FDA delays decision on Moderna RSV vaccine
Bio Pharma Dive
MAY 10, 2024
The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
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Pfizer, with new study results, seeks to bring RSV shot to adults aged 18-59
Bio Pharma Dive
APRIL 9, 2024
The company plans to submit the trial data to regulators in a bid to win approval of its vaccine Abrysvo in adults as young as 18 years old.
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Chinese regulator approves personalised cancer vaccine trial
Drug Discovery World
MARCH 30, 2023
Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Vaccines predicated on neoantigens therefore elicit truly tumour-specific T cell responses.
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HDT Bio receives Emergency Use Approval for Covid-19 vaccine in India
Pharmaceutical Technology
JUNE 30, 2022
HDT Bio has received Emergency Use Approval from Indian regulators for its Covid-19 vaccine, Gemcovac. The vaccine leverages self-amplifying RNA (saRNA), which can replicate itself after administration and could be effective at very low doses. HDT Bio CEO Steve Reed said: “Our saRNA vaccine is a game-changer.
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European regulators begin rolling review of AZ’s COVID-19 vaccine
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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Clinical trials: 2021 Recap and take-aways for 2022 and ahead. From Vaccine trials, new regulations, decentralized trials and patient-centricity
Clairnes
DECEMBER 17, 2021
The post Clinical trials: 2021 Recap and take-aways for 2022 and ahead. From Vaccine trials, new regulations, decentralized trials and patient-centricity appeared first on Clinical Trial Recruitment & Management Services.
WHO grants emergency use listing to SK bioscience’s SKYCovione
Pharmaceutical Technology
JUNE 20, 2023
The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.
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Merck and Moderna’s mRNA cancer vaccine aces its first efficacy trial
pharmaphorum
DECEMBER 14, 2022
The mRNA technology that was deployed so effectively in vaccines against COVID-19 has now been found to offer similar promise against cancer, according to Merck & Co and Moderna. The vaccine primes the immune system to attack the tumour cells, while Keytruda blocks an immunological ‘brake’ that protects the cancer.
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CDSCO declares sample of Bharat Biotech’s typhoid vaccine Typbar as NSQ
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 11, 2023
The Central Drugs Standard Control Organisation (CDSCO) has declared a batch of Typbar, the typhoid polysaccharide vaccine from Bharat Biotech International Ltd as not of standard quality (NSQ).
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‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about approval process
STAT News
NOVEMBER 15, 2022
As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government.
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AZ resumes UK coronavirus vaccine trial
pharmaphorum
SEPTEMBER 14, 2020
AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. There are other trials in progress outside the UK, including a phase 3 trial in the US, and AZ said it would work with health authorities to restart trials outside the UK.
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GSK Headed to Regulators with RSV Vaccine
BioSpace
JUNE 9, 2022
GSK reported positive headline data from a pre-specified efficacy interim analysis of the Phase III trial of its RSV vaccine.
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FDA clears Novavax's COVID-19 vaccine as 4th option in US
Bio Pharma Dive
JULY 13, 2022
The regulator’s decision comes more than a year after the main part of the principal trial was completed, raising questions about the shot’s effectiveness against omicron.
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Altimmune ditches nasal COVID vaccine on weak trial data
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. .
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With 70% Efficacy, AstraZeneca-Oxford COVID-19 Vaccine Heads to Regulators
BioSpace
DECEMBER 8, 2020
AstraZeneca and the University of Oxford published an interim analysis of their four Phase III clinical trials of AZD1222, their COVID-19 vaccine.
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AZ mulls trial of new COVID-19 vaccine dose as UK regulator begins review
pharmaphorum
NOVEMBER 27, 2020
AstraZeneca is to run an additional global trial to test its COVID-19 vaccine at a lower dosage, as the UK regulator begins to review trial data. The additional trial is unlikely to hold up regulatory approvals in the UK and EU, according to Soriot.
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Doubts emerge over AZ’s ‘outdated’ US vaccine trial data
pharmaphorum
MARCH 23, 2021
AstraZeneca has been rebuked by a US health authority after a trial monitoring board said data published from a large study of its COVID-19 vaccine may be out of date and may not give a representative view of its efficacy. The post Doubts emerge over AZ’s ‘outdated’ US vaccine trial data appeared first on.
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Agilex Biolabs Shares How to Select the Right Bioanalytical Tools for Immuno-oncology and Vaccines Studies – OCT Webinar
Pharma Mirror
OCTOBER 22, 2021
ADELAIDE, AUS, Oct 19, 2021 – (ACN Newswire) – Agilex Biolabs, the Australian regulated bioanalytical and toxicology laboratory facilities for clinical trials is presenting a new webinar entitled “Getting it right! Agilex Biolabs’ Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D,
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FDA starts speedy review of Takeda’s dengue vaccine
pharmaphorum
NOVEMBER 23, 2022
The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. Takeda said last year that the vaccine could reach up to $1.6 billion in peak sales.
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New Trivalent Flu Vaccine for 2024/2025 and Other Insights from Leading Infectious Disease Experts Dr. Willliam Schaffner and Dr. Kelly Moore
XTalks
MAY 10, 2024
Influenza viruses are highly mutable, which necessitates continuous monitoring and adjustments in vaccine formulations. These seasonal outbreaks can vary in severity, depending on the circulating strains of the virus and public health preparedness, including vaccination coverage and effectiveness.
