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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...Cue Biopharma Receives FDA Acceptance of IND Application for CUE-102 in Wilms’ Tumor 1 (WT1) - Expressing Cancers May 11, 2022
Cue Biopharma, Inc. recently announced the US FDA has accepted the company's Investigational New Drug (IND) application for the evaluation...MoonLake Immunotherapeutics Announces Publication of New Long-Term Disease Control Data From Phase 2b Psoriasis Trial May 9, 2022
MoonLake Immunotherapeutics AG recently announced the British Journal of Dermatology (BJD) has published a new data analysis, which can be accessed in the BJD online library, from the Phase 2b clinical trial assessing the effect of sonelokimab….
EXECUTIVE INTERVIEW - PCI Pharma Services: Broadening Our Biologics Footprint, Together May 2, 2022
Shawn Cain, SVP Development & Manufacturing at PCI Pharma Services, discusses the recent acquisition, the opportunities this presents to Biopharma companies, and the current trends in the sterile fill-finish industry.
Travere Therapeutics Submits NDA for Sparsentan for the Treatment of IgA Nephropathy March 21, 2022
Travere Therapeutics, Inc. recently announced it has submitted a New Drug Application (NDA) to the US FDA under Subpart H...SPECIAL FEATURE - Solubility & Bioavailability: Utilizing Enabling Technologies March 1, 2022
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
Brickell Biotech Acquires Exclusive Global Rights to Portfolio of Novel STING Inhibitors Targeting Autoimmune & Inflammatory Diseases from Carna Biosciences February 2, 2022
Brickell Biotech, Inc. and Carna Biosciences, Inc. recently announced they have entered into a licensing agreement, whereby Brickell will have the exclusive, worldwide rights to develop and commercialize….
PDS Biotech Announces Preliminary Efficacy Achievement in VERSATILE-002 Phase 2 Trial of PDS0101 in Combination With KEYTRUDA in Advanced Head & Neck Cancer February 2, 2022
PDS Biotechnology Corporation recently announced its VERSATILE-002 Phase 2 study for the treatment of advanced human papillomavirus (HPV)-associated head and neck...ASLAN Pharmaceuticals Initiates Phase 2b Study of ASLAN004 (Eblasakimab) in Moderate-to-Severe Atopic Dermatitis January 21, 2022
ASLAN Pharmaceuticals recently announced it has screened the first patient in its Phase 2b dose-ranging clinical study of eblasakimab in...Black Diamond Therapeutics Announces FDA Allowance of IND Application for a MasterKey Inhibitor of EGFR for the Treatment of Gliobastoma & Non-Small Cell Lung Cancer January 11, 2022
Black Diamond Therapeutics, Inc. recently announced the US FDA has cleared an investigational new drug (IND) application for its MasterKey...Albireo Announces Positive Topline Data from Phase 1 Study of A3907 December 16, 2021
Albireo Pharma, Inc recently announced positive topline results from its Phase 1 clinical trial of A3907, the first oral systemic...UniQure Announces Pivotal Phase 3 HOPE-B Study Meets Primary Endpoint for Hemophilia B Gene Therapy December 9, 2021
CSL Behring and uniQure N.V. recently announced that etranacogene dezaparvovec, an investigational adeno-associated virus five (AAV5)-based gene therapy for the treatment of...Vetter Wins Frost & Sullivan’s 2021 Global Customer Value Leadership Award & Looks Back on a Stable Year Under Ongoing Pandemic Circumstances December 7, 2021
Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), has been awarded the Frost & Sullivan’s 2021 Global Customer...Phathom Pharmaceuticals Announces Positive Topline Results from PHALCON-EE Pivotal Phase 3 Erosive Esophagitis Trial October 22, 2021
Phathom Pharmaceuticals, Inc. recently announced that vonoprazan successfully met its primary endpoints and key secondary superiority endpoints in PHALCON-EE, a pivotal Phase 3 trial evaluating….
Emergent BioSolutions Announces Initiation of Pivotal Phase 3 Study Evaluating the Safety & Immunogenicity of Its Single-Dose Chikungunya Vaccine Candidate October 15, 2021
Emergent BioSolutions Inc. recently announced the first participant dosed in its pivotal Phase 3 study evaluating the safety and immunogenicity...Pacira BioSciences to Acquire Flexion Therapeutics Further Expanding Leadership Position in Non-Opioid Pain Management October 12, 2021
Pacira BioSciences, Inc. and Flexion Therapeutics, Inc. recently announced a definitive agreement pursuant to which Pacira will acquire Flexion for...DEVICE DEVELOPMENT - Selecting Drug Delivery Systems for Higher Doses, Higher Viscosities & Lower Risk October 4, 2021
Nicolas Bralet and Megan Lan, MBA, MA, discuss how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
Dyadic & Sorrento Announce Binding Term Sheet to License Dyadic’s Lead COVID-19 Vaccine Candidate & C1 Technology for Protein-Based Coronavirus Vaccines & Therapeutics August 17, 2021
Dyadic International, Inc. and Sorrento Therapeutics, Inc. recently announced the signing of a binding term sheet to enter into a License Agreement to develop and commercialize vaccines, therapeutics, and diagnostics for….