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Concert Pharmaceuticals Achieves $2-Million Milestone September 1, 2014
Concert Pharmaceuticals, Inc. recently announced that it has achieved a $2- million milestone under its development and license agreement with...Coherus’ Biosimilar Meets Primary Endpoint In Pivotal Pharmacokinetic Clinical Study August 18, 2014
Coherus BioSciences, Inc. recently announced that CHS-1420, its proposed biosimilar of adalimumab (Humira), met the primary endpoint in a pivotal...CLINICAL TRIALS - Outsourcing Early-Stage Clinical Trials: How to Mitigate Costs & Risk June 3, 2014
Roundtable Discussion: Contributor Cindy H. Dubin gathered leading CROs together to discuss the benefits of outsourcing early-stage clinical trials, how to mitigate the risks, and lower costs in the process.
Pantec Biosolutions Reports First Successful IVF Pregnancy Using P.L.E.A.S.E. February 14, 2011
Pantec Biosolutions AG recently announced that a woman has successfully conceived after being implanted with a fertilized oocyte (egg cell)....DATA-SHARING PLATFORM - How to Overcome the Challenge of Differing Digital Maturity Levels in Biopharmaceutical Supply Chains February 29, 2024
David Brick, MS, and Harlan Knapp, MS, review how the efficient and timely delivery of therapeutics with complex manufacturing needs cannot be achieved by simply unifying the entire pharmaceutical landscape within the most advanced digital maturity level. A better approach is to implement a flexible data-sharing platform that can accommodate partners with different data management capabilities.
DRUG DEVELOPMENT - Using a Novel Deep Cyclic Inhibition Mechanism to Treat Broad Range of RAS-Mutant Cancers January 26, 2024
Ben Zeskind, PhD, addresses the question: rather than targeting individual RAS mutations and treating chronically, is it possible to achieve broad therapeutic activity in a way that focuses on malignant cells while minimizing damage to healthy cells?
Nanoform Commenced Relative Bioavailability Study of Nanotechnology-Enhanced Enzalutamide January 8, 2024
Nanoform Finland Plc recently announced it had completed the First Subject First Visit (FSFV) in a trial to evaluate the...Coya Therapeutics & Dr. Reddy’s Laboratories Enter Development & Commercialization Agreement for ALS Treatment December 11, 2023
Dr. Reddy’s Laboratories SA and Coya Therapeutics, Inc. recently announced they have entered into a development and license agreement for the development and commercialization of COYA 302, an investigational combination therapy for….
Lisata Therapeutics Announces Outcome of Interim Futility Analysis for its Phase 2b ASCEND Trial in Metastatic Pancreatic Ductal Adenocarcinoma September 6, 2023
Lisata Therapeutics, Inc. recently announced a positive outcome of the prespecified interim futility analysis for the ASCEND trial, a Phase...Harpoon Therapeutics Announces Completion of Planned Patient Enrollment in Phase 1 Study of HPN217 in Relapsed/Refractory Multiple Myeloma June 27, 2023
Harpoon Therapeutics, Inc. recently announced the completion of planned patient enrollment in the Phase 1 dose escalation study evaluating the...PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 & KEYTRUDA in Head & Neck Cancer June 14, 2023
PDS Biotechnology Corporation recently announced it achieved the threshold for efficacy as per investigator assessment in Stage 2 of the...Oculis Announces Positive Top Line Results From DIAMOND Stage 1 Phase 3 Trial in Diabetic Macular Edema With OCS-01 Eye Drops May 22, 2023
Oculis Holding AG recently announced positive top line results from Stage 1 of its Phase 3 DIAMOND trial of OCS-01...Biogen Exercises Option With Denali to Develop & Commercialize Antibody Transport Vehicle Program Targeting Amyloid Beta April 12, 2023
Biogen Inc. and Denali Therapeutics Inc. recently announced Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV):Amyloid beta program (ATV:Aβ). Accumulation of Aβ plaque in….
PDS Biotech Announces Plan to Initiate Phase 3 Study March 30, 2023
PDS Biotechnology Corporation recently announced it has completed key tech transfer, scale up, and manufacturing activities required to initiate a...AC Immune’s Anti-Amyloid Beta Vaccine for Alzheimer’s Shows Positive Initial Interim Safety & Immunogenicity in Phase 1b/2 Trial January 26, 2023
AC Immune SA recently announced the first interim safety, tolerability, and immunogenicity findings from the Phase 1b/2 ABATE trial of...Synlogic Announces SYNB1353 Achieves Proof of Mechanism for Treatment of Homocystinuria & Provides Business Update December 1, 2022
Synlogic, Inc. recently announced SYNB1353 has achieved proof of mechanism and positive results in a Phase 1 study in healthy...Key Patent Issued on Eligo’s Gene-Editing Breakthroughs Applied to Skin Disorders November 15, 2022
Eligo Bioscience recently announced the issuance by the USPTO of the first patent in a wide family covering genetic engineering of a key skin microbiome species, Cutibacterium acnes, to support….
CymaBay Completes Enrollment for the RESPONSE Global Phase 3 Study Evaluating Seladelpar for Patients With Primary Biliary Cholangitis August 1, 2022
CymaBay Therapeutics, Inc. recently announced the completion of enrollment for RESPONSE, a global Phase 3 study evaluating seladelpar for patients with Primary Biliary….
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022
Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.
Crinetics Pharmaceuticals Reports Positive Top-line Results Including Strong Adrenal Suppression from CRN04894 Phase 1 Study Multiple-Ascending Dose Cohorts May 25, 2022
Crinetics Pharmaceuticals, Inc. recently announced positive results from the multiple-ascending dose (MAD) portion of a first-in-human Phase 1 clinical study of...
