotham Therapeutics, a biotechnology company developing a novel drug class targeting RNA-modifying proteins, and ProQinase, an early stage drug-discovery company, recently acquired by Malvern/PA-based Reaction Biology Corp., today announced that they have established an array of advanced biochemical and cellular assays to characterize epitranscriptomic-directed compounds.“Establishing tailored target engagement, cell biology, phenotypic, and in-vivo assays to evaluate compounds originating from our three most advanced epitranscriptomic programs in parallel is a crucial next step to develop our broad pipeline towards the clinic,” said Dr. Gerhard Müller, Chief Scientific Officer of Gotham Therapeutics. “By pursuing the full range of the reader-writer-eraser continuum, we are able to focus on targets with the most compelling links to disease and advance those programs in tandem.”“Combining our high proficiency in providing customized solutions as early stage drug-discovery services, including tailor-made biochemical and cell-based assays, with Gotham’s expertise in epitranscriptomics, we were able to establish in a very short time a set of customized enzymatic and cellular assays for compounds addressing three different mRNA-modifying targets,” said Dr. Sebastian Dempe, Chief Executive Officer of ProQinase. “We look forward to supporting Gotham as the company advances its programs into lead optimization and to continued work with the Gotham team assisting the company to advance its broad pipeline in a time-effective manner.”In addition to establishing a tailor-made profiling cascade for compounds from its three most advanced programs, Gotham has also made progress in strengthening its drug discovery engine and developing its candidate base. Gotham previously completed the gene-to-lead phase for its drug discovery project targeting the METTL3/METTL14 complex and established a robust discovery process as a platform for future projects. The company has also generated a library of high-quality compounds tailor-made for accelerated hit generation and hit-to-lead expansion against large parts of the epitranscriptomic target space. This library includes a collection of over 2,000 analogues covering over 80 distinct chemotypes that will be used to further accelerate Gotham’s drug discovery efforts as it expands its pipeline.The original link:https://www.pharmafocusasia.com/news/gotham-therapeutics-establishes-advanced-oncology-profiling-cascade-with-proqinase-to-progress-its-portfolio-of-epitranscriptomic-drug-candidates2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/will be held in Beijing on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact：AnnPhone: 021-65650305Email：Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934 -
1223
United Airlines to pay $321,000 to settle sexual harassment case
From:businessinsuranceUnited Airlines Inc. will pay $321,000 plus attorneys fees to settle a sexual harassment lawsuit filed by the U.S. Equal Employment Opportunity Commission that charged a United captain sexually harassed a flight attendant for many years, the agency said Friday.The EEOC said the captain frequently posted explicit images of the flight attendant to multiple websites without her consent, referring to her name, home airport and the airlines’ tagline, “Fly the Friendly Skies.”It said also the images were seen by her co-workers as well as “untold numbers” of potential passengers, causing her humiliation and embarrassment and adversely affecting her work environment.The EEOC said the Chicago-based airline failed to prevent and correct the pilot’s behavior although the flight attendant had made numerous complaints and provided substantial evidence in the matter.The EEOC said the pilot was allowed to retire with benefits despite the initiation of a criminal prosecution by the U.S. attorneys office under federal internet stalking laws.According to a 2018 news report, after the pilot confessed and pleaded guilty and accepted a 41-month prison sentence, United placed him on long-term disability.The agency, which filed its lawsuit in the case in 2018, had charged the airline with violating Title VII of the Civil Rights Act of 1964.Under the consent decree resolving the case, in addition to paying the flight attendant $321,000 and attorney’s fees, United must revise its sexual harassment policies to explicitly include harassment conduct perpetrated through the internet or social media, whether on or off duty, that affects the work environment,Robert A. Canino, regional attorney of the EEOC’s Dallas District, said in the statement, “This case highlights the issues of employer accountability for harassment in the modern workplace.“Employee workdays and jobsites are no longer defined by timecards and the walls of a building, but by the breadth of a digital day and the reach of electronic communications.“The policy United has agreed to implement can perhaps serve to provide ideas for other companies adapting to the increased risks posed by employee misuse of technology.”United Airlines said in a statement, “The pilot’s actions were reprehensible, and he is no longer a United employee. We have a zero-tolerance policy for any type of harassment in the workplace and expect our employees to treat each other with dignity and respect.“We strongly disagree with the EEOC’s allegations and will continue to reinforce the procedures and training we have in place to protect our employees from sexual harassment.”The EEOC said Wednesday that Uber Technologies Inc. will establish a $4.4 million fund to compensate anyone whom the agency determines experienced sexual harassment and/or related retaliation at the company after Jan. 1, 2014.Organizer：China Insurance Digital & AI Development 2020Web:http://en.zenseegroup.com/p/560573/Contact:Ann 021-65650305
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