Search Results for: First Clinical Milestone Achieved in
Articles
Daré Bioscience Announces FDA Acceptance & Priority Review of NDA for DARE-BV1 for the Treatment of Bacterial Vaginosis August 10, 2021
Daré Bioscience, Inc. recently announced the US FDA accepted for filing the company’s New Drug Application (NDA) for DARE-BV1 for the treatment of bacterial vaginosis…..
Addex Therapeutics Initiates Pivotal Phase 2b/3 Study With Dipraglurant for Dyskinesia Associated With Parkinson’s Disease June 30, 2021
Addex Therapeutics Ltd recently announced that screening of patients has started for its pivotal Phase 2b/3 study with dipraglurant for...2021 Respiratory Drug Development eBook – The Three Cs Driving Respiratory Drug Delivery June 29, 2021
In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.
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.
Pfizer & BioNTech Reach Agreement to Supply the EU With 200 Million Doses of COVID-19 Vaccine November 11, 2020
Pfizer and BioNTech SE recently announced they have reached an agreement with the European Commission to supply 200 million doses of their investigational….
VBL Therapeutics Announces Additional New European Patent October 22, 2020
VBL Therapeutics recently announced the European Patent Office (EPO) has granted Patent No. 3328401, which covers VBL’s proprietary investigational anti-MOSPD2...PLATFORM TECHNOLOGY - Morphomer(TM) & SupraAntigen(TM) Platforms: Targeting Misfolded Proteins in Neurodegenerative Disorders October 1, 2020
Andrea Pfeifer, PhD, details the efforts to develop the therapeutic and diagnostic tools necessary to enable precision medicine approaches targeting the right protein, at the right time, in the right patient.
Liminal BioSciences Announces Resubmission of Biologics License Application September 9, 2020
Liminal BioSciences Inc. recently announced the company, through its US subsidiary Prometic Biotherapeutics Inc., has filed a resubmission of the...Mogrify & Sangamo Announce Collaboration & Exclusive License Agreement April 23, 2020
Mogrify Ltd and Sangamo Therapeutics recently announced they have executed a collaboration and exclusive license agreement for Sangamo to develop….
CANNABINOID THERAPY - NeuroDirect Effects(TM) CBD: Non-Systemic Cannabidiol for Autism Spectrum Disorder March 31, 2020
Ronald Aung-Din, MD, says NeuroDirect Effects Technology CBD is particularly attractive in this population as it utilizes the body’s own ECS, and in utilizing a non-systemic therapeutic mechanism, there is less likelihood for long-term negative effects in developing brains of children.
NATURAL LANGUAGE PROCESSING - How Life Sciences Companies Are Leveraging NLP From Molecule to Market March 31, 2020
Jane Z. Reed, PhD, MA, discusses some of the challenges facing pharma researchers and executives; the benefit NLP can bring; and some specific customer-use cases (covering patent landscaping, gene disease associations, access to safety silos, and more).
Menlo Therapeutics & Foamix Pharmaceuticals Complete Merger March 12, 2020
Menlo Therapeutics Inc. recently announced the completion of its merger with Foamix Pharmaceuticals Ltd. following the satisfaction of all closing...SPECIAL FEATURE - Improving Bioavailability & Solubility: Understand Your Molecule March 3, 2020
Contributor Cindy H. Dubin asked several leading companies about how they are currently overcoming today’s most pressing bioavailability and solubility challenges for their pharma clients.
Akcea & Ionis Report Positive Topline Phase 2 Study Results January 30, 2020
Akcea Therapeutics, Inc. and Ionis Pharmaceuticals, Inc. recently announced positive topline results from the Phase 2 study of AKCEA-ANGPTL3-LRx in...SPECIAL FEATURE - Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results January 14, 2020
Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.
ChemoCentryx & VFMCRP Announce Positive Topline Data From Pivotal Phase 3 Trial December 2, 2019
ChemoCentryx, Inc. and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) recently announced positive topline data from the pivotal Phase 3...Avadel Pharmaceuticals Achieves Enrollment Target in REST-ON Phase 3 Pivotal Trial December 2, 2019
Avadel Pharmaceuticals plc recently announced it has achieved its patient enrollment target of 205 patients in the REST-ON Phase 3...CDMO SELECTION - Ready to Launch: Developing Your Biologic With an Eye Toward Commercial Supply November 26, 2019
Stacey Treichler, PhD, believes the development process for new biologics is complex and requires a substantial amount of time and resources, and reviews some of the areas where careful choice of CDMO is key, including cell line development and cGMP manufacturing capabilities, and how an integrated approach can be beneficial.
Protalix BioTherapeutics & Chiesi Farmaceutici Announce Successful Pre-BLA Meeting November 18, 2019
Protalix BioTherapeutics, Inc. and its development and commercialization partner, Chiesi Farmaceutici S.p.A. recently announced that they have completed a successful Type B Pre-Biologics License Application (BLA) meeting with the US FDA regarding….
THERANOSTICS - The Outlook for the Theranostic Radionuclide Approach to Neuroendocrine Tumors & Other Cancers August 28, 2019
Eric P. Krenning, MD, PhD, and Rachel Levine provide a review of the evolution and development of theranostics, in general, citing the theranostic radionuclide approach to the management of neuroendocrine tumors to highlight this evolving modality.
