Phase I
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
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.
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.
Freeline Therapeutics’ hemophilia B drug demonstrated the strong possibility that a single injection of FLT180a, an experimental gene therapy, can reduce or eliminate the need for weekly injections.
Sandoz hopes its high-concentration formulation of an already greenlit biosimilar will be approved by the time AbbVie’s blockbuster drug Humira loses patent protection in the United States.
Hansa Biopharma secured $70 million in non-dilutive financing, OSE secured $300 million in funding while CN Bio opened a new contract research facility and more global biopharma news.
The buyout comes on the heels of promising Phase I/II results from GTX-102, an antisense oligonucleotide candidate being developed to treat Angelman syndrome.
MacroGenics’ Phase II trial shuts down after a patient death believed to be related to enoblituzumab combo, while Exelixis’ Cabometyx combo improves PFS in renal cell carcinoma.
Omega Therapeutics announced Thursday that the Investigational New Drug (IND) application for its hepatocellular carcinoma (HCC) candidate OTX-2002 has been granted by the FDA.
Kyowa Kirin announced it is dropping its Parkinson’s disease candidate, KW-6356, a follow-up to Nourianz, despite promising Phase II data that showed the drug is “potentially effective.”
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