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Antibody Drugs Touted by Trump Could Be Next to Get Authorized for Covid-19

President Trump’s endorsement of an experimental Covid-19 drug from

Regeneron Pharmaceuticals Inc.


REGN 0.37%

has raised expectations for a type of medicine that could be authorized for public use within weeks or even days.

Regeneron is racing against rival

Eli Lilly & Co.


LLY 2.20%

to bring the first monoclonal antibody drug on the market to treat Covid-19 patients who aren’t sick enough to be hospitalized. Both companies said Wednesday they had asked the U.S. Food and Drug Administration to authorize use, and they had already made tens of thousands of doses for patients.

If greenlighted, the shots would begin to fill a big hole in the Covid-19 medicine chest for treatment of early and less-severe cases. After more testing, they could offer temporary protection against infections until vaccines arrive. But supply is unlikely to meet demand until next year at the earliest.

Monoclonal antibodies, which are also used to treat cancer and other diseases, take a page from the body’s own soldiers for fighting pathogens. Both Lilly and Regeneron researchers derived their drugs from naturally occurring Covid-19 antibodies.

Each of the companies has released encouraging data from early-stage clinical trials showing their drugs helped reduce coronavirus levels and improve symptoms in patients not sick enough to be hospitalized. Lilly and Regeneron have already started studies to see if their antibody drugs can prevent Covid-19.

Given the urgent need, the companies asked the FDA to use a special review process reserved for emergencies such as pandemics and authorize use before the therapies have finished all the stages of testing normally required for approval.

The FDA could issue the go-ahead for the monoclonal antibody drugs as soon as Friday, SVB Leerink analyst Geoffrey Porges said. The agency could feel comfortable making a quick decision, he said, because it is already familiar with the way antibody drugs work, having approved many of them over the years to treat other diseases.

The FDA declined to comment about its review of the applications or the timing of a decision.

The agency has granted emergency-use authorizations for two therapies for hospitalized Covid-19 patients, the antiviral remdesivir from

Gilead Sciences Inc.

and antibody-rich convalescent plasma taken from recovered coronavirus patients. An antibody drug could be the next agent to be permitted for use.

Last Friday, Mr. Trump was given a high dose of Regeneron’s drug, code-named REGN-COV2, under a program that allows patients to take experimental drugs outside of clinical trials. He was later given the antiviral drug remdesivir, which the FDA authorized in May, and the already approved steroid dexamethasone.

Mr. Trump’s doctors have said he is symptom free. In a video released late Wednesday, the president attributed his return to health to Regeneron’s drug.

A growing number of hospitals are investigating antibody testing and blood plasma therapy as a way to combat the new coronavirus in sick patients. WSJ’s Daniela Hernandez explains. Photo illustration: Laura Kammermann

“They gave me Regeneron, and it was like, unbelievable. I felt good immediately,” he said. Independent doctors

Antibody drugs are no cure but seem promising for COVID-19

WASHINGTON (AP) — They’re not cures and it’s not likely that everyone will be able to get them as President Donald Trump has suggested. But experimental antibody drugs like the one Trump was given are among the most promising therapies being tested for treating and preventing coronavirus infections.

Eli Lilly and Regeneron Pharmaceuticals Inc. are asking the U.S. government to allow emergency use of their antibody drugs, which aim to help the immune system clear the virus. The medicines are still in testing; their safety and effectiveness are not yet known.

Trump is among fewer than 10 people who were able to access the Regeneron one under “compassionate use” rules, without enrolling in a study.

Q: How do they work?

A: Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help it be eliminated. Vaccines mimic an infection to spur antibody production. But it can take several weeks after a vaccine or natural infection for the most effective antibodies to form. The experimental drugs are concentrated versions of specific antibodies that worked best against the coronavirus in lab and animal tests. In theory, they start helping right away. The one-time treatment is given through an IV — it’s not like a pill that people can take at home.

Q: How do the drugs differ?

