'He's in our hearts': Family and friends still seek answers one year after Nathan Wise’s disappearance
It’s been a year since Nathan Wise went missing and his family is no closer to finding out what happened to him.
Pfizer said Tuesday it is asking U.S. regulators to authorize its experimental pill for COVID-19, setting the stage for a likely launch of the promising therapy in the coming weeks.
The company's filing comes as new infections are rising once again, driven mainly by hot spots in states where colder weather is driving more Americans indoors.
It is one of a handful of pills that have recently been shown to significantly cut hospitalizations and deaths among people infected with COVID-19. If authorized by the Food and Drug Administration it could be a major step toward managing the pandemic and returning to normal, offering an easy, effective way for patients people to treat themselves at home.
“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application,” said Albert Bourla, Pfizer's CEO, in a statement.
All FDA authorized treatments against COVID-19 require an IV or injection given by a health professional at a hospital or clinic.
FDA regulators will scrutinize company data on the safety and effectiveness of the drug, which will be sold as Paxlovid, before making a decision.
The FDA is holding a public meeting later this month where outside experts will scrutinize a competing drug from Merck, before voting on whether to recommend approval. The FDA isn't required to convene such meetings and it's not yet known whether Pfizer's drug will undergo a similar public review.
Some experts predict various COVID-19 therapies eventually will be prescribed in combination to better protect against the worst effects of the virus.
Several smaller drugmakers are also expected to seek authorization for their own antiviral pills in coming months.
Pfizer reported earlier this month that its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company studied its pill in people who were unvaccinated and faced the worst risks from the virus due to age or health problems, such as obesity. If authorized, the FDA will have to weigh making the pill available for vaccinated people dealing with breakthrough infections.
For best results, patients need to start taking the pills within three days of symptoms, underscoring the need for speedy testing and diagnosis. That could be a challenge if another COVID-19 surge leads to testing delays and shortages seen last winter.
Pfizer's drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body. That's different than the Merck pill, which causes tiny mutations in the coronavirus until the point that it can't reproduce itself.
On Tuesday, Pfizer signed a deal a with U.N.-backed group to allow generic drugmakers to produce low-cost versions of the drug for use in 95 countries, a move that could make the treatment available in more than half of the world's population.
The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given via time-consuming infusions at hospitals or clinics, and limited supplies were strained by the last surge of the delta variant.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.
It’s been a year since Nathan Wise went missing and his family is no closer to finding out what happened to him.
Dozens of Ontarians are expressing frustration in the province’s health-care system after their family doctors either dropped them as patients or threatened to after they sought urgent care elsewhere.
An Ottawa pizzeria is being recognized as one of the top 20 deep-dish pizzas in the world.
Amazon's paid subscription service provides free delivery for online shopping across Canada except for remote locations, the company said in an email. While customers in Iqaluit qualify for the offer, all other communities in Nunavut are excluded.
The fire burning near Fort McMurray grew from 25 hectares to 5,500 hectares over the weekend.
Russia’s President Vladimir Putin began a Cabinet shakeup on Sunday, proposing the replacement of Sergei Shoigu as defence minister as he begins his fifth term in office.
Police are searching for a male suspect after a man was “slashed in neck” on Sunday morning in downtown Toronto and died.
There were some scary moments for several people on a northern Ontario highway caught on video Thursday after a chain reaction following a truck fire.
Health Canada announced various product recalls this week, including electric adapters, armchairs, cannabis edibles and vehicle components.
English, history, entertainment, math and geography: high school trivia teams could be quizzed on any of it when they compete at the Reach for the Top Nationals in Ottawa in June.
An Ottawa pizzeria is being recognized as one of the top 20 deep-dish pizzas in the world.
A family of fifth generation farmers from Ituna, Sask. are trying to find answers after discovering several strange objects lying on their land.
A Listowel, Ont. man, drafted by the Hamilton Tigercats last week, is also getting looks from the NFL, despite only playing 27 games of football in his life.
The threat of zebra mussels has prompted the federal government to temporarily ban watercraft from a Manitoba lake popular with tourists.
A small Ajax dessert shop that recently received a glowing review from celebrity food critic Keith Lee is being forced to move after a zoning complaint was made following the social media influencer’s visit last month.
The Canada Science and Technology Museum is inviting visitors to explore their poop. A new exhibition opens at the Ottawa museum on Friday called, 'Oh Crap! Rethinking human waste.'
The Regina Police Service says it is the first in Saskatchewan and possibly Canada to implement new technology in its detention facility that will offer real-time monitoring of detainees’ vital health metrics.
Just as she had feared, a restaurant owner from eastern Quebec who visited Montreal had her SUV stolen, but says it was all thanks to the kindness of strangers on the internet — not the police — that she got it back.