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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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ACRP blog

MARCH 12, 2024

Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. Additionally, how do you ensure that the vaccine distribution is equitable?

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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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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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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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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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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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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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Rethinking Clinical Trials

FEBRUARY 7, 2024

Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated products. Winckler, RPh, Esq) appeared first on Rethinking Clinical Trials.

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BioPharma Reporter

FEBRUARY 4, 2021

An Oxford University trial, a world first, is looking at whether inoculating volunteers with doses of different combinations of two currently approved COVID-19 vaccines is effective.

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The Pharma Data

NOVEMBER 10, 2020

Brazil’s National Agency for Sanitary Surveillance (ANVISA) has suspended Beijing, China-based Sinovac’s phase 3 trial of its COVID-19 vaccine, CoronaVac, halting the study Tuesday to evaluate a serious adverse event that occurred. Source link.

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The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. The Cambridge, Mass.-based

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Pharmaceutical Technology

APRIL 20, 2023

Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Within such a tightly regulated industry, there is natural apprehension to being a first mover.

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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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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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pharmaphorum

MARCH 2, 2022

Pfizer’s vaccine for Clostridium difficile (C. diff) looks like it may join a growing list of candidates that have been shelved or delayed, after the shot failed to meet its primary objective in a phase 3 trial. With no approved vaccines to date, C. First, the bad news. The only other company with a C.

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pharmaphorum

JANUARY 6, 2023

The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines. The post UK partners with BioNTech on clinical trials of mRNA cancer therapies appeared first on.

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BioSpace

OCTOBER 19, 2020

Merck reported results from two more Phase III trials of V114, it’s 15-valent pneumococcal conjugate vaccine.

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pharmaphorum

SEPTEMBER 25, 2020

Novavax has begun a late-stage trial of its experimental COVID-19 vaccine in the UK, which could support filings for a licence in the UK, EU and other countries. The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out.

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