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Regeneron stops enrolling critically ill COVID-19 patients for antibody drug trial

Regeneron Pharmaceuticals has paused enrollment of critically ill COVID-19 patients in its trial studying the antibody cocktail treatment that was given to President Trump earlier this month. The decision is due to potential safety concerns. 

The drug maker on Friday said it was suspending the enrollment of hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation after an independent monitoring committee observed “a potential safety signal and an unfavorable risk/benefit profile at this time.” 


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The enrollment of patients in this category will be on hold pending the collection and analysis of additional data. 

Trials will continue to test the antibody cocktail in hospitalized patients requiring little or no extra oxygen. Other trials involving mild or moderately ill patients can also move forward. 

The drug has shown encouraging results. Regeneron on Wednesday said early data showed the therapy reduced COVID-19 related medical visits by 57 percent. 

Regeneron earlier this month asked the Food and Drug Administration for emergency approval and said it would make doses available to the American people at no cost. The drug maker said it could have enough doses for 300,000 people in the coming months. 

On Monday, a study of Eli Lilly’s monoclonal antibody in hospitalized patients was stopped after it was found the treatment did not provide any benefit to COVID-19 patients. 

Earlier this month, Trump was given a single 8 gram dose of Regeneron’s experimental treatment under a compassionate-use request and credited the drug for helping him overcome the illness. 


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Gilead’s Covid-19 Drug Is Mediocre. It Will Be a Blockbuster Anyway.

The United States reached a milestone, of sorts, when last week the Food and Drug Administration approved the first treatment for Covid-19.

The drug is called Veklury, although most people know it by its scientific name, remdesivir.

On Wednesday, its manufacturer, Gilead Sciences, said that remdesivir, which has been authorized for emergency use since the spring, had brought in $873 million in revenues so far this year and that it was the company’s second-best-selling drug in the third quarter, behind its H.I.V. drug, Biktarvy.

But the F.D.A.’s decision to grant the drug full approval — which means the company can now begin broadly marketing it to doctors and patients — has puzzled several outside experts, who say that it may not deserve the agency’s stamp of approval because it is, at best, a mediocre treatment for Covid-19, the disease caused by the coronavirus. And they have questioned whether Gilead deserves to pocket potential billions from the drug when the federal government has played a significant role in its development.

“This is a troubling approval,” said Dr. Peter B. Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center. “This is an extremely weak set of trials to support an approval for an antiviral.”

Remdesivir was seen as one of the brightest hopes in the dark days of March and April, when doctors had few tools to treat a new disease and families rushed to gain access to the drug in a desperate gambit to save their dying relatives.

More than six months later, enthusiasm has fizzled. One large, government-run trial showed that the drug shortens patients’ recovery times, but the two other studies the F.D.A. used to justify its approval — sponsored by Gilead — did not compare the treatments with a placebo, the gold standard for evaluating a drug. No studies have shown that it significantly lowers death rates.

And just days before the F.D.A. granted approval, a large study sponsored by the World Health Organization found that remdesivir provided no benefit to hospitalized patients.

“I think most people think that because a drug is F.D.A. approved, that means it must work,” said Dr. Aaron S. Kesselheim, a professor of medicine at Harvard Medical School who studies the drug industry. He and other researchers recently found that less than one-third of new drugs approved by the F.D.A. and its European counterpart over the past decade were rated as having a “high therapeutic value” by outside experts.

“I think it’s important to recognize that F.D.A. approval doesn’t guarantee a certain level of benefit — all it says is that there is some benefit,” he said.

On a call with investors on Wednesday, Gilead’s chief executive, Daniel O’Day, said remdesivir had a role to play, along with vaccines and other treatments.

“There’s a lot we don’t know about the pandemic, of course, but I think what we do know is that in order to get us all back to normal, this is going to

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Antibody drug tested in Cook County may be helpful to some COVID-19 patients, results show

A new antibody-based drug shows promise in treating outpatients who have mild to severe COVID-19, according to initial results of research conducted in part at Cook County Health and Northwestern University.

Patients given the drug were hospitalized or visited the emergency room less often than those given a placebo, Cook County Health officials said. The patients receiving the drug also showed improvement within two to six days, a shorter disease course that is not only good for patients but also may reduce the amount of time a person is infectious, helping protect other people.

The drug, manufactured by Eli Lilly and AbCellera Biologics Inc., was tested on 452 outpatients at 24 medical institutions across the country, including Cook County’s vast public health system and the Northwestern University Feinberg School of Medicine. Most of the 14 patients who took part at Cook County Health were Latino or Black, populations that have been hit especially hard by the disease.