A: Regeneron is using two antibodies to enhance chances its therapy will work even if the virus evades one. The company made a successful Ebola combo antibody treatment this way. Lilly is testing two different antibodies — one with the Canadian company AbCellera and another with a Chinese company, Junshi Biosciences — individually and in combination. Others testing similar drugs are GlaxoSmithKline and Vir Biotechnology Inc., which says it has engineered antibodies to last longer than they usually do. Amgen, Adaptive Biotechnologies and the Singapore biotech company Tychan Pte Ltd. also have studies underway.

Q: When might they be available?

A: Eli Lilly and Regeneron have asked the Food and Drug Administration for emergency authorization. During public health emergencies the FDA can speed drugs to market based on a lower standard of evidence than is normally required. Drugmakers need only show that the expected benefits of their therapies outweigh the risks for treating COVID-19. There is no deadline for the FDA to rule on the drugs, but it typically makes decisions on such emergency applications within days or weeks.

Q: Who would get them?

A: Researchers are still trying to determine the best candidates for antibody treatment. Some studies involve newly infected people to see if early treatment can lower the risk of becoming sick. Other studies in hospitalized patients aim to prevent serious illness, complications or death. Researchers also are testing these drugs to try to prevent infection in people at high risk of it, such as health workers, housemates of people with COVID-19, and nursing home workers and residents.

Q: Will there be enough for everyone?

A: It depends on how potent the drugs prove

Allergy Rhinitis Drugs Market – Actionable Research on COVID-19 | Growing Awareness about Allergic Rhinitis to Boost the Market Growth

The global allergy rhinitis drugs market size is poised to grow by USD 2.4 billion during 2020-2024, progressing at a CAGR of almost 4% throughout the forecast period, according to the latest report by Technavio. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment. The report also provides the market impact and new opportunities created due to the COVID-19 pandemic. Download a Free Sample of REPORT with COVID-19 Crisis and Recovery Analysis

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201007005668/en/

Technavio has announced its latest market research report titled Global Allergy Rhinitis Drugs Market 2020-2024 (Graphic: Business Wire)

This growing awareness about allergic rhinitis has proved critical in helping patients get treated in the early stages of the disease. It also increases the chances of accurate diagnosis by physicians. Globally, the prevalence of allergic rhinitis has increased, and there is an increase in the number of initiatives to increase awareness about the disease.

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Report Highlights:

  • The major allergy rhinitis drugs market growth came from the Antihistamines segment. They are increasingly being used as a first-line approach to prevent or relieve the symptoms of allergic rhinitis. One of the major factors associated with market growth in this segment is the growing number of companies investing in the development of intranasal antihistamines for the treatment of allergic rhinitis.

  • North America was the largest allergy rhinitis drugs market in 2019, and the region will offer several growth opportunities to market vendors during the forecast period. The growing prevalence of allergic rhinitis and the availability of a wide range of drugs for the treatment of rhinitis allergy will significantly influence allergy rhinitis drugs market growth in this region.

  • The global allergy rhinitis drugs market is fragmented. Alcon Inc., ALK-Abello AS, Dr. Reddy’s Laboratories Ltd., GlaxoSmithKline Plc, Glenmark Pharmaceuticals Ltd., Merck & Co. Inc., Novartis AG, Pfizer Inc., Sanofi, and Stallergenes Greer Ltd. are some of the major market participants. To help clients improve their market position, this allergy rhinitis drugs market forecast report provides a detailed analysis of the market leaders.

  • As the business impact of COVID-19 spreads, the global allergy rhinitis drugs market 2020-2024 is expected to have Neutral and At par growth. As the pandemic spreads in some regions and plateaus in other regions, we revaluate the impact on businesses and update our report forecasts.

Read the full report here: https://www.technavio.com/report/report/allergy-rhinitis-drugs-market-industry-analysis

Increasing Demand for Over-The-Counter Medicines will be a Key Market Trend

Patients with mild allergies often self-medicate with over-the-counter drugs.These over-the-counter pills that do not require a written prescription from a healthcare professional can be directly purchased from pharmacies. In addition, these over-the-counter drugs have increased the practice of self-medication among individuals. Self-medication also reduces the pressure of medical services. Therefore, patients are inclined toward over-the-counter drugs, which in turn positively impacts the market.

