Followers | 91 |
Posts | 3296 |
Boards Moderated | 0 |
Alias Born | 10/18/2010 |
Thursday, May 07, 2020 3:15:38 PM
Shares of Gilead Sciences Inc. GILD, +0.69%, which developed remdesivir, were up 1.0% in trading on Thursday.
The emergency use authorization (EUA) for remdesivir, which came out on Friday, states that distribution of the drug will be controlled by the U.S. government, which will then allocate the medication to hospitals and other health care providers. However, several organizations have raised questions this week about access to the treatment, which is only one of two types of COVID-19 drugs to receive an EUA since the COVID-19 pandemic began.
Advertisement
Read: FDA grants Gilead’s remdesivir emergency authorization for COVID-19 treatment
AmerisourceBergen Corp. ABC, +4.31%, the distributor for remdesivir, said in a statement on Tuesday that the administration is coordinating “the distribution of remdesivir to hospitals in regions most heavily impacted by COVID-19,” and that it and Gilead aren’t involved in that decision-making around distribution.
In a letter addressed to Vice President Mike Pence on Wednesday, the HIV Medicine Association and the Infectious Diseases Society of America said: “The plan for distributing remdesivir should be transparent and should be based on state and regional COVID-19 case data and hospitalization rates.”
NOW PLAYING:
What's the Difference Between a Bear Market and a Recession?
00:06
02:08
Visit our Video Center
A physician associated with Boston Medical Center tweeted that the hospital hasn’t received any doses of remdesivir. “We have the second highest absolute case count and highest per bed in Boston,” Dr. Benjamin Linas, an epidemiologist at the safety net hospital, tweeted on Wednesday. “We also had no access to early trials. Today, the family of a dying patient asked me why we do not have RDV. What am I supposed to say?”
Doctors at other hospitals around the U.S. have raised similar concerns, according to Stat News.
The development and distribution of remdesivir doesn’t follow the same model as drugs launched pre-pandemic. The therapy didn’t go through the FDA approval process; instead it received an EUA, and only the topline data from a Phase 3 clinical trial conducted by the National Institute of Allergy and Infectious Diseases has been shared publicly and used to inform the EUA. Gilead has said that additional data will be made available in a study that will be peer reviewed and published in a medical journal.
In addition, Gilead has said that through June it will donate 1.5 million doses of the drug, which can be used for 140,000 patients on a 10-day regimen.
Fuel for Investing Smarter
Make the smartest investment decisions with access to Barron's in-depth analysis and unrivaled market predictions -- all conveniently accessed on MarketWatch.com. Limited-Time Offer: $12 for $12 Weeks.
LEARN MORE
When the FDA granted an EUA to hydroxychloroquine and chloroquine as a treatment for COVID-19 patients, it prompted a run on the drug that led some states like New York to put requirements around who could get a prescription for hydroxychloroquine as patients who take the medicines for lupus and rheumatoid arthritis found themselves without access to their prescriptions.
Advertisement
See also: Majority of new COVID-19 hospitalizations in New York are people who stayed at home
Given the lack of proven treatments for a disease that has killed more than 266,000 people worldwide, since the novel coronavirus was detected last year, it’s not surprising that access to remdesivir has become a concern for those at the frontline of caring for severely ill COVID-19 patients. On Tuesday, the company announced that it was in talks with other drugmakers to produce remdesivir outside of the U.S.
“We intend to allocate our available supply based on guiding principles that aim to direct global access for appropriate patients in urgent need of treatment,” CEO Daniel O’Day told investors last week, according to a FactSet transcript of the earnings call.
Separately, Gilead announced Thursday that it received approval for remdesivir under the brand-name Vuklury in Japan as a treatment for severely COVID-19 patients there.
Since the start of the year, Gilead’s stock is up 20.0%, while shares of AmerisourceBergen have gained 4.9%. The S&P 500 SPX, 1.27% is down 11.8%.
