AZ gets FDA nod for Enhertu in first HER2-low cancer The FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu as the first targeted therapy for HER2-low breast cancer, Share X AZ gets FDA nod for Enhertu in first HER2-low cancer https://pharmaphorum.com/news/az-gets-fda-nod-for-enhertu-in-first-her2-low-cancer/
US Democrats’ blockbuster budget bill could spell big changes for drug prices The Inflation Reduction Act of 2022, a sweeping measure that now looks likely to be passed through budget Share X US Democrats’ blockbuster budget bill could spell big changes for drug prices https://pharmaphorum.com/market-access-2/us-democrats-blockbuster-budget-bill-could-spell-big-changes-for-drug-prices/
Sanofi looks east with €300m Innovent cancer alliance Sanofi is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring Share X Sanofi looks east with €300m Innovent cancer alliance https://pharmaphorum.com/news/sanofi-looks-east-with-e300m-innovent-cancer-alliance/
Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus Share X Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod https://pharmaphorum.com/news/pressure-rises-on-lucentis-as-coherus-biosimilar-gets-fda-nod/
Sarepta says early filing for DMD gene therapy is back on Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its Share X Sarepta says early filing for DMD gene therapy is back on https://pharmaphorum.com/news/sarepta-says-early-filing-for-dmd-gene-therapy-is-back-on/
AmerisourceBergen aims to make digital therapeutics access easier Pharma distributor AmerisourceBergen is working on a platform to make access to digital therapeutics (DTx) easier in the Share X AmerisourceBergen aims to make digital therapeutics access easier https://pharmaphorum.com/news/amerisourcebergen-aims-to-make-digital-therapeutics-access-easier/
Biogen gets much-needed pipeline lift with speedy ALS drug review Beleaguered Biogen has been handed some encouraging news from the FDA, after the regulator agreed to complete its Share X Biogen gets much-needed pipeline lift with speedy ALS drug review https://pharmaphorum.com/news/biogen-gets-much-needed-pipeline-lift-with-speedy-als-drug-review/
Roche’s fast-growing eye drug Vabysmo set for EU approval Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Share X Roche’s fast-growing eye drug Vabysmo set for EU approval https://pharmaphorum.com/news/roches-fast-growing-eye-drug-vabysmo-set-for-eu-approval/
CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for Share X CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision https://pharmaphorum.com/news/chmp-backs-jjs-myeloma-bispecific-tecvayli-ahead-of-us-decision/
Simcere gets China okay for G1’s bone marrow protector Cosela China’s Simcere Pharmaceutical has been granted approval in its home market for Cosela, a drug designed to limit Share X Simcere gets China okay for G1’s bone marrow protector Cosela https://pharmaphorum.com/news/simcere-gets-china-okay-for-g1s-bone-marrow-protector-cosela/
AZ, Daiichi challenge Roche with EU okay for earlier use of Enhertu AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive Share X AZ, Daiichi challenge Roche with EU okay for earlier use of Enhertu https://pharmaphorum.com/news/az-daiichi-challenge-roche-with-eu-okay-for-earlier-use-of-enhertu/
Byondis cues up US, EU decisions on breast cancer ADC in 2023 Byondis has filed its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the US and Europe, setting up possible Share X Byondis cues up US, EU decisions on breast cancer ADC in 2023 https://pharmaphorum.com/news/byondis-cues-up-us-eu-decisions-on-breast-cancer-adc-in-2023/
NICE unlocks use of Amarin’s Vazkepa in 425k NHS patients Health technology assessment (HTA) agency NICE has finalised its guidance on Amarin’s Vazkepa, clearing the path for GPs Share X NICE unlocks use of Amarin’s Vazkepa in 425k NHS patients https://pharmaphorum.com/news/nice-unlocks-use-of-amarins-vazkepa-in-425k-nhs-patients/
FDA clears Xalkori for inflammatory myofibroblastic tumours Pfizer’s tyrosine kinase inhibitor Xalkori has picked up a fourth approval from the FDA, adding a new use Share X FDA clears Xalkori for inflammatory myofibroblastic tumours https://pharmaphorum.com/news/fda-clears-xalkori-for-inflammatory-myofibroblastic-tumours/
NICE backs two new breast cancer drugs for NHS use Cost-effectiveness watchdog NICE has recommended routine NHS use of two new therapies for women with advanced breast cancer Share X NICE backs two new breast cancer drugs for NHS use https://pharmaphorum.com/news/nice-backs-two-new-breast-cancer-drugs-for-nhs-use/
HRA Pharma bids to bring first OTC contraceptive pill to US Perrigo’s HRA Pharma subsidiary has become the first drugmaker in the US to seek approval for an over-the-counter Share X HRA Pharma bids to bring first OTC contraceptive pill to US https://pharmaphorum.com/news/hra-pharma-bids-to-bring-first-otc-contraceptive-pill-to-us/
NICE makes J&J’s Tremfya more accessible in England and Wales NICE has updated its recommendations for NHS use of Johnson & Johnson’s IL-23 inhibitor Tremfya in the treatment Share X NICE makes J&J’s Tremfya more accessible in England and Wales https://pharmaphorum.com/news/nice-makes-jjs-tremfya-more-accessible-in-england-and-wales/
BMS’ Opdivo gets NHS use as adjuvant bladder cancer therapy NICE has recommended routine use of Bristol-Myers Squibb’s Opdivo for the adjuvant treatment of some patients with urothelial Share X BMS’ Opdivo gets NHS use as adjuvant bladder cancer therapy https://pharmaphorum.com/news/bms-opdivo-gets-nhs-use-as-adjuvant-bladder-cancer-therapy/
