BeyondSpring faces a tough winter as FDA rejects its lead drugBeyondSpring’s hopes of an early Christmas gift from the FDA were dashed today after the regulator said it Share XBeyondSpring faces a tough winter as FDA rejects its lead drughttps://pharmaphorum.com/news/beyondspring-faces-a-tough-winter-as-fda-rejects-its-lead-drug/
Califf re-joining FDA would be positive for industry; analystWith rumours growing that that ex-FDA head Robert Califf looks set to receive President Joe Biden’s nomination to Share XCaliff re-joining FDA would be positive for industry; analysthttps://pharmaphorum.com/news/califf-re-joining-fda-would-be-positive-for-industry-analyst/
MHRA cuts could affect UK regulatory decisions, say unionsA 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks Share XMHRA cuts could affect UK regulatory decisions, say unionshttps://pharmaphorum.com/news/mhra-cuts-could-affect-uk-regulatory-decisions-say-unions/
Does draft RCT guide set the scene for future trials?A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and Share XDoes draft RCT guide set the scene for future trials?https://pharmaphorum.com/views-analysis-patients/randomised-clinical-trials-guide-future-trials/
Global regulators seek permanent working group on AIRapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of Share XGlobal regulators seek permanent working group on AIhttps://pharmaphorum.com/news/global-regulators-seek-permanent-working-group-on-ai/
Pfizer and Flynn in the firing line again over UK epilepsy drug pricingThe UK’s Competition and Markets Authority (CMA) has resurrected a complaint against Pfizer and Flynn Pharma, claiming the Share XPfizer and Flynn in the firing line again over UK epilepsy drug pricinghttps://pharmaphorum.com/news/pfizer-flynn-in-the-firing-line-again-over-uk-epilepsy-drug-pricing/
UK fines Advanz £100m for raising thyroid drug price tenfoldThe UK has levied another big fine for anticompetitive activity in the pharma market in a fortnight, with Share XUK fines Advanz £100m for raising thyroid drug price tenfoldhttps://pharmaphorum.com/news/uk-fines-advanz-100m-for-raising-thyroid-drug-price-tenfold/
FDA gives speedy review to Bayer’s Parkinson’s stem cell therapyBayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based Share XFDA gives speedy review to Bayer’s Parkinson’s stem cell therapyhttps://pharmaphorum.com/news/fda-gives-speedy-review-to-bayers-parkinsons-stem-cell-therapy/
UK fines drugmakers record £260m for price gouging NHSThe UK’s competition authority has issued its largest ever fine of more than £260 million ($360 million) to Share XUK fines drugmakers record £260m for price gouging NHShttps://pharmaphorum.com/news/uk-fines-drugmakers-record-260m-for-price-gouging-nhs/