Recent GILD News
- EFFICACITÉ DE 100 % ET SUPÉRIORITÉ AVÉRÉES DU LÉNACAPAVIR DE GILEAD UTILISÉ DEUX FOIS PAR AN PAR RAPPORT À TRUVADA (MD) UNE FOIS PAR JOUR POUR LA PRÉVENTION DU VIH • PR Newswire (Canada) • 06/26/2024 02:45:00 PM
- Honeywell Acquires CAES Systems for $1.9 Billion, Sarepta Therapeutics Surges 34%, Gilead Continues Gains • IH Market News • 06/21/2024 12:00:38 PM
- Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention • Business Wire • 06/20/2024 12:51:00 PM
- Goldman Sachs Raises S&P 500 Forecast for 2024; Disney Secures Deadpool & Wolverine in Chinese Cinemas, and More • IH Market News • 06/17/2024 10:49:12 AM
- New Kite Clinical Research and Real-World Evidence for Yescarta® Demonstrate Benefit From Earlier Lines of Treatment • Business Wire • 06/14/2024 07:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/11/2024 11:25:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/11/2024 11:23:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/11/2024 11:20:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/11/2024 11:18:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/11/2024 11:15:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/11/2024 11:12:00 PM
- Gilead Announces New England Journal of Medicine Publication of Data that Demonstrate Bulevirtide with PegIFN Achieved Post-Treatment Undetectable HDV RNA • Business Wire • 06/06/2024 08:30:00 AM
- Gilead’s Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis • Business Wire • 06/05/2024 06:00:00 AM
- Kite’s Tecartus® Demonstrates Sustained Overall Survival in Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia • Business Wire • 06/03/2024 02:00:00 PM
- Encouraging New Data Presented on Kite’s Yescarta® for Relapsed/Refractory Central Nervous System Lymphoma • Business Wire • 06/03/2024 01:00:00 PM
- Gilead and Arcus Announce Etrumadenant Plus Zimberelimab Regimen Significantly Reduced the Risk of Death in Third-line Metastatic Colorectal Cancer • Business Wire • 06/02/2024 12:00:00 PM
- Gilead and Arcus Announce Etrumadenant Plus Zimberelimab Regimen Significantly Reduced the Risk of Death in Third-line Metastatic Colorectal Cancer • Business Wire • 06/02/2024 12:00:00 PM
- Gilead and Arcus Announce Anti-TIGIT Domvanalimab Plus Zimberelimab and Chemotherapy Exceeded One Year of Median Progression-Free Survival as a First-Line Treatment for Upper GI Cancers • Business Wire • 06/01/2024 12:00:00 PM
- Gilead and Arcus Announce Anti-TIGIT Domvanalimab Plus Zimberelimab and Chemotherapy Exceeded One Year of Median Progression-Free Survival as a First-Line Treatment for Upper GI Cancers • Business Wire • 06/01/2024 12:00:00 PM
- EVOKE-01 Study Results in Metastatic NSCLC to Be Presented at an Oral Session at ASCO 2024 • Business Wire • 05/31/2024 12:07:00 PM
- Gilead Provides Update on Phase 3 TROPiCS-04 Study • Business Wire • 05/30/2024 08:45:00 PM
- Gilead to Present Latest Research Across Key Liver Disease Indications at the European Association for the Study of the Liver Congress 2024 • Business Wire • 05/22/2024 12:30:00 PM
- Investigational Seladelpar Demonstrates Significant Improvements in Liver Disease Progression and Reduced Itching in Primary Biliary Cholangitis • Business Wire • 05/18/2024 12:30:00 PM
- Kite Data at EHA 2024 Demonstrate Positive Patient Outcomes and Advances in Delivery of CAR T-cell Therapy • Business Wire • 05/14/2024 02:09:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/09/2024 09:57:24 PM
FEATURED POET Wins "Best Optical AI Solution" in 2024 AI Breakthrough Awards Program • Jun 26, 2024 10:09 AM
HealthLynked Promotes Bill Crupi to Chief Operating Officer • HLYK • Jun 26, 2024 8:00 AM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM
ECGI Holdings Targets $9.7 Billion Equestrian Apparel Market with Allon Brand Launch • ECGI • Jun 25, 2024 8:36 AM
Avant Technologies Addresses Progress on AI Supercomputer-Driven Data Centers • AVAI • Jun 25, 2024 8:00 AM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM