Pfizer submits FDA software for emergency approval of Covid therapy capsule

Albert Bourla, CEO of Pfizer, speaks to a press conference after a visit to monitor the production of the Pfizer-BioNtech COVID-19 vaccine at the US pharmaceutical company Pfizer’s factory in Puurs, Belgium, on April 23, 2021.

John Thys | Swimming pool | Reuters

Pfizer filed an application with the Food and Drug Administration on Tuesday for emergency approval of its Covid-19 treatment pill, saying it reduces hospital stays and deaths by 89% when given with a popular HIV drug.

The pill, if approved by the FDA, could help revolutionize the fight against Covid by allowing high-risk people infected with the virus to take an oral antiviral drug at home instead of going to the hospital. Such treatment could help ease the burden on hospital systems during the pandemic.

In a clinical study of people aged 18 and over who were at increased risk of developing severe Covid, the pill reduced hospital stays and deaths by 89% when taken within three days of symptoms appearing. according to Pfizer.

The pill, known as paxlovid, blocks the activity of an enzyme that the virus needs to replicate. Paxlovid is used in combination with a low-dose ritonavir, an HIV drug, to slow the patient’s metabolism down so that the drug can stay active in the body at a higher concentration for longer to fight the virus.

Pfizer said the Covid treatment was shown to be safe, adding that study participants taking paxlovid reported fewer adverse events than the placebo, and most of them were “mild intensity”.

If approved, paxlovid is given in two 150 mg tablets with one 100 mg tablet of ritonavir twice a day.

“We are working hard to get this potential treatment into patients’ hands as soon as possible and look forward to working with the US FDA to review our application as well as other regulatory agencies around the world,” said Pfizer Das said CEO Albert Bourla in a statement on Tuesday.

Bourla had previously said that Pfizer planned to file its data with the FDA before Thanksgiving.

Early Tuesday, Pfizer announced that it would allow generic drug companies to ship their antiviral pill to 95 low and middle income countries.

Merck is also developing an antiviral pill, molnupiravir, to fight Covid. The company found in an interim analysis that the pill reduced the risk of hospitalization and death in adults with mild to moderate Covid by 50%.

Merck, which co-developed the drug with Ridgeback Biotherapeutics, filed an application with the FDA for approval of the pill last month.

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Merck to hunt emergency authorization for oral Covid-19 therapy

A nurse tends to a Covid-19 patient at SSM Health St. Anthony Hospital in Oklahoma City on August 24, 2021.

Nick Oxford | Reuters

Merck and Ridgeback Biotherapeutics plan to apply for emergency approval for their oral antiviral treatment for Covid after the drug shows “compelling results” in clinical trials.

The drug molnupiravir reduced the risk of hospitalization or death in patients with mild or moderate cases of Covid by around 50%, the companies said on Friday. Molnupiravir is given orally and works by stopping the coronavirus from replicating in the body.

An interim analysis of a Phase 3 study found that 7.3% of molnupiravir-treated patients were hospitalized within 29 days. Of the patients who received a placebo, 14.1% were hospitalized or died on day 29. No deaths were reported in patients receiving molnupiravir within the 29-day period, while eight deaths were reported in placebo-treated patients.

All 775 study participants had laboratory-confirmed symptomatic Covid-19 and were randomly assigned molnupiravir or a placebo within five days of symptoms.

Each participant was unvaccinated and had at least one underlying factor that placed them at a higher risk of developing a more severe case of the virus. The most common risk factors included obesity, over 60 years of age, and diabetes or heart disease.

The phase 3 part of the study was conducted in more than 170 locations in countries such as the United States, Brazil, Italy, Japan, South Africa, Taiwan, and Guatemala.

The study showed that molnupiravir’s effectiveness was not influenced by the time when symptoms appeared or the patients’ underlying risk factors. It was also shown to be consistently effective in treating all variants of Covid, including the widely used and highly transferable delta expansion.

Side effects were similar in the molnupiravir and placebo groups, with approximately 10% reporting adverse events. Only 1.3% of the molnupiravir group discontinued therapy because of an adverse event – less than the 3.4% of the placebo group who did.

Recruitment for the study will be terminated prematurely based on the positive results on the recommendation of an independent data monitoring committee and in consultation with the US Food and Drug Administration.

