Pharmaceutical Technology

OCTOBER 25, 2022

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. Companies can save valuable time and resources as well by taking advantage of the FDA’s 505(b)(2) approval pathway.

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XTalks

JUNE 14, 2023

Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology. One such approved medication is Miebo , an ophthalmic solution developed by Bausch + Lomb and Novaliq.

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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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pharmaphorum

AUGUST 19, 2022

Among these still in development, Glenmark’s orally active GRC17536 cleared a phase 2a study in diabetic neuropathy but has bioavailability issues that have held up a phase 3 programme. The post Grünenthal takes non-opioid pain drug resiniferatoxin into phase 3 appeared first on.

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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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Pharmaceutical Technology

FEBRUARY 13, 2023

Candidate selection case study: Progression of small molecule ‘developability’ Background: A US biotech company had identified nine structurally related compounds as potential candidates in an oncology discovery program. Quotient Sciences was asked to select the best candidate based on material science and oral bioavailability considerations.

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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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pharmaphorum

NOVEMBER 9, 2022

He continued: “We are impressed by the potential of NRG’s small molecules as orally-bioavailable and brain-penetrant treatments and look forward to working with the team to move the programmes through IND-enabling studies.”. NRG’s board of directors now also welcomes Omega Funds’ MD Claudio Nessi and partner Francesco Draetta.

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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

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Pharmaceutical Technology

JUNE 26, 2022

Placing traditionally siloed drug substance and drug product development activities within a single organization that also has commercial manufacturing capabilities accelerates clinical development and builds in quality and robustness of supply.

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XTalks

MAY 23, 2024

is a biotech and life sciences company dedicated to advancing the clinical development of innovative and groundbreaking therapeutic assets. Bokhari: The holy grail in improving treatment outcomes in skin diseases and substantial reduction in healthcare cost revolves around developing TDDS.

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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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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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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.

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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.

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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.

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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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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.

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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)).

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