Preclinical development

The Worldwide Clinical Trial Industry is Expected to Reach a Value of $57+ Billion by 2026 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 22, 2021
Health, Clinical trials, Clinical research, Health sciences, Health, Medical research, Pharmaceutical industry, Drug discovery, Food and Drug Administration, Design of experiments, Clinical trial, Investigational New Drug, Preclinical development, Drug development

Research centers and numerous organizations enhance clinical trials' productivity and effectiveness by advancing and managing clinical trials globally.

Key Points: 
  • Research centers and numerous organizations enhance clinical trials' productivity and effectiveness by advancing and managing clinical trials globally.
  • After preclinical development, the investigational new drug passes through clinical phases I, II, III, and IV during the clinical trial.
  • It expected that the Global Clinical Trials Market will expand, registering a CAGR of 14.13% during the forecast period, 2020-2026.
  • North America is a conventional clinical trial region, and because of the legal, regulatory considerations, the clinical trial market shifted to developing nations.

Bioasis Technologies Inc. Announces Stock Option Grants, Jeffrey Sprouse Appointed Preclinical Program Manager

Retrieved on: 
Tuesday, July 20, 2021
Drug discovery, Pharmaceutical industry, Preclinical development, Sprouse

NEW HAVEN, Conn., July 20, 2021 (GLOBE NEWSWIRE) -- BIOASIS TECHNOLOGIES INC. (TSXV:BTI; OTCQB:BIOAF), (the “Company” or “Bioasis”), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3™ platform technology for the delivery of therapeutics across the blood-brain barrier (“BBB”) and the treatment of central nervous system (“CNS”) disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, today announced that it has granted stock options to acquire a total of 1,367,606 common shares effective June 30, 2020 at a price of $0.38 per share to directors and officers of the Company and an investor relations consultant. All of the options expire five years from the date of the grant and are governed by the terms of the company’s stock option plan. The options are being issued as part of annual remuneration in lieu of cash compensation as the company prioritizes investment in partnership enhancing R&D.

Key Points: 
  • All of the options expire five years from the date of the grant and are governed by the terms of the companys stock option plan.
  • The company also announced the appointment of Dr. Jeffrey Sprouse PhD as Preclinical Program Manager.
  • Dr. Sprouse brings over 20 years of drug discovery experience to his role at Bioasis.
  • Since 2010, Dr. Sprouse has served as an industry consultant, managing all aspects of preclinical programs.

InVivo Therapeutics Announces FDA Acceptance of Preclinical Module in Support of Company’s Complete HDE Submission

Retrieved on: 
Tuesday, July 13, 2021
Health, FDA, Medical devices, Clinical trials, Research, Science, Biotechnology, Pharmaceutical industry, Health sciences, Drug discovery, Preclinical development, Food and Drug Administration, Module, Health

Acceptance of the module indicates that FDA has completed its review of this module of the HDE and has no outstanding questions.

Key Points: 
  • Acceptance of the module indicates that FDA has completed its review of this module of the HDE and has no outstanding questions.
  • The FDA previously approved the Companys proposed HDE modular shell submission and review process for the Neuro-Spinal Scaffold implant.
  • The HDE modular shell is comprised of three modules: the preclinical studies module, a manufacturing module and a clinical data module.
  • The preclinical module is the first module that the Company has submitted for review to the FDA.

Selvita scales its operations with the construction of new research space

Retrieved on: 
Monday, July 12, 2021
Pharmaceutical industry, Drug discovery, Administrative divisions, Preclinical development, Zagreb, Geography of Europe, Geography

The new facility will add much needed research capacity and allow for scale-up of business operations as well as expansion of services offer.

Key Points: 
  • The new facility will add much needed research capacity and allow for scale-up of business operations as well as expansion of services offer.
  • Selvita Research Centre will be created in the neighborhood of the current company HQ.
  • Selvita is a preclinical Contract Research Organization providing multidisciplinary support in resolving theunique challenges of research within area of drug discovery, regulatory studies, as well as research anddevelopment.
  • Selvita is headquartered in Krakow, Poland, with a second research site in Poznan, Poland, while Fidelta is located in Zagreb, Croatia.

Pharnext Announces First Patient Enrolled in Europe in the PREMIER Trial, its Pivotal Phase III Clinical Study of PXT3003 in Charcot-Marie-Tooth Disease Type 1A ('CMT1A')

Retrieved on: 
Monday, July 12, 2021
Health sciences, Pharmaceutical industry, Drug discovery, Life sciences, Health, Clinical research, Design of experiments, Clinical trial, Preclinical development, CHARCOT-MARIE-TOOTH DISEASE TYPE 1A ('CMT1A'), PXT3003, THE PREMIER TRIAL, PHARNEXT

Pharnext Announces First Patient Enrolled in Europe in the PREMIER Trial, its Pivotal Phase III Clinical Study of PXT3003 in Charcot-Marie-Tooth Disease Type 1A ('CMT1A')

Key Points: 
  • Pharnext Announces First Patient Enrolled in Europe in the PREMIER Trial, its Pivotal Phase III Clinical Study of PXT3003 in Charcot-Marie-Tooth Disease Type 1A ('CMT1A')
    Dissemination of a French Regulatory News, transmitted by EQS Group.
  • The main objectives of the PREMIER trial are to evaluate the safety and efficacy of PXT3003 for the treatment of CMT1A.
  • PXT3003 has shown promising and consistent results across preclinical and clinical studies in Phase II and Phase III (PLEO-CMT and PLEO-CMT-FU).
  • An international pivotal Phase III study of PXT3003 in CMT1A, the PREMIER trial, is currently ongoing.

