As the number of diagnosed cases of COVID-19 continue to increase across the globe and more and more governments are urging citizens to self-quarantine, the pharmaceutical and life sciences industry continues to work toward the development of a vaccine and therapies for the respiratory infection that was declared a pandemic by the World Health Organization last week. Here’s a biopharma industry overview as of late March 16.
As the number of diagnosed cases of COVID-19 continues to increase across the globe and more and more governments are urging citizens to self-quarantine, the pharmaceutical and life sciences industry continues to work toward the development of a vaccine and therapies for the respiratory infection that was declared a pandemic by the World Health Organization last week.
Here’s a biopharma industry overview as of late March 16:
FDA Actions
Issues Diagnostic Emergency Use: The FDA issued diagnostic emergency use authorization to Hologic and LabCorp.
More Regulatory Relief: The FDA will provide more regulatory relief during the outbreak and will continue to help expedite the availability of diagnostics.
Foreign Inspections: In response to the COVID-19 outbreak, the FDA is postponing most foreign inspections through April.
Warning letters: The FDA and FTC sent warning letters to seven companies selling fraudulent products.
Access to respirators: The FDA and CDC are taking action to increase access to respirators, including N95s, for health care personnel.
Expedite Availability of Diagnostics: The FDA issued a new policy to help expedite the availability of diagnostics.
Supply Chain: The FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain.
Authorization of Emergency Use: On the basis of this determination, the Secretary declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak.
Diagnosed Cases
Following an offsite meeting in Boston, several Biogen employees were diagnosed with COVID-19 and at least one of those employees later attended a meeting hosted by Cowen, according to reports.
Biopharma giant Arie Belldegrun revealed he had been diagnosed with COVID-19 and was in self-quarantine.
Also disclosing that he had been diagnosed is Apellis Pharmaceuticals CEO Cedric Francois. Like Belldegrun, Francois said he has self-quarantined.
Company Actions
Massachusetts-based Biogen has instructed its staff to work from home following additional employees testing positive for the coronavirus. The work-from-home order was first issued after a number of employees who attended a meeting were diagnosed with COVID-19. The order covers employees in Massachusetts, Research Triangle Park in North Carolina, and Baar, Switzerland.
Ireland-based Amarin, said it was suspending face-to-face sales meetings in order to prevent exposure to the virus. Merck and Amgen have also initiated similar actions. With more and more companies suspending face-to-face sales meetings in the face of the pandemic,
Veeva is providing its technology for free in China and other areas impacted by the spreading virus to keep doctors and pharma reps connected.
California-based Medable developed a new TeleVisit mobile application that can be used by patients worldwide to connect virtually with their clinical trial sites. The application makes it possible for clinical trial research to progress in an environment where many patients are being told to stay home and avoid social interaction.
Aftermath Services, a biohazard approval company, expanded its virucidal disinfectant program to include a Virus Eradication Program specially designed to combat COVID-19.
Laboratory Corporation of America (LabCorp) and Quest Diagnostics, announced they were now offering tests for the coronavirus. LabCorp’s testing started Thursday, March 5 and Quest’s began Monday, March 9.
“As COVID-19 continues to spread in the U.S., having high-quality, reliable, scalable laboratory tests available is a critically important part of the response,” said Marcia Eisenberg, LabCorp’s chief scientific officer. “Identifying people who are infected is necessary to make sure that patients receive the appropriate care, to better manage the use of healthcare resources, and to help contain the spread of the virus.”
Spectrum Health and insurer HAP are offering free coronavirus testing resources. HAP has indicated its members who are tested for the virus will not be asked for a copay, co-insurance or deductible for the lab tests. Spectrum Health is offering free virtual screenings via video screening. A health provider will then advise on whether the individual should seek more care.
Roche Holdings said on Tuesday, March 10 it would send all of its 1,200 Spanish employees in Madrid home to work remotely due to the coronavirus outbreak.
Bayer temporarily closed two locations in Missouri and two in New Jersey as an employee may have contracted the novel coronavirus.
On Tuesday, March 10, the Pharmaceutical Research and Manufacturers of America (PhRMA) closed its Washington, D.C. headquarters, for the remainder of the week after a recent visitor tested positive for the coronavirus.
Merck has guided employees who have visited areas affected by the coronavirus outbreak to work from home.
Trinity Life Sciences is launching an ongoing advisory program that will monitor the effects of the novel coronavirus on biopharmaceutical companies’ operations.
CVS Pharmacy plans to deliver prescribed medication to its customers at no cost due to the coronavirus outbreak.
