Saturday, December 3, 2022

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Biotechnology News Magazine

FDA Updates

B.More Submits FDA Investigational New Drug Application for Psilocybin Alcohol Use Disorder Program

According to Carey Turnbull, Co-founder and CEO of B.More, "B.More's psilocybin AUD program IND application is a major step forward in our mission to develop psychedelic medicines for individual struggling with alcohol use disorder. Our Phase 2b trial builds on the impressive work led by Dr. Bogenschutz and will provide vital data to further advance our drug development program."

Sandoz Supplemental Biologics License Application Accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) High Concentration Formulation (HCF)

Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study reports Sandoz.

FDA Grants Alpheus Medical Orphan Drug and Fast Track Designations for Novel Sonodynamic Therapy for Brain Cancer

Alpheus Medical is currently enrolling patients in a multi-center Phase 1 clinical trial for the treatment of recurrent glioblastoma (GBM).

Lipocine Reports FDA Clears LPCN 2101 IND for Adult Epilepsy Treatment

Lipocine notes LPCN 2101 is an orally delivered, endogenous neuroactive steroid ("NAS"), a positive allosteric modulator ("PAM") of GABAA receptor, with potential therapeutic effects in neurological and mood disorders. No concerning safety and tolerability signals were observed in the preclinical studies with LPCN 2101 while demonstrating a favorable pharmacokinetic profile.

CNS Pharmaceuticals Receives Approval from U.S. FDA for Protocol Amendment to Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with them to provide guidance on expediting the development and review process.

ANI Pharmaceuticals Announces the FDA Approval and Imminent Launch of Fludrocortisone Acetate Tablets USP

ANI Pharmaceuticals Fludrocortisone Acetate Tablets are the generic version of the Reference Listed Drug Florinef®. The current annual U.S. market for Fludrocortisone Acetate Tablets, 0.1 mg is approximately $24.2 million, according to IQVIA/IMS Health, a leading healthcare data, and analytics provider.