The results of the continuing study, which is being run by Eli Lilly, were published Wednesday by the New England Journal of Medicine.

The drug, administered through a one-time infusion, includes the replicated antibodies of one of the first patients in the United States to survive COVID-19. It’s classified as a monoclonal antibody treatment, the same type of medication given to President Donald Trump after he was diagnosed with the disease and which he described as “a cure.”

The drug in the Eli Lilly trial was formulated using a single antibody. The drug Trump received was made by Regeneron and involves two antibodies.

Dr. Gregory Huhn, an infectious disease expert who led the arm of the Eli Lilly research conducted at Cook County Health, made it clear that the drug is a treatment, not a cure.

“Our hope has been that the antibody drug will reduce COVID symptoms quickly after diagnosis and help to eradicate the virus more quickly,” Huhn said. “While a vaccine is still necessary, this drug therapy has the potential to prevent bad clinical outcomes and complications of COVID-19.”

Scientists have surmised that monoclonal antibodies would be more effective earlier in the course of the disease, and that so far appears to be the case. Another recently released study found the Eli Lilly drug had no benefit for patients sick enough to be hospitalized — results that brought the research to a halt. Most of those patients also were treated with the antiviral drug remdesivir.

“There’s a more compelling argument to administer antibodies early on, before our own bodies generate their own immune response,” Huhn said.

The results released Wednesday found that 1.6% of outpatients given the Eli Lilly drug needed to be hospitalized or visit an emergency room, compared with 6.3% of patients who received a placebo. The drug worked by reducing the amount of virus in people’s bodies, the study determined.

The study’s findings also indicate better outcomes among high-risk patients — defined as patients 65 or older or morbidly obese patients who were at least

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The Asia Pacific liposome drug delivery market is expected to reach US$ 1,562.92 million in 2027 from US$ 759.81 in 2019

The market is estimated to grow with a CAGR of 9. 6% from 2020-2027. The growth of the market is attributed to the some key driving factors such as high incidence of chronic diseases amongst the population, an upsurge in need for non-invasive drug delivery solutions, increasing investments in R&D for pharmaceutical companies.

New York, Oct. 29, 2020 (GLOBE NEWSWIRE) — Reportlinker.com announces the release of the report “Asia Pacific Liposome Drug Delivery Market Forecast to 2027 – COVID-19 Impact and Regional Analysis By Product ; Technology ; Application, and Country” – https://www.reportlinker.com/p05978829/?utm_source=GNW
However, high expense involved in the development of drug delivery systems is expected to obstruct the growth of the market to a certain extent during the forecast years.

Liposomes are small sphere-shaped artificial vesicles synthesized from cholesterol and phospholipids. They have multiple layers and a diameter range of 0.01 to 5.0 um. They also have hydrophilic and hydrophobic properties which help liposomes to encapsulate hydrophobic and hydrophilic drugs to be delivered to targeted body site. Liposomes provide an assured system for targeted drug delivery and thereby is the factor influencing the Liposome Drug Delivery market size growth. Liposomes are widely used for enclosing all types of drug molecules such as acyclovir, chloroquine diphosphate, paclitaxel, tropicamide, and cyclosporine. Liposomes are used as a drug carrier for drug therapy for many diseases since they are biodegradable and biocompatible. Also, they have many therapeutic properties like anticancer drugs, genetic materials, proteins, vaccines, macromolecules, and thus can be encapsulated in liposomes.

Research and development (R&D) in liposomal drug delivery systems are increasing across the world due to the increasing prevalence of chronic disease.Drug delivery is the process of dispensing a pharmaceutical compound to attain a therapeutic effect in humans.

Liposomal drug delivery offers multiple advantages such as better pharmacokinetics and pharmacodynamics, enhanced therapeutic efficacy, and decreased toxicity making these delivery systems ideal for patients suffering from various chronic conditions.

Death among the population worldwide has increased due to cancer.The targeted drug delivery system delivers the drug in a controlled manner at a preselected bio site.

Nanotechnology-based delivery systems are making a crucial impact on cancer treatment, and the polymers play a key role in the development of Nano particulate carriers for cancer therapy.Some of the major technological advantages involved in the nanotherapeutic drug delivery systems (NDDS) are prolonged half-life, improved bio-distribution, increased circulation time of the drug, controlled and sustained release of the drug, versatility of route of administration, increased intercellular concentration of the drug, and many more.

