pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. — Eric Topol (@EricTopol) December 15, 2020. The overall 94.5% Very encouraging! pic.twitter.com/6IVSj8E3F0.

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FDA Vaccines Documentation 98

pharmaphorum

DECEMBER 5, 2022

Valneva has moved a step closer to its goal of becoming the first company to file for approval of a vaccine against chikungunya virus in the US after reporting new clinical data today. Valneva estimates that the global market for vaccines against chikungunya could exceed $500 million annually by 2032.

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Vaccines FDA 98

pharmaphorum

OCTOBER 26, 2020

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial. Moderna shared demographic data from the study at an FDA committee meeting today which showed that it included some of the groups most at risk from COVID-19.

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Vaccines FDA 111

Pharmaceutical Technology

SEPTEMBER 15, 2022

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.

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Vaccines Documentation Compounding FDA 108

pharmaphorum

DECEMBER 2, 2020

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effective in a phase 3 trial.

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Vaccines FDA 88

pharmaphorum

NOVEMBER 9, 2020

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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pharmaphorum

MAY 11, 2021

The FDA has authorised Pfizer/BioNTech’s vaccine for 12- to 15 year-olds under emergency rules. In a statement the regulator said it had expanded the vaccine’s Emergency Use Authorization to include the new age group. The FDA noted that between the period of March 1 2020 until April 30 this year, there have been around 1.5

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Vaccines FDA 59

STAT

APRIL 19, 2023

The calamity of March 2020 arrived two years later for pediatric units.

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Vaccines Hospitals FDA 98

pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. Despite the fast review, the company insisted that the potential vaccine will be assessed according to the EMA’s normal standards for quality and safety.

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Vaccines FDA 88

pharmaphorum

JULY 27, 2022

Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that they hope will offer greater and broader protection against SARS-CoV-2 variants. Feature image copyright BioNTech SE 2020, all rights reserved. 1 subvariant of Omicron.

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pharmaphorum

JUNE 6, 2022

With vaccine hesitancy leading to a rise in measles cases, the FDA’s approval of GlaxoSmithKline’s venerable vaccine Priorix for sale in the US looks timely. The post FDA clears GSK’s Priorix, first new MMR vaccine in 50 years appeared first on.

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Vaccines FDA 59

pharmaphorum

FEBRUARY 21, 2022

A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. Twenty-three percent fewer clinical trials were launched from March through May 2020 because of the pandemic, and many clinical researchers switched to focusing on COVID-19 vaccines and treatments.

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Vaccines FDA Hospitals 111

pharmaphorum

DECEMBER 14, 2020

The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking delivery of Pfizer/BioNTech’s COVID-19 shot. In a statement the NHS said that GP practices in more than 100 parts of the country are taking delivery of the vaccine today.

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Vaccines FDA 105

pharmaphorum

JANUARY 5, 2022

GlaxoSmithKline places shingles vaccine Shingrix is among its top prospects, with peak sales potential of almost $6 billion. Shingrix was dubbed the “crown jewel” of GSK’s vaccine franchise at the company’s latest R&D update. Now, Pfizer and BioNTech are joining forces to try to grab a slice of the market.

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Vaccines Immunization FDA 105

pharmaphorum

SEPTEMBER 29, 2020

Inovio Pharma’s plan to start pivotal testing of its COVID-19 vaccine has been delayed by FDA requests for more information, sending its shares into a swift decline. Inovio’s vaccine takes the form of a DNA plasmid coding for the full length of the spike or ‘s’ glycoprotein antigen of SARS-CoV-2, the vaccine that causes COVID-19.

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Vaccines FDA Immunization 52

STAT

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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pharmaphorum

MAY 5, 2021

Pfizer expects revenues from its BioNTech-partnered COVID-19 vaccine to reach an eye-watering $26 billion this year, catapulting it to the top of the world’s biggest-selling medicines. . The vaccine made $3.5 The vaccine made $3.5 Spending and profit from the vaccine are split equally between Pfizer and BioNTech.

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pharmaphorum

JANUARY 8, 2021

The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for several weeks. The UK government has ordered 17 million doses of the new vaccine, but none will be available before March, when Moderna is able to bring new production capacity online.

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Vaccines FDA 64

European Pharmaceutical Review

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. The single-dose, live-attenuated vaccine is indicated for preventing chikungunya virus disease in individuals over 18 years old who are at increased risk of contracting the virus.

