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...
UK – Takeda’s Exkivity receives NICE recommendation for rare form of lung cancer
The treatment was licensed through by Project Orbis, an international programme to review and approve promising cancer drugs helping patients access treatments faster.
NICE’s decision...
USA – FDA relaxes EUA advertising limitation for some COVID drugs
The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs)....
UK – Research provides hope for patients with neurodegenerative disease
Scientists have discovered a new treatment that slows the progression of neurodegenerative disease in mice. The breakthrough research may offer hope in tackling currently...
UK – NICE publishes draft guidance recommending three COVID-19 treatments
The treatments recommended by NICE are Roche’s RoActemra (tocilizumab) and Eli Lilly’s Olumiant (baricitinib), both indicated for use in a hospitalised setting in patients...
USA – FDA Adds/Revises Product-Specific Guidances
The FDA has issued 29 new product-specific draft guidances and 22 revised draft guidances for complex and non-complex generic drug products.
The guidances provide product-specific...
USA – Stakeholders ask FDA to harmonize adverse events terms with standards orgs
Pharmaceutical companies are asking the US Food and Drug Administration (FDA) for more adverse events reporting standardization by harmonizing with standards organizations as well...
International – Modular plug-and-produce facilities for cell therapies
At the start of 2021, a crane lifted a shrink-wrapped, elongated structure off a truck flatbed and through a window into an upper floor...
Europe – Expert: Combination product firms need EU guidance amid regulatory ambiguity
The EU Medical Device Regulation (MDR) created confusion for medical device manufacturers in Europe, including drug-device combination (DDC) producers. As stakeholders seek more guidance...
UK – New T-cell study demonstrates ‘powerful’ potential for tailored cancer medicine
The clinical study involved 16 patients with either colon, breast or lung cancers that had failed to respond to other treatments, and was made...