Technavio’s sample reports

Bill Gates Says Antibody Drugs Could Sharply Reduce Covid-19 Death Rate

Antibody drugs that are in testing and were administered to President Trump could significantly reduce the death rate from Covid-19 once they are approved by regulators and more widely available, billionaire philanthropist Bill Gates said Tuesday.

The drugs, in a class of medicines known as monoclonal antibodies, have shown promise in early-stage patients with Covid-19. “That’s actually pretty exciting,” Mr. Gates told The Wall Street Journal’s CEO Council Summit. “The reduction in death rate there could be pretty high, and those will be out in volume by the end of the year, at least in the rich countries.”

The drugs, developed by

Regeneron Pharmaceuticals Inc.,

Eli Lilly

and others, are designed in laboratories to mimic antibodies that the immune system produces to fight off viruses and other pathogens. They are injected intravenously and have the potential to work soon after a person is infected and only mildly ill. Scientists believe they also hold promise as a preventive tool, blocking infection temporarily.

President Trump received Regeneron’s antibody drug cocktail late last week under a compassionate use program.

Mr. Gates also expressed optimism about vaccines in development. An effective vaccine could help return life to “pretty close to normal” by late next year in the developed world, he said. Eliminating or stopping virus transmission completely would take two to three years, he said.

Progress on both drugs and vaccines will take longer in the developing world, he said, emphasizing a divide that his foundation and other global players are seeking to close.

Some public health experts are concerned that misinformation, along with any rush by governments to approve vaccines before testing is complete, will make people hesitant to receive one. If only a small percentage of populations are vaccinated, the new coronavirus will continue to spread.

Covid-19 has put a spotlight on how misinformation on social media can be harmful. Bill Gates discusses why and how to best control it, at the WSJ CEO Council Summit. Photo: Qin Lang/Xinhua via ZUMA Wire

Mr. Gates said U.S. political and business leaders should speak out and help explain the value and safety of the vaccines to their constituents and employees, to lead by example and ease concerns. For example, he said, the Bill & Melinda Gates Foundation worked with religious leaders in northern Nigeria to persuade parents to allow their children to be vaccinated against polio.

“Here in the U.S., we should already be thinking about which voices will help reduce the hesitancy,” he said.

“The CDC that normally speaks out on these things hasn’t yet had that much visibility,” he added, referring to the U.S. Centers for Disease Control and Prevention.

If the data on the safety and efficacy of vaccines are clear, he said, “I think enough people will be interested and then you’ll build up that confidence as more and more people are taking the vaccine and getting good results.”

The Microsoft co-founder acknowledged that misinformation amplifies quickly on digital platforms, and said he doesn’t yet see a solution.

Covid-19 Medical

Pfizer, BioNTech, Regeneron Hit With Patent Lawsuits Over COVID-19 Drugs And Vaccines

Three top names in the fight against the coronavirus and the COVID-19 disease that can result from it have been sued for patent infringement. The trio includes Regeneron Pharmaceuticals (NASDAQ:REGN), Pfizer (NYSE:PFE), and BioNTech (NASDAQ:BNTX). The plaintiff is privately held Allele Biotechnology and Pharmaceuticals.

Allele alleges that the three all used its mNeonGreen fluorescent protein to develop their COVID-19 products without paying royalties for the substance. Medical researchers inject fluorescent proteins into cells to track reactions within those bodies. This tracking is used to help determine the effect of medicines and vaccines on the body.

Regeneron is currently developing REGN-COV2, an experimental cocktail of two antibodies to treat COVID-19. The company became a hot topic last week when it was revealed President Donald Trump was administered REGN-COV2 as part of his treatment for COVID-19.

Pfizer and BioNTech have teamed up to develop a coronavirus vaccine; their candidate, BNT162b2, is considered one of the front-runners in the race to bring a vaccine to market.

mNeonGreen was allegedly used in both programs. Allele said in its complaint, filed in a California federal court, that “only through the use of mNeonGreen” were the companies able to develop their products with relative speed.

