Biotech | September 26, 2021
U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
The company does not expect the outcome of this inspection to impact its plans
The company does not expect the outcome of this inspection to impact its plans
The company is the Clinical Research Organisation of Caplin Point Laboratories
Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
The company said in a regulatory filing that it was confident of addressing the observations satisfactorily
Initiation of EBT-101 Phase 1/2 clinical trial expected later this year
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
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Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
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