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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GM-backed Cruise seeks last approval for robotaxis in San Francisco

Cruise Origin driverless shuttle

cruise

General MotorsUS government-backed Cruise is seeking final California approval to begin commercializing its robotaxi fleet in San Francisco.

The self-driving car start-up announced Friday that it has filed for approval with the California Public Utilities Commission to allow autonomous vehicles to be used. It is the last of six permits required by the CPCU and California DMV to charge the public for travel.

It is unclear how long the review and approval process will take. Cruise is the first to apply for approval. Cruise CEO Dan Ammann recently said the company expects to begin commercialization as early as next year, pending regulatory approval.

If approved, Cruise could be the first to operate a taxi fleet without human drivers. alphabet-supported Waymo has also received approval from California DMV to bill Robotaxi rides, but their approval still requires a “safety driver” in the vehicle in the event of a problem.

The latest permit allows Cruise vehicles to operate on public roads in certain parts of San Francisco between 10:00 PM and 6:00 AM, even in light rain or fog. However, according to the DMV, they must not exceed 30 miles per hour.

Commercializing autonomous vehicles has been far more difficult than many predicted a few years ago, but Waymo and Cruise are considered two of the frontrunners.

Cruise was scheduled to launch a public transportation service in San Francisco in 2019. The enterprise delayed these plans this year to conduct further testing and obtain necessary regulatory approvals.

General Motors Cruise test vehicles

Source: General Motors

Cruise received DMV approval for self-driving vehicles for the first time in June 2015. Since then, the company has slowly expanded its test sites and expanded its fleet to hundreds of autonomous vehicles, while also obtaining additional permits.

Cruise’s current fleet of vehicles includes Chevrolet Bolt EVs that are retrofitted with self-driving vehicle software and additional technologies such as cameras, radar and lidar that enable vehicles to “see” their surroundings.

The next fleet of vehicles is expected to consist of the Cruise Origin, a rectangular shuttle-like vehicle designed exclusively as an autonomous vehicle. Ammann said earlier this year that GM is expected to begin producing the Origin for Cruise early 2023.

GM acquired Cruise in 2016. Since then, it has been like investors Honda engine, Softbank Vision Fund and, more recently, too Walmart and Microsoft.

Gottlieb says FDA approval for younger youngsters by Halloween potential

Aidan Mohl, 13, will be born on November 11th.

Christopher Aluka Berry | Reuters

Dr. Scott Gottlieb told CNBC on Wednesday that it is still possible for the Food and Drug Administration to grant approval Pfizer and BioNTechCovid-19 vaccine for young children by Halloween.

“I wouldn’t rule out the possibility that this could come out in October,” said Gottlieb, who sits on Pfizer’s board of directors and served as FDA commissioner in the Trump administration for two years.

Pfizer submitted an initial Covid Vaccine study data for children ages 5 to 11 with the FDA on Tuesday, and the company should file a formal application for emergency approval “shortly,” Gottlieb said in an interview Wednesday “Squawk Box.”

The Food and Drug Administration has a lot of experience with the Pfizer vaccine, noted Gottlieb, adding that the Covid vaccination is for young children the same two-dose regimen like adults, but given in smaller amounts. The agency has already approved the recordings for Americans aged 12 and over.

“You saw a lot of clinical data,” he said. “I’ve said for a long time that October is a possibility, but it’s an optimistic possibility. If it fails, it could fall by mid-November.”

Gottlieb’s comments come a day after the Wall Street Journal reported that regulatory clearance of the Pfizer vaccine for children ages 5-11 may not come before November.

Last week, Pfizer released new data showing that in a clinical study in children ages 5-11 years old, a two-dose 10 micrograms dose – one third of the dose for adolescents and adults – is safe and elicits a “robust” immune response .

Pfizer was expected to apply for emergency approval to use the vaccine in young children by the end of this month, but now the company says it will apply “in the coming weeks”.