The Bill & Melinda Gates Foundation, along with Wellcome and Mastercard announced they were launching a $125 million initiative, COVID-19 Therapeutics Accelerator, to help speed up the development of therapies to treat coronavirus.
Biotechnology companies are utilizing artificial intelligence (AI) to discover potential coronavirus medicines, including Insilico Medicince Inc., Vir Biotechnology Inc. and Atomwise.
Diagnostics
On March 13, the U.S. Food and Drug Administration approved Roche’s cobas SARS-CoV-2 test under Emergency Use Authorization. The new test can provide results in about three-and-a-half hours and is designed to run up to 4,128 test results per day. Hospitals and laboratories will be able to run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are already in wide use in the U.S. and internationally. The Emergency Use Authorization allows the test to be conducted in the U.S. and in countries that accept the CE mark showing they conform to European standards.
Other companies are also developing diagnostic kits, including Advaite, which announced it will supply its rapid response diagnostic testing kits, ADVAITE RAPCOV if the FDA and other regulatory agencies approved it under Emergency Use Authorization. In Europe, CerTest Biotech received a CE Mark for its VIASURE SARS-CoV-2 Real Time PCR Detection Kit. The kit will be available to clinical laboratories in countries recognizing the CE mark. Germany-based TIB Molbiol Syntheslabor has also developed a diagnostics kit. So far, they have produced about 40,000 kits, enough to test about 4 million people, according to reports.
N.C.-based BioMedomics is seeking emergency FDA approval for its diagnostics kit. Its COVID-19 IgM-IgG Rapid Test is an immunoassay designed to generate results from a blood sample in 15 minutes at the point of care.
Germany-based QIAGEN will develop a new QIAstat-Dx test kit to differentiate the novel SARS-CoV-2 coronavirus from 21 other serious respiratory infections. The kit will be a molecular testing panel designed to aid in the diagnosis of patients with respiratory syndromes, in about one hour, by differentiating the novel coronavirus from 21 other bacterial and viral respiratory pathogens.
Testing antivirals and vaccines
On March 16, Moderna began its first trial for mRNA-1273, the first vaccine candidate in the clinic for COVID-19. Moderna’s mRNA-1273 is a mRNA vaccine that encodes for a prefusion stabilized form of the Spike (S) protein. The candidate was developed in conjunction with the National Institute of Allergy and Infectious Disease.
Arcturus Therapeutics and Duke-NUS Medical School announced their partnership to develop a COVID-19 vaccine for Singapore. The development of a COVID-19 vaccine will be based on the company’s STARR technology and will take advantage of a unique platform developed at Duke-NUS allowing rapid screening of vaccines for effectiveness and safety.
Medicago announced it has successfully produced a Virus-Like Particle (VLP) of the coronavirus just 20 days after obtaining the SARS-CoV-2 gene. The company is now focused on developing a vaccine for COVID-19, the virus caused by SARS-CoV-2. The company plans to initiate preclinical testing for safety and efficacy and, if all goes well, the company anticipates the beginning of human trials by July or August.
Germany’s CureVac AG, which is using its mRNA technology to develop a vaccine for COVID-19, downplayed reports that the White House sought to acquire the vaccine for sole use in the United States. In a statement, the company said it is developing a candidate “with the goal to reach, help and to protect people and patients worldwide.”
CaroGen Corporation and Yale University are also pursuing a vaccine candidate.
Following reports that some COVID-19 patients have had severe immune responses to the virus, including attacks on the lungs, Regeneron and Sanofi are aiming the rheumatoid arthritis drug Kevzara at patients. Kevzara would not treat the underlying virus, just the immune system responses. In China, researchers have been using Roche’s Actemra, a drug similar to Kevzara, to help a small group of patients with severe or critical Covid-19 disease recover.
Eli Lilly and AbCellera teamed up to co-develop antibody products for the treatment and prevention of the virus. Following the sequencing of 500 unique fully human antibody sequences from a COVID-19 blood sample, the companies will screen the antibodies to find the ones most effective in neutralizing SARS-CoV-2.
Canada’s XORTX Therapeutics launched a study with its Oxypurinol formulation XRx-101 as a novel treatment for acute kidney and lung injury accompanying coronavirus infection and specifically for the COVID-19 infection. The company pointed to reports from china that illustrate that acute kidney injury and acute pulmonary injury are key factors in the most serious cases of COVID-19 hospitalization and death.
South Dakota-based SAb Biotherapeutics is using genetically engineered cows to produce antibodies as a potential treatment for coronavirus.