Merck is also testing molnupiravir in a separate global phase 3 study to evaluate its effectiveness in preventing the spread of Covid in households.

“Profound Effect”

Robert M. Davis, CEO and President of Merck, said in a press release on Friday that the company would do everything possible to get molnupiravir to patients as soon as possible.

“With these compelling results, we are optimistic that molnupiravir can become a key drug in the global effort to fight the pandemic,” he said.

Wendy Holman, CEO of Ridgeback Biotherapeutics, added, “As the virus continues to be widespread and the therapeutic options currently available are infused or require access to a health facility, antiviral treatments can be taken at home to help people with Covid-19 from the To keep disease away hospital urgently needed. “

“We are very encouraged by the results of the interim analysis and hope that molnupiravir, if approved for use, can have a profound impact on the control of the pandemic,” she said.

Authorization to use in an emergency

Merck said Friday it plans to apply for emergency approval for the drug in the US as soon as possible. The company also plans to file regulatory filings with other international drug regulatory agencies.

If approved by regulators, molnupiravir could be the first oral antiviral drug for Covid. Currently used antiviral treatments, such as Remdesivir, are administered intravenously.

Merck has already started production of molnupiravir. The pharmaceutical giant expects to produce 10 million treatment cycles by the end of 2021 and more doses in 2022.

The company agreed earlier this year to ship approximately 1.7 million molnupiravir courses if it receives FDA emergency or full approval.

Merck has also entered into supply and purchase agreements with other governments for the drug – pending regulatory approval – and is in talks with other governments regarding the supply of molnupiravir.

The company plans to implement a tiered pricing approach based on World Bank income criteria to ensure molnupiravir is available worldwide. Merck previously announced that it had entered into non-exclusive, voluntary licensing agreements for molnupiravir with generic drug companies to facilitate access to treatment for low- and middle-income countries. Approvals or emergency approvals from the local supervisory authorities are also pending for these agreements.

Profit sharing

Ridgeback received an upfront payment from Merck as part of the company’s development of molnupiravir. The company is also eligible for contingent payments based on development and regulatory approval milestones.

Profits from the collaboration will be shared equally between Merck and Ridgeback.

Ariana Grande Affords 1m Equal Therapy | Leisure Information

Ariana Grande offers $ 1 million worth of treatments.

The 7-ring hit maker is partnering with BetterHelp, an online treatment portal, to find new initiatives that encourage people to seek help when needed and remove the stigma surrounding counseling.

On Instagram, she announced: In the long run, I just wanted to do this because I feel like it’s okay for you to get your toes wet and ask for help, and I hope it will free you from all kinds of self-judgment. I’m going! “

This program allows people to receive one month of free treatment, and Ariana hopes to be a “useful starting point” to encourage fans to use the service for the long term. ..

She continued: “You are taking this opportunity betterhelp.com/ariana Play with a qualified therapist for one month for free.

“Then you can choose to update and continue. I hope this is a useful starting point and will allow you to make room in your life for it and move on. The healing can be direct or simple. No. But you are worth the effort and time, we promise! I really appreciate @betterhelp and can’t wait to work together more. “

The 28-year-old star believes the therapist saw it “saved” earlier. [her] Life”.

In 2018 fans tweeted, “Who are Ariana Therapists and are they accepting new clients?”

Singer “Thank U, Next” said, “This is as funny as fuck, but to be honest, therapy saved my life many times. If you’re scared to ask for help, don’t do it. You don’t. “You always have to be in pain and you can deal with the trauma. There is a lot to do, but I am beginning to see that it is possible.”

Ariana Grande Offers 1M Equivalent Treatment | Entertainment news

Source link Ariana Grande Offers 1M Equivalent Treatment | Entertainment news

Britain’s Prince Philip returns residence after therapy | Leisure




Britain’s Prince Philip leaves King Edward VII Hospital in a car in London on Tuesday March 16, 2021. The 99-year-old husband of Queen Elizabeth II was hospitalized after heart surgery.




A woman drives past a police car parked outside the King Edward VII Hospital where Britain’s Prince Philip will be treated in London on Monday March 15, 2021, London. Queen Elizabeth II’s 99-year-old husband remains in hospital after heart surgery.




