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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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

OCTOBER 23, 2024

A new FDA approval has given Pfizer a broader label for its respiratory syncytial virus (RSV) vaccine Abrysvo than rival shots from GSK and Moderna, but it may not make much of a difference in the battle for market share.The US regulator has cleared Abrysvo for use in adults aged 18 to 59 at risk of RSV-related disease, extending its earlier label (..)

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BioPharma Reporter

JANUARY 29, 2024

The global messenger ribonucleic acid (mRNA) vaccine market currently consists entirely of vaccines for COVID-19.

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Vaccination Vaccine Development Marketing 98

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

pharmaphorum

APRIL 21, 2021

The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. The PRAC was reviewing eight cases of thromboembolism with thrombocytopenia following vaccination in the US, one of which had a fatal outcome. Vaccinations save lives.

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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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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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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

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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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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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

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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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 105

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 116

XTalks

MAY 28, 2024

In a move signaling a major shift in influenza prevention strategies, CSL Seqirus, a global leader in flu vaccines, has transitioned from quadrivalent to trivalent formulations for the upcoming 2024/25 flu season in the US.

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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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Vaccination Vaccine Marketing Regulation 105

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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pharmaphorum

JANUARY 5, 2021

Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots. — Sandip Patel MD (@PatelOncology) January 2, 2021.

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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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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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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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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

OCTOBER 17, 2024

A report of a case of motor neuropathy in a patient who received the vaccine last year has led the FDA to halt its development while more information is gathered.

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Vaccination Vaccine Development Regulation 52

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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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

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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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

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

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 101

pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

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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

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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pharmaphorum

OCTOBER 17, 2022

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Takeda GmbH’s live, attenuated dengue tetravalent vaccine, Qdenga ( TAK-003 ). National regulators rely on the CHMP’s scientific assessment to decide on the use of the medicine within their countries.

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Vaccination Vaccine Medicine Regulation 52

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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