Entries by CAPTIS

Ocular Therapeutix announces first patient dosed in phase 1 clinical trial of OTX-CSI to treat dry eye disease

“We are pleased to be advancing OTX-CSI in the chronic treatment of dry eye disease,” said Michael Goldstein, MD, MBA, Chief Medical Officer. “We believe that the intracanalicular The post Ocular Therapeutix announces first patient dosed in phase 1 clinical trial of OTX-CSI to treat dry eye disease appeared first on Pharmaceutical Business review.

Appili Therapeutics submits CTA with Health Canada to sponsor trial of favipiravir as preventative measure against Covid-19

Favipiravir is approved in Japan as the anti-influenza drug Avigan. With FFTC providing support through donated drug product, the phase 2 study will be conducted at long-term care The post Appili Therapeutics submits CTA with Health Canada to sponsor trial of favipiravir as preventative measure against Covid-19 appeared first on Pharmaceutical Business review.

CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA RMAT designation granted to CTX001 to treat severe hemoglobinopathies

“RMAT designation is another important regulatory milestone for CTX001 and underscores the transformative potential of a CRISPR-based therapy for patients with severe hemoglobinopathies,” said Samarth Kulkarni, Ph.D., Chief The post CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA RMAT designation granted to CTX001 to treat severe hemoglobinopathies appeared first on Pharmaceutical Business review.

Lilly receives US FDA approval for Retevmo

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of objective response rate (ORR) and duration of response (DoR). Continued The post Lilly receives US FDA approval for Retevmo appeared first on Pharmaceutical Business review.