BioPharma Reporter

MARCH 8, 2021

A coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland has set out guidance for how variant-specific versions of authorized vaccines will be regulated: saying they will not need brand new approval or lengthy clinical studies.

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BioPharma Reporter

AUGUST 21, 2022

EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK.

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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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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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BioPharma Reporter

NOVEMBER 18, 2021

The European Medicines Agency (EMA) could issue an opinion on Novavaxâ Conditional Marketing Authorization for its COVID-19 vaccine âwithin weeksâ.

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BioPharma Reporter

NOVEMBER 6, 2023

million) in funding for four hubs dedicated to the development of vaccines for diseases with epidemic potential in low- and middle-income countries (LMICs). The UK has unveiled Â34.5 million ($42.8

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BioPharma Reporter

MARCH 7, 2023

Modernaâs RSV vaccine launch â expected either late this year or early in 2024 â will draw on the infrastructure and learnings gained from the company's COVID-19 vaccine launch.

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World of DTC Marketing

FEBRUARY 19, 2021

SUMMARY: More than 42,000 programmatic ads from 4,315 brands are running on websites spouting misinformation about the vaccine and COVID over the past year. Included in the programmatic ad errors is Pfizer, who developed a leading COVID vaccine. When will pharma stop using programmatic online ads?

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pharmaphorum

SEPTEMBER 2, 2022

The EMA’s human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as booster shots. The FDA has just authorised vaccines from the two companies that will specifically target the BA.4 Moderna’s BA.1

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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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BioPharma Reporter

FEBRUARY 4, 2021

New Zealandâs regulator Medsafe has given the Pfizer/BioNTech vaccine provisional approval, with border workers the first to be offered the vaccine.

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BioPharma Reporter

MARCH 22, 2021

CureVac is expanding its late-stage clinical trials for its COVID-19 vaccine candidate; while confirming it is on schedule to apply for formal market authorization in the EU in Q2 2021.

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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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BioPharma Reporter

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted Pfizerâs Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV in infants.

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BioPharma Reporter

JULY 25, 2022

The European Commission has extended the marketing authorization for Bavarian Nordicâs smallpox vaccine, Imvanex, to include protection from monkeypox and disease caused by vaccinia virus.

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pharmaphorum

DECEMBER 16, 2022

Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. There are already rules that dictate how countries should react against public health events that have the potential to traverse country borders, through the International Health Regulations.

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BioPharma Reporter

AUGUST 23, 2021

Valneva today commenced rolling submission for initial approval of its COVID-19 vaccine candidate, VLA2001, with the UK health regulator.

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BioPharma Reporter

DECEMBER 20, 2021

The European Commission has granted conditional marketing authorisation to Novavax for its COVID-19 vaccine: making it the first protein-based COVID-19 vaccine in the EU.

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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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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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BioPharma Reporter

FEBRUARY 1, 2022

US government agency, BARDA, is drawing on industry feedback to assist it in understanding the advanced developmental landscape of next-generation COVID-19 vaccines.

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BioPharma Reporter

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted Priority Review to GSKâs respiratory syncytial virus (RSV) older adult vaccine candidate with a decision expected in May 2023: which could make it the first vaccine approved against the virus.

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BioPharma Reporter

MAY 19, 2022

The World Health Organization (WHO) has today issued an emergency use listing (EUL) for Convidecia, a vaccine manufactured by CanSino Biologics, bringing the total number of COVID-19 vaccines validated by the organisation to 11.

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pharmaphorum

NOVEMBER 12, 2020

The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients. Vaccine doses for Europe will be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium.

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pharmaphorum

DECEMBER 2, 2020

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. Distribution will be prioritised – the Joint Committee on Vaccine and Immunisation has already set out priority groups who will receive the vaccine.

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pharmaphorum

AUGUST 12, 2021

The UK government has started ordering COVID-19 vaccines for a 2022 booster campaign, including a 32 million-dose order for the Pfizer/BioNTech shot, even before third doses for 2021 have been given the go-ahead. The Johnson & Johnson vaccine is also supplied on a no-profit basis. Pricing slammed.

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BioPharma Reporter

JANUARY 19, 2021

The European Commission has set out steps to ramp up production of COVID-19 vaccines; tackle issues in the supply chain; and boost vaccination campaigns.

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pharmaphorum

DECEMBER 10, 2020

The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. Shortly after however BioNTech confirmed that documents submitted as part of its marketing application for coronavirus vaccine BNT-162b had been accessed by the hackers.

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BioPharma Reporter

FEBRUARY 28, 2022

Medicago and GlaxoSmithKline (GSK) have gained approval for Covifenz, the companiesâ plant-based COVID-19 vaccine, from Health Canada.

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pharmaphorum

DECEMBER 7, 2020

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Health secretary Matt Hancock reportedly came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.

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BioPharma Reporter

DECEMBER 4, 2023

GSK CEO Emma Walmsley has told Reuters that the companyâs respiratory syncytial virus (RSV) vaccine is expected to make over $1.26 billion in its first year on the market.

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BioPharma Reporter

JANUARY 20, 2022

Valneva announced yesterday that results from a lab study showed three doses of its inactivated COVID-19 vaccine candidate, VLA2001, neutralized the Omicron variant.

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BioPharma Reporter

JANUARY 7, 2021

The World Health Organizationâs vaccine advisory group recommends the two doses of the Pfizer/BioNTech vaccine should be delivered 21 to 28 days apart: although it adds that the maximum time period between doses could be up to six weeks in some situations.

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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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BioPharma Reporter

FEBRUARY 27, 2024

Baseimmune, a biotech company that uses proprietary, deep learning AI to predict future pathogen mutations to generate novel vaccines, has closed its $11.3 million Series A funding round.

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BioPharma Reporter

JULY 24, 2023

LinKinVax, a clinical-stage biotech company, has announced the manufacture and bottling of a GMP batch of its next generation pan-sarbecovirus vaccines, known as PanCov, designed to prevent COVID-19 and other known coronavirus diseases.

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BioPharma Reporter

OCTOBER 5, 2020

The release of the FDA guidance on emergency use authorization (EUA) for vaccines to prevent the spread of COVID-19 would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the US regulator, says the Biotechnology Innovation Organization (BIO).

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