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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Vaccination Vaccine Marketing Sales 121

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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Regulation Vaccination Vaccine Trials 52

World of DTC Marketing

FEBRUARY 28, 2021

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Can a COVID-19 vaccine approval suddenly erase that? Johnson & Johnson has paid $2.7

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Vaccination Vaccine Contamination Compliance 180

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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Vaccination Vaccine Regulation Medicine 141

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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Vaccination Vaccine Marketing Clinical Trials 105

pharmaphorum

DECEMBER 9, 2021

If the UK creates regulatory frameworks that drastically diverge from those of its “science allies”, it could become a late – or even no – launch market for new treatments. The same principle applies to regulation,” she went on. The post Post-Brexit medicines regulation must have international scope appeared first on.

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Regulation Medicine Life Science Development 98

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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Vaccination Vaccine Protein Marketing 105

pharmaphorum

OCTOBER 28, 2022

The EMA has delivered some good news to GSK on a new long-acting HIV drug and vaccine for respiratory syncytial virus (RSV), in a week that saw multiple disappointments in other R&D projects. Those developments have placed much more onus on other projects – and particularly GSK’s RSV vaccine – to deliver quickly.

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Regulation Vaccination Vaccine Sales 52

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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Vaccination Vaccine Medicine Marketing 145

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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Vaccination Vaccine Regulation Marketing 98

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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Regulation Vaccination Vaccine Trials 52

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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Vaccination Vaccine Branding Regulation 180

pharmaphorum

DECEMBER 14, 2021

The first publication focused on market and patient access, whereas the new report concentrates on the final part of the route to marketing authorisation: from the final scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) to the final decision of the European Commission (EC). Tide of change.

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Regulation Marketing Life Science Medicine 90

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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Vaccination Vaccine Regulation Marketing 105

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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Vaccination Vaccine Marketing Development 102

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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Vaccination Vaccine Regulation Medicine 115

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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Vaccination Vaccine Marketing Regulation 105

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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Vaccination Vaccine Development Regulation 111

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

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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Vaccination Vaccine Protein Marketing 98

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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Vaccination Vaccine Protein Regulation 103

pharmaphorum

APRIL 30, 2021

It’s fair to say this is the most interesting time ever for market access. Not only has COVID forced companies, governments and healthcare systems to work towards approving drugs and vaccines in record times, the sector is also facing an influx of digital therapeutics and advanced drugs that don’t fit neatly into existing access frameworks.

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Marketing Sales Regulation Drugs 98

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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Vaccination Vaccine Regulation RNA 88

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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Vaccination Vaccine Protein Antibody 52

BioPharma Reporter

MARCH 15, 2021

AstraZeneca CEO, Pascal Soriot, has said 'there is absolutely no secondary market' in vaccines against COVID-19 amid rumors of broker activity.

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Marketing Vaccination Vaccine Regulation 52

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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Vaccination Vaccine Regulation Development 98

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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Vaccination Vaccine Regulation Marketing 95

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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Vaccination Vaccine Marketing Regulation 52

Drug Discovery World

MARCH 17, 2023

The conditional marketing authorisation was granted based on the results of two Phase II studies, MYR202 and MYR 203. The post Scottish regulator approves first chronic hepatitis delta virus drug appeared first on Drug Discovery World (DDW). However, to date, there have been severely limited treatment options for those affected.

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Regulation Drugs Licensing Licensing 52

BioPharma Reporter

OCTOBER 19, 2020

Moderna is engaging with international regulators to accelerate approval of its COVID-19 vaccine candidate.

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Vaccination Vaccine Regulation Marketing 105

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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Vaccination Vaccine Manufacturing Regulation 105

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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Vaccination Vaccine Production Licensing 96

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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Vaccination Vaccine Trials Regulation 95

BioPharma Reporter

DECEMBER 13, 2021

Moderna released what it deemed to be positive interim data from the phase 1 study of its quadrivalent flu vaccine, mRNA-1010, on Friday. But the markets were left underwhelmed.

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Vaccination Vaccine Marketing Regulation 105

pharmaphorum

AUGUST 8, 2022

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

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Marketing Sales Gene Editing Antibody 110

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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Vaccination Vaccine Licensing Licensing 98

BioPharma Reporter

FEBRUARY 18, 2021

South Africa has started administering the Janssen COVID-19 vaccine to health workers this week after the first doses arrived in the country. Meanwhile, J&J has submitted an application for Conditional Marketing Authorisation in the EU, following its application for EUA in the US.

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Vaccination Vaccine Marketing Regulation 119