Outsourcing Pharma

JANUARY 24, 2023

Evidence shows that animal models currently dominating bioavailability estimates are poor predictors and human, cell-based multi-organ microphysiological systems (MPS) should be investigated, CN Bio says.

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Pharmaceutical Technology

OCTOBER 25, 2022

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Developing and manufacturing FDCs factors to consider.

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XTalks

OCTOBER 2, 2024

With positive outcomes in preclinical models, EB-003 has confirmed oral bioavailability, adding to its therapeutic potential. Enveric is set to file an Investigational New Drug (IND) application by the third quarter of 2025, with plans to start clinical development by the end of the year.

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Research Bioavailability Trials Hormones 52

pharmaphorum

AUGUST 19, 2022

Development of TRPV1 agonists for pain isn’t a new concept, but many first-generation drugs were beset by safety issues – notably Amgen’s AMG517 and Merck & Co’s MK2295 – while AstraZeneca’s candidate AZD1386 made it into phase 2 in osteoarthritis but failed to show efficacy.

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Drugs Bioavailability Trials Clinical Development 52

The Pharma Data

NOVEMBER 19, 2020

Structure-based design approach has identified potent compounds for further development as oral treatments for SARS-CoV-2 infection and related human coronaviruses. This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products.

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Pharmaceutical Technology

JUNE 26, 2022

As every molecule and development program is unique, there is no single drug substance synthesis and manufacturing solution, so understanding what processes and technologies are available, what strategy is best, and who to partner with is key. . Important considerations for drug substance development. Polymorphic form issues.

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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.

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Licensing Licensing Bioavailability Antibody 52

pharmaphorum

NOVEMBER 9, 2022

A pre-clinical pipeline of potential first-in-class brain-penetrant small molecule inhibitors of the mitochondrial permeability pore (mPTP) are to be developed. A £16 million Series A financing – led by Omega Funds – has been announced by the innovative neuroscience company NRG Therapeutics Ltd.,

In-Vitro 52

In-Vitro Bioavailability Medicine Clinical Trials 52

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. Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology.

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Gene Silencing Drug Delivery FDA Approval RNA 88

XTalks

APRIL 11, 2023

Most people typically develop Parkinson’s disease after the age of 60, and early onset forms of Parkinson’s disease are often inherited, though some forms may be linked to genetic mutations or exposure to environmental toxins like pesticides. Anticholinergic medication can help reduce tremors and muscle stiffness.

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Bioavailability Genetics Nurses Development 97

XTalks

MAY 23, 2024

Companies specializing in dermatology and skincare have developed a range of products aimed at protecting the skin from harmful UV rays. These include broad-spectrum sunscreens, protective clothing and innovative skincare products developed using antioxidants and other protective agents.

Life Science 72

Life Science Dermatology Drug Delivery Systems Medicine 72

The Pharma Data

NOVEMBER 11, 2020

“These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As About Selva Therapeutics.

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Protein Bioavailability Development Drugs 52

Delveinsight

AUGUST 25, 2020

The drug is directly delivered to lungs via inhalation to achieve high local exposures, and address the concerns of low oral bioavailability linked to niclosamide. . The drug uses an optimized salt form of niclosamide, which is a safe oral drug and is in use for decades as an anthelmintic drug.

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Trials Bioavailability Drugs Protein 52

XTalks

SEPTEMBER 19, 2024

It was engineered to have high potency, bioavailability and kinase selectivity that led to improved efficacy and safety in B-cell malignancies. Zanubrutinib was specifically designed to improve outcomes and be successful where first- and second-generation BTK inhibitors were not. Additionally, there are many exciting things to come.

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Clinical Trials Clinical Trials Trials Clinical Research 52

The Pharma Data

OCTOBER 21, 2020

We designed KB-0742 to be an orally bioavailable CDK9 inhibitor with a differentiated selectivity profile,” said Norbert Bischofberger, Ph.D., We look forward to advancing clinical development of KB-0742 to establish the dose, safety and efficacy of this investigational therapy as a potential treatment for MYC-amplified tumors.”.

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In-Vivo In-Vitro Bioavailability Clinical Trials 40

Delveinsight

JULY 30, 2020

Key pharma players such as Bluebird Bio , Minoryx Therapeutics , MedDay Pharmaceuticals , Magenta Therapeutics , and others are proactively focusing on developing therapies to address the unmet needs prevailing in the ALD market. The pharma players are evaluating their pipeline candidates in different stages of clinical development.

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Hormones Marketing Gene Trials 52

The Pharma Data

JULY 12, 2021

“It continues to be critically important to advance potential antiviral treatments to address the devastating impact of COVID-19 globally,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “If About Molnupiravir. About Ridgeback Biotherapeutics.

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Clinical Trials Clinical Trials Bioavailability Trials 52

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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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)). intended use population.

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Clinical Trials Clinical Trials Development Drugs 57