Search Results for: LAB DEVELOPED TESTS FDA Working
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LAB DEVELOPED TESTS - FDA Working on LDT Guideline: Implications & Questions January 6, 2015
Aish Vivekanandan, Industry Analyst at Frost & Sullivan, reports that in the past several years, it seemed that a cry for regulation of LDTs was falling on deaf years at the FDA. However, after a thorough and intricate letter from the Senate and public outcry for regulations, it seems the FDA is finally taking action.
SPECIAL FEATURE - Improving Bioavailability & Solubility: The Never-Ending Quest February 29, 2024
Contributor Cindy H. Dubin speaks with several companies to review their innovative technologies in this annual report on bioavailability and solubility.
SPECIAL FEATURE - Outsourcing Analytical Testing: AI Could Transform Analytical Labs January 29, 2024
Contributor Cindy H. Dubin presents how today’s leading analytical testing service providers are taking advantage of AI and other types of automation and innovative technologies.
SPECIAL FEATURE - Bioavailability & Solubility: New Approaches to Enhance Drug Performance February 27, 2017
Contributor Cindy H. Dubin highlights many of the latest techniques to enhance bioavailability and solubility, how to determine the right technique for your compound, and how some companies are realizing faster time to market as a result.
BIOAVAILABILITY ENHANCEMENT - Navigating a Broad Spectrum of Solubilization Technologies: Part II of III October 15, 2013
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
SPECIAL FEATURE - Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance September 5, 2023
Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Putting Customers First June 5, 2023
Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.
SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector January 17, 2023
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
Akoya Biosciences to Partner With Acrivon Therapeutics for the Clinical Development of Acrivon’s Proprietary OncoSignature Test Into a Companion Diagnostic June 28, 2022
Akoya Biosciences, Inc. and Acrivon Therapeutics, Inc. recently announced an agreement to co-develop, validate, and commercialize Acrivon’s OncoSignature test, a first-of-its-kind...SPECIAL FEATURE - PFS & Parenteral Drug Delivery: Self-Injection is Very Much the “New Normal” May 2, 2022
Contributor Cindy H. Dubin showcases how leading CDMOs and drug delivery developers are responding to current market trends to create ergonomic technologies that are patient friendly, easy to use, reduce needle anxiety, and feature improved packaging materials.
SPECIAL FEATURE - Analytical Testing Trends in 2022 January 17, 2022
Contributor Cindy H. Dubin reports on the innovative technologies and techniques that several leading outsourcing providers currently offer for both small and large molecules.
Santhera & ReveraGen Announce Positive & Statistically Highly Significant Topline Results June 3, 2021
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc. recently announced positive key results from the VISION-DMD study, demonstrating robust efficacy across multiple...SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs June 2, 2021
Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
Qualigen Therapeutics Secures Option to Negotiate License for G-Quadruplex Anti-Cancer Technology March 4, 2021
Qualigen Therapeutics, Inc. recently announced it has entered into a Material Evaluation and Option Agreement with the University College London...FORMULATION FORUM - Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies March 1, 2021
Jim Huang, PhD, explains how a niche CDMO, which has specialized technologies in complex injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.
ASSAY DEVELOPMENT - Case Study: How Custom Assay Development Helped Spur Precision Medicine Research in Multiple Myeloma October 1, 2020
Steven Gross, MS, provides a behind-the-scenes look at the CMMC assay development process (from 2010 through today) to show how pharmaceutical companies can effectively partner with a laboratory to design customized assays that complement their drug discovery and development programs.
SPECIAL FEATURE - Injection Devices: Will COVID-19 Deliver Growth to the Market? September 1, 2020
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
Cost of Disrupted Clinical Research Due to COVID-19 Equates to $10+ Billion & Potential Study Delays July 22, 2020
What if you developed a potential cure for COVID-19, but couldn’t test the drug because of COVID-19? Thousands of researchers worldwide are facing this dilemma, as clinical studies are interrupted, altered, postponed – or even cancelled…
Biomerica Begins Shipping Samples of 10-Minute Test for COVID-19 Virus Exposure March 18, 2020
Biomerica Inc. recently announced it has commenced shipping initial samples of its COVID-19 IgG/IgM Rapid Test (a finger prick blood test with results in…..
BIOSIMILAR DEVELOPMENT - Biosimilar Biological Products: Development & Applications March 2, 2020
Kaiser J. Aziz, PhD, provides an in-depth overview of biosimilar products development and the evaluation criteria for FDA approval.
