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Makena Saga Shows How Hard It Is to Remove Unproven Drug from Market
Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.
Catalent Expands UpTempo AAV Platform
Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.
Vetter Joins United Nations Global Compact
Vetter has become a participant of the UN Global Compact Network.
Congress Probes PBM Link to Higher Drug Prices
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.
Merck Releases Data on Rare Blood Vessel Disorder Treatment
Sotatercept, a drug candidate acquired by Merck in an $11.5 billion acquisition, showed statistically significant improvements in various measures.
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.
Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15%
Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.
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.
AstraZeneca Strikes $1.16 Billion Licensing Deal for Gastric Cancer Candidate
AstraZeneca has entered into a global exclusive license agreement with KYM Biosciences for CMG901, which is being investigated as a gastric cancer treatment.
Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA
Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.
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.
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.
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.
