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EU fast-tracks process for Pfizer and BioNTech’s Covid-19 vaccine
German group says any accelerated regulatory approval would not dilute safety standards

Pfizer and BioNTech say they have the capacity to manufacture 100m doses of their vaccine in 2020 and at least 1.3bn doses in 2021

October 6, 2020 9:42 am by Joe Miller in Frankfurt and Donato Paolo Mancini in Rome

The European Medicines Agency has accelerated the approval process for a Covid-19 vaccine developed by Germany’s BioNTech and US pharma group Pfizer, to allow for the rapid authorisation of the shot as soon as safety data from its trial allows.

The decision by the EU regulator was based on preliminary results from the companies’ early clinical trials, which showed the vaccine triggers an immune response in adults, the regulator and the companies said on Tuesday.

The Pfizer/BioNTech shot is the second Covid-19 vaccine to be approved for the EMA’s accelerated process, which involves conducting “rolling reviews” of the trial data while the trial is ongoing. Last week, the agency confirmed that it had started that process with the vaccine developed by AstraZeneca and the University of Oxford.


Pfizer has previously said it could receive emergency approval for the vaccine from the EMA’s US counterpart, the Food and Drug Administration, this month.

Together, Pfizer and BioNTech say they have the capacity to manufacture 100m doses of their vaccine this year and at least 1.3bn doses in 2021.

Several countries have already secured tens of millions of doses of the vaccine — which will require a second booster shot — including the US, the UK and Japan.

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The EU is in the final stages of reaching an agreement to secure 200m doses from the companies.

Mainz-based BioNTech, whose vaccine relies on mRNA technology, stressed that the speeded-up process by the EMA would not dilute the regulator’s safety standards.

“It is our duty to ensure that while we are working to develop a vaccine at unprecedented speed to help break this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles,” said BioNTech’s co-founder, Ugur Sahin. The BioNTech and Pfizer trial involves more than 37,000 participants.

Rolling reviews are used to evaluate clinical data in separate chunks, as they become available, rather than in one go at the end of the trials.

They can speed up approval and marketing significantly, especially when there is high unmet medical need. The EMA has previously used this mechanism for Gilead’s remdesivir, the only antiviral partially approved to treat Covid-19 both in Europe and in the US.

Drugmakers and regulators have faced political pressure to rush through a Covid-19 vaccine.

US President Donald Trump, who is being treated for Covid-19 and seeking re-election next month, has pushed for early approval of a vaccine in a bid to secure another mandate.

But companies and regulators have sought to puncture that enthusiasm. Moderna and FDA commissioner Stephen Hahn have said that its vaccine would not be ready before election day and that standards would not be lowered because of political pressure, the Financial Times has reported.

In August, Russia became the first country to approve a Covid-19 vaccine — named Sputnik V — for civilian use, but western experts cast doubt on its efficacy and safety.







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Pfizer and Sangamo Dose First Participant in Phase 3 Study Evaluating Hemophilia A Gene Therapy Treatment

37 minutes ago,
NEW YORK & BRISBANE, Calif.--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today announced that the first participant has been dosed in the Phase 3 AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients.

AFFINE is a global Phase 3, open-label, multicenter, single arm study that will evaluate the efficacy and safety of giroctocogene fitelparvovec in patients with moderately severe to severe hemophilia A. The primary endpoint is impact on annual bleed rate (ABR) through 12 months following treatment with giroctocogene fitelparvovec, compared to ABR on Factor VIII (FVIII) replacement therapy collected in the Phase 3 lead-in study period. Participants will be analyzed throughout the 5-year study period following the single infusion to further assess the durability and efficacy.

“The initiation of the pivotal Phase 3 dosing study of giroctocogene fitelparvovec is a significant achievement for Pfizer as we continue our longstanding commitment to improving care for the hemophilia community,” said Brenda Cooperstone, Chief Development Officer, Rare Disease, Pfizer Global Product Development. “Enrollment in the lead-in study is progressing well and recruitment is on track for Phase 3. Given the Phase 1/2 study findings to date, we believe that giroctocogene fitelparvovec has the potential to sustain factor levels and reduce annual bleed rates, suggesting this one-time gene therapy could potentially transform the standard of care for eligible patients worldwide.”

