FarmaKology Newsletter - Issue #56

Aug 26, 2020

Today's Startup

TreeFrog Therapeutics

TreeFrog Therapeutics is a stem cell company that will enable millions of patients to access the medical revolution of cell therapies by overcoming current critical manufacturing issues.TreeFrog Therapeutics has developed C-Stem® : a proprietary technology platform that provides an end to end 3D scalable solution that will dramatically reduce treatment costs.Through strategic partnership and co-developments, TreeFrog Therapeutics will help cell therapy players to secure cell production and quality, fasten clinical development and facilitate market access.

News

FDA Approves Cysteamine Ophthalmic Solution for Cystinosis

The US Food and Drug Administration (FDA) has approved cysteamine ophthalmic solution (Cystadrops 0.37%) for treatment of cystinosis manifestations in adults and children. The cystine-depleting ophthalmic solution has been shown to significantly reduce cystine crystal deposits in the cornea of the eye. The FDA’s approval of the new treatment, granted to Recordati was supported by data from two clinical trials—a Phase 3 open label, randomized, controlled, two-arm multicenter trial and a Phase 1/2a open-label, adaptive dose-response clinical trial.

Bolder BioTechnology says MS drug candidate could be used for COVID-19

Bolder BioTechnology, Inc. announced today that preclinical studies have shown that its proprietary long-acting interferon beta analog, BBT-032, strongly inhibits growth of the SARS-CoV-2 virus in culture at concentrations expected to be readily achievable in patients. SARS-CoV-2 is the coronavirus responsible for the Covid-19 pandemic. Based upon these promising results, Bolder BioTechnology intends to file an Investigational New Drug Application with the U.S. Food and Drug Administration to begin testing BBT-032 in humans. BBT-032 may prove useful for accelerating clearance of the SARS-CoV-2 virus in infected patients and for preventing infections in uninfected individuals.

Pharmacy Times® and Parata Systems Announce the 2020 Next-Generation Pharmacist® Finalists

Pharmacy Times ®, the leading media resource for pharmacists, in conjunction with Parata Systems, a leading provider of pharmacy automation, reveal the 30 finalists for the 2020 Next-Generation Pharmacist® awards. The 11th annual virtual awards program will take place virtually on Oct. 21 st at 7:30 p.m. EST. “ This year marks the 11th year of the annual awards program with Parata,” said John Hydrusko, vice president of Pharmacy & Healthcare Communications. “We are incredibly honored to recognize each of these bright leaders in the pharmacy community, and we look forward to celebrating their outstanding contributions this fall at our 2020 Next-Generation Pharmacist® ceremony.”

New guidelines allow pharmacists to vaccinate children as young as 3, but doctors are unsure what it will achieve

Childhood vaccination rates plummeted in the middle of March after the COVID-19 pandemic hit, in a trend that’s worrying for public health officials. Now the Department of Health and Human Services (HHS) has issued guidance to help expand access to childhood vaccines. Under the guidelines, which were released on Aug. 19, pharmacists across the country are allowed to give shots to children, including the flu vaccine, starting at age 3. Previously, only 28 states allow pharmacists to vaccinate children. The goal, the HHS says, is “to increase access to childhood vaccines and decrease the risk of vaccine-preventable disease outbreaks as children across the United States return to daycare, preschool and school.”