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Update for FAQs on Diagnostic Testing for SARS-CoV-2: For patients that are symptomatic, nasal swabs can be used that access just the front of the nose providing more comfort for the patient.
Cancer and COVID-19: The FDA recognized that cancer patients are at greater risk of contracting COVID-19 and is working to address the critical needs of patients with cancer and health care providers. Actions include: continue to expedite oncology product development, modifications may be required in clinical trials, continue to process Expanded Access requests for investigational products, work to anticipate and prevent drug shortages and to continue to inform the cancer community.
FDA Diagnostics Update: The FDA issued an update, noting that in certain emergencies, they can often quickly issue an emergency use authorization for diagnostic tests. The FDA has worked with more than 160 test developers who have said they will be submitting applications to make tests that detect COVID-19.
Safety Alert, Fecal Microbiota for Transplantation (FMT): The FDA issued communication of the potential risk of transmission of SARS-CoV-2 virus by use of FMT and that additional safety protections are needed.
Roche: Roche told CNBC that in the current environment the United States won’t be able to broadly test for coronavirus for “weeks, if not months.” Severin Schwan, CEO of Roche told CNBC’s Squawk Box that “at the moment, capacities are limited.”
The Centers for Disease Control and Prevention recommends that only those most at risk of the virus or those showing symptoms should be tested for the coronavirus.
The two largest private laboratories in the U.S., LabCorp and Quest Diagnostics, told CNBC today that together they could process more than 300,000 COVID-19 tests by the end of the week.
Testing Therapies, Antivirals and Vaccines
New York will launch a clinical trial using blood plasma from patients who have recovered from COVID-19, the disease caused by the novel coronavirus. The plasma, which contains antibodies against the virus, will be administered into patients who are critically ill. Gov. Andrew Cuomo said this possibility “has shown promising preliminary results in stimulating the immune system against the disease,” Forbes reported Monday. The state will begin this trial in partnership with a pharmaceutical company that has yet to be identified.
Dynavax/Clove Biopharmaceuticals: Announced they have entered into a research collaboration to develop a vaccine for COVID-19. Dynax will provide the adjuvant CpG 1018 to help with the development of Clover’s protein-based COVID-19 vaccine, COVID-19 S-Trimer.
Akers Biosciences acquired a licensing agreement with Premas Biotech, where Akers will in-license a novel coronavirus vaccine candidate that Premas is developing.
Ology Bioservices and Inovio Pharmaceuticals received a Department of Defense contract worth $11.9 million to use DNA technology transfer to rapidly manufacture DNA vaccines against COVID-19. They will work to manufacture Inovio’s DN vaccine INO-4800.
IndieBio: Early-stage life sciences investor IndieBio will provide up to $250,000 in funding to up to eight startups tackling COVID-19, the disease caused by the novel coronavirus. IndieBio will make the funds available to companies pursuing the development of diagnostics, therapeutics, vaccines, disinfection and other solutions addressing the worldwide problem of emerging infectious diseases. IndieBio is screening applications for the funding awards and should make a decision by May. Po Bronson, Partner at IndieBio SF, called the coronavirus pandemic a “wake-up call.” Bronson said the healthcare system has under-invested in solutions for pandemics despite increased risk assessments. Stephen Chambers, IndieBio’s managing director, added that the coronavirus problem is solvable and the investment firm is doing its part to enable new solutions to combat infectious diseases.
AbbVie is giving up its patents for an HIV drug being studied as a treatment for COVID-19. The decision marks the first time a major drugmaker has dropped the rights a drug that could be used during a pandemic, the Financial Times reported. AbbVie has given up patents related to Kaletra (Aluvia), a combination of lopinavir and ritonavir. The drug has been used to treat novel coronavirus patients in China and elsewhere. It is being studied in clinical trials as a potential treatment for the disease. When AbbVie learned of the use of the drug in China, the company donated more than a million dollars’ worth of the drug to that country to combat the pandemic. Aluvia is thought to be a potential treatment for the coronavirus due to its ability to block a protease that the virus needs to replicate within the human body. AbbVie’s drug has previously been tested in patients with SARS and MERS, which are similar viruses.
Other Industry News
Rocket Pharmaceuticals: Rocket Pharmaceuticals CEO Gaurav Shah said the remote-working policies that have resulted from the global COVID-19 pandemic have created a challenging time for the pharmaceutical industry, as well as the rest of the global community, but believes a silver lining will be forthcoming.
Four separate research groups in the U.S., Australia and China analyzed how temperature and humidity affect the coronavirus and they predict that hot summer months could decrease the presence of the virus in the Northern Hemisphere. But they also predicted it would come back in autumn, when the humidity drops and temperatures cool down.
As a critical industry during the COVID-19 pandemic, biopharma companies are expected to remain in operation – but with a skeleton staff. Anticipating stay-at-home mandates, life sciences companies and labs in especially hard-hit regions began preparing a week ago.