pharmaphorum

AUGUST 19, 2022

Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. Along with knee osteoarthritis, Grünenthal also plans to test resiniferatoxin in other joints affected by the condition.

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Drugs Bioavailability Trials Clinical Development 52

pharmaphorum

NOVEMBER 9, 2022

If these mitochondrial therapeutics were to be successful in clinical trials, they would be the first disease-modifying medicine to actually prevent or delay progression of these diseases. Currently, the treatments available only provide management of symptoms of chronic neurodegenerative disorders.

In-Vitro 52

In-Vitro Bioavailability Medicine Clinical Trials 52

pharmaphorum

JANUARY 29, 2021

Lilly is paying $20 million upfront for exclusive rights to AK1780, a P2X7 receptor antagonist in early-stage clinical development for neuroinflammatory pain conditions, outside Japan and China. While tanezumab is an antibody and has to be delivered by subcutaneous injection, AK1780 is orally bioavailable.

Licensing 52

Licensing Licensing Bioavailability Antibody 52

Pharmaceutical Technology

OCTOBER 25, 2022

Dosing is not left up to physicians; it is built into the FDC product and based on clinical trial results. Furthermore, compared to the cost of developing a new API, substantial savings can be realised when developing an FDC comprised of previously approved new chemical entities or their generic counterparts.

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XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Additionally, the clinical trials underscored the favorable tolerability profile of Vevye.

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Gene Silencing Drug Delivery FDA Approval RNA 88

Pharmaceutical Technology

FEBRUARY 13, 2023

By associating molecular properties with in-silico absorption, distribution, metabolism, excretion, and toxicity (ADMET) models, we can significantly increase the robustness of candidate selection, which subsequently reduces the failure rate during clinical trials.

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Development In-Vivo Drugs Clinical Trials 130

XTalks

APRIL 11, 2023

By avoiding the stomach entirely, there is increased bioavailability and more sustained relief from symptoms. ND0612 is currently in Phase III of clinical development and is supported by four years of safety data.

Bioavailability 97

Bioavailability Genetics Nurses Development 97

XTalks

MAY 23, 2024

XTALKS WEBINAR: Enhancing Efficiency in Early-Phase Oncology Trials: Strategies for Accelerating Data Flow Live and On-Demand: June 24, 2024, at 11am EDT (4pm BST/UK) Register for this webinar today to gain insights into how you can navigate and overcome data flow challenges in early-phase oncology clinical trials.

Life Science 72

Life Science Dermatology Drug Delivery Systems Medicine 72

The Pharma Data

OCTOBER 21, 2020

Company is on t rack to s ubmit an IND in the fourth quarter of 2020 and i nitiate a Phase 1 /2 clinical trial for advanced solid tumors in 2021. We designed KB-0742 to be an orally bioavailable CDK9 inhibitor with a differentiated selectivity profile,” said Norbert Bischofberger, Ph.D., SAN MATEO, Calif., and CAMBRIDGE, Mass.,

In-Vivo 40

In-Vivo In-Vitro Bioavailability Clinical Trials 40

Delveinsight

JULY 30, 2020

The pharma players are evaluating their pipeline candidates in different stages of clinical development. A novel, brain penetrant, orally bioavailable and selective PPAR? Adrenoleukodystrophy Pipeline. Adrenoleukodystrophy pipeline therapies comprise Lenti D , leriglitazone , MGTA-456 , MD1003 , OP-101 , SOM1201 and others.

Hormones 52

Hormones Marketing Gene Trials 52

The Pharma Data

NOVEMBER 19, 2020

These compounds have demonstrated high potency in inhibiting the activity of the M pro protease as well as promising oral bioavailability and blood plasma levels in animal studies. Several compounds are being further optimized for preclinical studies. Details can be found at this link.

Development 40

Development Bioavailability Production Drugs 40

The Pharma Data

MARCH 8, 2021

We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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Trials In-Vivo Genotoxicity RNA 69

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.

Clinical Trials 52

Clinical Trials Clinical Trials Bioavailability Trials 52

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). by sex, age or by genetic variations).

Clinical Trials 57

Clinical Trials Clinical Trials Development Drugs 57