Tag: drug

India faces spike in coronavirus cases, says study, in test for health system

U.S. regulators delay decision on Roche SMA drug risdiplam to Aug. 24

ZURICH (Reuters) – U.S. regulators delayed a decision on Roche’s spinal muscular atrophy drug risdiplam, the Swiss drugmaker said on Tuesday, after the company submitted more data in February on the medicine against the genetic muscle-wasting disease.

Roche said the U.S. Food and Drug Administration will need longer than its original May 24 target date to review the new information. The new date is Aug. 24. Analysts have forecast risdiplam to eventually top $1 billion in annual sales, if it wins approval.

Basel-based Roche had been hoping to win a swift FDA blessing for the oral drug as it seeks to compete against Biogen’s Spinraza, the first SMA medicine, and Zolgensma, the gene therapy from Novartis that runs some $2.1 million per patient.

“In February 2020, based on discussions with the FDA, Roche submitted additional data,” Roche said in a statement. “Given the volume of additional data submitted, the FDA

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Hydroxychloroquine is Trump's coronavirus wonder drug. Does it work?

Hydroxychloroquine is Trump’s coronavirus wonder drug. Does it work?

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TL;DR: President Trump keeps hyping a potential coronavirus treatment — a “cocktail” of hydroxychloroquine and azithromycin. Does it work? Well, it doesn’t appear to be a miracle cure, but some early evidence suggests it might help. South Korea and China

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Donald Trump has advertised it as a coronavirus treatment. Here's what we know about the malaria drug.

Donald Trump has advertised it as a coronavirus treatment. Here’s what we know about the malaria drug.

The debate regarding the anti-malaria drug hydroxychloroquine is in the spotlight again after President Donald Trump advertised the drug’s potential in Sunday’s White House briefing.

Trump interrupted Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, during a tense moment in the news conference when Fauci was asked by a reporter about the drug’s effectiveness in treating coronavirus patients.

The day before, Fauci and White House trade adviser Peter Navarro reportedly got in an argument over the drug during a task force meeting, according to Axios and the New York Times. 

However, against the opinion of many public health experts, the White House has agreed to surge the supply of hydroxychloroquine to coronavirus hot zones.

Here’s a look at why there’s so much disagreement. 

Why are Donald Trump and Peter Navarro pushing a malaria drug?

The Trump administration is citing small studies in China and France as

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India faces spike in coronavirus cases, says study, in test for health system

REFILE-No proof drug touted by Trump is effective against coronavirus

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BRUSSELS, March 31 (Reuters) – The European Commission said on Tuesday there was no evidence that a drug touted by U.S. President Donald Trump as a potential miracle cure against COVID-19 was effective against the disease caused by the new coronavirus.

Trump had said that hydroxychloroquine, an anti-malaria drug, could be among “the biggest game changers in the history of medicine” for its potential effects against COVID-19.

“The efficacy of hydroxychloroquine in the treatment of COVID-19 patients has to date not been proved,” a spokesman for the European Commission said on Tuesday, relaying an internal opinion from the European Medicine Agency.

The spokesman said there was also no evidence either of the positive effects of chloroquine, another malaria drug, which is also being tested for its possible use against COVID-19.

The U.S. Health and Human Services on Thursday listed hydroxychloroquine as a protected medical resource after Trump signed an

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No proof drug touted by Trump is effective against coronavirus: EU

No proof drug touted by Trump is effective against coronavirus: EU

BRUSSELS (Reuters) – The European Commission said on Tuesday there was no evidence that a drug touted by U.S. President Donald Trump as a potential miracle cure against COVID-19 was effective against the disease caused by the new coronavirus.

Trump had said that hydroxychloroquine, an anti-malaria drug, could be among “the biggest game changers in the history of medicine” for its potential effects against COVID-19.

“The efficacy of hydroxychloroquine in the treatment of COVID-19 patients has to date not been proved,” a spokesman for the European Commission said on Tuesday, relaying an internal opinion from the European Medicine Agency.

The spokesman said there was also no evidence either of the positive effects of chloroquine, another malaria drug, which is also being tested for its possible use against COVID-19.

The U.S. Health and Human Services on Thursday listed hydroxychloroquine as a protected medical resource after Trump signed an executive order to

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Trump administration in talks with India to avoid U.S. drug supply shortage

Trump administration in talks with India to avoid U.S. drug supply shortage

WASHINGTON — Trump administration officials are asking India to lift restrictions to give the U.S. access to pharmaceutical ingredients to produce a range of drugs amid fears of a U.S. drug supply shortage prompted by the coronavirus outbreak, three sources familiar with the matter told NBC News.

