Clinical pharmacology

FDA Agrees with Galmed's Plan to use Aramchol Meglumine in the Randomized Double-Blind Placebo-Controlled Part of the Phase 3 ARMOR study

Retrieved on: 
Monday, August 2, 2021

Aramchol meglumine contains the same active pharmaceutical ingredient (API) called Aramchol.

Key Points: 
  • Aramchol meglumine contains the same active pharmaceutical ingredient (API) called Aramchol.
  • Exposure with once daily (QD) 383mg Aramchol meglumine oral dosage corresponds to that obtained with the existing twice daily (BID) 300mg Aramchol free acid form which is currently being evaluated in the Phase 3 ARMOR study.
  • This allows future development of the QD regimen with a potential improvement in convenience and adherence".
  • Our lead compound, Aramchol, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study.

Levitee Labs Acquires Three Specialized Alberta Pharmacies

Retrieved on: 
Thursday, July 29, 2021

Each of the Companies operates a pharmacy in Alberta specialized in filling prescriptions for medications used to treat people with substance use disorders, mental health conditions and chronic pain.

Key Points: 
  • Each of the Companies operates a pharmacy in Alberta specialized in filling prescriptions for medications used to treat people with substance use disorders, mental health conditions and chronic pain.
  • Purchasing these pharmacies was part and parcel to our strategy to be a vertically integrated company focused on substance abuse and chronic conditions, said Pouya Farmand, Chief Executive Officer at Levitee.
  • Adding three specialized pharmacies gives us a commanding position to serve Albertans in need, from curating treatment programs on-site or remotely to filling prescriptions and delivering them directly to patients homes.
  • Levitee Labs is establishing itself as a leader in the integrative wellness space.

Global Gallbladder Cancer Clinical Trials Review, H2 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 29, 2021

The "Gallbladder Cancer - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Gallbladder Cancer - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • "Gallbladder Cancer - Global Clinical Trials Review, H2, 2021" provides an overview of the Gallbladder Cancer Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Gallbladder Cancer.
  • Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
    The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
    The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
    Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials
    Facilitates clinical trial assessment of the indication on a global, regional and country level
    Clinical Trials by G7 Countries: Proportion of Gallbladder Cancer to Oncology Clinical Trials
    Clinical Trials by E7 Countries: Proportion of Gallbladder Cancer to Oncology Clinical Trials

Global Alopecia Clinical Trials Review, H2 2021 Research Report - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 29, 2021

The "Alopecia - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Alopecia - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • "Alopecia - Global Clinical Trials Review, H2, 2021" provides an overview of the Alopecia Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Alopecia.
  • Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
    The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
    The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
    Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials
    Facilitates clinical trial assessment of the indication on a global, regional and country level
    Clinical Trials by G7 Countries: Proportion of Alopecia to Dermatology Clinical Trials
    Clinical Trials by E7 Countries: Proportion of Alopecia to Dermatology Clinical Trials

Global Graves' Ophthalmopathy Disease Clinical Trials Review: H1, 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 29, 2021

Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status

Key Points: 
  • Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
    The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
    The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
    Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials
    Facilitates clinical trial assessment of the indication on a global, regional and country level

'What the Health?': The Drug Price Dilemma

Retrieved on: 
Friday, July 30, 2021

That is because the dilemma faced by many Americans is the struggle of paying the price for filling their prescriptions.

Key Points: 
  • That is because the dilemma faced by many Americans is the struggle of paying the price for filling their prescriptions.
  • Among other G7 nations the UK, France, and Italy have the lowest prescription drug prices.
  • Canada's drug prices are higher, but still considerably less than the cost for the same medications in the USA.
  • That improved access has yet to be seen, and so the dilemma of figuring out ways to afford prescription medication continues for many Americans.