The liposomal carriers used in nanotechnology drug delivery systems are likely to experience rapid adoption, which in turn is propelling the market growth.

As per the data provided by, European Society for Medical Oncology, China estimated there were 4.3 million new cancer cases and more than 2.8 million cancer deaths in China in 2015, with lung cancer the most common cancer and the leading cause of cancer death. With high incidences and mortality, cancer is the leading cause of death in China and

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Trump administration agrees to purchase $375 million of Lilly coronavirus antibody drug

The Trump administration will pay Eli Lilly $375 million to supply 300,000 doses of its experimental antibody drug to treat COVID-19, the Department of Health and Human Services said Wednesday.

If the Food and Drug Administration authorizes use of the drug, the federal government will allocate the doses to state and territorial health departments which, in turn, will determine which health care facilities receive the drug for use in outpatient care.

Lilly said it anticipates only high-risk patients will be indicated to receive the drug until more studies are completed and more supply is available.

The initial agreement is for delivery over the course of two months following authorization, with the option to purchase up to 650,000 additional doses through the end of June 2021 for up to an additional $812.5 million. 

The government-purchased doses would become available to Americans at no cost, although health care professionals could charge for administering the medicine.

Eli Lilly’s CEO, David Ricks, said the company is allocating the drugs to the countries that need them most, and will commit only to a few months of supply at a time to any given country in order to match demand with the limited supply.

“Unfortunately, the U.S. now leads the world in both COVID-19 cases and deaths. As a result, a top priority is helping reduce disease burden in the U.S.,” Ricks said. 

The rolling, seven-day average of daily cases in the U.S. topped 70,000, according to the COVID Tracking project data. With that many cases a day, the projected supply of the monoclonal antibodies would not be nearly sufficient to meet demand.

Lilly said it anticipates manufacturing up to 1 million doses of its drug by the end of 2020, with 100,000 doses ready to ship within days of authorization.

The agreement with Lilly is part of the administration’s Operation Warp Speed, the initiative created by the administration to fund the quick development and distribution of a COVID-19 vaccine.

Ricks said Lilly is pricing the drug at $1,250 per vial in wealthy countries, with a tiered system based on the country’s ability to pay. One vial represents the full course of treatment.

Ricks said the company expects to make a profit, and is pricing the drug “above our marginal cost to produce the medicine in developed markets,” meaning it expects “to produce a modest financial return for our investors by the end of 2021.”

The announcement of the agreement comes a day after Lilly said the drug had no clinical benefit for helping hospitalized patients. The company said it is confident the drug is helpful to those earlier in the course of a COVID-19 infection.

Antibody drugs are experimental, and while doctors think they promise as a potential treatment of COVID-19 and could be a bridge to a vaccine, clinical studies are still ongoing.

But President TrumpDonald John TrumpGiuliani goes off on Fox Business host after she compares him to Christopher Steele Trump looks to shore up support in Nebraska NYT: Trump had

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U.S. strikes deal with Lilly for potential COVID-19 antibody drug

(Reuters) – The U.S. government will pay as much as $1.19 billion to Eli Lilly and Co to secure nearly 1 million doses of its experimental COVID-19 antibody treatment, a drug similar to a treatment that U.S. President Donald Trump received.

Lilly will start delivering 300,000 doses of the treatment, for which it is being paid $375 million, within two months of receiving an emergency use authorization from the U.S. health regulator, the company said.

After that, the government has an option to buy an additional 650,000 vials for $812.5 million, the U.S. Department of Health and Human Services said in a statement.

The price per dose amounts to $1,250 as per the contract, but the vials purchased by the government will be free to the American public.

The U.S. has also signed deals with AstraZeneca and Regeneron Pharmaceuticals for their antibody therapies, under Trump administration’s Operation Warp Speed program.

The deal with Regeneron covers the cost of manufacturing, while the deal with AstraZeneca also includes support for development.

While vaccines are seen critical to ending the pandemic, governments are increasingly looking at other effective treatments to slow the spread of the virus and kick-start economic activity.

The company submitted a request to the U.S. Food and Drug Administration earlier this month for emergency use authorization of the drug to treat mild to moderate COVID-19 patients. The drug had a recent setback after it failed to show benefits in hospitalized patients.

In addition, Reuters reported that U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly plant that is ramping up to make its antibody therapy.

The antibody therapy is similar to a drug from Regeneron that was given to Trump during his bout with COVID-19.

