Biopharma Industry News for March 25: Update on the Novel Coronavirus

CV Update_March 25

News information is not all-inclusive. Please check back for updates.

FDA Actions

Access to Blood Donated by COVID-19 Survivors: The FDA is aiding access to convalescent plasma, antibody-rich blood products. This blood, donated from COVID-19 survivors, could shorten the length, or lessen the severity of the virus.

Action to Increase U.S. Supplies: The FDA took action to increase U.S. supplies to help the U.S. with COVID-19. This action provided instructions to manufactures importing personal protective equipment and other devices.

Vaccine Development: The FDA is working with both local and international experts to find vaccines to treat COVID-19. The FDA is collaborating with the EMA to facilitate SARS-CoV-2 vaccine development.

Filtering Facepiece Respirator Shortages (FFRs): The FDA has states that certain imported disposable FFRs that are not NIOSH-approved are appropriate to protect the publish health or safety.

Center for Devices and Radiological Health (CDRH) Steps to Prioritize Work: The FDA has issued a Letter to Industry that includes steps the CDRH has taken to address the impact of COVID-19 public health emergencies on day-to-day operations in both the CDRH and in the medical device industry.

The FDA has created a COVID-19 Diagnostic Tests Hotline for test developers and laboratories who have questions about the EUA process or who identify shortages of testing supplies. They also have a toll-free 24-hour phone line, 1-888-INFO-FDA.


PerkinElmer announced the U.S. Food and Drug Administration (FDA) had granted its New Coronavirus RT-PCR test Emergency Use Authorization (EUA). The company joins a growing list of firms that have been granted EUA for COVID-19 testing The first was Roche, which was granted use for its fully automated cobas 6800 and 8800 Systems, approved on March 13.

Heat Biologics and the University of Miami are collaborating on the development of a point-of-care diagnostic test. The test will require a pharyngeal throat swab to deliver on-the-spot results on a paper strip in under 30 minutes. This will vastly improve the four-to-five hour timeline for current tests that require blood draws to detect antibodies. Preliminary research suggests the new test is specific to the novel coronavirus, with no cross-reaction to previous coronavirus subtypes, the company said. The test is designed to enable cost-effective manufacturing amenable for mass production and deployment around the world.

Minnesota-based Bio-Techne Corporation’s Ella Automated Immunoassay Platform is being used by hospitals in the United States and Italy to monitor individual immune responses to COVID-19. Specifically, the Ella Cytokine Storm Panel is being used to detect an immune response known as Cytokine Release Syndrome (CRS) in real-time. CRS represents a critical point in individuals with severe COVID-19 disease where immune molecules, called cytokines, attack the patient's organs, representing a critical and potentially fatal point in disease management. Bio-Techne is investing in both near-term and long-term efforts to enable broader clinical adoption of Ella and is looking to partner with clinical research customers to pursue Emergency Use Authorization status for COVID-19 testing in key regions, as well as investing in manufacturing and quality control systems required for diagnostic products.  


Testing Therapies, Antivirals and Vaccines

Gilead has submitted a request to the U.S. Food and Drug Administration (FDA) to rescind the orphan drug designation it was granted for remdesivir for the treatment of COVID-19. 

The FDA said Tuesday that it will allow physicians to use what is referred to as convalescent plasma collected from recovered COVID-19 patients in an attempt to treat patients who are critically ill from the virus that was declared a pandemic.

China’s Sartorius is teaming up with CanSino Biologics and the Institute of Bioengineering at the Academy of Military Medical Sciences in China to develop a vaccine candidate against COVID-19. CanSinoBIO and the Institute of Bioengineering used Sartorius’ BIOSTAT STR single-use bioreactor system for the upstream preparation of the recombinant vaccine, thus ensuring the rapid linear amplification of the adenovirus vector, Ad5-nCoV.

San Francisco-based Vir Biotechnology indicated it has identified several human monoclonal antibody (mAb) candidates against SARS-CoV-2, the virus causing COVID-19. In the interest of saving time, the company’s lead development was transferred to WuXi Biologics and Biogen several weeks ago with human trials likely to begin in the next three to five months.

