Design of experiments

Kintor Pharmaceutical Announced FDA Has Greenlighted Pyrilutamide's Phase II Clinical Trial for Androgenetic Alopecia in the US

Retrieved on: 
Sunday, July 11, 2021
Health sciences, Health, Clinical research, Pharmaceutical industry, Life sciences, Drug discovery, Design of experiments, Clinical trial

SUZHOU, China, July 11, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited (HKEX:9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has greenlighted pyrilutamide's phase II clinical trial for androgenetic alopecia(AGA) to be conducted in the US.

Key Points: 
  • SUZHOU, China, July 11, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited (HKEX:9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has greenlighted pyrilutamide's phase II clinical trial for androgenetic alopecia(AGA) to be conducted in the US.
  • The phase II trial is a randomized, double-blind, vehicle-controlled, parallel group study, designed to evaluate the efficacy and safety of pyrilutamide in male subjects with AGA.
  • Dr. Tong Youzhi, the founder, chairman, and CEO of Kintor Pharmaceutical, commented, "We are delighted to receive the clearance from the US FDA for this phase II clinical trial of pyrilutamide in AGA Subjects.This has been the fifth clinical study sponsored by Kintor in the US.
  • The phase II clinical trial of pyrilutamide for the treatment of AGA in China is close to end, and we expect the data read-out in this quarter.

Cybin to Participate in Cowen’s Psychedelics & Novel Mechanisms in Neuropsychiatry Virtual Summit on July 13th

Retrieved on: 
Friday, July 9, 2021
Biotechnology, Mental health, Other Health, Health, Pharmaceutical, Health sciences, Clinical research, Health, Medical research, Design of experiments, Clinical trial, Drug discovery, Food and Drug Administration, Pharmacovigilance

Certain statements in this news release related to the Company are forward-looking statements and are prospective in nature.

Key Points: 
  • Certain statements in this news release related to the Company are forward-looking statements and are prospective in nature.
  • Cybin makes no medical, treatment or health benefit claims about Cybins proposed products.
  • Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials.
  • If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybins performance and operations.

Press release - Reinforcing the mandate for EU medicines regulator

Retrieved on: 
Thursday, July 8, 2021
Health sciences, Health, Life sciences, Clinical pharmacology, Pharmaceutical industry, Clinical research, Clinical trial, Design of experiments

On Thursday, Parliament adopted its position for negotiations with Council on extending the mandate of the European Medicines Agency and strengthening its role.

Key Points: 
  • On Thursday, Parliament adopted its position for negotiations with Council on extending the mandate of the European Medicines Agency and strengthening its role.
  • The new database would facilitate, on a permanent basis, access and exchange of information between the Agency and corresponding national authorities.
  • Moreover, we want to promote clinical trials for the development of vaccines and treatments, reinforcing public information about them.
  • With the new database, we also provide the Agency with a crucial tool to monitor medicines supply and prevent shortages at all times.

Prilenia’s Phase 3 Huntington’s Disease Clinical Trial Achieves 50% Enrollment

Retrieved on: 
Thursday, July 8, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Health sciences, Health, Huntington's disease, Pridopidine, Branches of biology, Clinical research, Pharmaceutical industry, Design of experiments, Huntingtons, Clinical trial

Prilenia Therapeutics B.V. , a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, has passed the milestone of 50% enrollment in its pivotal phase 3 Huntingtons Disease (HD - PROOF-HD ) trial.

Key Points: 
  • Prilenia Therapeutics B.V. , a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, has passed the milestone of 50% enrollment in its pivotal phase 3 Huntingtons Disease (HD - PROOF-HD ) trial.
  • The trial is investigating Prilenias lead candidate, pridopidine , for treatment of Huntingtons Disease.
  • The PROOF-HD clinical trial is enrolling patients across 60 sites in Europe and North America, in collaboration with the Huntingtons Study Group (HSG).
  • Dr. Andrew Feign, MD, North American Principal Investigator for the PROOF-HD Phase 3 trial, added: Rapidly achieving 50% enrolment shows great momentum as we push forward with recruitment for this Phase 3 clinical trial.

Dry Eye Disease Clinical Landscape Report 2021-2029 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 8, 2021
Pharmaceutical, Health, Optical, Health sciences, Life sciences, Health, Drug discovery, Food and Drug Administration, Pharmaceutical industry, Clinical research, Design of experiments, Novartis, Clinical trial

The "Market Spotlight: Dry Eye Disease" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Market Spotlight: Dry Eye Disease" report has been added to ResearchAndMarkets.com's offering.
  • The majority of industry-sponsored drugs in active clinical development for dry eye are in Phase II, with only one drug in the NDA/BLA phase.
  • Novartis has the highest number of completed clinical trials for dry eye, with 87 trials.
  • Novartis leads industry sponsors with the highest overall number of clinical trials for dry eye, followed by AbbVie.

