Hot-melt extrusion can improve bioavailability: Avomeen

Outsourcing Pharma

With bioavailability challenges a frequent frustration for drug developers, one research outfit suggests a technique that could reduce the headaches. Bioavailability Challenge

Take 2: Hanmi relaunches liver drug after boosting bioavailability

Fierce Pharma

Take 2: Hanmi relaunches liver drug after boosting bioavailability. ntaylor. Tue, 07/12/2022 - 08:58

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PureTech Meets Milestone of Achieving Oral Bioavailability of Allopregnanolone in Healthy Adults Dosed with LYT-300

BioTech 365

Global Drug Bioavailability Enhancement Summit 2022: Two Day Online Program – May 16-17, 2022 – ResearchAndMarkets.com

BioTech 365

Global Drug Bioavailability Enhancement Summit 2022: Two Day Online Program – May 16-17, 2022 – ResearchAndMarkets.com Global Drug Bioavailability Enhancement Summit 2022: Two Day Online Program – May 16-17, 2022 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “2022 Global Drug Bioavailability Enhancement Summit” … Continue reading → Business Wire

Valbiotis Announces the Positive Results of Its Clinical Study on the Bioavailability and Mode of Action of TOTUM•070, Against Hypercholesterolemia

BioTech 365

Valbiotis Announces the Positive Results of Its Clinical Study on the Bioavailability and Mode of Action of TOTUM•070, Against Hypercholesterolemia Valbiotis Announces the Positive Results of Its Clinical Study on the Bioavailability and Mode of Action of TOTUM•070, Against Hypercholesterolemia … Continue reading → Business Wire

Pharmanovia taps Nanoform to improve bioavailability of ‘iconic branded medicine’

Outsourcing Pharma

The pharmaceutical company has forged a partnership with the nanotechnology specialist to use nanoparticle tech and formulation to advance its products. Drug Delivery

Global Peptide Therapeutics Markets, 2021-2026 – Increase Bioavailability of Drugs and Broaden Application of Peptides Therapeutics – ResearchAndMarkets.com

BioTech 365

Global Peptide Therapeutics Markets, 2021-2026 – Increase Bioavailability of Drugs and Broaden Application of Peptides Therapeutics – ResearchAndMarkets.com Global Peptide Therapeutics Markets, 2021-2026 – Increase Bioavailability of Drugs and Broaden Application of Peptides Therapeutics – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Global Peptide … Continue reading → Business Wire

Alzamend Neuro Announces It Has Contracted With Altasciences to Conduct a Phase I Relative Bioavailability Study for AL001 for Dementia Related to Alzheimer’s Disease in September 2021

BioTech 365

Alzamend Neuro Announces It Has Contracted With Altasciences to Conduct a Phase I Relative Bioavailability Study for AL001 for Dementia Related to Alzheimer’s Disease in September 2021 Alzamend Neuro Announces It Has Contracted With Altasciences to Conduct a Phase I … Continue reading → Business Wire

Microsize Launched as Independent Pharma Services Company

BioTech 365

Microsize Launched as Independent Pharma Services Company Microsize Launched as Independent Pharma Services Company Meets the Growing Need for US-Based API Solubility and Bioavailability Enhancement Services QUAKERTOWN, Pa.–(BUSINESS

Biora Therapeutics Shares Preclinical Data on Oral Delivery of Biologics at Controlled Release Society 2022

BioTech 365

Biora Therapeutics Shares Preclinical Data on Oral Delivery of Biologics at Controlled Release Society 2022 Biora Therapeutics Shares Preclinical Data on Oral Delivery of Biologics at Controlled Release Society 2022 Demonstrates OBDS Device Performance and Bioavailability in Animal Models SAN … Continue reading → GlobeNewswire

Milk and water most efficient vehicles for absorbing vitamin D, study finds

Scienmag

By measuring the maximum concentration over time, the researchers found bioavailability of vitamin D […]. According to a new study that will be presented today (Saturday 21 May at 12:00 noon CEST) at the 24th European Congress of Endocrinology in Milan, Italy on vitamin D food fortification working better with water and milk than in juice. Latest News absorbing efficient finds milk study Vehicles vitamin water

Edgewise Therapeutics Announces Pricing of Initial Public Offering

BioTech 365

NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, announced … Continue reading → Business Wire

Venatorx Pharmaceuticals Expands Anti-Infective Portfolio with HBV Candidate

BioTech 365

Venatorx Pharmaceuticals Expands Anti-Infective Portfolio with HBV Candidate Venatorx Pharmaceuticals Expands Anti-Infective Portfolio with HBV Candidate VNRX-9945 Selected as 3rd Generation Hepatitis B Virus Orally Bioavailable CpAM; Clinical Trial Application and Phase 1 Planned for Second Quarter 2021 MALVERN, Pa.–(BUSINESS

Altasciences Performs Phase I Studies for FDA Approval of Vibegron

BioTech 365

PureTech Reveals New CBD Pill to Rival Jazz’s Epidiolex

XTalks

Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups.

Artios Doses First Patient in Phase 1/2a Study of Pol? Inhibitor ART4215

BioTech 365

inhibitor, ART4215, is the first selective, orally bioavailable, small molecule inhibitor of the Pol? Artios Doses First Patient in Phase 1/2a Study of Pol? Inhibitor ART4215 Artios Doses First Patient in Phase 1/2a Study of Pol? Inhibitor ART4215 Pol? polymerase … Continue reading → GlobeNewswire

CellCentric Strengthens Leadership Team

Pharma Mirror

CellCentric is developing inobrodib, an orally bioavailable drug that is transitioning into Phase II clinical trials in multiple indications.