That could mean the footage might not be available until November, when the FDA spends as much time reviewing the data for this age group as it does for 12-15 year olds. Pfizer and BioNTech filed for expanded use of their syringe in adolescents on April 9th ​​and were approved by the FDA on May 10th.

A Pfizer spokesman declined to comment on an approval schedule, saying the company couldn’t speculate on exactly when the FDA would make a decision on whether or not to approve the vaccine’s use.

“We are still on track to formally apply for EEA very soon,” Jerica Pitts told CNBC.

Approval couldn’t come sooner as children are starting the new school year, the Delta variant spills across America, and many parents are anxious to get their younger children vaccinated. The stress has led to an increase in hospital admissions in the United States, including among young children that currently cannot be vaccinated.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.

Dr. Scott Gottlieb weighs in on Pfizer’s Covid booster approval course of

Former Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb told CNBC that he believed the Centers for Disease Control and Prevention could soon provide more clarity on who is eligible for Covid booster doses.

Gottlieb, a Pfizer Board member, explained the FDA and CDC booster approval process in an interview on Tuesday at “The news with Shepard Smith. “The FDA could make a formal decision via Pfizer’s boosters before the CDC begins a two-day series of meetings on Wednesday and Thursday at which Gottlieb said health officials could expand the FDA’s instructions.

“They provide physicians and patients with detailed guidance and interpret the recommendations of the Food and Drug Administration,” Gottlieb said of the CDC. “For example, they could say they could enumerate the types of severe conditions that would qualify someone for a refresher.”

An FDA advisory committee rejected a plan on Friday that would have allowed a third dose for all Americans 16 and older, and raised reservations about insufficient data and the risk of myocarditis. But the committee then voted unanimously in favor of the approval of boosters for the medically weak and everyone over 65 years of age.

Gottlieb said the process had given conflicting messages about who should be eligible for boosters, but added that he always thought the FDA was holding two votes to narrow down potential recipients of a third Pfizer dose.

“I think the meeting gave the impression that there could be contradicting messages. I don’t think that is the case,” said Gottlieb. “The FDA initially voted on boosters for the entire age group 16 and over and finally agreed on a recommendation that boosters should be made available for people 65 and over and for those at risk of severe Covid disease, a higher one Risk from the disease itself. That always seemed to be the FDA’s goal, administrative. “

Dr. Scott Gottlieb, former Commissioner of the Food and Drug Administration, speaks during the Skybridge Capital SALT New York 2021 conference in New York City, the United States, on September 15, 2021.

Brendan McDermid | Reuters

Gottlieb added, “I think it gave the impression that the agency voted out Booster before they voted for it – that wasn’t the case. It was more of an administrative measure and I think this has caused some public confusion. “

As Pfizer awaits final approval of its boosters, vaccine makers will Modern and Johnson & Johnson both released data warranting approval of their own add-on doses. J&J said Tuesday that its Covid boosters are 94% effective when injected two months after the first dose, while Moderna reported fewer breakthrough cases in recently vaccinated participants in a study published on Sept. 15.

According to the CDC, more than 2.2 million people in the United States have received a booster vaccination since August 13.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co-chair of Norwegian Cruise Line Holdings ′ and Royal Caribbean’s Healthy Sail Panel.

Pfizer submits information to FDA for approval

Walgreens health professional Luis S. Solano prepares a dose of Pfizer BioNTec’s vaccine against coronavirus disease (COVID-19) on February 22, 2021 at the Victor Walchirk Apartments in Evanston, Illinois.

Kamil Krzaczynski | Reuters

Pfizer and BioNTech announced on Monday that they had submitted early-stage clinical trial data to the Food and Drug Administration as part of their U.S. filing to approve a Covid vaccine booster for all 16 and older – not just people with weak immune systems.

In a phase 1 study, a booster dose of the vaccine produced “significantly higher neutralizing antibodies” against the original coronavirus strain and the beta and delta variants, the companies said in a press release. Study participants received a third dose of the two-dose vaccine around eight to nine months after the second vaccination, they said.

