Here are the latest stories being discussed in biopharma today:
EMA Committee Gives Positive Recommendations for Two Drugs, Denounces Two Others
The European Medicines Agency’s Human Medicine Committee (CHMP) voted in favor of two new medicines while rejecting two others. Notably, Apellis’s geographic atrophy treatment, Syfovre, was barred despite being approved in the U.S for almost a year. Apellis plans to appeal the negative decision.
EC Report: Competition Enforcement Leads to Fair Prices, Innovative Products
According to a European Commission report, antitrust and merger enforcement has resulted in fair prices for medicines and a competitive market over the past few years. The report examined enforcement actions by the EC and National Competition Authorities from 2018 to 2022, finding that these actions ultimately enhanced access to medications.
J&J Unveils BRCA-focused Campaign
A new BRCA (breast cancer gene) communication initiative by Johnson & Johnson, called “Dad Genes,” aims to raise awareness about the mutation’s role in prostate cancer. The campaign encourages gene testing and early screening, particularly as BRCA-positive metastatic castration-resistant prostate cancer can be more aggressive.
Overemphasis on Covid-19 Leading to Lack of Depth in Vaccine Pipeline, According to BIO Report
A report from the Biotechnology Innovation Organization (BIO) suggests there may be too many Covid-19 vaccines currently in development and too little work being done on other infectious diseases. Out of the 249 novel vaccine programs being tested globally, 28% are for Covid-19 prevention.
AbbVie Invests $223M in Biologics Capacity Expansion in Singapore
AbbVie is investing $223 million to expand its biologics production capacity at its only manufacturing site in Asia, located in Singapore. The facility will add at least 100 jobs, and the expansion is set to start operations in 2026.
FDA Revises Draft Guidance on Remote Manufacturing Assessments
The U.S Food and Drug Administration (FDA) has released revised Q&A guidance regarding its use of mandatory remote regulatory assessments. This move is aimed at fostering a better understanding of biopharma manufacturers and aiding in approval decisions.