Cambridge, Mass.-based AlloVir, an immunotherapy company, teamed up with Baylor College of Medicine to discover and develop off-the-shelf, virus-specific T-cell therapies to combat SARS-CoV-2. With AlloVir’s proprietary technology, in addition to targeting SARS-CoV-2, the investigational virus-specific T-cell therapy may also address other coronavirus (CoV) strains including SARS-CoV, MERS-CoV, and also the endemic CoVs that commonly afflict immunocompromised patients, the company said. AlloVir aims to develop a therapy for CoVs that can be used as a stand-alone treatment or incorporated into the company’s multi-respiratory virus investigational therapy, ALVR106, which is designed to address other devastating and life-threatening community-acquired respiratory viruses.

CHF Solutions announced the use of its Aquadex therapy for treating COVID_19 in New York City and in Georgia. The Aquadex SmartFlow system is a way of removing excess fluid from patients suffering from fluid overload.

NeuroClear Technologies acquired the rights to develop a novel pharmaceutical to treat Covid-19 from BioSig Technologies. The product, Vicromax, has completed Phase I and three Phase II trials for other indications. In a preliminary internal review, Vicromax showed strong activity against COVID-19 in cell cultures. NeuroClear is a majority-owned subsidiary of BioSig. It intends to develop Micromax and take it through clinical trials under a new NeuroClear subsidiary, ViralClear Pharmaceuticals.


Company Actions

Immuron provided an update to the market regarding the current and future impact of COVID-19. Immuron’s Board has moved quickly to address the present situation and have mentioned radical cost-cutting and deferring certain research and development activities.  As a major first step in this process, Immuron’s CEO, Gary S. Jacob, has resigned as CEO and member of the Board of Immuron.

DermTech International has implemented a work-from-home policy for much of its staff, however, the company said its laboratory remains fully-operational due to the necessity of providing results for early melanoma detection. While the company is taking every precaution due to the pandemic, it maintains that assessing an atypical mole for melanoma should be considered essential, and as such is “evaluating all opportunities to make our test available to patients and ensure timely results.” The California-based company noted that its patient-focused teams continue to operate normally and are following appropriate safety procedures including, social distancing, proper respiratory etiquette and hand hygiene, staggered shifts, requiring sick employees to stay home, and frequent environmental cleaning. The company suspended face-to-face interactions between its sales team and healthcare clinicians.

Eloxx Pharmaceuticals paused enrollment in its Phase II trials for ELX-02 in cystic fibrosis in response to the COVID-19 pandemic.

Takeda Pharmaceutical is donating more than $6.25 million to organizations in the U.S. impacted by COVID-19. The American Red Cross will receive $4 million. It will match employee donations to the American Red Cross dollar for dollar, up to a collective total of $500,000. The City of Cambridge Mayor’s Relief Fund will receive $2 million and the Town of Lexington’s Emergency Assistance Fund will receive $250,000.

Applied Biosciences Corporation, a company focused on the development of synthetic cannabinoid therapeutics, has diverted its manufacturing resources to build products that will help battle the spread of the coronavirus. The company said it is prioritizing the development of additional products to complement its hand sanitizer line and anticipates launching them within the coming weeks, which will include, a travel-sized sanitizing spray, anti-bacterial hand soap and bottles of Isopropyl Alcohol.

Other Industry News

Hours before the U.S. Food and Drug Administration granted Emergency Use Authorization to California-based Cepheid’s rapid Xpert Xpress SARS-CoV-2 point-of-care diagnostic, Jeff Hawkins, chief executive officer of Truvian Sciences, noted that in all of the industry response to the pandemic, approval of such a device was still missing.

On Tuesday, the former Food and Drug Administration Commissioner, Scott Gottlieb, told CNBC that the pandemic is going to be a long fight and the U.S. officials shouldn’t consider lifting stringent mitigation measures.

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