tag small-data 
pharmaphorum
APRIL 5, 2022
The European population is meanwhile estimated at several thousand patients, across all stages, according to registry data. GlobalData analyst Dr Sakis Palioras said in a recent research not that Kimmtrak’s 5.7 ” Image by Pexels from Pixabay .
Pharmaceutical Technology
NOVEMBER 9, 2022
On November 7, the company announced that the FDA has scheduled a pre-licensure inspection of BioMarin’s manufacturing facility, and required the company to submit three-year Phase III Roctavian data in the approval application. million price tag. The post Can gene therapies for haemophilia defend their high price tags?
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pharmaphorum
APRIL 27, 2022
Enhertu is already approved as a third-line therapy for HER2-positive metastatic breast cancer and a second-line therapy for HER2-positive metastatic gastric cancer, and recent data from the DESTINY-Breast03 study looks set to expand its use into second-line treatment in breast cancer.
pharmaphorum
DECEMBER 17, 2021
Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.
pharmaphorum
JULY 25, 2022
That alliance also yielded $6 billion blockbuster Darzalex as well as Rybrevant (amivantamab), J&J’s first bispecific antibody which is used to treat EGFR-mutated non-small cell lung cancer (NSCLC). Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.
pharmaphorum
JANUARY 5, 2021
The FDA’s breakthrough status is for tiragolumab plus Tecentriq is the first for a TIGIT drug, and covers the first-line treatment of patients with advanced-stage non-small cell lung cancer (NSCLC) that expresses high levels of PD-L1. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.
Pharmaceutical Technology
JULY 14, 2022
Due to the high price tags associated with these speciality medicines, innovators have naturally favoured big markets with high GDP such as the US and EU-5 (Germany, France, Spain, Italy, and the UK). “The Go-to-market strategies. The choice of where to launch an orphan drug is an important and difficult decision.
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