October 23, 2020

The California Biotechnology Foundation is committed to keeping you up to date about COVID-19 testing, treatment and prevention advancements. The following resources track what progress has been made as of October 23, 2020. Notable advancements include:

• The Food and Drug Administration approved Gilead Sciences’ antiviral drug remdesivir as a treatment for the coronavirus.
• Pfizer Inc said it may file for U.S. authorization of its COVID-19 vaccine in late November if the vaccine is effective based on its 40,000 person clinical trial.
• The National Institutes of Health launched a new trial of three companies’ immune modulator drugs to treat hospitalized COVID-19 patients: Johnson & Johnson, Bristol Myers Squibb and AbbVie.

​Recent News:

• FDA approves Gilead’s remdesivir as coronavirus treatment
  NBC News – October 22, 2020
  The Food and Drug Administration approved Gilead Sciences’ antiviral drug remdesivir as a treatment for the coronavirus.
• First large-scale US COVID-19 vaccine trial reaches target enrollment of 30,000 participants
  CNN – October 22, 2020 
  Moderna, the first company to start US clinical trials of a COVID-19 vaccine, finished enrolling all 30,000 of its participants. All 30,000 have received their first shot, and most of them have also received the required second shot.
• How Pfizer Partner BioNTech Became a Leader in COVID-19 Vaccine Race
  Wall Street Journal – October 22, 2020 
  BioNTech has partnered with Pfizer Inc., and the tandem is nearing the end of clinical trials on a vaccine candidate. The companies could file for an emergency authorization in late November, potentially making the shots available then or in December.
• FDA advisory committee assesses COVID-19 vaccine development
  PBS News Hour – October 22, 2020
  A committee of experts — known as the Vaccines and Related Biological Products Advisory Committee, or VRBPAC — met for the first time to consider COVID-19 vaccines.
• Roche joins the COVID-19 antiviral drug race, betting $350M on a startup
  BioPharma Dive – October 22, 2020 
  Roche will pay $350 million in cash for partial rights to an oral antiviral drug that the Boston biotech Atea Pharmaceuticals has been developing to treat COVID-19. The antiviral, known as AT-527, is currently being tested in a Phase 2 study in hospitalized patients with moderate COVID-19.
• AstraZeneca’s U.S. COVID-19 vaccine trial may resume as soon as this week, sources say
  CNBC – October 20, 2020 
  AstraZeneca’s COVID-19 vaccine trial in the United States is expected to resume as early as this week after the U.S. Food and Drug Administration completed its review of a serious illness, four sources told Reuters.
• Moderna CEO says COVID-19 vaccine emergency approval could come in December
  Fox Business – October 20, 2020 
  Stephane Bancel, chief executive officer of Moderna, said the company could see emergency approval for its COVID-19 vaccine candidate in December.
• Plasma therapy manufactured at Takeda in clinical trial as treatment for COVID-19; plasma donations needed
  Rockdale Newtown Citizen – October 19, 2020
  A plasma therapy manufactured at Takeda in Stanton Springs for treatment of adults at high risk for complications from COVID-19 is now in a Phase 3 clinical trial.
• Pfizer Says Earliest COVID-19 Vaccine Application to US Regulators Would Be After Election
  Medscape – October 19, 2020
  Pfizer Inc said it may file for U.S. authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November if the vaccine is effective based on its 40,000 person clinical trial.
• A ‘Herculean’ effort: States finalize their COVID-19 vaccine distribution plans
  USA Today – October 19, 2020
  State public health departments say they’re ready to leap into action as soon as a COVID-19 vaccine is approved, but caution so many things are still unknown that exactly what that leap looks like is hard to say right now.
• Michelle McMurry-Heath discusses the latest in COVID-19 Vaccines
  CNN – October 17, 2020
  Dr. Michelle McMurry-Heath joins CNN to discuss the latest in COVID-19 vaccine development.
• An Open Letter From Pfizer Chairman and CEO Albert Bourla
  Pfizer – October 16, 2020
  Pfizer CEO and Chairman Albert Bourla authors letter regarding the latest developments on their work towards creating a safe and effective COVID-19 Vaccine.
• NIH launches COVID-19 test of J&J, Bristol Myers and AbbVie anti-inflammatory drugs
  Fierce Pharma – October 16, 2020 
  The search for effective COVID-19 drugs presses on, with the National Institutes of Health (NIH) launching a new trial of three immune modulator drugs in hospitalized patients. The phase 3 study will examine Johnson & Johnson’s popular TNF blocker Remicade, Bristol Myers Squibb’s arthritis med Orencia and an experimental drug from AbbVie called ceniciviroc.
• Pfizer Seems To Lead COVID-19 Vaccine Development Race. How Did It Get Ahead?
  NPR – October 15, 2020 
  One company appears to lead the pack for getting a green light for its COVID-19 vaccine – Pfizer. The company’s CEO has hinted that preliminary results from its vaccine trial could be available as soon as the end of this month.
• El Segundo firm to begin Phase 1 clinical trial for COVID-19 vaccine
  Los Angeles Times – October 15, 2020 
  ImmunityBio, an El Segundo biotech company headed by Dr. Patrick Soon-Shiong, said it had received approval from the Food and Drug Administration to begin preliminary testing of the company’s COVID-19 vaccine candidate.

Rely on California Biotechnology Foundation to monitor breaking news and provide updates on the latest advancements in COVID-19 diagnostics, vaccines and treatments.

Stay informed on the latest news and trends on the economic and health benefits of this industry by visiting the new CABiotech.org

If you have any questions about informational briefings contact California Biotechnology Foundation Executive Director Patty Cooper at (916)764-2434 or [email protected].