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2020-03-05 -Signs, Portents, and the Weather-
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China Approves Use Of Immunosuppressive Arthritis Drug For Covid-19 Patients, more possibilities in the pipeline
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 [ChannelNewsAsia] China will use a Roche Holding arthritis drug to treat some COVID-19 patients in severe conditions, health authorities said on Wednesday (Mar 4), as the country seeks to build up treatment regiments to help the infected recover.
Tocilizumab, sold by the Swiss pharma giant under the trade name Actemra, can be prescribed to coronavirus patients who show serious lung damage and show elevated level of a protein called Interleukin 6, which could indicate inflammation or immunological diseases, the National Health Commission said in the latest version of its treatment guidelines published online.
Actemra can help contain inflammation related to Interleukin 6, according to Roche.
Continued from Page 3
There is no clinical trial evidence yet that the drug will be effective on coronavirus patients, however. Actemra also has not received approval from China's National Medical Product Administration to be sold for use for coronavirus infections.
Chinese researchers recently registered a 3-month clinical trial for Actemra that will recruit 188 coronavirus patients and take place from Feb. 10 to May 10, according to records shown on China's clinical trials registration database.
Roche could not be immediately reached for comment. The firm said on Monday it donated 14 million yuan (US$2.02 million) worth of Actemra during February.
The firm said in January it expects sales and profits growth this year as demand for new drugs and more business in China offsets declines in older medicines whose patents have expired.
Chinese drugmakers have been racing to develop alternatives to Roche’s treatment. Bio-Thera Solutions expects to file new drug approval for its Actemra biosimilar in 2021, and Zhejiang Hisun Pharmaceutical received in 2016 regulatory approval to conduct clinical trials for its Tocilizumab candidate, company filings showed.
Biosimilars are cheaper versions of complex biotech drugs such as Actemra.
In the months since the novel coronavirus rose from a regional crisis to a global threat, drug makers large and small have scrambled to advance their best ideas for thwarting a pandemic.
Some are repurposing old antivirals. Some are mobilizing tried-and-true technologies, and others are pressing forward with futuristic approaches to human medicine.
Here’s a guide to some of the most talked-about efforts to treat or prevent coronavirus infection, with details on the science, history, and timeline for each endeavor.
GILEAD SCIENCES
Approach: Treatment
Stage: Phase 3
Gilead’s remdesivir, an intravenous treatment, has already been used to treat one infected patient in the U.S. and will soon be deployed in a pair of large, late-stage studies in Asia. Later this month, Gilead will recruit about 1,000 patients diagnosed with the coronavirus to determine whether multiple doses of remdesivir can reverse the infection. The primary goals are reducing fever and helping patients get out of the hospital within two weeks. The drug, which previously failed in a study on Ebola virus, is also being studied in smaller trials in China and the U.S.
MODERNA THERAPEUTICS
Approach: Vaccine
Stage: Phase 1
Moderna set a drug industry record with mRNA-1273, a vaccine candidate identified just 42 days after the novel coronavirus was sequenced. The company is working with the National Institutes of Health on a healthy-volunteer study expected to begin next month. If mRNA-1273 proves itself to be safe, the two organizations will enroll hundreds more patients to determine whether the vaccine protects against infection. Moderna’s product is a synthetic strand of messenger RNA, or mRNA, designed to convince bodily cells to produce antibodies against the virus. The company, founded in 2010, is yet to win Food and Drug Administration approval for any of its mRNA medicines.
CUREVAC
Approach: Vaccine
Stage: Preclinical
Like Moderna, CureVac uses man-made mRNA to spur the production of proteins. And, like Moderna, it got a grant from the nonprofit Coalition for Epidemic Preparedness Innovations to apply its technology to coronavirus. CureVac has said it expects to have a candidate ready for human testing within a few months. The company is also working with CEPI on a mobile mRNA manufacturing technology, one that would theoretically allow health care workers to rapidly produce vaccines to respond at the site of an outbreak.
GLAXOSMITHKLINE
Approach: Vaccine
Stage: Preclinical
GlaxoSmithKline, one of the world’s largest vaccine manufacturers, is lending its technology to a Chinese biotech firm at work on a coronavirus vaccine. Under an agreement signed last month, GSK is providing its proprietary adjuvants — compounds that enhance the effectiveness of vaccines — to Clover Biopharmaceuticals, a privately held company based in Chengdu. Clover’s approach involves injecting proteins that spur an immune response, thereby priming the body to resist infection. The company has not said when it expects to advance into human testing.
INOVIO PHARMACEUTICALS
Approach: Vaccine
Stage: Preclinical
Inovio has spent the last four decades working to turn DNA into medicine, and the company believes its technology could quickly generate a vaccine for the novel coronavirus. Working with CEPI grant money, Inovio has come up with a DNA vaccine it believes can generate protective antibodies and keep patients from infection. The company has partnered with a Chinese manufacturer, Beijing Advaccine Biotechnology, and is working through preclinical development with a candidate called INO-4800. The company expects to progress into clinical trials later this year.
JOHNSON & JOHNSON
Approach: Vaccine and treatment
Stage: Preclinical
Johnson & Johnson, which has in the past responded to outbreaks of the Ebola and Zika viruses, is taking a multipronged approach to the coronavirus. The company is in the early days of developing a vaccine that would introduce patients to a deactivated version of the virus, triggering an immune response without causing infection. At the same time, J&J is working with the federal Biomedical Advanced Research and Development Authority on potential treatments for patients who are already infected, a process that includes investigating whether any of its older medicines might work against the coronavirus.
REGENERON PHARMACEUTICALS
Approach: Treatment
Stage: Preclinical
Regeneron has grown into a $50 billion business based on its ability to craft human antibodies out of genetically engineered mice. Now it’s tapping that technology in hopes of treating coronavirus. The company is immunizing its antibody-generating mice with a harmless analog of the novel coronavirus, generating potential treatments for the infection. The most potent antibody results will go into animal testing, and if everything goes according to plan, Regeneron will be ready for human testing by late summer. The last time Regeneron embarked on this process, during the Ebola outbreak of 2015, it came up with an antibody cocktail that roughly doubled survival rates for treated patients.
SANOFI
Approach: Vaccine
Stage: Preclinical
Sanofi, which has successfully developed vaccines for yellow fever and diphtheria, is working with BARDA on an answer to the coronavirus. Sanofi’s approach involves taking some of the coronavirus’s DNA and mixing it with genetic material from a harmless virus, creating a chimera that can prime the immune system without making patients sick. Sanofi expects to have a vaccine candidate to test in the lab within six months and could be ready to test a vaccine in people within a year to 18 months. Approval would likely be at least three years away, the company said. Sanofi previously put its technology to work against SARS, a close relative of the novel virus.
VIR BIOTECHNOLOGY
Approach: Treatment
Stage: Preclinical
Vir Biotechnology, a company focused on infectious disease, has isolated antibodies from people who survived SARS, a viral relative of the novel coronavirus, and is working to determine whether they might treat the infection. Teaming up with Chinese pharma contractor WuXi Biologics, the San Francisco-based Vir is in the early stages of development and hasn’t specified when it expects to have products ready for human testing. Vir’s CEO, Biogen veteran George Scangos, is also coordinating the trade group BIO’s response to the coronavirus outbreak.
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Posted by Elmerert Hupens2660 2020-03-05 00:00||
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