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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WHO declared the monkeypox outbreak a “public health emergency of international concern [PHEIC].” As COVID-19 wanes, Tonix, SIGA, Emergent Bio and others are now targeting monkeypox.
Here’s a look at global biopharma company news stories including Rona Therapeutics, Genuine Bio and NEOsphere Bio.
Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted
A study published this month in Science discusses data that may support a devious alter ego of T-cells present within colorectal cancers that appear to inhibit and promote tumor progression.
The announcement signals that the WHO now views the outbreak as significant enough that a coordinated global response is necessary to control it.
VistaGenTherapeutics announced data showing that its nasal spray candidate for anxiety, depression and other central nervous system disorders, fell short of its primary endpoint.
“The applications for mRNA are quite broad, because, basically, you are giving information to a cell to make any protein you want,” CureVac CFO Pierre Kemula told BioSpace.
Researchers evaluate just how well therapeutic antibodies and antivirals work against Omicron, Vaxart’s oral vaccine shows early promise and hypertension doubles the risk of hospitalization.
The data used to support the argument that Aβ*56 is responsible for the Alzheimer’s Disease hallmark of memory loss appears to have been fabricated or heavily tampered with.
Prometheus completed its Phase II trial in UC, Algernon announced its Phase II trial of IPF and chronic coffee, Seelos dosed the first patient of SLS-005 for patients with ALS.