Biopharma Update on the Novel Coronavirus: June 4

CV Update_June 4

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FDA Actions

Web-based Resource: The FDA announced a new resource, Testing Supply Substitution Strategies, that contains details to help support labs performing authorized COVID-19 test.

Update to Guidance: The FDA added information to the Q&A appendix in the guidance, Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.

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, 120 individual EUAs have been issued, which includes 104 molecular tests, 15 antibody tests and 1 antigen test.



Roche announced it received EUA from the FDA for the Elecsys IL-6 test, which measures levels of IL-6 (interleukin-6), a protein that triggers the body’s immune and inflammatory response to fight infections. Because IL-6 is released so early during severe infection, it helps physicians to identify severely ill COVID-19 patients as early as possible. 

Stilla Technologies announced it is offering a new high-throughput testing approach for COVID-19, combing digital PCR technology with a group testing method and published a large comparative study for group testing of SARS-CoV-2.


Testing Therapies, Antivirals and Vaccines

Elixirgen Therapeutics conducted a pre-IND meeting with the FDA regarding the company's COVID-19 vaccine candidate, EXG-5003. EXG-5003 is a temperature-sensitive, intradermally-injected srRNA (self-replicating RNA) vaccine expressing the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein.


Company Actions

The European Union is planning to leverage an emergency fund worth $2.7 billion to buy promising COVID-19 vaccines ahead of approval. Four countries, Germany, France, Italy and the Netherlands told a meeting of EU ambassadors yesterday they planned to accelerate negotiations with biopharmaceutical companies to access vaccines that are currently being developed.

Hackensack Meridian Health published a number of studies in major journals based on their experience with the first wave of the COVID-19 pandemic. These include publications in medRxiv, The Journal of Urology, Cureus, Catheterizations and Cardiovascular Interventions, Annals of Surgery, Medicine, Neuromodulation: Technology at the Neural Interface, American Journal of Otolaryngology, and Advances in Radiation Oncology.

The PolyPeptide Group, a contract development and manufacturing organization (CDMO) partnered with Novavax on large-scale GMP production of a critical component of Novavax’s COVID-19 vaccine candidate, NVX-CoV2373. They will produce two key intermediates in the production of Matrix-M, the adjuvant component of the vaccine.

iBio launched a preclinical immunization study of its second COVID-19 vaccine platform. The new subunit vaccine (IBIO-201) combines antigens from the SARS-CoV-2 spike protein fused with iBio’s patented lichenase booster molecule (LicKM).

AstraZeneca announced it has taken the next steps for broad and equitable global access to the University of Oxford’s COVID-19 vaccine. The company reached a $750 million agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi the Vaccine Alliance. The agreement is to support manufacturing, procurement and distribution of 300 million doses of the vaccine. In addition, AstraZeneca has reached a licensing agreement with the Serum Institute of India (SII) to supply one billion doses, with a commitment of 400 doses before the end of 2020.


Other Industry News

A summit hosted by British Prime Minister Boris Johnson today is expected to set a goal of at least $7.4 billion. The funds will go to global vaccine alliance Gavi, the Vaccine Alliance, which is backed by the Bill & Melinda Gates Foundation, among others. The Gates Foundation is a founding partner of Gavi, which was founded in 1999, and pledged $750 million to establish it.

Questions continue to arise around a small company called Surgisphere and the data it collected that was used to form the results in two large COVID-19 studies, including one major study involving the use of the antimalarial drug hydroxychloroquine. Investigations are likely imminent as concerns over the data increase. Two major medical journals, The Lancet and The New England Journal of Medicine, first expressed concerns over some of the data collected by Surgisphere that formed the basis for studies published in their pages. 

The ongoing COVID-19 pandemic has increased the demand for drugs used to sedate the mechanically ventilated COVID-19 patients and has resulted in shortages for some of these drugs, specifically propofol and dexmedetomidine hydrochloride, according to GlobalData, a data and analytics company.

A number of existing drugs are being assessed against inflammatory responses seen in COVID-19 patients. New research from GlobalData suggests that anti-tumor necrosis factor (TNF) therapies, such as Remicade (infliximab) and Humira (adalimumab) could treat COVID-19 patients with acute respiratory distress (ARDS). These drugs could reduce COVID-19 mortality, as about 17% of COVID-19 patients develop ARDS.

Aurora, Illinois-based INEOS Styrolution donated 650 face shields to frontline healthcare workers battling COVID-19 in some of the hardest-hit regions across the U.S.

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