Phase I
Only weeks after announcing a new chief executive officer and chief medical officer, Editas Medicine reported promising early data for its Phase I/II RUBY trial of EDIT-301 for severe sickle cell disease (SCD).
Ionis announced that the FDA has accepted its NDA for tofersen for SOD1-ALS. The application has been given the priority review designation and an action date of January 25, 2023.
BridgeBio announces positive Phase II trial results for achondroplasia, Astellas-Seagen announces promising outcomes from Padcev Plus Keytruda Trial and Kelun-Biotech’s exclusive MSD deal.
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.
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