Data from the Phase 3 lead-in study will provide a baseline for patients evaluated in the Phase 3 study. Updated Phase 1/2 data announced at a Pfizer investor event on September 15, 2020 demonstrated that giroctocogene fitelparvovec was generally well tolerated. Each of the five patients in the high dose cohort sustained FVIII activity levels without bleeds or the need for prophylactic factor through up to 85 weeks. Factor VIII activity levels were sustained at a clinically meaningful level, with a geometric mean of ~71% when measured between the weeks of 9 and 52.

“We are encouraged that findings from the Phase 1/2 Alta study met two critically important measures for the hemophilia A patient community, showing clinically meaningful factor levels and reduced bleeds,” said Bettina M. Cockroft, M.D., M.B.A, Chief Medical Officer of Sangamo. “The progress of this program, the most advanced of our gene therapy product candidates, into Phase 3 is an important milestone for Sangamo, as it represents our first asset in a registrational trial.”

Per the terms of the collaboration agreement, Sangamo has now earned a $30 million milestone payment. The giroctocogene fitelparvovec collaboration was established in May 2017. Under the terms, Pfizer is now operationally and financially responsible for research, development, manufacturing and commercialization activities for giroctocogene fitelparvovec following the transfer of the Investigational New Drug (IND) from Sangamo to Pfizer in December 2019. Sangamo is eligible to receive total potential milestone payments of up to $300 million for the development and commercialization of giroctocogene fitelparvovec, and up to $175 million for additional hemophilia A gene therapy product candidates that may be developed under the collaboration. Sangamo will, additionally, receive tiered royalties starting in the low teens and up to 20% of annual net sales of giroctocogene fitelparvovec.

About the AFFINE study

The Phase 3 AFFINE (efficAcy and saFety Factor vIii geNe thErapy in hemophilia A patients; NCT04370054) study is an open-label, multicenter, single arm study to evaluate the efficacy and safety of a single infusion of giroctocogene fitelparvovec in more than 60 adult (ages 18-64 years) male participants with moderately severe to severe hemophilia A. Eligible study participants will have completed at least six months of routine FVIII prophylaxis therapy during the lead-in Phase 3 study (NCT03587116) in order to collect pretreatment data for efficacy and selected safety parameters.

The primary endpoint is impact on ABR through 12 months following treatment with giroctocogene fitelparvovec, as compared to ABR on prior FVIII prophylaxis replacement therapy. The secondary endpoint is FVIII activity level after the onset of steady state and through 12 months following infusion of giroctocogene fitelparvovec.

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Het ene goed nieuws na het andere en geen beweging in dit aandeel. De bang 💥 zal uiteindelijk des te groter zijn. Welke richting... 😉

Pfizer Announces Positive Phase 3 Top-line Results for Once-Weekly Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency

57 minutes ago,
NEW YORK & MIAMI--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that C0311002, a Phase 3, randomized, multicenter, open-label, crossover study evaluating somatrogon dosed once-weekly in children 3 to <18 years of age with growth hormone deficiency (GHD), met its primary endpoint of improved treatment burden compared to GENOTROPIN® (somatropin) for injection administered once-daily.

Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12 weeks of treatment (8.63) compared to treatment with somatropin administered once-daily (24.13). The point estimate of the treatment difference was -15.49 (-19.71, -11.27 (95% CI); p<0.0001) in favor of somatrogon at the nominal 0.05 level. In addition, key secondary endpoints showed an overall benefit in treatment experience with the somatrogon once-weekly dosing regimen compared to the somatropin once-daily dosing regimen.