This, in turn, allowed them to be awarded “an immediate $400 million in grants and over $4 billion in sales of the vaccine to date,” although BNT162b2 has, like other candidates, not yet been approved for use by any major pharmaceutical regulator. Allele is seeking to recover the royalties for its product, although it wasn’t immediately clear how much it is requesting.

Regeneron said it disagreed with Allele’s complaint and would “vigorously defend” its position in court. Neither Pfizer nor BioNTech has formally reacted to the lawsuit.

This article originally appeared in the Motley Fool.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

The Pfizer company logo is seen in front of Pfizer's headquarters in New York The Pfizer company logo is seen in front of Pfizer’s headquarters in New York Photo: AFP / Don EMMERT

Source Article

Some Health Workers Suffering From Addiction Steal Drugs Meant For Patients : NPR

The federal government estimates one in 10 healthcare workers experience substance use disorder. There is rising concern that medical professionals are stealing powerful opioid pain medications meant for their patients.

Kaz Fantone/NPR


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Kaz Fantone/NPR

The federal government estimates one in 10 healthcare workers experience substance use disorder. There is rising concern that medical professionals are stealing powerful opioid pain medications meant for their patients.

Kaz Fantone/NPR

When Kristin Waite-Labott, a nurse in Wisconsin, began stealing fentanyl and morphine from her hospital’s medical supply cabinets, she found it was relatively easy to cover her tracks.

Her drug inventory paperwork often didn’t add up, but she found coworkers willing to cover for her.

“They trusted me” she said. “Unfortunately I was taking advantage of that trust and that happens all the time.”

But Waite-Labott’s addiction to fentanyl quickly spiraled out of control.

“Taking it one time, I instantly craved more. It’s so powerful and deadly,” she said.

Waite-Labott eventually lost her job and spent time in jail before entering recovery and regaining her nursing license.

She works now helping other health workers who struggle with addiction and says she’s still haunted by the thought of patients she might have harmed.

“I don’t know that I made any errors,” she said. “But I can’t be certain of that because I was under the influence at work.”

NPR found a growing number of health industry experts and researchers who warn this kind of on-the-job drug theft by health workers may be increasing.

“It’s extremely common and the consequences can be very very grave,” said Kimberly New, an expert on medical drug misuse, known in the industry as diversion.

Patients in pain, patients taking contaminated medications

Harm to patients from drug diversion can be severe. In extreme cases, health workers divert so much medication, patients wind up undergoing cancer treatments or post-surgical recovery without pain relief.

“Patients will be left to linger in pain and not receive the doses that they were supposed to receive,” New said. “The diverter has progressed to the point where they’re no longer willing to share with the patients.”

Studies by the Centers for Disease Control and Prevention and the Mayo Clinic also found healthcare workers who steal drugs frequently tamper with medications, leaving them contaminated.

“I go and take a fentanyl vial, I administer the entire vial to myself and I refill the vial with water,” New said, describing a typical scenario. “Unfortunately many patients have been infected with blood-born pathogens.”

The Mayo Clinic study found as many as 28,000 hospital patients were put at risk of contracting Hepatitis C over a 10-year period because of this kind of drug theft and tampering.

Last year, physicians at a Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., reported six of their patients contracted a rare bacterial blood infection after a nurse replaced opioid medications with tap water.

“We share our experience to alert health care providers,” the doctors wrote in The New England Journal of Medicine

Brisbane doctor John Robert Ullman, 52, accused of supplying drugs to bikies

A Brisbane doctor accused of supplying and trafficking drugs to outlaw motorcycle gang members has been suspended from practising medicine by the Health Ombudsman.

Chermside skin cancer doctor John Robert Ullman, 52, was arrested and slapped with more than 160 charges last week relating to allegations he supplied testosterone, diazepam and other drugs to at least 39 different people over a two-year period.

As part of his bail application, Ullman’s lawyer Tyronne Thomas argued the doctor should be released because he was the only GP rostered on to work during the school holidays at the skin cancer clinic.

“He also within the next couple of weeks he also has patients that require skin cancer treatment,” Mr Thomas told the court on Wednesday last week.

“I’m instructed he’s the only general practitioner working at the clinic over the school holidays.”