The treatments belong to a class of drugs called monoclonal antibodies that are manufactured copies of antibodies created by the body to fight against an infection.

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U.S. signs deal with Lilly for supply of potential COVID-19 antibody drug

FILE PHOTO: Eli Lilly logo is shown on one of the company’s offices in San Diego, California, U.S., September 17, 2020. REUTERS/Mike Blake

(Reuters) – The U.S. Government has awarded an initial $375 million contract to drugmaker Eli Lilly and Co LLY.N to secure 300,000 doses of its potential experimental COVID-19 antibody treatment, a drug that has been touted by U.S. President Donald Trump.

Lilly will start delivering the treatment within two months of receiving an emergency use authorization from the U.S. health regulator, the company said.

The U.S. government also has the option to purchase up to an additional 650,000 vials for $812.5 million, the U.S. Department of Health and Human Services said in a statement.

While vaccines are seen critical to ending the pandemic, governments are increasingly looking at effective treatment options to slow the spread of the disease and kick-start economic activity.

The company submitted a request to the U.S. Food and Drug Administration earlier this month for emergency use authorization of the drug to treat mild to moderate COVID-19 patients.

The U.S. government has committed that patients will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product’s administration, Lilly said.

The antibody therapy is similar to a drug from Regeneron Pharmaceuticals REGN.O that was given to Trump during his bout with COVID-19.

The treatments belong to a class of drugs called monoclonal antibodies that are manufactured copies of antibodies created by the body to fight against an infection. Lilly’s antibody was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Reporting by Manas Mishra in Bengaluru; Editing by Saumyadeb Chakrabarty

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CLINUVEL to Trial Innovative Drug in Stroke

Acute Ischaemic Stroke

A clot in the brain vessel of a stroke patient leads to instant death of brain tissue closest to the clot, shown in dark pink. The larger area surrounding the core (shaded) is characterised as the penumbra, tissue which can still be rescued.
A clot in the brain vessel of a stroke patient leads to instant death of brain tissue closest to the clot, shown in dark pink. The larger area surrounding the core (shaded) is characterised as the penumbra, tissue which can still be rescued.
A clot in the brain vessel of a stroke patient leads to instant death of brain tissue closest to the clot, shown in dark pink. The larger area surrounding the core (shaded) is characterised as the penumbra, tissue which can still be rescued.

MELBOURNE, Australia, Oct. 28, 2020 (GLOBE NEWSWIRE) — The drug afamelanotide will be used for the first time in patients with acute stroke. The study will evaluate the safety and efficacy of afamelanotide, developed by Australian company CLINUVEL, in arterial ischaemic stroke (AIS). The aim is to offer a treatment for patients suffering a stroke who are unable to receive treatment to dissolve or remove the underlying blood clot. AIS accounts for approximately 85% of the 15 million strokes suffered worldwide each year.

“Stroke is most commonly caused by a clot in a patient’s brain which starves surrounding tissue of blood and essential oxygen, causing the destruction of brain cells,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “This brain damage can have an irreversible effect on a patient’s ability to speak, move, and function, and tragically leads to an early death for more than 5.5 million people per annum. It is our aim to show that treatment with afamelanotide can safely reduce and prevent brain damage in the majority of stroke patients who cannot be offered standard therapy.”

Strokes cause death of brain tissue at the site of the clot and lead to a shortage of oxygen in a larger area of the brain, known as the penumbra, which is salvageable brain tissue if treated quickly. The longer the delay in a stroke patient receiving treatment, the greater the potential threat to their life and overall prognosis as tissue within the penumbra becomes irreversibly damaged.

Current stroke therapies rely on early intervention to restore blood flow to the brain by either chemically dissolving or physically removing the clot. In Europe, no treatment can be offered to over 85% AIS patients due to a critical delay between the start of the stroke and presentation of the patient to a hospital. Additionally, the location of the clot within the artery is also an important factor impacting the possibility to offer treatment.

Research has indicated that afamelanotide – which is approved in Europe and the USA for patients with a rare metabolic disorder called EPP1 – may rapidly exert its effects to protect brain tissue, act on blood vessels to optimise blood flow, and reduce the size of swelling in the brain following a stroke. More than 10,000 doses of afamelanotide have been administered to over 1,400 individuals during its development and use across a period of nearly two decades.

The pilot Phase IIa clinical study (CUV801) will be conducted

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Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness | Health News

By Robin Foster and E.J. Mundell
HealthDay Reporters

(HealthDay)

TUESDAY, Oct. 27, 2020 (HealthDay News) — Testing of Eli Lilly’s antibody drug for hospitalized COVID-19 patients has been halted because the treatment doesn’t help them recover from their infection.

