Pfizer gets first approval, in UK, for Xeljanz follow-up CibinqoPfizer has claimed its first regulatory approval worldwide for Cibinqo, its JAK inhibitor for atopic dermatitis, from the Share XPfizer gets first approval, in UK, for Xeljanz follow-up Cibinqohttps://pharmaphorum.com/news/pfizer-gets-first-approval-in-uk-for-xeljanz-follow-up-cibinqo/
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/
NICE changes its mind on J&J’s Erleada in prostate cancerNICE has reversed its position on Johnson & Johnson’s oral prostate cancer therapy Erleada in patients with hormone-relapsed Share XNICE changes its mind on J&J’s Erleada in prostate cancerhttps://pharmaphorum.com/news/nice-changes-its-mind-on-jjs-erleada-in-prostate-cancer/
EMA looks at booster data for Pfizer/BioNTech COVID-19 jabThe EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, Share XEMA looks at booster data for Pfizer/BioNTech COVID-19 jabhttps://pharmaphorum.com/news/ema-looks-at-booster-data-for-pfizer-biontech-covid-19-jab/
NICE backs Cosentyx’ use in thousands of children with psoriasisNICE has recommended broadening NHS use of Novartis’ IL-17 inhibitor Cosentyx to include children aged six to 17 Share XNICE backs Cosentyx’ use in thousands of children with psoriasishttps://pharmaphorum.com/news/nice-backs-cosentyx-use-in-thousands-of-children-with-psoriasis/
FDA schedules adcomm for Pfizer’s COVID booster filingThe FDA will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech’s filing for Share XFDA schedules adcomm for Pfizer’s COVID booster filinghttps://pharmaphorum.com/news/fda-schedules-adcomm-for-pfizers-covid-booster-filing/
NICE backs NHS use of Novartis’ cholesterol drug LeqvioNovartis’ cholesterol-lowering drug Leqvio will be made available on the NHS in England and Wales, and could help Share XNICE backs NHS use of Novartis’ cholesterol drug Leqviohttps://pharmaphorum.com/news/nice-backs-nhs-use-of-novartis-cholesterol-drug-leqvio/
NICE rejects J&J’s Darzalex regimen for multiple myelomaNew guidance from NICE has rejected a combination regimen based on Johnson & Johnson’s Darzalex for a group Share XNICE rejects J&J’s Darzalex regimen for multiple myelomahttps://pharmaphorum.com/news/nice-rejects-jj-darzalex-regimen-for-multiple-myeloma/
AbbVie’s Rinvoq cleared in EU for atopic dermatitisThe FDA may be reluctant to trust JAK inhibitors, but the European Commission is more willing, and has Share XAbbVie’s Rinvoq cleared in EU for atopic dermatitishttps://pharmaphorum.com/news/abbvies-rinvoq-is-first-jak-drug-cleared-in-eu-for-atopic-dermatitis/
Cara’s Korsuva is first drug cleared for itching in dialysis patientsOne of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – Share XCara’s Korsuva is first drug cleared for itching in dialysis patientshttps://pharmaphorum.com/news/caras-korsuva-is-first-drug-cleared-for-itching-in-dialysis-patients/
IL-17 tailender UCB gets EU OK for bimekizumab in psoriasisUCB has been bringing up the rear in the IL-17 inhibitor category with bimekizumab, but now has EU Share XIL-17 tailender UCB gets EU OK for bimekizumab in psoriasishttps://pharmaphorum.com/news/il-17-tailender-ucb-gets-eu-ok-for-bimekizumab-in-psoriasis/
FDA grants full approval to Pfizer/BioNTech COVID jabPfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and Share XFDA grants full approval to Pfizer/BioNTech COVID jabhttps://pharmaphorum.com/news/fda-grants-full-approval-to-pfizer-biontech-covid-jab/
COVID prompts another milestone, as India clears first DNA vaccineThe COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots Share XCOVID prompts another milestone, as India clears first DNA vaccinehttps://pharmaphorum.com/news/covid-prompts-another-milestone-as-india-clears-first-dna-vaccine/
After FDA snub, EMA backs FibroGen, Astellas’ roxadustatThe EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease Share XAfter FDA snub, EMA backs FibroGen, Astellas’ roxadustathttps://pharmaphorum.com/news/after-fda-snub-ema-backs-fibrogen-astellas-roxadustat/
NICE says yes to Novartis’ Rydapt for rare blood disorderNovartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis Share XNICE says yes to Novartis’ Rydapt for rare blood disorderhttps://pharmaphorum.com/news/nice-says-yes-to-novartis-rydapt-for-rare-blood-disorder/
Jardiance gets parity with Farxiga in US as FDA clears use in heart failureEli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with Share XJardiance gets parity with Farxiga in US as FDA clears use in heart failurehttps://pharmaphorum.com/news/jardiance-gets-parity-with-farxiga-in-us-as-fda-clears-use-in-heart-failure/
Amid Actemra shortage, WHO asks Roche to ensure equitable accessRoche’s arthritis drug Actemra has become a key treatment for people with severe COVID-19, leading to shortages, and Share XAmid Actemra shortage, WHO asks Roche to ensure equitable accesshttps://pharmaphorum.com/news/amid-actemra-shortage-who-asks-roche-to-ensure-equitable-access/
Merck kicks off oral COVID-19 antiviral filing in CanadaHealth Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for Share XMerck kicks off oral COVID-19 antiviral filing in Canadahttps://pharmaphorum.com/news/merck-kicks-off-oral-covid-19-antiviral-filing-in-canada/
