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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.
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.
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.
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.
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.
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.
iotaSciences Launches Single-Cell Picker
iotaSciences isoPick is designed to expand handling solutions for cell biology and gene therapy applications.
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.
Thermo Fisher Scientific Collaborates to Introduce Fully Automated Cell Line Automation Platform
Thermo Fisher and Celltrio are introducing a new automation platform to address critical scale-up challenges in biotherapeutics.
Astellas to Appoint New CEO and President
Naoki Okamura, Astellas’ current chief strategy officer, will take over the role from Kenji Yasukawa.
BioNTech Strengthens Manufacturing Capabilities with First In-house Plasmid DNA Manufacturing Facility
The new plasmid manufacturing facility aims to increase BioNTech’s autonomy and flexibility in manufacturing.
Thermo Fisher Scientific Announces Founding Sponsorship of Momentum Labs
Thermo Fisher’s sponsorship of Momentum Labs is intended to support biotech businesses in the greater Gainesville region.
Fluid Air Launches Enhanced Magnaflo Filter Blowback System
Improvements to Fluid Air’s Magnaflo filter blowback system are intended to increase powder yield in PolarDry Models 001 and 004.
FDA Food Center Reorg Puts Field Inspections in Limbo
A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.
Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided.
Gerresheimer Presents New Clinical Trial Kit at Pharmapack
Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris.
FDA Resumes In-Person Meetings with Industry … Sort Of
FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.
Pharmapack Experts Predict Increased Packaging Consolidations in 2023
Pharmapack Europe experts expect smaller and medium European packaging companies to grow or be acquired.
Be The Match BioTherapies Launches CRO Services for Cell and Gene Therapy
Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.