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UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster
Pharmaceutical Technology
NOVEMBER 9, 2022
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 Based on all data available on the original Pfizer/BioNTech Covid-19 vaccine and its adapted vaccines, the MHRA granted the approval.
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AstraZeneca resumes COVID-19 vaccine trials in the UK; awaits regulators elsewhere
BioPharma Reporter
SEPTEMBER 14, 2020
AstraZeneca has resumed UK clinical trials for its Oxford coronavirus vaccine, having paused all trials last week for a safety review. Other late-stage global trials, however, remain on hold while AstraZeneca waits for regulators in each market.
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Concerns emerge after AZ’s lucky vaccine trial ‘mistake’
pharmaphorum
NOVEMBER 26, 2020
AstraZeneca may have tried a positive spin on the trial mistake that led to the accidental discovery of the low dose COVID-19 vaccine regime with the highest efficacy– but the revelation has drawn a mixed response from commentators.
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MHRA looks to AI to hunt for COVID-19 vaccine side effects
pharmaphorum
NOVEMBER 2, 2020
The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”.
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AZ, J&J COVID-19 vaccine trials okay to restart in US
pharmaphorum
OCTOBER 26, 2020
US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot.
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Pfizer cut vaccine production targets because of raw material shortage – reports
pharmaphorum
DECEMBER 4, 2020
Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.
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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel
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. of participants. of participants.
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Bimervax Covid-19 vaccine authorised in UK
Drug Discovery World
AUGUST 3, 2023
It becomes the ninth Covid-19 vaccine to be authorised by the UK’s independent medicines regulator. The vaccine demonstrated a strong immune response, and the most common side effects were mild, and self-resolved within a few days of vaccination. It is approved as a booster injection for those aged 16 years and over.
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First trial participants vaccinated with Oxford-AstraZeneca COVID-19 variant shot
BioPharma Reporter
JUNE 28, 2021
The University of Oxford in partnership with AstraZeneca began vaccinations yesterday for a new phase in human trials to test a COVID-19 vaccine âAZD2816â in volunteers against the Beta [South African] variant.
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Clinical trial set to test efficacy of mixing Sputnik V and COVID-19 Vaccine AstraZeneca
BioPharma Reporter
FEBRUARY 9, 2021
Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.
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mRNA Cancer Vaccines and Therapies: An Overview
Advarra
JANUARY 11, 2024
While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.
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The Future of Vaccine Development
VirTrial
OCTOBER 25, 2023
Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participation follow-up periods, multiphase designs, and critical data management needs. In recent years, Signant has been a part of more than 95 vaccine studies involving 140,000+ patients in more than 30 countries.
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China approves Sinovac’s coronavirus vaccine
pharmaphorum
FEBRUARY 8, 2021
China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme.
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EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine
The Pharma Data
JANUARY 29, 2021
EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. The move comes after the European Medicines Agency has been criticized for not moving fast enough to vaccinate its population.
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Germany and Canada restrict AZ vaccine again over blood clot fears
pharmaphorum
MARCH 31, 2021
Germany and Canada have both slapped restrictions on the AstraZeneca vaccine, recommending its use only in older patients, because of concerns over a link with blood clots. According to STIKO the side effect occurred four to 16 days after vaccination and was predominantly seen in people under 60 years of age.
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Valneva accelerates Lyme disease vaccine R&D project with Pfizer
pharmaphorum
DECEMBER 4, 2020
Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.
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UK prepares for decision on AZ/Oxford vaccine as COVID cases soar
pharmaphorum
DECEMBER 24, 2020
The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.
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Brazilian Regulator Announces Patient Death in AstraZeneca Vaccine Trial
The Pharma Data
OCTOBER 21, 2020
Brazil’s health regulator ANVISA (Agência Nacional de Vigilância Sanitária) disclosed Wednesday that a participant had died in AstraZeneca’s Brazilian late-stage COVID-19 vaccine trial, though the UK drugmaker said the incident was not grounds for stopping the study. Source link.
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J&J single-shot COVID-19 vaccine shows early promise
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. J&J expects to file with the FDA first, followed by other regulators.
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National Immunization Awareness Month: Vaccines Work and Catching Up
XTalks
AUGUST 17, 2022
August is National Immunization Awareness Month (NIAM), which is marked to help raise awareness about the importance of vaccines in the protection of public health. One of the themes of this year’s National Immunization Awareness Month is “vaccines work.” Vaccination Awareness from the FDA.
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Coronavirus vaccine may have allergy warning in US, says expert
pharmaphorum
DECEMBER 10, 2020
The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Both recovered after appropriate treatment. Both are recovering well.”.
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Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy
XTalks
APRIL 26, 2021
After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.
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AstraZeneca pauses COVID-19 vaccine trials ‘to allow review of safety data’
BioPharma Reporter
SEPTEMBER 9, 2020
AstraZeneca has paused vaccination in all of its Oxford COVID-19 vaccine candidate trials globally, because of an unexplained illness in one of the trials.
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COVID-19 Vaccine and Drug Development Coverage
XTalks
NOVEMBER 9, 2020
SARS-CoV-2 Vaccines Inch Towards Regulatory Approval. Over the past month or so, investigators have been amassing data on SARS-CoV-2 candidate vaccines as quickly as possible and some of that data is making its way—ever so much more slowly—through regulatory agencies for official scrutiny.
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