Formulation Development
Arrivo BioVentures Emerges From Stealth Mode With a Robust Pipeline & Promising Data
After launching the company over 5 years ago with a team of seasoned serial entrepreneurs, $49 million in committed capital, and the promise to assemble…
Halberd Successfully Eradicates Interluekin-1 in Its Continued Progress Toward Eliminating Neurodegenerative Diseases
Halberd Corporation has demonstrated 100% eradication of Interleukin-1 (IL-1) from synthetic cerebral spinal fluid (CSF) in preliminary testing. Interleukin-1 is associated with numerous diseases ranging from autoimmune…
Intensity Therapeutics Reports Promising Early Efficacy Results Using INT230-6 as a Monotherapy or in Combination With Pembrolizumab in Metastatic Breast Cancer
Intensity Therapeutics, Inc. recently reported safety, pharmacokinetic, biomarker, and efficacy data using INT230-6, with and without pembrolizumab, in heavily pretreated refractory breast cancer patients as part of the….
UniQure Announces Pivotal Phase 3 HOPE-B Study Meets Primary Endpoint for Hemophilia B Gene Therapy
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 patients with severe to moderately…
CinCor Pharma, Inc., Doses First Patient in HALO, a Phase 2 Clinical Trial Evaluating Selective Aldosterone Synthase Inhibitor in Patients With Uncontrolled Hypertension & High Plasma Aldosterone
CinCor Pharma, Inc. recently announced the dosing of the first patient in its Phase 2 clinical trial evaluating CIN-107, a highly selective, oral small molecule…
Checkpoint Therapeutics Announces Initiation of CONTERNO Phase 3 Trial of Cosibelimab Combined With Chemotherapy in Patients With First-Line Non-Squamous Non-Small Cell Lung Cancer
Checkpoint Therapeutics, Inc. recently announced the initiation of the CONTERNO study, a global, randomized Phase 3 trial of cosibelimab in combination with pemetrexed and platinum…
BrainStorm Cell Therapeutics & Catalent Announce Completion of Technology Transfer for NurOwn Manufacturing
BrainStorm Cell Therapeutics Inc. and Catalent recently announced that the technology transfer for NurOwn manufacturing at Catalent’s facility has been finalized….
Salubrent Pharma Solutions Strengthens Analytical Team
Salubrent Pharma Solutions recently it is continuing to build upon its vision of becoming a full service, technology-focused CDMO by filling the positions of Director of Analytical Development and Analytical Development Chemist at….
Sequana Medical Announces Positive Interim Results of SAHARA DESERT, the alfapump DSR Study in Heart Failure Patients With Persistent Congestion
Sequana Medical NV recently announced positive interim results from six patients in SAHARA DESERT, the safety and feasibility study of alfapump DSR (Direct Sodium Removal)…
Vetter Wins Frost & Sullivan’s 2021 Global Customer Value Leadership Award & Looks Back on a Stable Year Under Ongoing Pandemic Circumstances
Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), has been awarded the Frost & Sullivan’s 2021 Global Customer Value Leadership Award in the…
Innovative Inhaled Drug Delivery Developer Aerami Therapeutics to Merge With Special Purpose Acquisition Company FoxWayne Enterprises Acquisition Corp. to Become Public Company
Aerami Therapeutics Holdings, Inc. and FoxWayne Enterprises Acquisition Corp. recently announced they have entered into a definitive business combination agreement…..
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)…