UK – MHRA updates biosimilar guidance to allow interchangeability between products
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if they use...
USA – FDA finalizes neurodegenerative disease gene therapy guidance
The US Food and Drug Administration (FDA) last week finalized guidance to assist sponsors developing human gene therapy (GT) products for neurodegenerative diseases. In...
USA – Global Pharma’s eye drops contaminated with “filth” while Amazon made unapproved claims...
The US Food and Drug Administration (FDA) lambasted India-based Global Pharma Healthcare in a 14 November warning letter for manufacturing eye drops that have...
UK – Brainomix’s AI-enabled stroke software endorsed by NICE
The National Institute of Health and Care Excellence (NICE) has issued guidance endorsing the use of Brainomix’s artificial intelligence (AI)-enabled software, Brainomix 360, to...
International – International regulators and WHO: support healthcare professionals to enhance public confidence in...
EMA has endorsed a statement for healthcare professionals jointly developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). The statement is aimed...
USA – FDA finalizes guidance on electronic submission of BA/BE adverse event reports to...
The US Food and Drug Administration (FDA) has finalized guidance that spells out how generic drug manufacturers can electronically submit expedited individual case safety...
USA – FDA Approves New Drug to Prevent RSV in Babies and Toddlers
Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates...
International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new...
Europe – New features further strengthen Priority Medicines scheme (PRIME)
EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of...
UK – Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment recommended by NICE
The final draft guidance issued by NICE means that patients will be eligible to receive the antifibrotic treatment, which is currently recommended for patients...