The British Prince Philip returns home after treatment

A police officer stands in front of the entrance to the King Edward VII Hospital where Britain’s Prince Philip is being treated in London on Monday March 15, 2021 in London. Queen Elizabeth II’s 99-year-old husband remains in hospital after heart surgery.




The British Prince Philip returns home after treatment

A woman drives past a police car parked outside the King Edward VII Hospital where Britain’s Prince Philip will be treated in London on Monday March 15, 2021, London. Queen Elizabeth II’s 99-year-old husband remains in hospital after heart surgery.




The British Prince Philip returns home after treatment

Britain’s Prince Philip leaves King Edward VII Hospital in a car in London on Tuesday March 16, 2021. The 99-year-old husband of Queen Elizabeth II was hospitalized after heart surgery.




The British Prince Philip returns home after treatment

On Sunday March 14, 2021, police officers will be guarded in London at the side entrance of King Edward VII Hospital, where Britain’s Prince Philip is guarded as a police car. Queen Elizabeth II’s 99-year-old husband remains hospitalized after heart surgery.




The British Prince Philip returns home after treatment

A doorman and a police officer guard the main entrance of King Edward VII Hospital, where Britain’s Prince Philip will be guarded as a police car in London on Sunday 14 March 2021. Queen Elizabeth II’s 99-year-old husband remains in hospital after heart surgery.




The British Prince Philip returns home after treatment

Britain’s Prince Philip leaves King Edward VII Hospital in a car in London on Tuesday March 16, 2021. The 99-year-old husband of Queen Elizabeth II was hospitalized after heart surgery.




The British Prince Philip returns home after treatment

Hospital staff put a screen next to a car in the back of King Edward VII’s Hospital in London, where Prince Philip stayed for further treatment following his heart surgery at St. Bartholomew’s Hospital on Tuesday March 16, 2021. The 99-year-old Queen Elizabeth II’s husband was hospitalized after heart surgery.




The British Prince Philip returns home after treatment

Britain’s Prince Philip leaves King Edward VII’s hospital on Tuesday March 16, 2021, in a car in London. The 99-year-old husband of Queen Elizabeth II was hospitalized after heart surgery.




The British Prince Philip returns home after treatment

Britain’s Prince Philip, center, leaves King Edward VII’s hospital in a car in London on Tuesday March 16, 2021. The 99-year-old husband of Queen Elizabeth II was hospitalized after heart surgery.

From DANICA KIRKA Associated Press

LONDON (AP) – Britain’s Prince Philip returned to Windsor Castle on Tuesday after a month of hospital treatment for infection and heart surgery.

Philip, 99, husband of Queen Elizabeth II, was admitted to King Edward VII’s private hospital in London on February 16, where he was being treated for an infection.

He was later transferred to a specialized cardiac ward at St. Bartholomew’s Hospital before returning to King Edward VII.

Photographers standing in front of the door of the private hospital recorded his departure in a black car. Buckingham Palace later issued a statement confirming Philip’s release.

“His Royal Highness thanks all the medical staff who have looked after him at both King Edward VII’s Hospital and St. Bartholomew’s Hospital, as well as everyone who sent their good wishes,” the palace said in a statement.

Philip’s illness is not believed to be related to COVID-19. Both Philip and Elizabeth received coronavirus vaccines in January and decided to publicize the matter to encourage others to take the vaccine as well.

Philip, also known as the Duke of Edinburgh, retired in 2017 and rarely makes public appearances. Before going to hospital, he had isolated with the Queen at Windsor Castle, west of London.

WATCH: Payments fan finishes most cancers therapy, celebrates Payments Mafia type

(WIVB) – Victor Neilson is a huge Buffalo Bills fan and had received intense chemotherapy for non-Hodgkin lymphomas for the past 5 months. On January 21, he had to ring the bell to indicate the end of his treatment, but did it with a Bill’s Mafia twist.

Neilson was diagnosed with cancer in August 2020 and started chemotherapy shortly afterwards. In a post on Twitter, he made his announcement with a video.

Neilson gathered outside with staff and others, put on a Bill’s helmet, and jumped through a folding table with the word “cancer” on it.

Check out Victor Neilson’s video:

Nielson said he wanted to pay it up and started a GoFundMe in aid of the Leukemia & Lymphoma Society. To donate, click Here.

Patrick Ryan is a digital producer who is part of the News 4 Team since 2020. See more of his work Here.