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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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 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading.

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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

JUNE 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Merck's (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years. The post US FDA grants approval for Merck’s pneumococcal vaccine for children appeared first on Pharmaceutical Technology.

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European Pharmaceutical Review

APRIL 25, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

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pharmaphorum

FEBRUARY 24, 2021

The FDA has issued guidelines allowing for faster development of updated coronavirus vaccines, based on previously approved shots that have been tweaked to combat emerging variants of the SARS-CoV-2 virus. If vaccines need updating, the FDA expects that manufacturing information will remain generally the same.

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pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing.”

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pharmaphorum

JANUARY 15, 2021

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.

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Pharmaceutical Technology

JUNE 24, 2022

As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 1 variant of concern.

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pharmaphorum

DECEMBER 17, 2020

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR).

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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

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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pharmaphorum

AUGUST 16, 2021

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. Data from a larger phase 3 study of the third dose is also expected shortly and will be submitted to the FDA when available, said the drugmakers.

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pharmaphorum

MARCH 3, 2021

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

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Pharmacy Times

JUNE 23, 2022

Vaxneuvance was approved for an expanded indication by the FDA on June 22, 2022, for active immunization in children 6 weeks of age and older.

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pharmaphorum

SEPTEMBER 17, 2020

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. Nath told CNN: “The highest levels of NIH are very concerned.

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pharmaphorum

JUNE 29, 2022

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). They are however both based on the original BA.1 1 will be “already somewhat outdated.”

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pharmaphorum

AUGUST 25, 2021

Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that will ramp up the pressure on Pfizer and its market-leading Prevnar franchise.

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European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs).

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European Pharmaceutical Review

JANUARY 23, 2023

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. EVX-01 cancer immunotherapy EVX-01 is a peptide-based cancer immunotherapy generated based on gene analysis of a patient’s tumours and on matching with their immune system. Moderna, Inc.

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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pharmaphorum

AUGUST 13, 2021

The FDA has cleared the use of third dose of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with weakened immune systems, but stopped short of recommending a broader booster campaign. The US hit its target of 70% of adults being fully vaccinated earlier this month.

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Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.

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Pharmaceutical Technology

AUGUST 26, 2022

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On the same day, the FDA granted a EUA to Bavarian Nordic’s (Copenhagen, Denmark) Jynneos vaccine.

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STAT

JULY 17, 2023

Use of the antibody treatment, the brand name for which is Beyfortus, still needs to be recommended by the Advisory Committee on Immunization Practices, an independent expert panel that advises the Centers for Disease Control and Prevention. A special meeting of the ACIP has been set for Aug.

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The Checkup by Singlecare

NOVEMBER 23, 2022

Food and Drug Administration (FDA) approved the first drug to delay the onset of Type 1 diabetes. Tzield received priority review from the FDA, a status given to drugs with the potential for “significant improvement” in the treatment, diagnosis, or prevention of a serious condition. 17, the U.S. RELATED: Type 1 vs. Type 2 diabetes.

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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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pharmaphorum

FEBRUARY 25, 2021

Pfizer may have been making headlines with the COVID vaccine it developed with BioNTech, but it’s not the only infectious disease the big pharma is targeting. In a statement, Pfizer said the FDA has granted a fast review for TicoVac tick-borne encephalitis (TBE) vaccine, to prevent the disease in individuals one year of age or older.

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European Pharmaceutical Review

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours.

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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. Subjects in the study will be separated into different groups, depending on the number of months since their first booster.

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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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pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. The post Budget 2021: Sunak focuses on vaccine development to restart economy appeared first on.

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pharmaphorum

SEPTEMBER 12, 2022

Pfizer and BioNTech’s COVID-19 vaccine targeting Omicron BA.4 The EMA said the decision by the CHMP will “further extend the arsenal of available vaccines to protect people against COVID-19 as the pandemic continues and new waves of infections are anticipated in the cold season.” 1 strain of the variant.

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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. What’s more, VAX-24 achieved a higher immune response to 16 of the 20 serotypes it shares with Prevnar 20.

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PharmaShots

FEBRUARY 20, 2023

Shots: The USPTO issued the company a patent for its transformative technology to produce orally delivered animal vaccines by the number Patent US-11566255-B2, "Expression of PEDV Sequences in Plants and Plant Produced Vaccine for Same" on the 31st of Jan 2023 The patent covers foundational technology for the company’s first vaccine (..)

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pharmaphorum

NOVEMBER 17, 2020

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements. The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials.

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