Bio Pharma Dive

OCTOBER 15, 2021

Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.

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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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Bio Pharma Dive

SEPTEMBER 12, 2020

study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume. Six days after a worrisome illness in a U.K.

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pharmaphorum

MARCH 11, 2021

European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. Batch ABV5300 was delivered to 17 EU countries and comprises 1 million doses of the vaccine.

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Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5

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pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. Early commercial batches of Pfizer/BioNTech’s COVID-19 vaccine had lower than expected levels of intact mRNA.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 13, 2024

The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.

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World of DTC Marketing

FEBRUARY 21, 2022

Pfizer expects to make as much as $22bn from its new Covid pill this year, on top of $37bn it made in 2021 from the vaccine. The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. Pfizer’s Paxlovid currently costs about $530 for a five-day course of the treatment.

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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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BioSpace

JUNE 16, 2024

The use of artificial intelligence in the development of cancer vaccines allows for individualized therapy, but the prospect of an ever-changing product poses new challenges for drug developers and regulators.

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BioSpace

JUNE 2, 2022

Top research stories, including gene regulation and longevity, a head-to-head comparison of COVID-19 vaccines, a newly discovered type of brain cell and more.

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Bio Pharma Dive

APRIL 7, 2021

Europe's drug regulator affirmed the benefits of vaccination outweigh the risks, but recommended the shot's label be updated to warn of the newly established side effect.

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Bio Pharma Dive

APRIL 13, 2021

A call by regulators to stop J&J vaccinations won't dramatically disrupt supply in the U.S. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.

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Bio Pharma Dive

OCTOBER 6, 2020

The decision by European regulators to start speedy, "rolling" reviews of two vaccine candidates comes as the FDA and White House have reportedly been unable to agree on early approval standards.

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pharmaphorum

MARCH 17, 2021

European regulators are “worried” that national regulators may have undermined trust in the Oxford University/AstraZeneca vaccine by temporarily suspending its use, despite central guidance to keep using it until a safety review has concluded later this week. . Politically motivated?

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Bio Pharma Dive

DECEMBER 2, 2020

The approval is a notable milestone in the historic pursuit of a protective shot for COVID-19. The two drugmakers plan to ship the first doses within days.

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BioSpace

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s COVID-19 vaccine candidate, mRNA-1273.

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World of DTC Marketing

AUGUST 26, 2021

The government has latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” With respect to children, parents do not have carte blanche. The bottom line is that we have to take bolder steps to get everyone vaccinated because the unvaccinated represent a danger to us all.

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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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Bio Pharma Dive

JULY 11, 2023

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.

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Bio Pharma Dive

AUGUST 25, 2022

In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall.

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Bio Pharma Dive

MARCH 18, 2021

The two drug regulators each believe the benefits of the shot outweigh the risks after investigating rare and unusual clotting events that have led more than 20 countries to halt vaccinations.

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XTalks

OCTOBER 8, 2024

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. This control plays a critical role in development and cellular function.

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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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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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Fierce Pharma

JULY 11, 2023

travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. | U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting.

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NY Times

APRIL 20, 2021

The European Union’s drug regulator said that the Johnson and Johnson vaccine should carry a warning of potential risk for rare blood clots on the label, but did not recommend stopping the vaccine, saying the benefits of the vaccine outweighed the risks.

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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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Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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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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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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Clairnes

DECEMBER 17, 2021

From Vaccine trials, new regulations, decentralized trials and patient-centricity appeared first on Clinical Trial Recruitment & Management Services. The post Clinical trials: 2021 Recap and take-aways for 2022 and ahead.

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pharmaphorum

OCTOBER 4, 2023

Novavax has been given the go-ahead by regulators in the US for an updated version of its COVID-19 vaccine that targets the XBB.1.5 directed mRNA-based vaccines from Pfizer/BioNTech and Moderna as options for the upcoming immunisation campaign in the US. variant of the coronavirus.

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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 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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BioSpace

DECEMBER 19, 2023

The competition between Merck’s pneumococcal vaccine and Pfizer’s Prevnar series of vaccines is intensifying after the regulator granted priority review to the former’s BLA for V116.

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STAT News

JANUARY 27, 2023

pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. And his remarks, which ran in December 2021, prompted a complaint from an advocacy group that argued Bourla was inappropriately touting Covid-19 vaccines.

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