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/
FDA staffers defend Aduhelm approval in JAMA editorialThree FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Share XFDA staffers defend Aduhelm approval in JAMA editorialhttps://pharmaphorum.com/news/fda-staffers-defend-aduhelm-approval-in-jama-editorial/
Final hurdle falls as UK backs AZ’s $39bn takeover of AlexionThe UK’s competition regulator has approved AstraZeneca’s $39 billion acquisition of US-based drugmaker Alexion, without opting for a Share XFinal hurdle falls as UK backs AZ’s $39bn takeover of Alexionhttps://pharmaphorum.com/news/final-hurdle-falls-as-uk-backs-azs-39bn-takeover-of-alexion/
Double resignation over Aduhelm approval depletes FDA’s CNS adcommTwo members of an FDA advisory committee have now resigned in protest over Monday’s approval of Biogen’s Alzheimer’s Share XDouble resignation over Aduhelm approval depletes FDA’s CNS adcommhttps://pharmaphorum.com/news/double-resignation-over-aduhelm-approval-depletes-fdas-cns-adcomm/
EU starts rolling review of GSK’s antibody for COVID-19The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which Share XEU starts rolling review of GSK’s antibody for COVID-19https://pharmaphorum.com/news/eu-starts-rolling-review-of-gsks-antibody-for-covid-19/
Merck gets confirmatory trial win for Keytruda in endometrial cancerMerck & Co’s conditional FDA approval for checkpoint inhibitor Keytruda in endometrial cancer looks secure, thanks to a Share XMerck gets confirmatory trial win for Keytruda in endometrial cancerhttps://pharmaphorum.com/news/merck-gets-confirmatory-trial-win-for-keytruda-in-endometrial-cancer/
FTC clears Mylan merger with Pfizer’s Upjohn – with conditionsMylan’s $12 billion takeover of Pfizer’s Upjohn unit has been cleared by the US authorities, but on the Share XFTC clears Mylan merger with Pfizer’s Upjohn – with conditionshttps://pharmaphorum.com/news/ftc-clears-mylan-merger-with-pfizers-upjohn-with-conditions/
FDA’s review date for BMS’ ide-cel sneaks under the CVR wireThe FDA has given a 27 March 2021 review date for Bristol-Myers Squibb’s multiple myeloma cell therapy ide-cel, Share XFDA’s review date for BMS’ ide-cel sneaks under the CVR wirehttps://pharmaphorum.com/news/fdas-review-date-for-bms-ide-cel-sneaks-under-the-cvr-wire/
