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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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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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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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

JULY 5, 2023

The vaccine has a chance to become Moderna’s second approved product and could help offset declining sales for its COVID-19 shot.

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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

OCTOBER 24, 2020

Experts convened by the regulators debated how much data would warrant an approval, while pressing government officials on their distribution plans.

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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

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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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

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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Bio Pharma Dive

SEPTEMBER 20, 2021

But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators. The results position Pfizer and BioNTech to seek clearance in children as young as five years old.

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Bio Pharma Dive

OCTOBER 1, 2021

Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 14, 2024

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 The vaccine variant […]

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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

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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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

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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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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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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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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Bio Pharma Dive

JUNE 29, 2022

Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as decide how COVID-19 vaccines should be updated.

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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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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

JANUARY 28, 2021

and plans to begin talks with the FDA and other regulators, too. The drugmaker is already discussing an authorization with health authorities in the U.K.,

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Bio Pharma Dive

AUGUST 15, 2022

Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus.

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NY Times

AUGUST 20, 2021

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.

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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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World of DTC Marketing

FEBRUARY 28, 2021

Can a COVID-19 vaccine approval suddenly erase that? So should we forget all that because they developed a COVID vaccine? Let’s not fool ourselves J&J stands to make a lot of money from the development and approval of this vaccine. Johnson & Johnson has paid $2.7 billion in penalties. That’s a LOT of money.

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pharmaphorum

JANUARY 7, 2021

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.

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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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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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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).”. The post MHRA looks to AI to hunt for COVID-19 vaccine side effects appeared first on.

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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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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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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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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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