Drug Development
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
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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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Alnylam revealed its Phase III APOLLO-B study, which showed that patisiran improves both functional capacity and quality of life in patients with ATTR amyloidosis with cardiomyopathy.
Roche signed a big $6 billion-plus collaboration deal with Poseida on blood cancers while its partner, AC Immune, parsed failed data on an Alzheimer’s drug to suggest a positive spin.
Although no new safety concerns were observed, Merck’s Keytruda did not demonstrate significant improvements based on the pre-specified statistical plan.
While Moderna’s sole marketable program is its COVID-19 vaccine, CEO Stéphane Bancel said the company is “actively working to prepare...new product launches to help patients and drive growth.”
Ipsen said that Onivyde did not show greater benefit than topotecan used in patients with SCLC who have progressed on or after platinum-based first-line therapy treatment.
Gilead’s total revenue for Q2 increased 1% to $6.3 billion compared to Q2 in 2021. Overall, the company exceeded both its own expectations and the predictions of market analysts for the second quarter.
The FDA has placed a clinical hold on Beam Therapeutics’ leukemia/lymphoma therapy and has lifted the hold on Celyad’s CAR-T candidate for colorectal cancer.
The annual Alzheimer’s Association International Conference (AAIC) is running from July 31-August 4 at the San Diego Convention Center and online. Here are some of the highlights presented so far.
According to two recent studies, 10 to 30% of people with COVID-19 reported at least one persistent symptom up to six months after infection, which qualifies as Long COVID.
The exact implications of the paxalisib disappointment are still unclear, though it is highly likely that the candidate will be dropped from the GBM AGILE umbrella trial.