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Orchard Therapeutics to Reimburse Access to Libmeldy for MLD Patients in Sweden
Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.
Bio-Rad’s New StarBright Blue and Yellow Dyes Enhance Multiplex Flow Cytometry
Bio-Rad’s newly launched StarBright Blue and StarBright Yellow dyes are intended for use in various flow cytometry applications.
Eurofins Viracor Launches Test for Assessing Expansion and Persistence of CAR-T Therapy in Cancer Patients
Eurofins Viracor ExPeCT CAR-T qPCR assay is a tool designed for monitoring and optimizating CAR-T therapies.
Moderna and Life Edit Therapeutics Enter Gene Editing Collaboration
Moderna will leverage Life Edit’s suite of gene editing technologies to advance development of in vivo gene editing therapies.
FDA Approves Sanofi Hemophilia Treatment
Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.
AbbVie and Capsida Strike $674 Million Gene Therapy Development Deal
AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.
Predictive Oncology and Cvergenx Enter Genomics-Based Personalized Therapy Collaboration
The goal of this collaboration is to develop an approach to personalized radiotherapy and drug discovery that is based in genomics and artificial intelligence.
IRBs Need More Monitoring
GAO calls for more oversight of institutional review boards in clinical trials.
FDA Recommends Recall of Artificial Eye Ointment for Potential Bacterial Contamination
This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.
Agilent Gains Design Support from CRB for Manufacturing Facility Expansion
Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.
Pfizer Announces Positive Data for Prostate Cancer Combination Treatment
Pfizer reports that the combination of talazoparib and enzalutamide demonstrated statistically significant improvement in patient survival in a Phase III trial.
FDA Approves First Treatment for Geographic Atrophy
Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.
Quotient Sciences Expands Formulation Development Capabilities at Nottingham Facility
Quotient Sciences’ facility expansion is designed to increase support for fully integrated drug development programs.
LIfT BioSciences and Minaris Regenerative Enter Cell Therapy Partnership
LIfT and Minaris will work together to develop a manufacturing process for LIfT’s allogeneic neutrophil progenitor cell therapy.
FDA Publishes New Product-Specific Guidelines for Generic Drug Development
Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.
FDA Announces BsUFA III Regulatory Science Program to Support Future Research
The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.
Takeda Completes $6 Billion Acquisition of Nimbus Therapeutics Subsidiary
Takeda’s acquisition of Nimbus Lakshmi will grant them rights to NDI-034858, an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases.
Bayer Names Bill Anderson as CEO
Bill Anderson, former CEO of Roche’s pharmaceutical division, will take over as CEO of Bayer on June 1, 2023.
GenScript PrioBio and Bio Immunitas Announce Platform Collaboration
GenScript PrioBio and Bio Immunitas will work together to develop and fast track manufacturing of a novel therapeutic platform.
Charles River Launches Novel IgY-based ELISA Kit
The kit is meant for use for the detection and quantitation of residual host cell protein.
Biopharmaceutical Manufacturing Growth
Growth in outsourcing has been the result of COVID-19 projects taking precedence, which has pushed some contract manufacturing to second-tier CDMOs.
Clinical Trial Diversity Continues to Face Challenges
After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.
New Data from EMA’s Review of Medicines with Pseudoephedrine
Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.
FDA Accepts Biologics License Application for Proposed Biosimilar Denosumab
The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.
Elektrofi Establishes Contract Manufacturing Agreement with Thermo Fisher Scientific
The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.
Biden Hits Drug Prices for Boosting Health Care Costs
Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.
Pharmapack Europe Announces Winners of Pharmapack 2023 Awards
Pharmapack Europe has announced the winners of the 2023 Pharmapack Awards spanning five categories across two dedicated awards.
Roche Reports Positive Data for Rare Blood Condition Treatment
Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.
Recent Initiatives to Support Development of Medicines for Children
Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.
FDA Proposes Longer National Drug Code
The change would impact every package and hundreds of systems.
