The Pharma Data

JANUARY 3, 2021

Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform’s platform technologies. The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules’ formulation performance through its nanoforming services.

Containment 52

Containment Bioavailability Clinical Trials Clinical Trials 52

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.,

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In-Vivo In-Vitro Bioavailability Clinical Trials 40

Pharmaceutical Technology

AUGUST 3, 2022

The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. This is where the process development stage, which directly follows the drug discovery and early formulation work, can make or break a drug’s success.

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The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e., About Maribavir.

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Drugs Medicine Trials Containment 52

Drug Discovery World

OCTOBER 25, 2023

JV: A key bottleneck in the research and development of a drug is the lengthy experimentation that is required to gain the confidence to run clinical trials. VeriSIM Life has developed a hybrid biosimulation and AI-based platform that can assess the likely success of drug candidates, similar to a credit score.

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Drugs Pharma Companies Clinical Trials Clinical Trials 111

Camargo

AUGUST 22, 2021

To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC.

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Containment Bioavailability Cosmetics Packaging 190

Pharmaceutical Technology

NOVEMBER 24, 2022

The ADME study results form an important part of the Investigational New Drug (IND) approval process in the US and for the submission of a national Clinical Trial Authorization (CTA) in the EU. How does your unique Synthesis-to-Clinic® offering streamline the drug development process?

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Bioavailability Manufacturing Drugs Production 130

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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Trials Clinical Trials Clinical Trials Drugs 59

Pharmaceutical Technology

MAY 10, 2023

Within the pharmaceutical industry, it is critical to measure particle size as it influences surface area and porosity, impacting a drug’s bioavailability, effectiveness, and shelf life. Particle size is monitored in quality control as well as the development of active pharmaceutical ingredients (APIs).

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Contamination Filler Bioavailability Production 130

The Pharma Data

NOVEMBER 17, 2020

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. About PureTech Health.

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Production Trials Bioavailability Drugs 52

Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. Of 2,787 small molecule API CMOs analysed by GlobalData in 2021, only a third offered containment capabilities, and only 256 facilities (9%) featured controlled substance capabilities.

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Manufacturing Production Containment Contamination 130