EU okays BMS’ azacitidine pill for first-line maintenance of AMLBristol-Myers Squibb has been granted EU approval for Onureg (azacitidine), a tablet form of an intravenous drug that Share XEU okays BMS’ azacitidine pill for first-line maintenance of AMLhttps://pharmaphorum.com/news/eu-okays-bms-azacitidine-pill-for-first-line-maintenance-of-aml/
NICE backs Novartis’ Cosentyx for underdiagnosed back conditionNICE has extended the range of indications that Novartis’ Cosentyx can be prescribed for by the NHS in Share XNICE backs Novartis’ Cosentyx for underdiagnosed back conditionhttps://pharmaphorum.com/news/nice-backs-novartis-cosentyx-for-underdiagnosed-back-condition/
Blueprint’s latest approval for Ayvakit sets up clash with NovartisBlueprint Medicines has claimed its second FDA approval for Ayvakit, getting the nod for advanced systemic mastocytosis (SM), Share XBlueprint’s latest approval for Ayvakit sets up clash with Novartishttps://pharmaphorum.com/news/blueprints-latest-approval-for-ayvakit-sets-up-clash-with-novartis/
Consumer group seeks resignation of top FDA staffers over Aduhelm okayWith the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer Share XConsumer group seeks resignation of top FDA staffers over Aduhelm okayhttps://pharmaphorum.com/news/consumer-group-seeks-resignation-of-top-fda-staffers-over-aduhelm-okay/
Artificial pancreas will be piloted in 1,000 diabetics, says NHS CEONHS England will provide artificial pancreas devices to 1,000 type 1 diabetes patients as part of a pilot Share XArtificial pancreas will be piloted in 1,000 diabetics, says NHS CEOhttps://pharmaphorum.com/news/artificial-pancreas-will-be-piloted-in-1000-diabetics-says-nhs-ceo/
And then there were three: another FDA adcomm member quits over AduhelmThe fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a Share XAnd then there were three: another FDA adcomm member quits over Aduhelmhttps://pharmaphorum.com/news/and-then-there-were-three-another-fda-adcomm-member-quits-over-aduhelm/
Ocugen gets a black eye as FDA denies emergency OK for COVID jabOcugen is the first company to be affected by the FDA’s recent decision to raise the bar on Share XOcugen gets a black eye as FDA denies emergency OK for COVID jabhttps://pharmaphorum.com/news/ocugen-gets-a-black-eye-as-fda-denies-emergency-ok-for-covid-jab/
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/
Aduhelm approval could signal new era for CNS drugs; analystsThe unexpected approval and lofty pricing of Biogen’s Alzheimer’s therapy Aduhelm is clearly the biopharma event of the Share XAduhelm approval could signal new era for CNS drugs; analystshttps://pharmaphorum.com/news/aduhelm-approval-could-signal-new-era-for-cns-drugs-analysts/
FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tagThe FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” Share XFDA slammed over Aduhelm OK as Biogen takes heat for $56k price taghttps://pharmaphorum.com/news/fda-slammed-over-aduhelm-ok-as-biogen-takes-heat-for-56k-price-tag/
Scotland backs rare blood cancer drug Poteligeo rejected by NICEA north-south divide has emerged in UK medicines access after the Scottish Medicines Consortium (SMC) okayed Kyowa Kirin’s Share XScotland backs rare blood cancer drug Poteligeo rejected by NICEhttps://pharmaphorum.com/news/scotland-backs-rare-blood-cancer-drug-poteligeo-rejected-by-nice/
Jubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumabBiogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab Share XJubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumabhttps://pharmaphorum.com/news/jubilation-at-biogen-as-fda-says-yes-to-aducanumab/
After FDA approval, Alkermes plans soft launch for antipsychotic LybalviThe FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but Share XAfter FDA approval, Alkermes plans soft launch for antipsychotic Lybalvihttps://pharmaphorum.com/news/after-fda-approval-alkermes-plans-soft-launch-for-antipsychotic-lybalvi/
NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient groupNICE has rejected routine NHS funding for Roche’s Evrysdi (risdiplam) for spinal muscular atrophy drug in draft guidance, Share XNICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient grouphttps://pharmaphorum.com/news/nice-no-to-roches-risdiplam-for-sma-not-unexpected-says-patient-group/
Janssen COVID jab cleared in UK as fears of third wave mountWith concern already growing about a possible third wave of COVID-19 infections, the UK has cleared the use Share XJanssen COVID jab cleared in UK as fears of third wave mounthttps://pharmaphorum.com/news/janssen-covid-jab-cleared-in-uk-as-fears-of-third-wave-mount/
GSK, Sanofi eye Q4 approval as COVID jab starts phase 3GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered Share XGSK, Sanofi eye Q4 approval as COVID jab starts phase 3https://pharmaphorum.com/news/gsk-sanofi-eye-q4-approval-as-covid-jab-starts-phase-3/
Belgium halts dosing of J&J COVID vaccine in under 41s after deathBelgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s Share XBelgium halts dosing of J&J COVID vaccine in under 41s after deathhttps://pharmaphorum.com/news/belgium-halts-dosing-of-jj-covid-vaccine-in-under-41s-after-death/
CHMP backs bluebird bio’s gene therapy for rare disease ALDUS biotech bluebird bio has had a challenging time in the last few months, so a recommendation for Share XCHMP backs bluebird bio’s gene therapy for rare disease ALDhttps://pharmaphorum.com/news/chmp-backs-bluebird-bios-gene-therapy-for-rare-disease-ald/
