Formulation Development
BioNTech & DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate in Prostate Cancer
BioNTech SE and Duality Biologics recently announced the US FDA granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic…
TFF Pharmaceuticals Provides Regulatory Update on Tacrolimus Inhalation Powder Clinical Program for the Prevention of Lung Transplant Rejection
TFF Pharmaceuticals, Inc. recently announced a regulatory update on its TFF TAC clinical program following its recent interaction with the US FDA. In April 2024,…
Checkpoint Therapeutics Announces Alignment With FDA Enabling Upcoming Cosibelimab BLA Resubmission
Checkpoint Therapeutics, Inc. recently announced it has reached alignment with the US FDA on its biologics license application (BLA) resubmission strategy for cosibelimab. Accordingly, Checkpoint…
4DMT Announces FDA Clearance of IND Application for Genetic Medicine for the Treatment of Geographic Atrophy
4D Molecular Therapeutics recently announced the US FDA clearance of the Investigational New Drug Application (IND) for 4D-175, an R100 vector-based intravitreal genetic medicine, for…
IMUNON Announces Database Lock for Phase 2 OVATION 2 Study With IMNN-001 in Advanced Ovarian Cancer
IMUNON, Inc. recently announcef database lock for its Phase 2 OVATION 2 Study evaluating the safety and efficacy of IMNN-001 in patients with advanced ovarian…
Bio-Rad Extends Range of Anti-Biotherapeutic Antibodies to Accelerate Antibody Drug Development
Bio-Rad Laboratories, Inc. recently launched four new anti-idiotypic antibodies to the following drugs: atezolizumab (Tecentriq), avelumab (Bavencio), obinutuzumab (Gazyvaro), and ocrelizumab (Ocrevus), extending its range…
Abzena & Argonaut Partner to Offer Fully Integrated Drug Substance & Drug Product Solution
Abzena and Argonaut Manufacturing Services, Inc. recently announced a strategic partnership to provide a fully integrated drug substance and drug product manufacturing solution for biopharmaceutical organizations. This…
Purdue-Engineered Compound Designed to Treat Drug-Resistant Acute Myeloid Leukemia
Researchers at Purdue University’s College of Science have developed a patent-pending compound called HSN748 to treat drug-resistant acute myeloid leukemia (AML). AML is a cancer that…
Sound Bioventures Expands Portfolio With New Investment in US Company NephroDI Therapeutics
Sound Bioventures recently announced a new investment in NephroDI Therapeutics, a US-based, near-clinical stage pharmaceutical company focusing on concentration disorders of the kidney. In conjunction…
Bora Pharmaceuticals Expands North American Footprint With Agreement to Acquire First Sterile Manufacturing Facility
Bora Pharmaceuticals Co., Ltd. recently announced it has successfully entered into an agreement for Emergent BioSolutions’ sterile manufacturing facility in Baltimore-Camden, MD, as part of…
Medigene AG Announces Lead Selection for MDG2021, Expanding TCR-T KRAS Library Targeting Solid Tumors
Medigene AG recently announced it has selected its lead candidate for MDG2021, a T cell receptor engineered T cell (TCR-T) therapy targeting Kirsten rat sarcoma…
Alto Neuroscience Initiates Phase 2 Study of a Novel PDE4 Inhibitor in Cognitive Impairment Associated With Schizophrenia
Alto Neuroscience, Inc. recently announced the initiation of a Phase 2 double-blind, placebo-controlled study of its transdermal formulation of ALTO-101, a novel PDE4 inhibitor in development…
Neurona Therapeutics Receives FDA’s Regenerative Medicine Advanced Therapy Designation for NRTX-1001 in Focal Epilepsy
Neurona Therapeutics recently announced the US FDA has granted the company’s lead product candidate, NRTX-1001, the RMAT expedited program designation for drug-resistant mesial temporal lobe…
Macomics & the Institute of Oncology Research Announce Macrophage Scientific Collaboration in Prostate Cancer Drug Development
Macomics Ltd recently announced it has entered a scientific collaboration with Prof. Andrea Alimonti at IOR (Institute of Oncology Research), one of Switzerland’s leading research…
Sterling Pharma Solutions Expands Bioanalytical Method Development Capabilities
Sterling Pharma Solutions recently announced it has expanded its bioanalytical services offering at its Deeside, UK, site, which is the company’s dedicated facility for antibody-drug…
WACKER & CordenPharma Enter Pandemic Readiness After Successful Expansion & Qualification
WACKER and CordenPharma recently announced their joint consortium has officially entered the pandemic readiness state as of June 2024. Following a successful expansion and qualification…
Alvotech & Advanz Pharma Sign Commercialization Agreement
Alvotech and Advanz Pharma recently announced they have entered into an exclusive partnership agreement regarding the supply and commercialization of Alvotech’s proposed biosimilar to Eylea…
Altus Formulation & Spektar Join Forces in New Specialty Company Spektus Pharma
Spektar Therapeutics FZCO and Altus Formulation Inc. recently announced the launch of Spektus Pharma Inc. a new Canadian specialty pharma company developing patent-protected value-added medicines…
Zentalis Pharmaceuticals Provides Update on Azenosertib Clinical Development Program
Zentalis Pharmaceuticals, Inc. recently announced the US FDA has placed a partial clinical hold on the following studies of azenosertib: the Phase 1 ZN-c3-001 dose-escalation…
Arch Biopartners Announces University of Calgary Ethics Approval to Proceed With Phase 2 Trial for LSALT Peptide
Arch Biopartners Inc. recently announced the University of Calgary’s Conjoint Health Research Ethics Board (CHREB) has approved the Phase 2 trial for LSALT peptide targeting…
