Digital Pharmacist

OCTOBER 26, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

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pharmaphorum

DECEMBER 21, 2020

As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee. The biotech now expects to have between 100 and 125 million doses available in the first quarter of 2021, of which 85 to 100 million have been claimed by the US.

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Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Children between the ages of five and 36 months are at highest risk of death from malaria.

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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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The Checkup by Singlecare

SEPTEMBER 22, 2023

This year, there are new vaccines to help at-risk populations ward off severe sickness, including that caused by RSV. Here’s what you need to know about the new FDA-approved RSV vaccine. Is there a vaccine for RSV? Not all vaccines work via the same science. Is there an RSV vaccine for children? What is RSV?

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pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

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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%. Both vaccines will be provided free of charge to recipients. The overall 94.5%

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STAT

DECEMBER 18, 2023

and Europe in August 2021 , STAT writes. The Food and Drug Administration found quality control lapses at Moderna’s main factory, including with equipment used to manufacture drug substance for its Covid-19 vaccine , Reuters reports. The September 2021 inspection took place at Moderna’s facility in Norwood, Mass.,

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pharmaphorum

NOVEMBER 20, 2020

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. On the efficacy side, the filing will highlight a vaccine efficacy rate of 95% in a phase 3 study testing patients with and without previous infection with SARS-CoV-2.

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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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Pharmaceutical Technology

JANUARY 31, 2023

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. vaccine efficacy (VE) against RSV-LRTD, defined by two or more symptoms and 82.4% The findings showed 83.7%

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The Checkup by Singlecare

SEPTEMBER 12, 2023

Luckily, there’s a shot to help prevent it: Shingrix, the shingles vaccine. The Shingrix vaccine triggers the immune system to respond to the varicella virus and suppress the outbreak of shingles,” says David Cutler , MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California.

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European Pharmaceutical Review

FEBRUARY 14, 2023

Recently there have been several key advances in the clinical development of messenger RNA (mRNA) vaccines, including vaccines for RSV and a personalised cancer vaccine. Progress on mRNA vaccines for RSV Moderna’s mRNA vaccine mRNA-1345 demonstrated vaccine efficacy of 83.7

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pharmaphorum

OCTOBER 30, 2020

Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 That is the basis for filing for emergency use authorisation (EUA) of the vaccine in the US, according to criteria set out by the FDA. billion in deposits for the shot.

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pharmaphorum

JUNE 11, 2021

Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. — FDA Biologics (@FDACBER) May 25, 2021. . — FDA Biologics (@FDACBER) May 25, 2021.

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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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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. 1 subvariant of Omicron. Pfizer and Moderna have both started regulatory filings for approval of their BA.1-containing

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pharmaphorum

FEBRUARY 28, 2021

The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Today, FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of #COVID19 caused by SARS-CoV-2.

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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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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 The sales forecast for 2021 is based on contracts to deliver 1.6 billion. .

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Outsourcing Pharma

JANUARY 4, 2021

As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.

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pharmaphorum

FEBRUARY 11, 2021

AstraZeneca is aiming to get a next-generation vaccine targeting emerging variants approved and into the arms of patients by the autumn, company representatives said in a press conference. While the vaccine is approved in Europe, the UK and several other countries, FDA approval hangs on a study in the US.

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Pharma Times

NOVEMBER 26, 2021

The Food and Drug Administration (FDA) granted approval for emergency use of the Comirnaty vaccine in children in October 2021.

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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. Add to this the fact that the world missed the WHO targets for global vaccination by the end of 2021 and will likely continue to miss targets in 2022.

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European Pharmaceutical Review

DECEMBER 7, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Comirnaty ® , the Pfizer/BioNTech COVID-19 vaccine for infants and children aged six months to four years in Great Britain. The common, expected side effects were within expectations for a vaccine in this age group.

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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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pharmaphorum

MARCH 17, 2021

At the start of the pandemic GlaxoSmithKline made its vaccine booster tech available looking for collaborations with other vaccine developers – but GSK has been lagging behind rivals like Pfizer and AstraZeneca after its big tie-up with Sanofi hit technical troubles. micrograms of the vaccine are administered 21 days apart.

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pharmaphorum

SEPTEMBER 1, 2022

Dr. B was founded in 2021 to connect providers with leftover COVID vaccines to the patients seeking to receive them. at the height of the COVID crisis to save lives by getting vaccines to people who needed them. The post Dr. B: Expanding the business model from COVID vaccines to antiviral medications appeared first on.

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Pharmaceutical Technology

OCTOBER 9, 2023

The FDA decision follows a similar designation for the vaccine UV1 against malignant melanoma in December 2021.

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pharmaphorum

APRIL 21, 2021

The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. The PRAC was reviewing eight cases of thromboembolism with thrombocytopenia following vaccination in the US, one of which had a fatal outcome. Vaccinations save lives.

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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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STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. The first therapy that delays the onset of type 1 diabetes received approval from the U.S.

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Pharmaceutical Technology

OCTOBER 28, 2022

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.

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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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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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Pharmaceutical Technology

SEPTEMBER 5, 2022

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We Prior to this, the FDA had granted Enhertu regulatory approval for breast cancer treatment.

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