“The data we’ve seen so far suggest that a third dose of our vaccine elicits antibody levels well in excess of those on the primary two-dose schedule,” said Albert Bourla, Pfizer CEO. “We are excited to provide this data to the FDA as we continue to work together to address the evolving challenges of this pandemic.”

The companies said the results of the late-stage trial evaluating the third dose are expected shortly and will also be presented to the FDA and other regulatory agencies worldwide.

The announcement by the drug manufacturer comes according to federal health officials Friday approved Giving Covid booster shots of Pfizer and Moderna vaccines to Americans with compromised immune systems, including cancer and HIV patients, and people who have had organ transplants.

New data from the US suggests that immunocompromised individuals do not generate adequate immune responses after receiving two doses of a Covid vaccine.

The latest data from Pfizer investigates the booster’s safety and immune response in people with otherwise healthy immune systems.

Federal health officials are not currently recommending booster doses for the general public, but Dr. White House Chief Media Officer Anthony Fauci said: Everyone is “likely” to need a booster at some point.

Covid vaccine manufacturers including Pfizer and Modern, have repeatedly argued that everyone will need a booster dose at some point and possibly additional doses each year, just like seasonal flu.

Pfizer has cited data from Israel where state officials said last month the two-dose vaccine was only 39% effective against the disease, which attributed the drop in performance to the highly contagious Delta variant. When Pfizer submitted its original application to the FDA in December, it said its vaccinations were about 95% effective at preventing Covid infections.

The vaccine is still considered highly effective against serious illness, hospital admissions and deaths, according to Israeli health officials.

FDA chief tells reporter ‘transfer on’ when pressed on Biogen Alzheimer’s drug approval

A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts on Monday, June 7, 2021.

Adam Glanzman | Bloomberg | Getty Images

Acting Commissioner of the Food and Drug Administration, Dr. Janet Woodcock, on Wednesday, opposed a journalist’s questions about the controversial approval of rejected BiogenicAlzheimer’s drug, Aduhelm.

During an interview at STAT’s Breakthrough Science Summit, STAT reporter Nicholas Florko asked Woodcock several questions about the drug, including whether she was surprised that the agency approved it for such widespread use.

When the FDA approved Aduhelm last month, it didn’t limit its use to specific Alzheimer’s patients. But after facing heavy criticism, about a month later, U.S. regulators changed course, updated the label, and restricted use of the drug for people with mild or early-stage Alzheimer’s disease.

Woodcock said Wednesday that the broader label is in line with other drugs for neurodegenerative disease. The FDA chief also admitted that Biogen’s drug approval process could possibly have been handled differently.

“It is possible that the process would have been managed in a way that would have reduced the controversy associated with it,” she said.

Florko asked if she was surprised at the label. She replied, “I think we should go ahead.”

When Florko then pressed Woodcock to see if she was one reported meeting Between an FDA regulator and Biogen in 2019, Woodcock said she worked for Operation Warp Speed, former President Donald Trump’s Covid drug and vaccine program, all last year. Then she said, “Nick, this is an interrogation right now,” and asked again to move on from the biotech company’s drug questions.

“I will not comment if and when and who. I really think we should go ahead, ”she replied.

The interview came less than a week after Woodcock’s call for a federal investigation in the approval of Biogen’s drug. On Friday, she asked the independent Office of Inspector General to investigate interactions between the US agency and Biogen prior to the drug’s approval on June 7th.

Biogen’s stock rose last month after the FDA issued the Drug from the biotech company, the first US regulator-approved drug to slow cognitive decline in people with Alzheimer’s disease, and the first new drug for the disease in nearly two decades.

This decision was a departure from the recommendations of the agency’s independent panel of external experts, who unexpectedly refused to support the drug last fall, citing unconvincing data. At least three members of the committee resigned in protest after the agency’s approval.

