USA – FDA updates statistical approaches for assessing bioequivalence

The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies...

UK – Janssen and AbbVie’s Imbruvica combination recommended by NICE for leukaemia

CLL is the common type of leukaemia in adults, with around 3,800 people in the UK diagnosed with the disease each year. While patient outcomes...

UK – NICE approval for Janssen’s Darzalex combination

Recommendation concerns routine use across the NHS as therapy for multiple myeloma The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the National...

USA – FDA finalizes drug-drug interaction guidance for therapeutic proteins

The US Food and Drug Administration (FDA) on Friday issued a final guidance to assist sponsors in determining whether to conduct drug-drug interaction studies...

USA – FDA Approves First Over-the-Counter Naloxone Nasal Spray

Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first...

USA – Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation

Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a...

Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended...

EMA’s human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original...
Ajovy bags NICE approval

UK – NICE recommends Pfizer’s Paxlovid on NHS

Pfizer has announced today that the National Institute for Health and Care Excellence (NICE) has issued an appraisal consultation document which recommends Paxlovid. Also known...
New guidance on biologics affects authorized generics

USA – FDA issues 80 guidances for topical products

The FDA has issued eight new product-specific draft guidances and 72 revised draft guidances for sponsors of topical products applied to the skin or...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – OIG raises concerns about accelerated approval pathway

More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years...