Biopharma Industry News: Update on the Novel Coronavirus

Coronavirus update

Seemingly in response to global uncertainty over the coronavirus outbreak, the stock markets have plunged, with the Dow down 1,900 points on March 9, numerous conferences are being canceled and biopharma companies are taking action. Here’s a biopharma industry overview as of late March 10.*

FDA Actions

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.

 

Company Actions

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.

There has been significant reportage on Biogen staffers who have tested positive for the coronavirus after attending a management meeting in Boston. The company has instructed its workers to stay home and log in over the internet as it works to fight the spread of the disease.

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.

Testing antivirals and vaccines

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.

On February 25, Moderna shipped its first batch of mRNA-1273, a vaccine against the virus, for a planned Phase I clinical trial in the U.S. The experimental vaccine was sent to the NIAID.

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 10, 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

Conference on Retroviruses and Opportunistic Infections (CROI)

Boston, MA

March 8 – March 11

Virtual

Healthcare Information and Management Systems Society (HIMSS)

Orlando, FL

March 9 – 13

Canceled

The American Association for Cancer Research: Advances in Prostate Cancer Research

Denver, CO

March 12 – 15

Postponed

American Academy of Allergy Asthma & Immunology Annual Meeting

Philadelphia

March 13 – 16

Canceled

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

Proceeding/          Monitoring

Experimental Biology Meeting San Diego, CA April 4 – April 7 

Canceled

Eighth Annual Symposium on Global Cancer Research (ASGCR2020)

Washington D.C.

April 17

Proceeding

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

Proceeding/          Monitoring

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.

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