“We’re encouraged by findings to date that demonstrate once-weekly somatrogon, if approved, has the potential to reduce lifestyle interference, support patient preference, and improve adherence as compared to a daily treatment,” said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. “Patients and their loved ones have endured the burden of daily growth hormone injections for nearly 40 years, and we are working to improve this current standard of care with a long-acting, weekly option for the growth hormone disorders community.”

No serious adverse events (SAEs) were reported during either of the treatment periods, and one participant discontinued use of somatrogon following a nonserious treatment-emergent adverse event (AE). The incidence of treatment-emergent AEs between the treatment arms were comparable and all AEs were mild to moderate in severity.

In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product. The companies will evaluate the potential for additional pediatric and adult indications, as appropriate.

About the Study

C0311002 is a Phase 3, randomized, multicenter, open-label, crossover study assessing subject perception of treatment burden with use of somatrogon administered once-weekly versus GENOTROPIN® administered once-daily in children 3 to <18 years of age with growth hormone deficiency (GHD). The primary objective of the crossover study, which included 87 randomized and treated subjects (43 randomized to Sequence 1 [somatropin followed by somatrogon] and 44 randomized to Sequence 2 [somatrogon followed by somatropin], was to evaluate the treatment burden of a somatrogon once-weekly injection schedule and a somatropin once-daily injection schedule, as assessed by the difference in mean overall Life Interference total scores after each 12-week treatment schedule experience.

About Somatrogon

Somatrogon is a new molecular entity that contains the natural sequence of growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic hCG at the N-terminus and two copies at the C-terminus. The CTPs extend the half-life of the molecule. Somatrogon received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.

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New Zealand signs deal with Pfizer, BioNTech for COVID-19 vaccine
By Reuters Staff


SYDNEY (Reuters) - The New Zealand government signed a deal on Monday to buy 1.5 million COVID-19 vaccines from Pfizer Inc PFE.N and Germany's BioNTech 22UAy.F, with delivery potentially as early as the first quarter of 2021.

The government did not disclose financial terms of the deal, its first vaccine purchase, which will provide enough doses to vaccinate 750,000 people.

Officials said talks were continuing with other drug companies to secure more vaccine supplies for the country of 5 million people and further announcements were expected next month.

“The additional agreements will ensure that once the portfolio is completed, we will have sufficient COVID-19 vaccines for the whole population,” Research Minister Megan Woods said in a statement.

The Pfizer-BioNTech vaccine is one of the leading candidates in the race to be the first to get regulatory approval in the United States and Europe.

New Zealand appeared to have stamped out community transmission of COVID-19 earlier this year following a tough nationwide lockdown. A renewed outbreak in the city of Auckland in August was also brought under control with fresh lockdown measures.

The country has reported just over 1,500 cases, including 25 deaths, far less than most other developed nations.

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Pfizer may apply for emergency use of COVID-19 vaccine by late November: CEO Albert Bourla

14 minutes ago,

In an open letter from Pfizer (NYSE:PFE) Chairman and CEO Albert Bourla, the company provide greater clarity around the development timelines for its and partner BioNTech’s (NASDAQ:BNTX) COVID-19 vaccine.

PFE said it could be ready to apply for emergency-use authorization (EUA) of its COVID-19 vaccine by late November, assuming it receives positive efficacy and safety data from late-stage human trials.

To grant EUA, FDA requires companies to provide two months of safety data on half of the trial participants.

All the data would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.

The drug giant also said that it will continue running the trial through its final analysis point even if it is declared effective at an earlier stage.

PFE and BNTX are committed to supplying over 450M doses of COVID-19 this year and next year, contingent on the efficacy.

The U.S. government placed an initial order of 100M doses, with the option to purchase 500M additional doses.

The EU ordered 200M doses with an option for another 100M.

The government of Japan ordered 120M doses, and Britain ordered 30M.

All orders are subject to regulatory approval, and only the price of the U.S. deal - $1.95B has been disclosed so far.

