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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective.

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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.

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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.

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

Camargo

The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC. 3.1.1: Bioavailability Study Reports.

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Compliance to convenience: understanding the latest innovations in capsule formulation

Pharmaceutical Technology

Softgel capsules, containing a liquid, paste or emulsion active ingredient, are trusted and favoured by many patients. They also offer enhanced bioavailability, exact dosing and an extended shelf life.

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Solving pharma’s process development challenges one API at a time

Pharmaceutical Technology

Milling is a central part of powder processing, as this is where coarse particles are broken down into smaller ones for a variety of processability, bioavailability, reactivity, and safety-related reasons.

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Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

The FDA Law Blog

This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol. By Faraz Siddiqui & Deborah L.

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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. (

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Calliditas Announces Full Enrollment of the Phase 3 NefIgArd Trial

The Pharma Data

In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. STOCKHOLM , Jan.

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Nanoform sets a new near-term business target for 2021

The Pharma Data

Nanoform’s capabilities span the small to large molecule development space and the company focuses on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. HELSINKI , Jan.

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Kura Oncology Announces Pricing of $300 Million Public Offering of Common Stock

The Pharma Data

Kura’s most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma. SAN DIEGO, Dec.

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Nanoform launches technology for biologics and sets new near-term business target for 2021

The Pharma Data

Nanoform’s capabilities span the small to large molecule development space and the company focuses on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. HELSINKI , Nov.

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ProstaStream

The Pharma Data

The natural green tea contained by this formula, and the broccoli leaf extracts are also powerful ingredients. Product Name: ProstaStream.

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Sosei Heptares’ COVID-19 Program Identifies Potent Broad Spectrum Anti-Viral Small Molecules for Further Development

The Pharma Data

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. This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products. Program focused on inhibitors of SARS-CoV-2 main protease, a highly conserved protein essential for viral replication.

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Kronos Bio Announces Publication of Preclinical Study Results for Investigational CDK9 Inhibitor KB-0742 in Cell Chemical Biology

The Pharma Data

We designed KB-0742 to be an orally bioavailable CDK9 inhibitor with a differentiated selectivity profile,” said Norbert Bischofberger, Ph.D., Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. KB-0742 is a transcription regulatory network modulator discovered using the company’s proprietary high – throughput screening platform.

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XPhyto Announces Drug Formulation Strategy and 2021 Milestones Innovation to Impact

The Pharma Data

Each study is planned to be carried out over an approximately two-week period as an open label, randomized, crossover, two-period, two-sequence, single dose pilot study to assess the relative bioavailability of each product.

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PureTech’s LYT-100 (Deupirfenidone) Demonstrates Tolerability and Pharmacokinetic Proof-of-Concept in Phase 1 Multiple Ascending Dose and Food Effect Study

The Pharma Data

The strong results from this Phase 1 readout reinforce our view that LYT-100 has the potential to offer a tolerability and bioavailability profile that could be highly differentiated at the same exposure levels as pirfenidone,” said Daphne Zohar, co-founder and chief executive officer of PureTech.

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New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary Endpoint

The Pharma Data

Maribavir, an orally bioavailable anti-CMV compound, is the only antiviral agent presently in Phase 3 development for the treatment of post-transplant patients with CMV in SOT or HSCT. 4, 2020 11:00 UTC.

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Warrior's Secret

The Pharma Data

Contains a unique “living chemistry” that was poorly understood until recently…. We’ll start with all-natural food #1 which contains powerful compounds that…. Because this food also contains a mineral that’s proven to help men over 45 burn fat, build muscle, and bound with energy….