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?

Vaccine 180

Vaccine Vaccination Branding Regulation 180

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.

Vaccine 145

Vaccine Vaccination Medicine Marketing 145

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.

Vaccine 147

Vaccine Vaccination Immune Response Protein 147

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.

Vaccine 122

Vaccine Vaccination Marketing Sales 122

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.

Vaccine 105

Vaccine Vaccination Marketing Clinical Trials 105

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.

Regulation 98

Regulation Vaccine Vaccination Development 98

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.

Doctors 126

Doctors Doctor Vaccine Vaccination 126

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.

Vaccine 119

Vaccine Vaccination Bacterium Protein 119

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.

Vaccine 116

Vaccine Vaccination Regulation Medicine 116

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.

Vaccine 105

Vaccine Vaccination Regulation Marketing 105

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.

Vaccine 98

Vaccine Vaccination Regulation Marketing 98

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.

Regulation 98

Regulation Medicine Life Science Development 98

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.

Vaccine 140

Vaccine Vaccination Regulation Marketing 140

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.

Vaccine 105

Vaccine Vaccination Manufacturing 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.

Vaccine 117

Vaccine Vaccination Marketing Regulation 117

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).

Vaccine 98

Vaccine Vaccination Regulation Development 98

pharmaphorum

NOVEMBER 13, 2020

Hungary is to order a consignment of Russia’s Sputnik V COVID-19 vaccine, as the country struggles to contain the infection rate. According to press reports , the decision puts Hungary on “collision course” with the EU, which has not approved the vaccine or plans to review it either. The country has had more than 1.8

Vaccine 115

Vaccine Vaccination Pharma Companies Containment 115

BioPharma Reporter

FEBRUARY 28, 2022

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

Vaccine 133

Vaccine Vaccination Regulation Marketing 133

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.

Marketing 97

Marketing Sales Regulation Drugs 97

BioPharma Reporter

JANUARY 29, 2024

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

Vaccine 88

Vaccine Vaccination Development Marketing 88

pharmaphorum

OCTOBER 5, 2020

As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any vaccine that is deemed to be a safe and effective way of preventing the disease. There is going to be no vaccination of people under 18.

Vaccine 111

Vaccine Vaccination Regulation Development 111

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.

Vaccine 93

Vaccine Vaccination Protein Marketing 93

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.

Vaccine 111

Vaccine Vaccination Immune Response Sales 111

BioPharma Reporter

FEBRUARY 9, 2021

Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.

Clinical Trials 145

Clinical Trials Clinical Trials Vaccine Vaccination 145

pharmaphorum

NOVEMBER 26, 2020

The UK’s pharma industry trade body has warned that Brexit could derail the government’s efforts to get coronavirus vaccines to the population, but welcomed other measures in this week’s spending review aimed at reviving the economy after the pandemic.

Vaccine 105

Vaccine Vaccination Life Science Regulation 105

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.

Vaccine 104

Vaccine Vaccination Marketing Regulation 104

BioPharma Reporter

SEPTEMBER 21, 2020

Sanofi and GSK will provide the EU with up to 300 million doses of their COVID-19 vaccine candidate, with the agreement suppporting scale-up of manufacturing capabilities in several European countries.

Vaccine 138

Vaccine Vaccination Manufacturing Regulation 138

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

Vaccine 102

Vaccine Vaccination Protein Regulation 102

BioPharma Reporter

DECEMBER 1, 2020

Johnson & Johnson has started a rolling submission with the European Medicines Agency (EMA) for its single-dose COVID-19 vaccine candidate.

Vaccine 127

Vaccine Vaccination Medicine Regulation 127

BioPharma Reporter

DECEMBER 17, 2020

New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.

Vaccine 125

Vaccine Vaccination Regulation Marketing 125

BioPharma Reporter

MARCH 11, 2021

Denmark has halted its vaccination campaign with COVID-19 Vaccine AstraZeneca, as a precautionary measure while a full probe is ongoing into reports of blood clots in people who received the vaccine, including one case in that country, where a person died.

Vaccine 115

Vaccine Vaccination Regulation Marketing 115

Pharma in Brief

DECEMBER 3, 2020

Any authorization for drugs, vaccines, and medical devices issued pursuant to the interim orders are also set to terminate when the respective interim order expires or is withdrawn. Drugs and Vaccines. require market authorization holders to meet post-marketing regulatory requirements; and.

Vaccine 98

Vaccine Vaccination Drugs Manufacturing 98

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.

Vaccine 89

Vaccine Vaccination Recombinant DNA Technology Trials 89

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.

Marketing 111

Marketing Sales Gene Editing Antibody 111

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.

Vaccine 95

Vaccine Vaccination Marketing Regulation 95

pharmaphorum

SEPTEMBER 15, 2020

As pharmaceutical marketers prepare their brands for the future, there are a number of important ways they can learn from digitally-native brands. This is reinforced by web-focused marketing strategies that give them a highly-targeted approach when it comes to marketing execution.”. Be more agile .

Branding 127

Branding Marketing Pharma Companies Life Science 127

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.

Vaccine 86

Vaccine Vaccination Protein Marketing 86