BioBiz: Moderna, Inc in talks to supply US with 100M vaccine doses; Pluristem uplists to NASDAQ; Q BioMed gets FDA nod for Orphan Drug Designation

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Moderna, Inc. confirmed that the Company is in discussion with the U.S. government to purchase an additional 100 million doses of the Moderna COVID-19 Vaccine for delivery in the third quarter of 2021. To date, the U.S. government has agreed to purchase 200 million doses of the Moderna COVID-19 Vaccine. This new purchase would bring the U.S. government’s confirmed order commitment to 300 million doses.

Moderna will continue to leverage the Company’s U.S.-based manufacturing infrastructure to supply the Moderna COVID-19 Vaccine to the U.S. government. The Moderna COVID-19 Vaccine received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) on December 18, 2020, and Moderna began supplying to the government shortly thereafter.

 Pluristem Therapeutics announced that effective as of market open on January 29, 2021, its common shares have been approved for listing to the Nasdaq Global Market® and will continue trading under the company’s current ticker symbol – PSTI.

“We believe that this move is important for the growth of our Company. The listing of our common shares on the Nasdaq Global Market® may help increase our visibility within the institutional marketplace and enhance our ability to broaden our shareholder base with the goal of driving long-term shareholder value,” said Pluristem CEO and President, Yaky Yanay.

Q BioMed Inc’s liver cancer drug, Uttroside-B was granted Orphan Drug Designation by the U.S. Food and Drug Administration’s Office of Orphan Products Development. The drug is a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. In preclinical studies, Uttroside-B was up to 10-times more potent against HCC cells than Sorafinib, the standard of care drug at the time.

With an Orphan Drug designation, Uttroside-B may benefit from a seven-year market exclusivity following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. Preclinical testing is now underway to support an FDA Investigational New Drug (IND) application expected this year.  

Cognito Therapeutics announced the appointment of Mark Day, Ph.D., as Chief Business Officer. In this role, Dr. Day will drive business development and partnership activities at Cognito in conjunction with the Cognito leadership team. Dr. Day brings more than 21 years of business, corporate, research and development strategy expertise to Cognito. He has evaluated over 300 programs, resulting in a uniquely broad knowledge base and network in the pharmaceutical industry.