How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

The results of the population analysis reveal the average relative bioavailability of the test to reference. The comparison of relative bioavailability based on simulated data then indicates if BE can be achieved.

Nanoparticles: Emerging Stars for Pharmaceutical Industry

Roots Analysis

In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the prime reasons that leads to failure in obtaining approval authorization.

EC approves BeiGene’s chronic lymphocytic leukaemia therapy

Pharmaceutical Technology

It was specifically designed to provide targeted and sustained BTK protein inhibition by optimising bioavailability, selectivity, and half-life. The European Commission (EC) has approved BeiGene’s Brukinsa (zanubrutinib) to treat chronic lymphocytic leukaemia (CLL) in adult patients.

The Composition and Value of a Portfolio Analysis

Camargo

Clinical pharmacology may also involve comparative bioavailability analyses, which are generally required for drug formulation bridging studies, to demonstrate bioequivalence.

Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Pharmaceutical Technology

Given our expertise in the provision of IVMT studies to investigate the absolute bioavailability of oral drug molecules, we have developed a particular focus in recent years on the conduct of integrated IVMT/ADME studies.

Advancing from Research to Development: What Can Go Wrong?

Camargo

While formulation changes for an ongoing program may improve stability, they might also impact the bioavailability, toxicokinetic profile, or toxicology – potentially rendering all previous work void and irrelevant and costing the program money and time.

Zerion and Insud to develop Dispersome formulations of drugs

Pharmaceutical Technology

Reduced solubility and low bioavailability affect a huge number of solid drug products, especially tablet formulations on the market.

PharmaEngine, Inc. and Sentinel Oncology Limited Enter into an Exclusive Collaboration and License Agreement for SOL-578, a Chk1 inhibitor

The Pharma Data

SOL-578 is a best-in-class checkpoint kinase 1 (Chk1) inhibitor featuring high kinase selectivity and oral bioavailability which targets the DNA Damage Response (DDR) network. TAIPEI , Dec. 4, 2020 /PRNewswire/ — PharmaEngine, Inc.

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

3.1.1: Bioavailability Study Reports. When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance.

The Changing R&D Landscape – Contract Pharma

The Pharma Data

While oral delivery route (62%) is still the most prevalent amongst marketed drug products, alternative adminstrations such as injection (22%), cutaneous, mucosal, inhalation, and others are making up a greater percentage as the industry works to improve bioavailability and subsequent efficacy.

Oral Protein / Peptide-based Drugs: Addressing Key Unmet Needs Across Disease Indications

Roots Analysis

However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability.

Intranasal Therapeutics and Drug Delivery Systems: The Perfect Alternative to Conventional Route of Administration

Roots Analysis

This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration.

In the News: June 2021 Regulatory and Development Updates

Camargo

In June, the FDA issued an updated (draft) guidance titled “ Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.”

Catalent to purchase Metrics Contract Services from Mayne Pharma

Pharmaceutical Technology

Catale n t has signed an agreement for the acquisition of full-service specialty Contract Development and Manufacturing Organization (CDMO) Metrics Contract Services for $475m from Mayne Pharma.

Biopharmaceutical Excipient Manufacturing – Current Scenario and Future Trends

Roots Analysis

Furthermore, excipients play a critical role in biologics development by enhancing the solubility and bioavailability, controlling pH and tonicity of the active pharmaceutical ingredients (APIs).

EverGrain’s Line of Barley-Based Products Scores Upcycled Certification

XTalks

In terms of its nutritional profile, EverPro is high in bioavailable protein, low in carbohydrates, contains just half a gram of sugar per 100 grams and is free from cholesterol, dairy and soy.

Drug developers look at innovative mechanisms to tackle dry eye syndrome

Pharmaceutical Technology

GlobalData anticipates CyclASol to be positioned as the superior cyclosporine due to its favorable tolerability profile and better bioavailability, with the potential to capture market share from other cyclosporine-based therapies.

Grünenthal takes non-opioid pain drug resiniferatoxin into phase 3

Pharma Phorum

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.

NRG announces £16m Series A for IND for Parkinson’s and ALS

Pharma Phorum

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.”.

New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.

Pfizer puts up $1bn to buy into Arvinas breast cancer programme

Pharma Phorum

The company said other companies were also looking at the orally bioavailable drug, but Pfizer emerged as an ideal partner for ARV-371.

Gilead files first hepatitis delta therapy with FDA

Pharma Phorum

The drug, which is given by subcutaneous injection once a day, looks set to beat a rival antiviral therapy for HDV from Eiger Biopharmaceuticals to the US market, although the latter is orally bioavailable so could prove to be a potent competitor if it reaches the market.

Cybin Announces First Quarter Financial Results of Clarmin Explorations Inc.

The Pharma Data

Cybin is developing technologies and delivery systems, aiming to improve bioavailability, to potentially achieve the desired medicinal effects of psychedelics at low dosage levels. 30, 2020 01:00 UTC. TORONTO–( BUSINESS WIRE )– Cybin Inc. (

Novartis’s Spartalizumab Combo Stubles; Union Therapeutics Doses In COVID-19 Trial; Yumanity To Merge With Proteostasis

Delveinsight

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. . Novartis’s Spartalizumab Combo Fails To Meet The Primary Goal In The Melanoma Trial.

New FDA Gudiances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.

New FDA Gudiances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.