Biopharma Update on the Novel Coronavirus: June 22
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
Respirator Webinar: The FDA, along with the CDC’s NIOSH and the OSHA, will host the second webinar in the respirator webinar series on Tuesday, June 23 from 12:00-1:00 pm ET.
Updated Guidance: The FDA updated guidance to facilitate notification regarding device manufacturing interruptions or discontinuances during the COVID-19 pandemic.
Guidance for Pharmaceutical Manufacturers: The FDA issued guidance to provide recommendations to pharmaceutical manufacturers when an employee has a confirmed COVID-19 infection, symptoms, or had been exposed.
Warning Letter: The FDA issued a warning letter to Project 1600, Inc., for selling fraudulent COVID-19 products.
Letter to Clinical Laboratory Staff and Health Care Providers: The FDA issued a letter recommending they stop using COVID-19 antibody tests that are listed on the FDA’s removed test list.
Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 144 individual EUAs have been issued, which include 122 molecular tests, 21 antibody tests and 1 antigen test.
Testing Therapies, Antivirals and Vaccines
As companies scramble to develop a vaccine against the SARS-CoV-2 virus, a team of husband and wife researchers have found that the measles, mumps, rubella (MMR) vaccine can reduce the symptoms of COVID-19.
Ridgeback Biotherapeutics announced the launch of two Phase II clinical trials. The trials will test the efficacy of EIDD-2801 as an anti-viral treatment for COVID-19.
Clover Pharmaceuticals and GlaxoSmithKline are starting a Phase I clinical trial of their COVID-19 vaccine candidate, SCB-2019, which showed promising results with animal studies.
Gilead Sciences announced it had received FDA approval to move forward with clinical trials of an inhaled version of remdesivir, its antiviral drug against COVID-19. The company expects to begin screening healthy volunteers for the Phase I trials this week and begin the studies in August.
Catalent announced it has signed an agreement with ViralClear, a subsidiary of BioSig Technologies. Catalent will develop two oral dosage forms of ViralClear’s anti-viral agent, merimepodib. Read more about ViralClear here.
Orgenesis Inc. announced it has partnered with Leidos to develop and potentially obtain FDA marketing approval of Orgenesis’ Ranpirnase for the treatment f patients suffering from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Medakit Ltd, on June 10th, received a warning letter from the FDA for their antibody diagnosis tests for COVID-19 over the concern of terminology used on Medakit’s website suggesting the use of its test for “home-use” settings. Medakit announced it initiated a series of immediate measures taken to correct any misunderstanding and to ensure none of its products mistakenly reach the United States.
bioBoaVista, a Brazilian culture media manufacture for microbiological diagnosis, developed a viral transport medium for more efficient nasal tests for COVID-19. The medium stabilizes samples for up to 48 hours at room temperature and up to 5 days between 2 to 8 degrees C compared to standard saline samples that last only 12 hours.
Other Industry News
COVID-19 has created a shortage of sedatives due to the number of patients who require ventilation. Some drugs, like propofol, are now on the FDA’s Drug Shortage list. To meet demand, several manufacturers have increased production of these medicines including Bachem Holding AG, Recipharm AB and Hikma Pharmaceuticals which have increased production of propofol, GlobalData reported.
CVS Health and the American Lung Association have launched a campaign at CVS Pharmacy locations to support the Lung Association's COVID-19 Action Initiative, which will expand COVID-19 research and fund the development of new vaccines, detection tests and treatment to defend against future respiratory viruses.