Doctor John Robert Ullman leaves the police watch house in Brisbane. Picture: NCA NewsWire / Dan Peled
media_cameraDoctor John Robert Ullman leaves the police watch house in Brisbane. Picture: NCA NewsWire / Dan Peled

But the Health Ombudsman has announced it has taken “immediate action” against Ullman, suspending his medical registration as of Friday last week.

“In accordance with (the Health Ombudsman Act), the Health Ombudsman’s decision will continue to have effect until the Queensland Civil and Administrative Tribunal sets the decision aside or the Health Ombudsman revokes the suspension of (Ullman’s) registration…,” the ombudsman said.

Ullman’s profile was also removed from the website of the skin cancer clinic within 24 hours of his arrest despite him being granted bail.

Magistrate Michael Quinn said at the time he was satisfied the prosecution had a “strong case” but granted the bail on strict conditions including that Ullman provide a $50,000 surety.

Under the bail conditions he is also required to reside at his Chelmer home with his family, surrender his passport, report to Indooroopilly police each Monday and Friday and have no contact with the people he is accused of supplying drugs to.

Police prosecutor Senior Constable Hayley Kipps had objected to Ullman being granted bail, alleging he was a risk of further reoffending if released from custody.

“Of serious concern is that some of the alleged supplies relate to outlaw motorcycle club gang members,” Snr Const Kipps told the court.

She said allegations Ullman had supplied drugs to 39 people were of “serious concern” and there was a “high probability” he would commit offences if released on bail.

“It is the prosecution submission that an actual period of custody is within range so there is not a risk of (Ullman) serving too much time (if not granted bail),” she said.

Ullman will face court again on November 16.

Source Article

Global Antifungal Drugs Market to Surpass US$ 13,132.8 Mn by 2027, Says Coherent Market Insights (CMI)

According to Coherent Market Insights, the global antifungal drugs market is estimated to be valued at US$ 11,591.0 Mn in 2020 and is expected to exhibit a CAGR of 1.8% during the forecast period (2020-2027).

Key Trends and Analysis of the Global Antifungal Drugs Market:

The increasing incidence of invasive candidiasis and vaginal candidiasis is expected to propel the global antifungal drugs market growth. The rising prevalence of invasive candidiasis, vaginal candidiasis, and preterm births poses high economic burden on the patient-population. For instance, according to the Centers for Disease Control and Prevention (CDC), candidemia, a form of invasive candidiasis, was one of the most common bloodstream infections in the U.S., with an average incidence of around 9 per 100,000 cases between 2013 and 2017.

Moreover, according to the same source, in 2017, around 84% of the total healthcare cost and 48% of the hospitalizations for candida infections was attributable to invasive candidiasis. The average cost per hospitalization for invasive candidiasis was around US$ 64,723 to US$ 153,090.

The increasing number of preterm births is expected to boost the market growth. For instance, according to the Kolling Institute of Medical Research published its result in 2015, that shows vaginal candidiasis can increase the risk of preterm births.

Moreover, according to a survey by researchers from the University of Miyazaki in 2017, the incidence of vulvovaginal candidiasis (VC) during pregnancy is 13 to 20% globally.

Furthermore, according to the Obstetric and Gynecology Department, Italy, 2018, VC is estimated to be the second most common cause of vaginitis and is found in 40% of women with vaginal discomfort. VC can cause systemic infections in premature neonates, particularly those with low birth weight.

Request Sample Copy of this Report @ https://www.coherentmarketinsights.com/insight/request-sample/237

Key Market Takeaways:

The global antifungal drugs market is expected to exhibit a CAGR of 1.8% during the forecast period (2020-2027), owing to the increasing incidence of invasive candidiasis and vaginal candidiasis.

The growth of the North America antifungal drugs market is attributed to launches of antifungal drugs in the U.S.

Competitive Landscape:

Key players operating in the global antifungal drugs market are GlaxoSmithKline Plc, Bayer AG, Abbott Laboratories, Merck & Co., Inc, Glenmark Pharmaceuticals Limited, Enzon Pharmaceuticals, Inc., Pfizer Inc., Gilead Sciences, Inc., Sanofi S.A. and Astellas Pharma, Inc.

