Regulatory
MediciNova, Inc. announced that the U.S. Food and Drug Administration has completed its review of the protocol and determined that MediciNova may proceed with a Phase 2b/3 clinical trial of MN-166 in amyotrophic lateral sclerosis.
Novartis will use a priority review voucher to expedite review of the treatment that could hit blockbuster status within two years of launching.
The vast majority of immune cells are found in the gut but historically, the gut has been viewed as a liability to drug development. The question of whether or not greater understanding of harnessing the gut could drive more promising drug development has led to the formation of a new company, Kintai Therapeutics.
Auris Medical Holding Ltd. announced that the Nasdaq Hearings Panel has granted the Company’s request for the continued listing of the Company’s securities on The Nasdaq Capital Market.
TLC announced the successful completion of its End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) on receiving guidance, and discussing the clinical and regulatory pathway for a potential U.S. approval of TLC599, a BioSeizer® liposomal formulation of dexamethasone sodium phosphate for the treatment of knee osteoarthritis.
The FDA’s approval marks the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer.
Polyphor AG announced that the US Food and Drug Administration has designated murepavadin as a Qualified Infectious Disease Product in four additional indications; hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infection, bloodstream infection and complicated intra-abdominal infection.
Sprout wanted the warning regarding alcohol to be completely removed but the FDA said it must remain, although with a caveat.
Pharma and biotech companies from Asia to Europe provide updates on business and clinical activities.
With the ever-rising concerns over the costs of various prescription medications, a report from consumer pharmaceutical watchdog group Institute for Clinical and Economic Review released a report questioning the potential pricing of two yet-to-be-approved peanut allergy treatments.
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