Biopharma Update on the Novel Coronavirus: May 6

CV Update_may 6

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FDA Actions

Warning Letters: The FDA and FTC issued warning letters to Honey Colony LLC and Dr. Dhole’s Sushanti Homeopathy Clinic for selling fraudulent COVID-19 products.

FDA Approvals: The FDA approved two generic drugs used during surgery or mechanical ventilation to facilitate tracheal intubation and provide skeletal muscle relaxation. The drugs include succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL.

Diagnostics Update: The FDA has worked with more than 385 test developers who plan to submit EUA requests to detect COVID-19. Also, 59 individual EUAs have been issued. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). The FDA has been notified that more than 240 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.



Twist Bioscience reported that it has identified competitive antibodies for SARS-CoV-2. These antibodies could potentially be used for therapeutic treatments or diagnostic testing.

LabCorp announced its COVID-19 Immunoglobulin G (IgG) antibody test is now available for individuals through The COVID-19 IgG antibody blood test detects the presence of antibodies to the virus and can help determine if an individual may have been exposed to the virus. 


Testing Therapies, Antivirals and Vaccines

Montreal-based Laurent Pharmaceuticals Inc. has obtained the approval from Health Canada to initiate RESOLUTION, a Phase II testing once-a-day oral LAU-7b as a potential drug candidate for COVID-19. The trial will enroll approximately 200 hospitalized COVID-19 patients for a treatment duration of 14 days. LAU-7b is being developed to keep the inflammatory response of the body under control without interfering with its immune role. LAU-7b is believed to interfere with coronavirus replication and host avoidance by acting on the same lipid-modulating pathways it uses for the pro-resolving effect.

Mesoblast Limited announced that the first patients have been dosed in Phase II/III trial of Mesoblast’s allogeneic cellular medicine remestemcel-L in COVID-19 infected patients with moderate to severe acute respiratory distress syndrome (ARDS) on ventilator support. The clinical protocol for the trial is based on initial promising results from use of remestemcel-L in patients with moderate to severe COVID-19 ARDS under an emergency IND application or expanded access protocol at The Mount Sinai Hospital in New York.

Relief Therapeutics Holding AG said that New York University Langone is participating in the Phase II clinical study of its drug Aviptadil for the treatment of ARDS in COVID-19. The multicenter trial will enroll patients who are already on mechanical ventilation in the hopes that Aviptadil can decrease mortality in this condition and help to improve the ability of the patient’s lungs to transfer oxygen to the body. The trial is being led by Relief’s US partner, NeuroRx, Inc.


Company Actions

Gilead Sciences has the daunting task of scaling up manufacturing and distribution of the antiviral drug remdesivir that reportedly takes approximately six months to produce for global distribution during a pandemic. On May 5, the company issued a statement describing their efforts in response to the COVID-19 pandemic. 

U.K.-based NuCana has reopened its ongoing global Phase III study of Acelarin (NUC-1031) plus cisplatin in patients with biliary tract cancer in certain geographies, including Australia, Canada, South Korea, Taiwan, Ukraine, and the United Kingdom. The trial had been impacted by the outbreak of COVID-19.

As reported by the San Francisco Business Times, Durect Corp. gave back $2 million in federal PPP relief funds they received.

According to an Abbott statement, it has continued expanding accessibility to its COVID-19 tests. To date, Abbott has shipped nearly 1.4 million of its rapid ID NOW tests across the nation and is currently manufacturing 50,000 tests per day. Abbott plans to increase this manufacturing to 2 million tests a month by June.


Other Industry News

Vaccine expert Rick Bright, who was abruptly dismissed from his post as director of the Biomedical Advanced Research and Development Authority (BARDA) last month, filed a whistleblower complaint against the administration over its failures to heed warnings about the COVID-19 pandemic and accused the White House of cronyism in awarding contracts. Bright was terminated from his role last month and reassigned to a lesser role overseeing the development and deployment of point-of-care COVID-19 testing platforms due to his opposition to statements made by the White House regarding malaria drug hydroxychloroquine as a potential treatment for COVID-19. In the complaint, Bright alleges that the Trump administration planned to ship massive quantities of hydroxychloroquine to New York and New Jersey, two areas that have been hard-hit by the pandemic, the Associated Press reported Wednesday. 

As reported by CNBC, Dr. Scott Gottlieb, addressed a new study suggesting the coronavirus has mutated with a new dominant strain appearing to be more contagious. Dr. Gottlieb cautioned that the study doesn’t prove the new strain is more infectious.

As reported by the Wall Street Journal, there is a weekly forum, created back in March, in the Boston biotech hub and beyond which is a place to discuss the challenges of the COVID-19 pandemic.  The group, started by Jodie Morrison, CEO of Cadent Therapeutics Inc., includes dozens of biotech executives and venture capitalists.

All the ways we know that you can get coronavirus. You may be wondering where the novel coronavirus (called SARS-CoV-2) is hiding out all around you, especially when you have to go out in public – what is ‘safe’ to do and to touch?

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