The two governments are holding discussions aimed at easing new restrictions on pharmaceutical exports from India, which New Delhi introduced to ensure that the country would have medicine needed to handle the pandemic inside its borders, the sources said.

With the coronavirus potentially disrupting the global supply chain for medicine, India earlier this month restricted the export of 26 pharmaceutical ingredients and the medicines made from them, including acetaminophen — a common pain reliever. India, the world’s leading supplier of generic drugs, is a key source for active pharmaceutical ingredients used to produce a range of medicines.

Full coverage of the coronavirus outbreak

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The Coronavirus Pandemic Is Creating a Drug Supply Crisis Just When We Most Need Medicine

The Coronavirus Pandemic Is Creating a Drug Supply Crisis Just When We Most Need Medicine

As the world scrambles for a magic pharmaceutical bullet to stop the coronavirus, drugs perceived as cures – despite reed-thin evidence — have vanished from pharmacy shelves. Just last Friday, after President Trump touted the still unproven remedy of a malaria drug, hydroxychloroquine, the Food and Drug Administration lifted a restriction it had imposed on a Indian drug manufacturer with a record of manipulating its quality data, to allow it to make the active ingredient now suddenly in hot demand. With the United States long dependent on foreign drug manufacturers for low-cost medicine and key drug ingredients, it is little wonder that we have arrived at this frightening moment, with the FDA allowing companies that it didn’t even trust enough last month to make any drug for the American public, to now churn out unproven drug ingredients for a largely untested off-label use.

Coronavirus has now done what years of

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Scientists chase two fronts in how to treat coronavirus, but 'there's no magic drug right now'

Scientists chase two fronts in how to treat coronavirus, but ‘there’s no magic drug right now’

SAN FRANCISCO – Doctors and scientists are working furiously to find effective treatments for the illness caused by the new coronavirus but are cautioning the public not to self-medicate or hoard mentioned drugs not yet proven to work.

Despite widespread rumors, social media reports and President Donald Trump’s own optimism surrounding the effectiveness of several existing drugs, so far there are no proven treatments for COVID-19, according to the U.S. Centers for Disease Control and Prevention.

“There’s no magic drug out there right now,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said at a news conference Thursday. 

When COVID-19 treatments do arrive, they will likely fall into two categories, experts say. The first will be aimed at slowing down replication of the virus in patients early in the disease. The second will help stop the deadly autoinflammatory response in the lungs in its critical stage.

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Could chloroquine treat coronavirus? 5 questions answered about a promising, problematic and unproven use for an antimalarial drug

Could chloroquine treat coronavirus? 5 questions answered about a promising, problematic and unproven use for an antimalarial drug

<span class="caption">An employee in Nantong, China, checks the production of chloroquine phosphate, an old drug for the treatment of malaria. </span> <span class="attribution"><span class="source">Feature China/Barcroft Media via Getty Images</span></span>
An employee in Nantong, China, checks the production of chloroquine phosphate, an old drug for the treatment of malaria. Feature China/Barcroft Media via Getty Images

An Arizona man died, and his wife was hospitalized, after taking a form of chloroquine, which President Trump has touted as an effective treatment for COVID-19. The couple decided to self-medicate with chloroquine phosphate, which they had on hand to kill parasites in their fish, after hearing the president describe the drug as a “game changer.”

Dr. Anthony Fauci, head of NIH’s National Institute for Allergies and Infectious Diseases, quickly corrected the statement, explaining that Trump’s comments were based on anecdotes and not a controlled clinical trial.

I am a medicinal chemist who specializes in discovery and development of antiviral drugs, and I have been actively working on coronaviruses for seven years.

However, because I am a scientist and I deal in facts and evidence-based

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Antimalarial drug no better than standard coronavirus care: study

Antimalarial drug no better than standard coronavirus care: study

Hydroxychloroquine, an antimalarial drug dubbed a “gift from God” by US President Donald Trump for its potential ability to fight the new coronavirus, was found to be no more effective than standard treatment in a small Chinese study.

The paper, which was published in the Journal of Zhejiang University on March 6, looked at 30 COVID-19 patients, half of whom received the medicine.

After seven days, 13 of the patients who were on the drug tested negative, compared to 14 people who weren’t on it.

One of the patients on it went on to develop severe illness, while the median time taken for the individuals to recover was similar in both groups.

The sample size is considered too small to be statistically significant. 

But a similar number of patients were examined in a recent French study that found the same drug to be highly effective at fighting the infection, especially

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