Drug Development
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
FEATURED STORIES
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
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Jazz Pharma is breaking new ground with its cannabidiol epilepsy treatment Epidiolex, taking the drug into a Phase III study in children and adolescents.
Researchers at Case Western University looked at the real-world experiences of 13,644 patients who were treated with Paxlovid or Lagevrio (molnupiravir) during the first half of 2022.
Ryvu and Opthea have new funding to work with, Tessa Therapeutics and Enlivex kick off new trials and Revive Therapeutics amends the Phase III protocol for its COVID-19 hopeful.
Researchers recently developed a peptide called A1R-CT that could ultimately have therapeutic applications in both epilepsy and Alzheimer’s disease.
Blueprint Medicines’ Ayvakit is headed to the FDA for a new indication after the drug hit the mark in Part 2 of the PIONEER trial for non-advanced systemic mastocytosis.
I-Mab quietly announced that its partner AbbVie is ending a Phase IB trial on lemzoparlimab for two types of cancers, despite a $2 billion deal inked in 2020.
All other ongoing and pending studies of Sanofi’s amcenestrant, including the early-stage breast cancer trial AMEERA-6, will also be discontinued.
Novavax seeks EUA for COVID-19 Booster, a 100-year-old TB vaccine may protect against the disease and public health officials struggle with fall planning.
Weeks after AstraZeneca and Daiichi Sankyo were able to move the bar in the treatment of metastatic breast cancer with Enhertu, Gilead is answering that challenge with Trodelvy.
Clene Nanomedicine’s CNM-Au8 demonstrated surprising improvements in some MS patients, despite the study being halted early due to COVID-19.