Awakn Establishes Separate Preclinical and Clinical Expert Advisory Boards to Optimize Delivery of Its Expanding Development Pipeline

Retrieved on: 
Wednesday, July 7, 2021
Drug discovery, Pharmaceutical industry, Life sciences, Preclinical development, Drug development, Natural sciences

Awakn's Chief Research Officer Prof. David Nutt Will Chair Both Advisory Boards with Prof. Stephen Husbands, Prof. Harriet De Wit, and Prof. Kevin Fone Joining the Preclinical Advisory Board

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - July 7, 2021) - Awakn Life Sciences Corp. (NEO: AWKN) (Awakn), a biotechnology company with clinical operations developing and delivering psychedelic medicines to better treat Addiction, announced today that it will establish separate preclinical and clinical expert advisory boards to add to its existing Scientific Advisory Board's capabilities, to optimize delivery of its expanding development pipeline.
  • Awakns new clinical and preclinical boards will ensure that Awakn adopts and delivers optimum strategies to bring new therapeutic paradigms to market rapidly.
  • These pioneering boards consist of leading preclinical and clinical experts in the fields of drug discovery, psychedelic drug development and clinical trials.
  • Awakn is delighted to announce the addition of Prof. Stephen Husbands, Prof. Harriet de Wit, and Prof. Kevin Fone to the Preclinical Advisory board.

Global Medical Device Testing Services Markets 2021-2028: Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Test, Package Validation, Phase - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 30, 2021
Medical devices, Health, Contemporary history, Health, Pharmaceutical industry, Medical device, COVID-19 pandemic, Preclinical development

The global medical device testing services market size is expected to reach USD 18.6 billion by 2028.

Key Points: 
  • The global medical device testing services market size is expected to reach USD 18.6 billion by 2028.
  • A significant rise in preclinical spending is a recent trend among pharmaceutical and medical device companies, which is expected to significantly contribute to market growth.
  • The COVID-19 pandemic has created an unprecedented demand for medical device testing services in 2020.
  • This is due to the rising demand for medical devices in developing nations such as India and China

Valbiotis Announces the Implementation of the TOTUM•63 Mode of Action Clinical Study by INAF1 at Laval University in Quebec City, in Partnership With Nestlé Health Science

Retrieved on: 
Monday, June 28, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical trials, Other Health, Drug discovery, Pharmaceutical industry, Preclinical development

This collaboration is an undeniable asset for the completion of TOTUM63 development under the global strategic partnership with Nestl Health Science.

Key Points: 
  • This collaboration is an undeniable asset for the completion of TOTUM63 development under the global strategic partnership with Nestl Health Science.
  • The TOTUM63 mode of action clinical study will explore, in humans, the main mode of action hypotheses resulting from preclinical work.
  • This is what we will explore in humans, with this study on the mode of action of TOTUM63.
  • In February 2020, Valbiotis signed a long-term global strategic partnership with Nestl Health Science for the development and worldwide commercialization of TOTUM63.

Epredia And Aiforia Announce Partnership For Global Distribution Of AI-powered Pathology Software

Retrieved on: 
Monday, June 21, 2021
Life sciences, Drug discovery, Pharmaceutical industry, Natural sciences, Biology, Digital pathology, Microscopy, Pathology, Clinical pathology, Drug development, Preclinical development

Under the terms of this agreement, Epredia has been appointed as a global distribution partner for Aiforia's portfolio of preclinical and clinical pathology tools, including segment exclusivity for distribution in Japan, Germany, UK, Italy, Spain, Sweden, Norway, Denmark, Iceland, France and the USA.

Key Points: 
  • Under the terms of this agreement, Epredia has been appointed as a global distribution partner for Aiforia's portfolio of preclinical and clinical pathology tools, including segment exclusivity for distribution in Japan, Germany, UK, Italy, Spain, Sweden, Norway, Denmark, Iceland, France and the USA.
  • From Summer 2021, Epredia will begin to commercialize the Aiforia portfolio of AI solutions.
  • These solutions will be available as part of Epredia's comprehensive digital pathology portfolio that already features the best-in-class CE-marked 3DHistech P1000 WSI scanner*.
  • Their solutions aim to enhance the speed and accuracy of pharmaceutical drug development and cancer diagnostics using intuitive, AI-powered software.

Epredia And Aiforia Announce Partnership For Global Distribution Of AI-powered Pathology Software

Retrieved on: 
Monday, June 21, 2021
Life sciences, Drug discovery, Pharmaceutical industry, Natural sciences, Biology, Digital pathology, Microscopy, Pathology, Clinical pathology, Drug development, Preclinical development

Under the terms of this agreement, Epredia has been appointed as a global distribution partner for Aiforia's portfolio of preclinical and clinical pathology tools, including segment exclusivity for distribution in Japan, Germany, UK, Italy, Spain, Sweden, Norway, Denmark, Iceland, France and the USA.

Key Points: 
  • Under the terms of this agreement, Epredia has been appointed as a global distribution partner for Aiforia's portfolio of preclinical and clinical pathology tools, including segment exclusivity for distribution in Japan, Germany, UK, Italy, Spain, Sweden, Norway, Denmark, Iceland, France and the USA.
  • From Summer 2021, Epredia will begin to commercialize the Aiforia portfolio of AI solutions.
  • These solutions will be available as part of Epredia's comprehensive digital pathology portfolio that already features the best-in-class CE-marked 3DHistech P1000 WSI scanner*.
  • Their solutions aim to enhance the speed and accuracy of pharmaceutical drug development and cancer diagnostics using intuitive, AI-powered software.