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Pfizer may apply for emergency use of COVID-19 vaccine by late November: CEO Albert Bourla

14 minutes ago,

In an open letter from Pfizer (NYSE:PFE) Chairman and CEO Albert Bourla, the company provide greater clarity around the development timelines for its and partner BioNTech’s (NASDAQ:BNTX) COVID-19 vaccine.

PFE said it could be ready to apply for emergency-use authorization (EUA) of its COVID-19 vaccine by late November, assuming it receives positive efficacy and safety data from late-stage human trials.

To grant EUA, FDA requires companies to provide two months of safety data on half of the trial participants.

All the data would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.

The drug giant also said that it will continue running the trial through its final analysis point even if it is declared effective at an earlier stage.

PFE and BNTX are committed to supplying over 450M doses of COVID-19 this year and next year, contingent on the efficacy.

The U.S. government placed an initial order of 100M doses, with the option to purchase 500M additional doses.

The EU ordered 200M doses with an option for another 100M.

The government of Japan ordered 120M doses, and Britain ordered 30M.

All orders are subject to regulatory approval, and only the price of the U.S. deal - $1.95B has been disclosed so far.

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Pfizer could know if COVID-19 vaccine candidate is effective by end of October
Last Updated: Oct. 16, 2020 at 7:10 a.m. ET
First Published: Oct. 16, 2020 at 6:46 a.m. ET
By Tomi Kilgore
1
Pfizer on track to apply for EUA in the U.S. for potential vaccine by the second-half of November

Shares of Pfizer Inc. rallied in premarket trading Friday, after the drug maker said it is on track to know whether its potential COVID-19 vaccine is effective by the end of October, and currently expects to apply for Emergency Use Authorization by the second half of November.

Pfizer PFE, -0.84%, which is developing its vaccine candidate with Germany-based biotechnology company BioNTech S.E. BNTX, +4.05%, said before it can apply for the EUA, it will have to prove the vaccine is safe.


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To do so, the Food and Drug Administration requires two months of safety data on half of the trial participants following the final dose of the vaccine.

“Based on current trail enrollment and dosing pace, we estimate we will reach this milestone in the third week of November,” Chief Executive Albert Bourla wrote in an open letter posted on its website Thursday. He said he wrote the letter to clear up any confusion regarding the development and approval of the vaccine candidate.

Pfizer’s stock rose 1.1% in premarket trading, while BioNTech shares surged 2.7%.

Once the vaccine candidate is indicated to be effective and safe, Pfizer said another requirement will be to submit manufacturing data showing the “quality and consistency” of the vaccine that will be produced. The company said it expects to have that manufacturing data ready before the safety milestone is reached.

“So let me be clear, assuming positive data, Pfizer will apply for emergency authorization use in the U.S. soon after the safety milestone is achieved in the third week of November,” Bourla wrote. “All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency .”

Pfizer’s stock has lost 6.7% year to date through Thursday, while BioNTech shares have nearly tripled (up 166.8%). In comparison, the Dow Jones Industrial Average DJIA, -0.06% has slipped 0.2% this year.

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Coronavirus vaccine rolls off production line in Belgium


US company Pfizer has manufactured hundreds of thousands of doses of a COVID-19 vaccine in Belgium.
A coronavirus vaccine on track for the new year is rolling off the production line.
Pfizer has manufactured hundreds of doses of the drug in Belgium.
It comes as Astra Zeneca, the company behind the vaccine Australia is aligned with, says the jab could be available as soon as Christmas.

However, Pfizer's CEO announced on Friday in the US, it cannot request emergency authorisation of its COVID-19 vaccine before the third week of November - and that's if everything goes well.
Live Updates: Melbourne wakes to new freedoms
A coronavirus vaccine on track for the new year is rolling off the production line.

Pfizer has manufactured hundreds of doses of the drug in Belgium. It vomes as Astra Zeneca, the company behind the vaccine Australia has bought says the jab could be available as soon as Christmas

Despite President Donald Trump's repeated promises of a vaccine before Election Day, scientists have been cautioning that it's unlikely data showing a leading shot actually works would come until November or December.
Another leading US contender, Moderna Inc, previously announced the earliest it could seek authorization of its own vaccine would be November 25.
Pfizer CEO Albert Bourla has long said it's possible testing might reveal by the end of October if his company's vaccine actually protects against the coronavirus.
But in Friday's announcement, he made clear that effectiveness is only part of the equation.

