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OSD FORMULATIONS - Dissolving Bioavailability & Solubility Challenges in Formulation & Development September 30, 2020
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
IMMUNOGENICITY TESTING - Regulatory Updates for Immunogenicity Assessment of Therapeutic Proteins September 30, 2020
Leon Shi, PhD, Lan Li, MS, and Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.
Orgenesis Announces Agreement to Acquire Koligo Therapeutics September 29, 2020
Orgenesis Inc. and Koligo Therapeutics, Inc. recently announced the two companies have entered into a definitive merger agreement, subject to final closing conditions, with expected completion….
TriNetX Acquired by Carlyle Group to Help Advance Health Research Optimization September 22, 2020
TriNetX recently announced global investment firm The Carlyle Group has made a strategic growth investment and will acquire a majority...Imanis Life Sciences Presents a First-in-Class Neutralizing Antibody Test for COVID-19 September 15, 2020
Imanis Life Sciences, LLC recently announced presentations about the development and validation of IMMUNO-COV, the first scalable, quantitative neutralizing antibody...Fortress Biotech Announces Initiation of Phase 3 Studies September 15, 2020
Fortress Biotech, Inc. recently announced that Caelum Biosciences, Inc., in collaboration with Alexion Pharmaceuticals, Inc., initiated the Cardiac Amyloid Reaching...RedHill Biopharma’s Opaganib Demonstrates Complete Inhibition of SARS-CoV-2 September 9, 2020
RedHill Biopharma Ltd. recently announced that opaganib demonstrated potent inhibition of SARS-CoV-2, the virus that causes COVID-19, achieving complete blockage of viral...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.
DRUG DEVELOPMENT - Bringing New Drugs to Patients Faster by Integrating Traditionally Separate Pharma Development Functions August 31, 2020
Nutan Gangrade, PhD, says reducing R&D project timelines saves on overhead in development while increasing the likelihood of primacy in the marketplace (which engenders significantly more sales) and describes new approaches drug developers are taking to streamline drug development.
GENE-EDITING TECHNOLOGY - The Importance of Assessing Off-Target Effects of CRISPR Gene Editing August 31, 2020
Mark Behlke, MD, PhD, says gene editing raises legitimate questions and fears about possible risks and misuse, and given the relative technical ease and low cost of CRISPR gene editing, this is likely to find widespread use in both medicine and agriculture.
DEVICE DEVELOPMENT - Mapping the Regulatory Strategy to Better Navigate Electronic Drug Delivery Device Development for Patient Safety & Security August 31, 2020
Ahmed Mallek, Hadrien Gremillet, and Audrey Chandra say that along with technology advancement in the medical industry, the behaviors and needs of different stakeholders also evolve, resulting in a clear interest in electronic drug delivery devices for a variety of reasons.
PEPTIDE THERAPEUTICS - Oral Peptide Therapeutics – Opportunities Abound as Barriers Fall August 31, 2020
John S. Vrettos, PhD, says numerous technologies are currently in development that are designed to enable the oral delivery of peptides. Though each has its unique set of properties and capabilities, all must overcome key obstacles to successfully deliver peptides via the oral route.
2020 Analytical Testing in Drug Development e-Book: A Critical Role in End-to-End Drug Development August 24, 2020
This second annual Drug Development & Delivery Analytical Testing eBook shines a light on analytical outsourcing providers that are optimizing testing solutions to ensure more robust results, speed time to market, and characterize methods earlier in development.
ANA Therapeutics & Quotient Sciences Announce Manufacturing Partnership August 20, 2020
ANA Therapeutics, a Silicon Valley-based biotech start-up, and Quotient Sciences, a leading provider of innovative drug development and manufacturing solutions, recently announced a partnership to support the….
Immunic, Inc. Reports Positive Top-line Data From Phase 2 EMPhASIS Trial August 7, 2020
Immunic, Inc. recently announced positive top-line data from its phase 2 EMPhASIS trial of lead asset, IMU-838, the company’s selective...Rafael Pharmaceuticals Achieves Target Enrollment of 500 Patients in Pivotal Phase 3 Trial August 7, 2020
Rafael Pharmaceuticals, Inc. recently announced it has reached its target enrollment of 500 patients in its pivotal Phase 3 clinical...Arrowhead Pharmaceuticals Earns $20-Million Milestone Payment From Amgen July 29, 2020
Arrowhead Pharmaceuticals Inc. recently announced it has earned a $20-million milestone payment from Amgen following the administration of the first dose of….
NGM Bio Announces Initiation of Phase 2 CATALINA Study July 27, 2020
NGM Biopharmaceuticals, Inc. recently announced it has initiated the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial, to evaluate the safety and efficacy of….