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Chloroquine Phosphate and Hydroxychloroquine Sulfate Product-Specific Guidance: Due to an increase in demand, the FDA published guidance to support generic drug development of chloroquine phosphate and hydroxychloroquine sulfate. The FDA is also prioritizing a review of any newly submitted ANDAs for these drugs.
Emergency Use Authorizations (EUAs):
- The FDA issued a EUA for the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES (“B. Braun Space and Outlook Pumps”) to treat COVID-19 or suspected COVID-19 patients.
- The FDA issued a EUA to Advanced Sterilization Products, Inc. (ASP) for the ASP STERRAD Sterilization Systems. This has the potential to decontaminate N95 or N95-equivalent respirators.
Diagnostics Update: The FDA has worked with more than 300 test developers who plan to submit EUA requests to detect COVID-19. Also, 34 EUAs have been issued. The FDA has been notified that more than 180 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
Origin: Origin, a 3D printing specialist for medical devices, just completed clinical trials and validation of its 3D-printed nasopharyngeal swabs for use in COVID-19 test kits. It is scaling up production and accepting orders to manufacture millions of the swabs.
Horizon Discovery Group announced special commercial licensing terms to facilitate rapid access to its cGMP-compliant CHOSOURCE platform for the development or production of therapeutic proteins, diagnostic assay components or vaccines relating to COVID-19. announced special commercial licensing terms to facilitate rapid access to its cGMP-compliant CHOSOURCE platform for the development or production of therapeutic proteins, diagnostic assay components or vaccines relating to COVID-19.
Testing Therapies, Antivirals and Vaccines
There are more than 70 vaccine candidates in development for COVID-19, with three in clinical trials, according to the World Health Organization. The most advanced is CanSino’s asset, which is in Phase II.
Moderna: Moderna’s chief executive officer, Stephane Bancel, recently indicated that the company’s work with other experimental vaccines helps him feel more confident its COVID-19 vaccine will work. The company released promising early data from a Phase I trial of its experimental Zika vaccine this morning, which could possibly set the stage for similar data for the COVID-19 vaccine.
Ligandal, Inc.: Ligandal is using its peptide-based delivery technologies to develop a vaccine and a potential antidote for COVID-19.
GlaxoSmithKline/Sanofi: As the world continues to wait with bated breath for a vaccine against COVID-19, GlaxoSmithKline and Sanofi have joined forces to develop an adjuvanted vaccine for COVID-19.
AstraZeneca will initiate a randomized, global clinical trial to assess the potential of cancer drug Calquence (acalabrutinib) in the treatment of the exaggerated immune response associated with COVID-19 infection in severely ill patients. The trial is based on strong scientific evidence supporting the role of the Bruton’s tyrosine kinase (BTK) pathway in the production of inflammatory cytokines and on encouraging early clinical data. Calquence is a next-generation, highly selective BTK inhibitor currently used to treat certain types of blood cancers.
Sinovac Biotech and the Wuhan Institute of Biological Products, an affiliate of state-owned China National Pharmaceutical Group, have initiated clinical trials of vaccine candidates against COVID-19.
Researchers are looking at older vaccines to determine if they may be useful against COVID-19. The hope is that using an older vaccine, such as BCG, a 100-year-old tuberculosis vaccine, might get to the public more quickly than a new vaccine, should it show efficacy against the new disease. An oral polio vaccine is also being assessed, the AP reported.
Northwestern University and ShanghaiTech University leveraged cell-free synthetic biology to produce a drug that kills SARS-CoV-2 in cell cultures. They indicate they could create the new drug by taking the molecular machinery out of cells and using that machinery to make a product in a safe, cheap and quick way. The molecule is called valinomycin. By using this method, they were able to increase production yields more than 5,000 times in only a few quick design cycles.
Jiangsu Provincial Center for Disease Control and Prevention in China and the Hubei Provincial Center for Disease Control and Prevention and Zhongnan Hospital of Wuhan University have launched a Phase II clinical trial of a COVID-19 vaccine. The vaccine was developed by the Institute of Biotechnology, Academy of Military Medical Sciences. The Phase I trial apparently suggested appropriate safety, while the Phase II trial will focus more on the vaccine’s ability to stimulate an immune response.
The Harvard T.H. Chan School of Public Health/Human Vaccines Project: COVID-19 has shifted vaccine development into the global spotlight. Both organizations announced a joint effort with the goal to revolutionize the understanding of the immune system and help accelerate the development of effective vaccines. The joint effort is the Human Immunomics Initiative.
BriaCell: BriaCell announced that it has filed a provisional patent application with the U.S. Patent and Trademark Office for coronavirus immunotherapy.
Healios K.K.: Healios announced it has made a protocol change to their ONE-BRIDGE study which is a phase II clinical trial in Japan evaluating the safety and efficacy of its somatic stem call regenerative medicine treatment for pneumonia-induced Acute Respiratory Distress Syndrome (ARDS). This protocol change will now add COVID-19 ARDS patients.
Johnson & Johnson is the first U.S. drugmaker to report earnings post-COVID-19 outbreak. Not surprisingly, it lowered its 2020 adjusted earnings forecast and its medical-device unit sales dropped 8.2% to $5.9 billion during the quarter as hospitals postponed elective surgeries and citizens stayed home. The pharma business generated $11.13 billion in revenue, while its consumer unit created $3.6 billion, up 8.7% and 9.2%, respectively. J&J has committed more than $1 billion in partnership with BARDA to co-fund vaccine research for COVID-19.
Thirty-seven member states of the World Trade Organization (WTO) have agreed not to use compulsory licensing, which is when a government allows someone else to produce a patented product or process without the consent of the patent owner. The AIDS Healthcare Foundation (AHF) joined the signers of a letter demanding that these governments reverse the policy in order to help fight the COVID-19 pandemic.
Other Industry News
According to GlobalData, pharmaceutical companies are shifting their priorities away from some current drug development toward COVID-19. By shifting priorities, several Alzheimer’s drugs could be at risk for delay. For Alzheimer’s drugs, there are 38 in Phase I, 19 in Phase III and 37 in Phase II.
Hydroxychloroquine has been called a “game-changer” by President Donald Trump in the fight against COVID-19 despite a lack of clinical data supporting the anti-malarial drug’s efficacy against the disease and concerns over its safety. The Washington Post is reporting that the CIA, one of the nation’s top intelligence agencies, has advised its employees against taking the medication due to concerns of the dangerous side effects/