Biopharma Industry News for March 26: Update on the Novel Coronavirus
News information is not all-inclusive. Please check back for updates.
Compounding Using Bulk Drug Substances: The FDA added hydroxychloroquine sulfate to category 1 under an interim policy on compounding using bulk drug substances. The FDA determined there was sufficient information to evaluate the substance for outsourcing facilities to use in compounding. The approach did not change, but the FDA prioritized this substance due to the COVID-19 pandemic.
Emergency Use Authorization (EUA) for Ventilators: An EUA was issued due to concerns of insufficient supply and availability of FDA-cleared ventilators during the COVID-19 pandemic. Manufacturers and other stakeholders may submit a request to the FDA to have their device(s) added to the EUA, following the process outlined.
Diagnostics Update: The FDA has now worked with 190+ test developers. To date, 16 EUAs have been issued.
Quidel: Quidel’s Lyra SARS-CoV-2 Assay has received Emergency Use Authorization to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q.
U.K.-based Mologic initiated early validation of COVID-19 point-of-need diagnostic tests. Once ready, the device will allow users to test for exposure to the virus at home, with results available within 10 minutes. Mologic will sell the diagnostic test at a cost to low-income settings to ensure affected countries have access to the kits during the global emergency.
One week after receiving authorization from the FDA, Thermo Fisher Scientific was given the green light from the European Union for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19. The Thermo Fisher test is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis.
Testing Therapies, Antivirals and Vaccines
Infectious disease researchers in Italy have said they analyzed the SARS-CoV-2 genome from samples gathered locally. The early data reveals the rapidly spreading virus’s genome is stable. This increases the likelihood that future COVID-19 vaccines can have a higher rate of effectiveness.
VERO Biotech received expanded access emergency use authorization from the FDA for its proprietary inhaled nitric oxide (iNO) delivery system, Genosyl DS, for cardiopulmonary symptoms associated with COVID-19.
iBIO announced that immunization studies for its SARS-CoV-2 Virus-Like Particle program are proceeding at Texas A&M University System labs. This is part of a Master Joint Development Agreement between iBio and TAMUS signed in 2016.
VERO Biotech: The FDA has granted expanded access emergency use to allow VERO Biotech’s proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS, to immediately be used for the treatment of cardiopulmonary symptoms associated with COVID-19.
Ironwood Pharmaceuticals: Ironwood outlined the steps they are taking in order to help slow the spread of COVID-19 such as employees working remotely. With the help of their partner, Allergan, Ironwood is focused on maintaining the availability of LINZESS for adult patients suffering from irritable bowel syndrome and believes there is sufficient supply. Ironwood also continues the clinical development of its gastrointestinal drug candidates.
Mylan/Pfizer Merger: Social distancing measures for COVID-19 are having an impact on the planned merger of Mylan and Pfizer’s off-patent business, Upjohn. This morning, the two companies said the “unprecedented circumstances” surrounding the COVID-19 pandemic are creating unforeseen delays in the merger of the two companies.
Merck: Merck announced they are donating 300,000 masks to New Jersey. On Sunday, Merck announced a donation of half a million masks to New York City.
BriaCell: BriaCell is continuing work on its lead candidate, Bria-IMT™ with Incyte Corporation’s immune checkpoint inhibitor, INCMGA00012. A Phase I/IIa clinical study is ongoing and recruiting patients despite the COVID-19 pandemic.
Sophia Genetics and Paragon Genomics extended their partnership to develop next-generation sequencing (NGS) assays and leveraging the SOPHIA Platform analytical capabilities for COVID-19.
LexaGene Holdings tapped Steven Armstrong to oversee the company’s submission for FDA Emergency Use Authorization of its commercial technology and other regulatory approvals, as well as to institute quality systems for manufacturing. Bringing him on as senior director of operations was important due to the push to address COVID-19, Chief Executive Officer Jack Regan said. The COVID-19 diagnostic crisis has prevented effective mitigation and treatment measures, Regan said. Placing Armstrong in a position to guide the company’s manufacturing is important for the company as it aims to provide a solution for rapid point-of-need diagnostics that can be easily configured for new tests as needed, Regan said.
Startup OneThree Biotech is offering free artificial intelligence-based toxicity screening to any researcher or academic working on developing a new drug to treat COVID-19.
Other Industry News
Lab suppliers report sales and backorders are up, and some distributors are allocating medications. For most biotech companies, supplies are available, although they are monitoring the situation closely.
How drugs are manufactured and distributed is a complicated global supply chain, with numerous drugs and their component parts manufactured in other countries. Research firm GlobalData issued a statement that the COVID-19 pandemic threatens biopharma in-house manufacturing.
Clinical Research IO survey shows that clinical trials investigators are seeing significant disruptions in their trials because of the pandemic. It showed 24% have halted enrollment of new patients, and of the 76% remaining, 37% are considering halting enrollment.
Industry Conference Changes
Bioprocessing Summit Europe: Postponed to July 21-23, 2020: https://www.bioprocessingeurope.com/
Bio-IT World Conference & Expo: Postponed from April 2020 to October 6-8, 2020 at the Hynes Convention Center, Boston: https://www.bio-itworldexpo.com/