The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
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Anna Begley (European Pharmaceutical Review)
Imfinzi plus chemotherapy is the first immunotherapy combination to demonstrate superior clinical outcomes over standard of care for BTC.
Dupixent® reduced eosinophilic oesophagitis symptoms by 64 percent compared to placebo and met primary endpoints in second Phase III study.
The vaccine showed a relative vaccine efficacy of 95.6 percent and is the first efficacy results from a COVID-19 vaccine booster trial.
Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.
Dupixent® is the first biologic to significantly reduce itch and skin lesions in Phase III trial for prurigo nodularis.
The highest dose of tirzepatide led to an A1C reduction of 2.58 percent and reduced body weight by 11.7kg in Phase III study.
A Swedish study found that heterologous Vaxzevria and mRNA prime-boost vaccination is effective against COVID-19.
Interferon treatment with a bone marrow transplant bolstered outcomes for patients with advanced, high-risk leukaemia.
Imfinzi (durvalumab) demonstrated a meaningful overall survival (OS) benefit versus sorafenib as a first-line treatment for liver cancer.
The FDA has awarded 11 grants equating to about $25 million of funding to clinical trials for the development of rare disease treatments.
Enspryng (satralizumab) significantly reduced relapse in patients with neuromyelitis optica spectrum disorder (NMOSD) in Phase III study.
MR-guided focused ultrasound safely delivered antibody therapy to breast cancer that has metastasised to the brain in Phase I study.
Zeposia® (ozanimod) also demonstrated a low annualised relapse rate (ARR) of 0.103 in the five-year Phase III DAYBREAK study.
2021 Medicines for Europe-IGBA conference speakers assert that off-patent medicines will be crucial to rebuild healthcare post-COVID-19.