Formulation Development
Fortress Biotech, Cyprium Therapeutics & Sentynl Therapeutics Announce the Initiation of Rolling Submission of an NDA for Treatment of Menkes Disease
Cyprium Therapeutics, Inc., a Fortress Biotech, Inc. partner company, with support from its licensing partner Sentynl Therapeutics, Inc., a wholly owned subsidiary of Cadila Healthcare Limited, recently announced the initiation of a rolling submission of a New Drug Application….
Recce Pharmaceuticals Announces Update on Phase 1/2 Clinical Trial for the Treatment of Burn Wound Infections
Recce Pharmaceuticals Ltd recently announced an update on its Phase 1/2 clinical trial for the treatment of burn wound infections. The West Australian Health department…
Vaccitech Reports Promising Interim Efficacy Analysis in Phase 1b/2a Clinical Study in Chronic HBV
Vaccitech plc recently announced a promising interim analysis of safety and efficacy data from the HBV002 study, including a review of surface antigen (HBsAg) levels…
Operations Commence at Genezen’s Lenti- & Retroviral Vector Process Development Lab
Genezen, Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) focused on early-phase process development, vector production and analytical testing services, has officially….
SCYNEXIS Announces Agreement With FDA on Innovative Strategy for Approval of Oral Ibrexafungerp for Treatment of Invasive Candidiasis
SCYNEXIS, Inc. recently announced initiation of a global Phase 3 study to evaluate the efficacy, safety, and tolerability of oral ibrexafungerp as a step-down therapy…
ASLAN Pharmaceuticals & IQVIA Biotech Enter Strategic Collaboration
ASLAN Pharmaceuticals recently announced the appointment of IQVIA Biotech, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, as its preferred….
Longeveron Granted Orphan Drug Designation by FDA for Lomecel-B to Treat Infants With Hypoplastic Left Heart Syndrome
Longeveron Inc. recently announced the US FDA has granted Orphan Drug Designation (ODD) for Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a…
Fulcrum Therapeutics Announces Additional HBG mRNA Induction From Higher Dose Cohorts in Phase 1 Healthy Adult Volunteer Trial of FTX-6058 for Sickle Cell Disease & New Preclinical Mechanism Data
Fulcrum Therapeutics, Inc. recently announced positive results from the 20-mg and 30-mg dose cohorts in healthy adult volunteers in its Phase 1 clinical trial of…
Biofrontera Inc. Enrolls First Subject in Phase 1 Safety Study Evaluating Photodynamic Therapy With Three Tubes of Ameluz
Biofrontera Inc. recently announced the first subject has been enrolled in a Phase 1 study to evaluate the safety and tolerability of photodynamic therapy (PDT)…
NGM Bio Announces Clinical Trial Collaboration With Merck Related to Ongoing Phase 1/2 Trial of an ILT2/ILT4 Dual Antagonist Antibody in Combination With Merck’s KEYTRUDA
NGM Biopharmaceuticals, Inc. recently announced a clinical trial collaboration and supply agreement with Merck to evaluate NGM707, NGM’s wholly owned novel ILT2/ILT4 dual antagonist antibody, in combination with….
Enlivex Receives Notice of Allowance for US Patent Application Covering the Treatment of Sepsis Patients With Allocetra
Enlivex Therapeutics Ltd. recently announced the US Patent and Trademark Office issued a notice of allowance for a new patent application (number 16/194,417) covering Allocetra,…
Ventyx Biosciences Announces First Patient Dosed in Phase 2 Clinical Trial of VTX002 for the Treatment of Moderate-to-Severe Ulcerative Colitis
Ventyx Biosciences, Inc. recently announced the first patient has been dosed in a Phase 2 randomized, placebo-controlled trial of VTX002 for the treatment of moderate-to-severe ulcerative colitis (UC)…..
ARCA biopharma Announces Completion of Enrollment in Phase 2b ASPEN-COVID-19 Clinical Trial Evaluating rNAPc2 as a Potential Treatment for Patients Hospitalized With COVID-19
ARCA biopharma, Inc. recently announced that enrollment has been completed in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized…
Progenity Announces New Patent for Single-Molecule Detection Technology
Progenity, Inc. recently announced a new patent related to its single-molecule detection platform under development. The USPTO has issued U.S. Patent No. 11,186,863 titled Methods,…
Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings
Adare Pharma Solutions recently announced the acquisition of Frontida BioPharm, a vertically integrated CDMO focused on oral formulations. The acquisition reinforces….
Sterling Pharma Solutions Announces Exclusive Partnership to Develop Novel Route to Newly Approved COVID-19 Therapy
Sterling Pharma Solutions recently announced an exclusive partnership with the University of Manchester Institute of Biotechnology (MIB), to support the development of a novel, low-cost manufacturing route to molnupiravir, a new….
SAB Biotherapeutics Announces SAB-176 Met its Primary Endpoint in Phase 2a Challenge Study in Adults Infected With Influenza Virus
SAB Biotherapeutics recently announced that SAB-176, its investigational therapeutic for the treatment of seasonal influenza, achieved statistically significant (p = 0.026) reductions in viral load and….
BioXcel Therapeutics Announces Extension of FDA Review Period of its NDA for BXCL501 for the Acute Treatment of Agitation Associated With Schizophrenia & Bipolar Disorders
BioXcel Therapeutics, Inc. recently announced the US FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of BXCL501 for the acute treatment of….
Arch Biopartners’ Lead Drug LSALT Peptide to Enter the Canadian Treatments for COVID-19 (CATCO) Trial
Arch Biopartners Inc. recently announced its lead drug candidate, LSALT Peptide (LSALT and Metablok) will enter the Canadian Treatments for COVID-19 (CATCO) human trial, a…
Vaxart Announces Acquisition of Second GMP Manufacturing Facility
Vaxart, Inc. has entered into an agreement with Kindred Bioscience, Inc. for the purchase of KindredBio’s manufacturing equipment and sublease of its GMP (Good Manufacturing…
