Biopharma Update on the Novel Coronavirus: May 22
News information is not all-inclusive. Please check back for updates.
FDA Actions
List of Antibody Tests: The FDA posted a list of antibody tests that are being withdrawn voluntarily by the test’s commercial manufacturer. Those removed are not expected to be marketed or distributed.
Issued Guidance: The FDA issued guidance to help the availability of medical devices during the COVID-19 pandemic. To see more information, please see “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”.
Two ANDAs: The FDA approved two abbreviated new drug applications, dexmedetomidine hydrochloride in 0.9% sodium chloride injection indicated for sedation of initially intubated and mechanically ventilated patients and succinylcholine chloride injection USP 200 mg/10 mL indicated as an addition to general anesthesia.
Diagnostics
Abbott released a positive interim analysis of an ongoing clinical study assessing the accuracy of its ID NOW COVID-19 rapid that showed the test that can provide results within 15 minutes has a high degree of specificity and sensitivity. The company released the data days after a study conducted in New York showed the test, which has become a daily testing tool in the White House, had a high rate of generating false negatives in COVID-19 cases.
As reported by the Milwaukee Business Journal, Nimble Therapeutics is collaborating with Roche Diagnostics to discover and develop novel peptide-based molecules for diagnostics of SARS-CoV-2.
Lawrence Berkeley National Laboratory is working to help health care providers test patients for COVID-19 with carbon nanotubes, as reported by SciTechDaily. The company hopes to have the detector available in June.
Testing Therapies, Antivirals and Vaccines
Henry Li, Sorrento Therapeutics' co-founder, director, president and chief executive officer, did a follow-up interview with BioSpace to discuss the news and speculation surrounding its criticism of COVID-19 neutralizing antibodies.
Researchers at Brigham and Women’s Hospital in Boston and international colleagues published the results of a study of 96,032 hospitalized COVID-19 patients, evaluating whether the use of antimalarial drugs chloroquine or hydroxychloroquine (HCQ), with or without an antibiotic, were helpful in battling the disease. They found that of the 15,000 patients who received either of the drugs were almost twice as likely to die compared to the patients who did not receive them. The research was published in the journal The Lancet.
China-based Sinovac Biotech Ltd. secured $15 million in funding to further the development of an inactivated vaccine against COVID-19 called CoronaVac. Preclinical results regarding CoronaVac were recently published in the peer-reviewed academic journal Science in an article noting that the vaccine candidate is safe and provides protection to rhesus macaques (monkeys) through an animal challenge study.
The University of Oxford announced its COVID-19 vaccine will begin phase II/III clinical trials and have begun recruiting. The study will enroll up to 10,260 adults and children.
Ampio Pharmaceuticals filed Investigative New Drug applications for Ampion with the FDA and has maintained an ongoing dialog with the regulatory agency regarding the company’s development of treatment options which includes inhalation and intravenous applications for COVID-19 affected patients.
Nemechek Technologies registered a clinical trial to study transcutaneous vagus nerve stimulation (tVNS) in patients with moderate, severe, or critical pneumonia associated with COVID-19. The theory is that electrical stimulation of the vagus nerve, known as the Inflammatory Reflex, might decrease the cytokine reaction. The study would use the company’s Vitality Smartcable tVNS device to suppress pro-inflammatory cytokines and improve patient outcomes.
Other Industry News
The CDC now says by touching surfaces or objects, COVID-19 does not spread easily but it still may be possible. The CDA still warns that person-to-person contact is the main way the virus is spread.
Clinical trials across the globe continue to be disrupted due to COVID-19. According to analytics company GlobalData, among global clinical trials that have been disrupted since April 2020, 69.9% are due to the suspension of enrollment, 17.3% due to slow enrollment and 12.8% due to delayed initiation. Furthermore, within the 17.3% of trials affected by slow enrollment, 15.4% are specifically due to the availability of sites and investigators.
The Pioneer Institute published a study that finds many biopharmaceutical companies may emerge from the pandemic commercially weaker. The pandemic is causing delays in new product launches and fewer resources to invest in research and development.
Research published in Science found that being infected by SARS-CoV-2 protects against reinfection. The research was conducted in rhesus macaque monkeys. What this suggests is that people recovering from the disease will have protective immunity.
Thomas Lynch, president and director of Seattle’s Fred Hutchinson Cancer Research Center believes that in order to battle future pandemics, the scientific community is going to have to pick up their game, largely by developing infectious disease and/or viral research centers similar to cancer centers like Fred Hutch.