Federal agencies have faced heavy pressure from friends and family of Alzheimer’s patients to ask for the drug scientifically known as aducanumab to be expedited. The drug targets a “sticky” compound in the brain known as beta-amyloid that scientists expect to play a role in the devastating disease.

The investigation is the most recent setback for the company and the drug, which has been controversial since 2016.

In March 2019, Biogen withdrew from development of the drug after analysis by an independent group found it was unlikely to work. The company then shocked investors a few months later by announcing that it would apply for regulatory approval for the drug after all.

When Biogen filed for approval for the drug in late 2019, its scientists said a new analysis of a larger data set showed that aducanumab “reduces clinical decline in patients with early-stage Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it difficult for other companies to enroll patients in their own drug trials.

Some doctors said they won’t prescribe it aducanumab due to the mixed data package supporting the company’s application.

Overland Park pickleball leisure venues at Prairiefire, 91st and Metcalf win remaining approval

The Overland Park Planning Commission swiftly and unanimously approved final development plans for two entertainment venues around pickleball courts on Monday.

A new Chicken N Pickle restaurant and bar is on already under construction at Prairiefire along 135th Street, but the developers had made some minor changes to the site plan that needed approval.

The commissioners have also given the final site plan of the SERV Promontory the green light, a venue in the 91st and Metcalf This includes pickleball courts and several restaurants that are housed in converted shipping containers.

Both points fell under the approval agenda of the commission, which was unanimously adopted with 9: 0 without discussion.

Chicken N Pickle Optimizations

Chicken N Pickle, which operates its popular flagship location in North Kansas City, laid the foundation for its Prairiefire franchise last year with the hope of being able to open sometime in the fall.

The new zoning plan approved on Monday reduces the number of outdoor pickleball playgrounds from five to four.

A rendering previously filed with the Overland Park Planning Commission depicting a new chicken and pickle at Prairiefire on 135th Street. A green area planned for the site can be converted into an ice rink in winter according to the development plans. Photo credit Yaeger Architecture.

This allows a nearby building with indoor spaces to be relocated to make room for electrical equipment that can be mounted on the floor and shielded from the view of passing motorists.

The revised plan of Chicken N Pickle also dispenses with fabric covering the outdoor areas and replaces them with a metal roof.

In a memo to the commission, city officials said this was done because the fabric material did not work well on the elements at another Chicken N Pickle location.

A large green area seems to be planned on the site, which can be converted into an ice rink in the winter months.

Details on the SERV foreland plan

The final plan for the development of the SERV foothills on 91st and Metcalf was largely unchanged from the plan approved by the planning commission in April.

This plan includes six indoor and two outdoor pickleball courts, seven repurposed shipping containers that house restaurants, bars or coffee kiosks, a performance stage and a large outdoor TV screen.

The latest SERV Promontory plan included traffic and environmental impact studies. City officials concluded that the development would not have a negative impact on traffic flow along the busy Metcalf Corridor.

A rendering of the SERV Promontory project planned for the 91st and Metcalf, which will include an outdoor entertainment area with a large TV screen, a performance stage and several converted shipping containers with restaurants and bars. Image via Overland Park Planning Commission.

The staff note also came to the conclusion that SERV’s design plan would not require any additional rain or flood protection measures, as the site plan would reduce the amount of “impermeable surface” compared to today’s.

There are still concerns about the noise that the SERV Promontory will make after its completion.

The city employees stated: “The applicant is aware of these concerns and must mitigate complaints from surrounding property owners and comply with the noise ordinance.”

Concerns about possible noise problems led Commissioner Holly Streeter-Schaefer to cast the only vote against the plan in April.

However, together with the eight other commissioners, she unanimously agreed to the SERV plan on Monday.

The developers had previously announced that they would break the ground at SERV Promontory this year, with the aim of opening sometime in 2022.

Dementia knowledgeable says proof ‘wasn’t ample’ for approval

Dementia expert Dr. Jason Karlawish told CNBC he was skeptical of that Approved by the Food and Drug Administration of BiogenicAlzheimer’s drug Aduhelm said “the evidence to support the drug’s approval was insufficient”.