Buy-Now this Research report @ https://www.coherentmarketinsights.com/insight/buy-now/237

 

Market Segmentation:

  • Global Antifungal Drugs Market, By Dosage Form:

    • Powders

    • Ointments

    • Drugs

    • Others

  • Global Antifungal Drugs Market, By Region:

    • North America

    • Europe

      • U.K.

      • Germany

      • Italy

      • Spain

      • France

      • Russia

      • Rest of Europe

    • Asia Pacific

      • Australia

      • India

      • China

      • Japan

      • ASEAN

      • South Korea

      • Rest of Asia Pacific

    • Latin America

      • Brazil

      • Mexico

      • Argentina

      • Rest of Latin America

    • Middle East

      • GCC

      • Israel

      • Rest of Middle East

    • Africa

      • South Africa

      • Central Africa

      • North Africa

Related Market Intelligence Report:

Brain Health Supplements Market, by Product Type (Herbal Extracts {Ginseng, Ginkgo Biloba, Curcumin, Lions Mane, and Others}, Vitamins & Minerals {Vitamin B, Vitamin C &  E, and Others}, and Natural Molecules {Acetyl-L-Carnitine, Alpha GPC, Citicoline, Docosahexaenoic Acid, and Others}), by Application (Memory

Health Benefits Of Greek Ouzo ‘To Farmako’ The Drugs

Daily penis care performs an enormous position in men’s sexual health. Patients could try to distract themselves from the ache by crying and even laughing. The important thing areas of potential danger below the Federal Anti-Kickback statute additionally come up from pharmaceutical producer relationships with 3 teams: purchasers, physicians or other health care professionals, and gross sales agents.

Maybe now you can see why cayenne is regarded as a “miracle herb.” With over seven hundred,000 People experiencing a stroke each year and virtually half one million dying of coronary heart disease, the cure to a healthy coronary heart is as close as your native grocery store.

At this stage of dying, sufferers are offered humane therapy akin to hospice and pain medicine for comfort. Sufferers with chronic ache can developed certain inner coping mechanisms to help them deal with the pain. In current, American society, evidently members of lower courses have restricted entry to healthy meals; in Ancient Hawaii, the situation was the alternative.

Lastly, when the Inexpensive Care Act was being implemented, states had the choice of implementing their very own state-run health alternate or using a federally-facilitated exchange”, allowing the state to choose whether or not or not they would increase Medicaid advantages for individuals incomes up to 138 % of the federal poverty line (Nguyen).

• A coronary heart that is healthy and powerful will enable the body to operate more effectively. Given beneath is the outline of a few of the commonest benefits of CBD oil for cancer sufferers. Your patient may have a three-day stay within the hospital and have five completely different nurses maintain them.…

How Are Drugs Categorised And Grouped?

Stretch marks elimination: Biotin makes your pores and skin more healthy and helps get rid of stretch marks. We can’t anticipate assist from the federal government of the Philippines because the medical advisers are schooled in typical medicine who ignore or scorn the free radical theories of illness.

I also agree that animal testing should be banned, because it’s animal cruelty, there are other ways to test medicine, and animals react differently than humans do. It isn’t necessary that Dr. Estuita conducts the research himself however somebody who shares the framework (free radical theories of disease) and passion for the well being of individuals.

Many people turn to CAM due to adversarial results of pharmaceutical drugs. I didn’t know that the folks before me had animals with mange & knew concerning the fleas, so I shrugged it off & acquired Front Line & now they’re all losing fur & have pink spots, they’re warm to the touch.

Consuming plenty of water is at all times good, however a glass or two of Ouzo thins the blood and alleviates a number of the worst symptoms. The synthesis of sulfonamide started with the synthesis of protonsil of the antagonistic effects of sulfonamides was hypoglycemia, which led to the development of sulfonylurea medicine.

So these medicines are useful to cure chest ache referred to as as Angina. It is okay as a nurse, to counsel to the physician a affected person managed analgesia (PCA) but most the time these are standard for acute ache that develops after surgical procedure. Nurses must lay apart private biased about ache therapy and judgement of affected person reputation.…