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Oral Dose Articles & Analysis

38 news found

Biopharma Stock News Bite - Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) Spikes on News Potential Treatment for Alcohol Use Disorder

Biopharma Stock News Bite - Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) Spikes on News Potential Treatment for Alcohol Use Disorder

According to the publication, low-dose AD04 did not significantly change biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin. Additionally, while patients with AUD displayed elevated GGT levels, typically associated with increased alcohol consumption, this parameter remained unaffected by low-dose AD04. Additionally, no significant adverse ...

ByInvestorideas.com


Novel Drug Delivery System Unveiled: CD Formulation Launches Oral Thin Films Technology   

Novel Drug Delivery System Unveiled: CD Formulation Launches Oral Thin Films Technology  

Oral Thin Film Technology is a user-friendly drug delivery method involving the placement of a thin film strip in the oral cavity, where it quickly dissolves and releases medication directly into the bloodstream. ...

ByCD Formulation


Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment of Attention Deficit Hyperactivity Disorder

Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment of Attention Deficit Hyperactivity Disorder

Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada. ...

ByTris Pharma, Inc.


Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDU (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer

Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDU (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer

This therapy targets the ESR1 mutations in metastatic breast cancer and provides patients with a convenient oral once-daily dose.” “Each year 300,000 Americans are diagnosed with breast cancer and metastatic breast cancer causes the vast majority of deaths from the disease: more than 43,000 annually. ...

ByThe Menarini Group


Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD

Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD

” Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, no currently available medications offer a single oral dose that provides patients entire active-day efficacy. This Phase 3 trial is being conducted in an Adult Laboratory Setting (ALS) which has been used extensively ...

ByCingulate


Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease

(“Inversago”), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD). ...

ByInversago Pharma


Onconova Therapeutics Announces Plans For A Phase 1/2a Trial Of Narazaciclib Combined With Letrozole In Endometrial Cancer, Reports Third Quarter 2022 Financial Results, And Provides A Business Update

Onconova Therapeutics Announces Plans For A Phase 1/2a Trial Of Narazaciclib Combined With Letrozole In Endometrial Cancer, Reports Third Quarter 2022 Financial Results, And Provides A Business Update

Both narazaciclib and letrozole will be administered orally with a continuous daily dosing schedule in the trial, which will begin with a Phase 1 dose escalation phase before moving to a Phase 2 expansion cohort designed to enroll approximately 30 patients. ...

ByTraws Pharma


FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

“LYTGOBI is an effective, well-tolerated therapy for patients with intrahepatic CCA that can be taken orally,” said Tim Whitten, President and CEO of Taiho Oncology, Inc. ...

ByTaiho Oncology, Inc.


Cingulate Presents Data for Its Triple-Release Buspirone Product Candidate: CTx-2103

Cingulate Presents Data for Its Triple-Release Buspirone Product Candidate: CTx-2103

” In the study, the pharmacokinetics were evaluated for three multi-layered, timed-release oral tablets and one immediate release dose of buspirone. Scintigraphic imaging visualized transit of the tablets through the gastrointestinal tract to confirm both the site and onset of release, which will then be correlated with pharmacokinetic data to establish ...

ByCingulate


Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian

Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian

Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain. (PACIFIC-STROKE), https://www.clinicaltrials.gov/ct2/show/NCT04304508 Study to ...

ByBayer AG


CD Formulation Expands Its Service Portfolio for Drug Delivery Research

CD Formulation Expands Its Service Portfolio for Drug Delivery Research

With the advance of modern medicine, now a wide range of innovative drug delivery systems have been developed and applied, such as oral controlled release systems, fast dispersing dosage forms, taste-masking systems, and site-specific delivery systems,” said the Marketing Chief of CD Formulation. ...

ByCD Formulation


Starton Therapeutics Reports Positive Results from Phase 1 Study Evaluating STAR-LLD, Continuous Delivery Lenalidomide

Starton Therapeutics Reports Positive Results from Phase 1 Study Evaluating STAR-LLD, Continuous Delivery Lenalidomide

The Phase 1 study met all of its primary and secondary endpoints; in all subjects dosed with STAR-LLD, the plasma lenalidomide concentration (AUC) was 57% lower with STAR-LLD continuous subcutaneous (SC) delivery compared to once-daily Revlimid oral delivery. ...