Javara Appoints CTO to Deliver Digital Innovation to the Clinical Research Industry

Retrieved on: 
Wednesday, July 7, 2021
Health sciences, Health, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Food and Drug Administration, Pharmaceutical industry, Clinical

From 2010 to 2017, she worked for IQVIA, leading teams to deliver technology for global delivery networks for clinical trials and drive efficiencies for clinical research staff.

Key Points: 
  • From 2010 to 2017, she worked for IQVIA, leading teams to deliver technology for global delivery networks for clinical trials and drive efficiencies for clinical research staff.
  • Javara is the leading Integrated Research Organization (IRO) partnering with large healthcare organizations in local communities across the US to integrate clinical research into clinical care.
  • Our team includes experienced clinical research leaders who have collectively led 10,000+ trials and engaged 200,000+ patients in clinical trials.
  • As pioneers of Clinical Research as a Care Option (CRAACO), Javara is transforming healthcare and changing lives by connecting the right patients to the right trials at the right time.

Atossa Therapeutics Receives Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Retrieved on: 
Wednesday, July 7, 2021
Health sciences, Health, Clinical research, Design of experiments, Medical research, Drug discovery, Pharmaceutical industry, Clinical trials, Placebo-controlled study, COVID-19

If the initial parts of the study are successful we will study the efficacy of our proprietary AT-H201 on moderately ill COVID-19 patients who can be treated via a nebulizer.

Key Points: 
  • If the initial parts of the study are successful we will study the efficacy of our proprietary AT-H201 on moderately ill COVID-19 patients who can be treated via a nebulizer.
  • Up to one third of hospitalized patients have pulmonary function changes 60 days or more after recovering from COVID.
  • The Phase 1/2a placebo-controlled study will enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients.
  • The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized.

Citius Pharmaceuticals, Inc. Provides First Half 2021 Business Update, Highlights Upcoming Milestones

Retrieved on: 
Wednesday, July 7, 2021
Health sciences, Clinical research, Health, Design of experiments, Pharmaceutical industry, Drug discovery, Medical research, Medical statistics, Clinical trial, Mino

Whether Mino-Lok demonstratesstatistical superiority will only be known to us once the trial is finished and the data is unblinded.

Key Points: 
  • Whether Mino-Lok demonstratesstatistical superiority will only be known to us once the trial is finished and the data is unblinded.
  • "Mino-Lok trial patients represent an extremely ill population, which is challenging to enroll under the best of circumstances.
  • Like many clinical trials conducted during the pandemic, the timeline for our study has been impacted by COVID-19.
  • During the first half of 2021, we raised more than $127 million, of which approximately $17 million was from warrants exercised since March 31, 2021.

Suvoda Announces the Expansion of its Leadership Team to Support Worldwide Growth

Retrieved on: 
Wednesday, July 7, 2021
Health sciences, Health, Clinical research, Pharmaceutical industry, Clinical pharmacology, Clinical trial, Design of experiments, Food and Drug Administration

CONSHOHOCKEN, Pa., July 7, 2021 /PRNewswire/ --Suvoda LLC, an innovator in clinical trial software, today announced the expansion of its leadership team with the appointments of E.K.

Key Points: 
  • CONSHOHOCKEN, Pa., July 7, 2021 /PRNewswire/ --Suvoda LLC, an innovator in clinical trial software, today announced the expansion of its leadership team with the appointments of E.K.
  • Suvoda scales to support increasingly complex clinical trials and the shift towards patient-centric decentralization.
  • As Chief Marketing Officer, Filimonova will drive worldwide brand and go-to-market strategy with targeted marketing initiatives to support Suvoda's business and growth goals.
  • "Suvoda is an exceptional company centered around a great team, innovative products, and an outstanding level of customer service.

CATO SMS Appoints President Of Clinical Trial Operations

Retrieved on: 
Wednesday, July 7, 2021
Health sciences, Health, Contract research organizations, Pharmaceutical industry, Life sciences, Clinical research, Clinical pharmacology, Clinical trial, Design of experiments, ERT, SMS

CARY, N.C., June 7, 2021 /PRNewswire/ --CATO SMS, a global provider of specialized clinical research solutions, announced today that it has appointed Robert Millham to president of clinical trial operations.

Key Points: 
  • CARY, N.C., June 7, 2021 /PRNewswire/ --CATO SMS, a global provider of specialized clinical research solutions, announced today that it has appointed Robert Millham to president of clinical trial operations.
  • Mr. Millham brings to CATO SMS more than 20 years of leadership experience across global pharmaceutical, biotech and contract research organizations (CROs).
  • He has spearheaded scientific teams, clinical development programs and operations worldwide to drive the success of cancer therapeutics throughout his career.
  • CATO SMS is a provider of specialized clinical research solutions including regulatory consulting, clinical pharmacology, clinical trial operations and biometrics.