Two weeks ago, enrollment in the study was paused because of a possible safety issue, the Associated Press reported. But the U.S. National Institute of Allergy and Infectious Diseases, which sponsored the Lilly study, pulled the plug on the trial Monday — not because of any safety problem, but because there was only a slight chance that the drug would be effective, the AP said.

Although it is a setback for one of the most promising treatment approaches for COVID-19, Lilly said in a statement that the government is continuing a separate study testing the antibody drug in mild to moderately ill patients, to try to prevent hospitalization and severe illness.

A similar, two-antibody cocktail from Regeneron Pharmaceuticals Inc. was given to President Donald Trump on an emergency basis when he was sickened with the coronavirus. Earlier this month, former New Jersey Gov. Chris Christie said he had received Lilly’s experimental treatment shortly after he was diagnosed with COVID-19, The New York Times reported.

Dr. Eric Topol, a clinical trial expert at the Scripps Research Institute who has been following the treatment’s development, told the Times that the news “tells us they stopped the trial due to futility, as suspected,” and that it “suggests that the timing of monoclonal antibody administration — early [in the illness] — will be important.”

Antibodies are proteins the body makes when an infection invades the body ; they attach to a virus and help eliminate it. The experimental drugs are concentrated versions of one or two specific antibodies that worked best against the coronavirus in lab and animal tests, the AP reported.

Lilly and Regeneron have both asked for emergency use authorization from the U.S. Food and Drug Administration while late-stage studies continue. Lilly said Monday that its request is based on other results suggesting that the drug helps patients who are not hospitalized, and that it will continue to seek the FDA’s permission for emergency use.

Hospitals feel the strain of surging COVID case counts

As the United States has witnessed record-breaking daily coronavirus case counts, public health experts have warned that hospitals may soon reach a breaking point.

More than 41,000 COVID-19 patients are hospitalized across the country, a 40 percent rise in the past month, Times reported.

But in sharp contrast to the early days of the pandemic, more of these patients are being cared for in sparsely populated parts of the country, where the medical infrastructure isn’t as strong as it is in metropolitan areas, the Times reported.

In Utah, hospital administrators have warned Gov. Gary Herbert that they would soon have to ration access to intensive care units, and requested state approval for criteria to decide which patients should get priority, The Salt Lake Tribune reported.

“We told him, ‘It

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Coronavirus live updates: Study stops using Eli Lilly’s antibody drug

The number of new cases of COVID-19 recorded across the United States has increased substantially, as has the number of new deaths from the disease, according to an internal memo from the U.S. Department of Health and Human Services that was obtained by ABC News on Monday night.

The memo, which is circulated among the highest levels of the federal government and is used to determine daily priorities for the agencies working on a COVID-19 response, said 40 U.S. states and territories are in an upward trajectory of new infections, while nine jurisdictions are at a plateau and seven others are in a downward trend.

There were 488,498 new cases confirmed during the period of Oct. 19-25, a 26% increase from the previous week. There were also 5,615 fatalities from COVID-19 recorded during the same period, a 15.1% increase compared with the week prior, according to the memo.

The national positivity rate for COVID-19 tests increased from 5.6% to 6.1% in week-to-week comparisons. Meanwhile, 22% of hospitals across the country have intensive care units that are more than 80% occupied. That figure is up from the summertime peak, when 17-18% of U.S. hospitals had 80% of ICU beds full, the memo said.

Arizona reported 848 COVID-19 hospitalizations on Oct. 21, its highest count since Aug. 26, according to the memo.

In the U.S. territory of Guam, which continues to be classified as a “red zone” for COVID-19 infections, an average of 89.7% of inpatient beds and 80.2% of ICU beds were occupied in the week ending Oct. 20, the memo said.

North Dakota saw a record high of 1,036 new cases on Oct. 20, surpassing the 1,000 mark of daily incident cases for the first time, according to the memo.

New Jersey reported 852 daily COVID-19 hospitalizations on Oct. 22, its highest since late July, the memo said.

Oklahoma reached a record 956 COVID-19 hospitalizations on Oct. 22. The previous record was set just two days earlier, according to the memo.

Utah reported an all-time high of 314 COVID-19 hospitalizations on Oct. 21, as several hospitals in the state reached capacity, the memo said.

ABC News’ Josh Margolin contributed to this report.

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