ByStarton Therapeutics


Rani Therapeutics Unveils High-Capacity RaniPill Device for Oral Delivery of Biologics

Rani Therapeutics Unveils High-Capacity RaniPill Device for Oral Delivery of Biologics

Rani Therapeutics Holdings, Inc. recently announced the development of a high-capacity oral biologics device known as the RaniPill HC (High Capacity), capable of delivering up to a 500%-plus higher drug payload than Rani’s existing oral biologics capsule. ...

ByRani Therapeutics


Starton Therapeutics Announces Approval to Proceed with Final Dose Escalation in Phase 1 Clinical Study Evaluating STAR-LLD

Starton Therapeutics Announces Approval to Proceed with Final Dose Escalation in Phase 1 Clinical Study Evaluating STAR-LLD

Eight subjects in the first two cohorts received 24 hours of STAR-LLD continuous lenalidomide, and a single oral dose of lenalidomide after a 24 hour washout period. “The Phase 1 study evaluated STAR-LLD bioavailability, safety, and pharmacokinetics,” said Jamie Oliver. ...

ByStarton Therapeutics


Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress

Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress

The AURORA 2 study assessed long-term safety and tolerability of voclosporin compared to placebo (both taken in combination with mycophenolate mofetil (MMF) and low-dose oral steroids) in patients with LN receiving treatment for an additional 24 months following completion of one year on treatment in the AURORA 1 study. ...

ByAurinia Pharmaceuticals Inc.


Inversago Pharma presents data on INV-202 in Diabetic Nephropathy at the ERA 2022 Congress

Inversago Pharma presents data on INV-202 in Diabetic Nephropathy at the ERA 2022 Congress

In particular, there was a marked, dose-dependent reduction in albuminuria in this model of diabetes and associated kidney injury. ...

ByInversago Pharma


Locus Biosciences Announces $35 Million Financing

Locus Biosciences Announces $35 Million Financing

In addition, funds will support the expansion of Locus’ discovery platform engine and enhancement of its in-house manufacturing capability to support oral solid dose delivery of its products. “Locus’ novel scientific approach has the potential to fundamentally change the way bacterial diseases are treated. ...

ByLocus Biosciences, Inc.


Starton Therapeutics Provides Update on STAR-LLD Lenalidomide Clinical Program

Starton Therapeutics Provides Update on STAR-LLD Lenalidomide Clinical Program

Four subjects in the first cohort received 24 hours of STAR-LLD continuous lenalidomide, and a single oral dose of lenalidomide after a 24 hour washout period. The Independent Data Monitoring Committee reviewed the totality of the safety data from the first cohort and recommended advancement to Part B, where subjects will receive the second-highest of three ...

ByStarton Therapeutics


Report On Activities For The Quarter Ended 31 March 2022

Report On Activities For The Quarter Ended 31 March 2022

The latest data, reported on 17 March 2022, demonstrated that BIT225 protected against COVID related death in K18 transgenic mice (a strain generated to be infectable with SARS-CoV-2, resulting in severe COVID) that were infected with a lethal dose of the virus. Control mice that were not dosed with BIT225 all died by Day 8 post-infection with SARS-CoV-2 from ...

ByBiotron Limited


Jubilant Therapeutics Inc. reports isoform-selective PAD4 inhibitors demonstrating high In Vitro selectivity and potency and In Vivo oral bioavailability and anti-tumor activity

Jubilant Therapeutics Inc. reports isoform-selective PAD4 inhibitors demonstrating high In Vitro selectivity and potency and In Vivo oral bioavailability and anti-tumor activity

Jubilant Therapeutics Inc’s drug discovery platform created a number of lead molecules with b in vitro potency and high selectivity to PAD4 compared to PAD1, PAD2 or PAD3. Oral dosing with a mouse breast cancer model resulted in approximately 50% tumor growth inhibition versus approximately 35% with anti-PD1 antibody and was well tolerated. ...

ByJubilant Therapeutics Inc.

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