Industry News
Congress Probes PBM Link to Higher Drug Prices
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.
Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone
Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.
Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products
The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.
FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins
The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.
Eli Lilly to Cap Out-Of-Pocket Insulin Costs at $35
Lilly will cap insulin prices for patients with and without insurance at $35 per month.
WHO Calls for Increased Funding to Aid Yemen’s Health Crisis
WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.
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.
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.
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 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.
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.
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.
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.
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.