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pharmaphorum

OCTOBER 27, 2020

Pfizer is one of the front-runners in the race to approve a COVID-19 vaccine but the US company has had to weather lower revenues for the third quarter due to the ongoing impacts of COVID-19. Total third-quarter 2020 revenues hit $12.1 The drug had been given FDA fast track designation. billion, an increase of 4% from last year.

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pharmaphorum

JULY 9, 2021

With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases. . Feature image copyright BioNTech SE 2020, all rights reserved.

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Vaccines Immunization FDA 98

pharmaphorum

JULY 29, 2021

billion in sales from its COVID-19 vaccine Vaxzevria in the first half of this year, but making it available at no profit had weighed on its profit margins. billion from its one-dose vaccine. A delayed FDA filing – held up by data requests from the US regulator – should take place before the end of the year, according to the CEO.

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Vaccines FDA 98

pharmaphorum

JANUARY 10, 2022

The arrival of COVID-19 brought precious few positives, but one that emerged for the pharmaceutical industry was the emergence and validation of mRNA vaccine technology to prevent disease. Pfizer already has a head start on competitors in the field, having achieved the first US FDA approval for an mRNA vaccine, alongside BioNTech.

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Vaccines Immunization FDA 111

Pharmaceutical Technology

MAY 30, 2023

Valneva has submitted a regulatory application to Health Canada, seeking marketing approval for its chikungunya vaccine candidate, VLA1553. The vaccine is designed to be administered as a single shot and is intended for individuals aged 18 years and older. Valneva plans to make further regulatory submissions.

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Vaccines FDA 52

pharmaphorum

SEPTEMBER 21, 2021

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. Feature image copyright BioNTech SE 2020, all rights reserved.

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Vaccines FDA Hospitals 98

pharmaphorum

AUGUST 23, 2021

Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US. The US has fully vaccinated more than half its total population, but is facing problems with vaccine hesitancy that is slowing down the rollout.

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FDA Vaccines Nursing Homes 52

pharmaphorum

JANUARY 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. The next phase of the Covid-19 – from vaccines to treatments. Lagevrio was approved by the FDA, MHRA and EMA before the end of 2021.

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HIV Treatment and Prevention Agents Vaccines FDA 98

pharmaphorum

JANUARY 5, 2021

Anyone who proposed that a novel, deadly virus would spread, with a vaccine developed demonstrating 95% efficacy, and approved for patients in less than a year would have been scoffed at. Healthcare systems ended 2020 in a very different place to where they were in 2019, with hospital capacity (and hospital finances) challenges.

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Hospitals Vaccines Pharmaceutical Companies Pharmaceutical Companies 105

pharmaphorum

JUNE 22, 2022

The US FDA plays a key role in ensuring the quality of drugs that are being manufactured and brought into the country, a task that became fundamentally more difficult alongside the pandemic. By its own figures, the agency managed 61% of the planned inspections it had scheduled for 2020.

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Generic Medicine FDA Vaccines 114

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

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Vaccines Immunization Medical Schools FDA 59

pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

Vaccines 59

Vaccines Immunization Medical Schools FDA 59

pharmaphorum

MARCH 3, 2022

Pfizer has been awarded breakthrough status from the FDA for its respiratory syncytial virus (RSV) vaccine in pregnant women, putting the company in pole position to bring a shot to market that will protect infants from the life-threatening infection. AZ, Sanofi antibody aces phase 3 trial. Last year, sales were around $273 million.

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Vaccines FDA 52

pharmaphorum

SEPTEMBER 27, 2021

trillion by end of 2020. As the vaccines were developed and rolled out, the disparity in their take up among different sections of the community highlighted how excluded some minority communities felt from areas of healthcare. This already significant industry is growing – it is estimated to be worth $1.27

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Vaccines Communication FDA 122

pharmaphorum

FEBRUARY 10, 2022

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains. The post AZ halts development of Beta variant COVID-19 vaccine appeared first on.

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Vaccines Immunization FDA 52

pharmaphorum

APRIL 30, 2021

Pharmaceutical sales were flat on the same period of 2020 at $10.7 billion, with vaccines sales falling nearly 19% to $1.8 It’s Merck’s last remaining COVID-19 programme after it scrapped development of its vaccine candidate and immune modulator MK-7110. Overall revenues for the quarter came in at $12.1

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Vaccines FDA Immunization 90

pharmaphorum

APRIL 16, 2021

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. It is undeniable that 2020 was a particularly challenging year to launch non-COVID innovative prescription medicines.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry. The previous record for vaccine development and approval was four years for the measles vaccine.

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Vaccines FDA Research Laboratories Documentation 128