Pfizer and BioNTech Announce Early Positive Data from Ongiing Phase 1/2 Study of mRNA-based Vaccine Candidate Against SARS-COV-2

  • In an ongoing U.S. Phase 1/2 placebo-controlled, observer-blinded clinical trial, nucleoside-modified messenger RNA vaccine candidate (BNT162b1) expressing the SARS-CoV-2 receptor binding domain (RBD) is being evaluated in 45 subjects
  • At day 28 (7 days after dose 2), all subjects who received 10 or 30 µg of BNT162b1 had significantly elevated RBD-binding IgG antibodies with geometric mean concentrations (GMCs) of 4,813 and 27,872 units/ml which are 8- and 46.3-times, respectively, the GMC of 602 units/ml in a panel of 38 sera of convalescent patients who had contracted SARS-CoV-2.
  • At day 28 (7 days after dose 2), all subjects who received 10 or 30 µg of BNT162b1 had SARS-CoV-2 neutralizing antibodies with geometric mean titers (GMTs) of 168 and 267, which are 1.8- and 2.8-times, respectively, the GMT of the convalescent serum panel
  • Local reactions and systemic events after immunization with 10 µg and 30 µg of BNT162b1 were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported
  • Further data from the ongoing Phase 1/2 clinical trial of four vaccine candidates will enable selection of a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study that may begin as early as July 2020
  • Efforts to manufacture the leading candidates, at risk, are gearing up. In case the safety and efficacy study is successful, and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021

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Cancer Prevention Pharmaceuticals Submits New Drug Application to the FDA for CPP-1X/sul for Treatment of Familial Adenomatous Polyposis

Company seeks accelerated approval for cancer drug

 TUCSON, Arizona, June 29, 2020 – Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for CPP-1X/sul for treatment of adults with familial adenomatous polyposis (FAP).Continue reading

Gilead Announces Pricing for Remdesivir in Open Letter

According to Daniel O’Day, Chairman & CEO, Gilead Sciences,  “In the U.S., the same government price of $390 per vial will apply. Because of the way the U.S. system is set up and the discounts that government healthcare programs expect, the price for U.S. private insurance companies, will be $520 per vial. At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access.”

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C-Path Launches CURE Drug Repurposing Collaboratory to Accelerate Identification of New Uses of Existing Drugs to Treat Infectious Diseases, Including COVID-19

Clinicians to report novel uses of existing drugs through FDA-NCATS CURE ID Mobile App.

TUCSON, Ariz., June 23, 2020 — As millions of patients struggle with diseases that lack adequate treatments, there is a critical need to understand how existing drugs can be used in new ways to improve clinical outcomes. Health care professionals use drugs in novel ways as a potential life-saving intervention when no specific approved therapies are available. However, without the ability to share these experiences in a systematic manner, the clinical and research communities cannot benefit from lessons learned.Continue reading