“Another study is needed to see if this drug is actually effective. Unfortunately, the FDA has approved the drug for marketing, although they also want another study,” said the co-director of the Penn Memory Center at the University of Pennsylvania on Monday after the agency’s formal OK.

The FDA approval marks that first new treatment for Alzheimer’s in almost two decades. Alzheimer’s is a progressive neurodegenerative disease that slowly destroys memory and thinking skills. More than 6 million Americans are reportedly living with the disease Alzheimer’s Association estimates.

Carlavian told “The News with Shepard Smith” that there are many promising Alzheimer’s drugs in the pipeline.

“I’m optimistic about the future here so I have hope. I just think this is not the drug we can put our hopes on,” he said. “Desperation should drive funding for Alzheimer’s research, not interpretation of scientific evidence.”

Clinical studies have found that some patients who received the approved dose of Aduhelm had painful brain swelling.

“What you are asking someone to do is risk an uncertain benefit but a known risk,” said Karlawish of prescribing the drug to patients.

The FDA said it would continue to monitor the drug when it hits the US market. The agency granted approval on the condition that Biogen conduct another clinical study.

Karlawish told host Shepard Smith that Biogen will face a challenge “how to conduct this study when the drug is also available for clinical prescription.”

Representatives from Biogen and the FDA did not immediately respond to requests for comment on Karlawish’s statements.

Esports Leisure will get New Jersey gaming license approval

E.

Sport Entertainment Group announced that its GMBL’s subsidiary Application became formal accepted until New Jersey Division of Gaming Enforcement (DGE) On Monday. This assumption enables the company to send its software to the DGE test laboratory and apply for a transaction waiver.

As soon as the DGE tests are passed, the license enables the EEG to operate and maintain weather in the Garden State. This includes through its esports-oriented sports betting VIE.bet. The company expects Complete this process and take live bets in the state by the end of the first fiscal year.

The CEO of Esports Entertainment Group, Grant Johnson, said: “This is an important step for us in our growth strategy in the US. According to a study by the data company Interpret, over 50% of US sports fans said they are likely to bet on sports betting. We are therefore confident that the demand will be strong. Getting access to what is currently the largest sports betting market in the United States is very exciting. We are also in talks with partners and regulators in other countries to continue our expansion plans.

New Jersey won a case in the U.S. Supreme Court in 2018 where all 50 states can offer legal sports betting if they so choose. It quickly dominated the east coast market, challenging Nevada for national leadership. With a solid legal framework based on player protection, business stability and growth, the New Jersey gambling industry has seen exceptional growth in recent years.

Pfizer and BioNtech start the method of searching for full FDA approval for his or her Covid vaccine

Walgreens Doctor Luis S. Solano prepares a dose of Pfizer BioNTec’s Coronavirus Disease (COVID-19) vaccine on February 22, 2021 at the Victor Walchirk Apartments in Evanston, Illinois.

Kamil Krzaczynski | Reuters

Pfizer and German drug manufacturers BioNTech started the process to apply for full approval of the Covid-19 vaccine in the United States. This makes the companies the first to apply for full approval in the nation.

The Food and Drug Administration issued emergency approval for their Covid vaccine at the end of December. Since then, Pfizer has distributed millions of doses in the US, with the goal of dispensing 300 million doses by the end of July. If approved, Pfizer could market its shots directly to consumers and potentially change the pricing of its cans.

It usually takes the FDA about a year or more to determine whether a drug is safe and effective for the general public. Due to the once in a century pandemic that killed nearly 600,000 people in the United States, the FDA allowed the gunshots to be used as part of an emergency clearance.

The permit grants conditional approval based on data for two months. It’s not the same as a biological license application that requires six months of data and ensures full approval. Companies apply for approval on a “rolling filing” basis, which speeds the review process by allowing the FDA to review new data as soon as the company receives it.

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