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FDA sets up Novel Excipient Review Pilot Program
Manufacturers can submit their novel excipients for FDA review under the voluntary Novel Excipient Review Pilot Program.
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US Food and Drug Administration (FDA)
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FDA awards 11 grants for rare disease treatment developments
The FDA has awarded 11 grants equating to about $25 million of funding to clinical trials for the development of rare disease treatments.
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Anti-amyloid antibody receives Breakthrough Therapy Designation in US
Roche's gantenerumab is an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients.
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New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
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HIV treatment evolution: drug development to meet the modern needs of patients
In this article, European Pharmaceutical Review’s Hannah Balfour explores some of big pharma’s latest developments in HIV treatment, with commentary from ViiV Healthcare’s Head of Research and Development, Kimberly Smith.
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FDA authorises Comirnaty® booster dose for certain populations
The US FDA amended the emergency use authorisation to allow for a Comirnaty booster dose in individuals at high-risk for COVID-19.
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Temperature stable microneedle patch successfully delivers DNA COVID-19 vaccine
A microneedle patch, which can be stored for >30 days at room temperature, safely delivered a DNA-based COVID-19 vaccine in mice.
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Comirnaty® effective in children aged five to 11 years
Positive results from pivotal trial show that the COVID-19 vaccine Comirnaty is safe and effective in children aged five to 11 years old.
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Kisqali® demonstrates longest overall median breast cancer survival
Kisqali plus letrozole achieved a median overall survival of over five years, the longest ever reported for HR+/HER2 breast cancer.
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Ampion™ reduces severe knee osteoarthritis pain in 12 weeks
Ampion significantly reduced pain and improved function in severe osteoarthritis of the knee (OAK) in 12 weeks, shows Phase III study.
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Mobocertinib approved as first oral therapy for EGFR Exon20+ NSCLC
FDA approves mobocertinib as the first oral therapy for patients with non-small cell lung cancer with EGFR Exon20 insertion mutations.
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Novartis submit BLA for tislelizumab for oesophageal cancer treatment
US FDA have accepted Biologics License Application (BLA) for tislelizumab for the treatment of oesophageal squamous cell carcinoma cancer.
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3D printing – current pharmaceutical applications and future directions
3D printing has the potential to revolutionise the pharmaceutical manufacturing industry; however, few 3D-printed products have been approved since the first in 2015. In this article, EPR’s Hannah Balfour explores the technologies currently being evaluated for use in the 3D printing of pharmaceuticals, and the work of key market players…
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Data integrity is a key concern with microbial methods, says expert
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
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Embedding inclusion in pharmaceutical design
In this article, Included’s Raafi-Karim Alidina explores biases in product design, outlining how they impact pharmaceuticals as well as technologies, and practical steps to enhance diversity and ensure inclusion.