drug-pricing-drug-development 
STAT
NOVEMBER 27, 2023
The drug, which is jointly developed by Sanofi and Regeneron Pharmaceuticals, has already racked up approvals for several indications, including asthma, atopic dermatitis, and eosinophilic esophagitis. Food and Drug Administration by the end of the year. Continue to STAT+ to read the full story…
Safe Biologics
NOVEMBER 12, 2023
By limiting the type of data the FDA can consider when determining suitability for automatic substitution it risks undermining the data-driven confidence physicians and patients have developed in interchangeables. View the full webinar here or watch individual segments linked below. Read the full letter here.
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Express Pharma
NOVEMBER 30, 2023
On the positive side, drug manufacturers will be able to raise their prices, which will increase sales revenue, although government legislation will attempt to curb drug prices. Consumers may not react favorably to increasing prices.” Instead, many manufacturers will refocus on operational efficiency. “On
Pharma in Brief
NOVEMBER 12, 2023
The Patented Medicine Prices Review Board ( PMPRB ) has released a scoping paper on themes and questions to develop new price review Guidelines. The Board previously indicated that a second phase of consultation in 2024 would focus on the development of new Guidelines. Price Reviews during Product Life Cycle.
Quality Matters
NOVEMBER 27, 2023
Q&A: Building a More Resilient Medicines Supply Chain In this conversation, US Pharmacopeia (USP) Director of Regulatory and Public Policy Development Amy B. Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium (DM): How do you see the Consortium addressing ongoing drug shortage and drug supply chain issues?
European Pharmaceutical Review
NOVEMBER 9, 2023
Issue 5 of European Pharmaceutical Review features articles on manufacturing, development and quality control of biopharmaceuticals from antibodies to mRNA and cell and gene therapies. We also explore opportunities for outsourcing of regulatory activities, the challenges of paediatric drug formulation and much more.
Express Pharma
NOVEMBER 1, 2023
Immunoadoptive Cell Therapy (ImmunoACT)’s NexCAR19 (actalycabtagene autoleucel) chimeric antigen receptor T-cell (CAR-T) therapy was approved in October by the Central Drug Standards Control Organisation (CDSCO) of India for the treatment of relapsed or refractory (r/r) B-cell lymphomas and leukemia.
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