Optinose Announces Preliminary Second Quarter 2021 XHANCE Net Revenue of $18.4 Million

Retrieved on: 
Wednesday, July 28, 2021

YARDLEY, Pa., July 28, 2021 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced preliminary XHANCE® (fluticasone propionate) net product revenue of $18.4 million for the three months ended June 30, 2021. This represents a 79% increase compared to the three months ended June 30, 2020, and a 67% increase compared to the three months ended March 31, 2021. The Company expects XHANCE net product revenue for the full year of 2021 to be at least $80 million.

Key Points: 
  • The Company expects XHANCE net product revenue for the full year of 2021 to be at least $80 million.
  • In addition, the number of XHANCE prescriptions increased by 33% from 62,500 in the second quarter 2020 to 82,900 in the second quarter 2021 based on third-party prescription data and data from XHANCE preferred pharmacy network partners.
  • XHANCE net revenue per prescription increased 35% from $164 in the second quarter 2020 to $221 in the second quarter 2021 based on preliminary second quarter net product revenue of $18.4 million.
  • We are pleased with the growth in demand for XHANCE and increased net product revenue per prescription based on preliminary second quarter net product revenue of $18.4 million, stated CEO Peter Miller.

Gencaro Atrial Fibrillation Phase 2B Results Selected for Publication in Circulation: Arrhythmia and Electrophysiology

Retrieved on: 
Wednesday, July 28, 2021

Cumulative 24-week AF burden was 24.4% (95% CI: 18.5, 30.2) for bucindolol and 36.7% (95% CI: 30.0, 43.5) for metoprolol (36% reduction, p =0.002).

Key Points: 
  • Cumulative 24-week AF burden was 24.4% (95% CI: 18.5, 30.2) for bucindolol and 36.7% (95% CI: 30.0, 43.5) for metoprolol (36% reduction, p =0.002).
  • AF burden is increasingly being recognized as a more sensitive measure of arrhythmia that is closely linked to key clinical outcomes.
  • In the GENETIC-AF Phase 2b clinical trial device substudy and in the entire trial cohort, Gencaro demonstrated favorable treatment effects compared to the comparator arm.
  • The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing.

THREAD and Almac Clinical Technologies Partner to Eliminate Common Clinical Trial Delays

Retrieved on: 
Wednesday, July 28, 2021

THREAD , a technology and service provider enabling decentralized clinical trials (DCTs), and Almac Clinical Technologies , a member of the contract and development organization, Almac Group , today announced a strategic partnership.

Key Points: 
  • THREAD , a technology and service provider enabling decentralized clinical trials (DCTs), and Almac Clinical Technologies , a member of the contract and development organization, Almac Group , today announced a strategic partnership.
  • Almacs IXRS solution and industry-leading services for randomization and clinical trial supply management will be available to THREAD customers and THREADs DCT solution will be available to Almac customers.
  • Were thrilled to be working with THREAD, an acknowledged leader in DCT technology, said George Tiger, vice president of Global Business Development, Almac Clinical Technologies.
  • Our solutions facilitate more than simplifying patient and trial material management they engineer quality into the clinical trial process.

Global Academic Research Organization UCL Selects Phlexglobal's Innovative eTMF Solution to Enhance TMF Compliance and Inspection-Readiness Across Entire Study Portfolio

Retrieved on: 
Wednesday, July 28, 2021

PhlexTMF will support the entire portfolio at UCL's Institute of Clinical Trials and Methodology (ICTM), a pre-eminent center for clinical trials and amongst the largest of its kind in Europe.

Key Points: 
  • PhlexTMF will support the entire portfolio at UCL's Institute of Clinical Trials and Methodology (ICTM), a pre-eminent center for clinical trials and amongst the largest of its kind in Europe.
  • The decision by the UCL team followed a comprehensive tendering process with Phlexglobal appointed as the preferred bidder to help UCL streamline TMF management and oversight while reducing cost and risk.
  • "We're honored that a highly respected research organization like UCL selected Phlexglobal for their eTMF solution," said John McNeill, Chief Executive Officer of Phlexglobal.
  • The Institute of Clinical Trials and Methodology at UCL is a centre of excellence for clinical trials, meta analysis and epidemiological studies.