The vaccine also must be proven safe. And to qualify for an "emergency use authorization," any COVID-19 vaccine must track at least half the participants in large-scale studies for two months after their second dose, the time period in which side effects are likely to appear.

Mr Bourla estimated Pfizer's 44,000-person study will reach that milestone in the third week of November.
"We are operating at the speed of science," he wrote in a letter posted to the company's website.

The vaccine made by Pfizer and its German partner BioNTech are among several leading candidates in final testing.
Even if a vaccine emerges by year's end, only limited doses will be available right away.

The US government is deciding who would be first in line, almost certainly health care workers, and estimates there may be enough for widespread vaccinations in the spring.

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Pfizer Reportedly Manufactures ‘Several Hundred Thousand’ Covid-19 Vaccines Anticipating November Regulatory Approval


TOPLINE U.S. drug giant Pfizer has started work manufacturing hundreds of thousands of Covid-19 vaccines ahead of an expected U.S. approval in November, the Mail on Sunday reports.

KEY FACTS

The coronavirus vaccines are being made at the company’s factory in Puurs, Belgium, according to the Mail on Sunday, who interviewed Pfizer’s U.K. head, Ben Osborn and showed a video that appears to show Pfizer’s manufacturing process, although it is not clear whether the clip shows the Covid-19 vaccine being manufactured. .

The company says it hopes to make 100 million doses available this year, should the vaccine be granted regulatory approval, with plans to manufacture 1.3 billion in 2021.


Every patient will need to receive two doses of the vaccine, according to the Mail on Sunday.

The vaccines produced are now being stockpiled, and are ready to ship worldwide when given the go ahead, the Mail on Sunday report.

Forbes has contacted Pfizer for comment and to confirm the nature of the clip.



Pfizer is a frontrunner in the global race to develop a safe and effective Covid-19 vaccine, which it is developing with Germany’s BioNTech. While not yet approved, production comes ahead of an anticipated approval in the U.S. when the company applies in the middle of November. Last week, the company’s CEO publicly clarified its best estimates for when it could apply for emergency approval, a thinly veiled critique of President Trump, who has been insisting a vaccine will be ready and available before the November 3 election. By Pfizer’s best estimate, the third week of November will be the earliest they will be able to apply for approval.

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Het wordt wel eens tijd dat de viagra zijn werk doet 🙄

Moderna and Pfizer will meet with FDA vaccine committee meeting this week
From CNN’s Elizabeth Cohen and Wes Bruer
Moderna and Pfizer, the two frontrunners in the US race for a Covid-19 vaccine, will be making presentations to an all-day meeting Thursday of a US Food and Drug Administration advisory committee, but both companies said they will not be presenting data from their Phase 3 clinical trials.

"This is not a moment where we will be sharing data. This is a discussion from the FDA to discuss the requirements for efficacy, safety and manufacturing,” a spokesperson for Pfizer said in an email to CNN.

Both companies have said they could possibly apply to the FDA for authorization to market their vaccines in the coming weeks if their Phase 3 clinical trial data turns out to be positive.

Pfizer has said it could apply for emergency use authorization after the third week in November. Moderna has said the federal government could give an EUA to the company’s experimental Covid-19 vaccine in December if the company gets positive interim results in November.

Once the companies apply for emergency use authorization from the FDA, the Vaccines and Related Biological Products Advisory Committee will advise the agency on whether it thinks authorization should be given.

The Thursday meeting is scheduled from 10 a.m. to 5 p.m., but Dr. Paul Offit, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee, said members have been asked to keep their schedules clear until 7 p.m. because it might run long.

Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said “general parameters” will be discussed for how to measure vaccine safety and efficacy.


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