Japanese drugmaker Takeda Pharmaceutical Co., is attempting to develop a drug based on the blood of patients who recovered from COVID-19.
Vir Biotechnology and Alnylam Pharmaceutical announced on March 4 they were expanding their existing collaboration to include RNAi therapeutics targeting SARS-CoV-2, the virus that causes COVID-19.
Gilead Sciences announced it was launching two Phase III clinical trials of its investigational antiviral drug remdesivir in adults diagnosed with COVID-19. The company is also conducting a randomized, controlled trial in Wuhan, China, testing remdesivir in COVID-19 patients with mild to moderate forms of pneumonia.
The University of Nebraska Medical Center (UNMC) in Omaha and NIAID have initiated a clinical trial of Gilead’s remdesivir in COVID-19.
Another study is ongoing of favipiravir compared to AbbVie’s Kaletra, an antiretroviral for HIV.
Paris-based Sanofi’s Sanofi Pasteur, its global vaccines business, is collaborating on a vaccine with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response, part of the U.S. Department of Health and Human Services (HHS).
GlaxoSmithKline is providing the University of Queensland access to its vaccine adjuvant platform technology, which should strengthen the response of any vaccine and limit the amount of vaccine needed in each dose. Also, on February 24, GSK announced that Chinese biotech company Clover Biopharmaceuticals is also using the adjuvant technology in combination with its vaccine candidate, COVID-19 S-Trimer, in preclinical studies.
Inovio Pharmaceuticals has begun preclinical testing and small-scale manufacturing of its DNA-based vaccine, INO-4800. It hopes to begin clinical trials in the U.S. with 30 participants in April and launch human trials in China and South Korea at the same time.
Johnson & Johnson is working with BARDA to test its vaccine candidate. On March 2, the company indicated it hoped to start Phase I trials by the end of 2020.
Regeneron Pharmaceuticals is working on developing monoclonal antibodies using its VelocImmune platform. It hopes to have hundreds of thousands of prophylactic doses ready for human testing by the end of August 2020.
GT Biopharma is collaborating with Cytovance® Biologics to help move their TriKE™ drug product into clinical testing for the treatment of the novel coronavirus.
Other Industry News
Due to the coronavirus outbreak, the trial with the state of New York against a number of companies for allegedly fueling the opioid epidemic has been postponed.
Biopharma Conferences in the United States – this list is not all inclusive
Date as of March 16, 2020
If you know of any conferences or meetings that are not on our list, please forward us the information at news@biospace.com
| Conference | Location | Date of Conference | Status |
| Annual Clinical Genetics Meeting | San Antonio, TX | March 17 – 21 | Canceled |
| 2020 Cancer Immunology and the Tumor Microenvironment Symposium | La Jolla, CA | March 18 | Canceled |
| ACS National Meeting & Expo: Macromolecular Chemistry: The Second Century | Philadelphia, PA | March 22 – 26 | Canceled |
| A Gut-Systemic Perspective for Metabolic Disease | Santa Fe, NM | March 22 – 26 | Canceled |
| HIV Vaccines / HIV Pathogenesis and Cure | Keystone, CO | March 22 – 26 | Canceled |
| NIH-AACR Cancer, Autoimmunity, and Immunology Conference | Bethesda, MD | March 23 – 24 | Changed to a virtual meeting |
| The American College of Cardiology (ACC.20/WCC) | Chicago, IL | March 28 – 30 | Canceled |
| Synthetic Biology: At the Crossroads of Genetic Engineering and Human Therapeutics | Breckenridge, CO | March 29 – April 1 | Canceled |
| Ubiquitin Biology / Targeted Protein Degradation | Snowbird, UT | March 29 – April 1 | Canceled |
| Gene Therapy for Rare Disorders 2020 | Boston, MA | March 30 – April 2 | Canceled |
| Experimental Biology Meeting | San Diego, CA | April 4 - April 7 | Canceled |
| Eighth Annual Symposium on Global Cancer Research (ASGCR2020) | Washington D.C. | April 17 | Canceled |
| Bio-IT World Conference & Expo Update | Boston, MA | April 21 - 23 | Postponed |
| AACR Annual Meeting 2020 | San Diego, CA | April 24 – 29 | Canceled |
| American Society of Clinical Oncology (ASCO Annual Meeting) | Chicago, IL | May 29 – June 2 | Monitoring, may move to a digital format |
| BIO | Boston, MA | June 8 – 11 | Closely monitoring |
| 24th Annual Green Chemistry & Engineering Conference | Seattle, WA | June 16 – 18 | Proceeding |
* The list of news is not all-inclusive. Please check back for updates.
