BioPharma Reporter

JANUARY 29, 2024

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

Vaccination 98

Vaccination Vaccine Development Marketing 98

VirTrial

OCTOBER 25, 2023

Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participation follow-up periods, multiphase designs, and critical data management needs. In recent years, Signant has been a part of more than 95 vaccine studies involving 140,000+ patients in more than 30 countries.

Vaccination 52

Vaccination Vaccine Development Clinical Trials 52

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.

Vaccination 162

Vaccination Vaccine Clinical Trials Clinical Trials 162

XTalks

APRIL 15, 2021

Federal authorities in the US have recommended pausing the administration of J&J’s COVID-19 vaccine as half a dozen cases of rare blood clots reported among women who received the vaccine are under investigation. Related: COVID-19 Vaccine Messaging: Why Vaccine Efficacies Can’t Be Compared and Shopped.

Vaccination 98

Vaccination Vaccine Regulation Drugs 98

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.

Vaccination 145

Vaccination Vaccine Engineer Clinical Trials 145

pharmaphorum

MARCH 4, 2021

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. The post Budget 2021: Sunak focuses on vaccine development to restart economy appeared first on.

Vaccination 104

Vaccination Vaccine Development Life Science 104

XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. Related: Could Pfizer and BioNTech’s COVID-19 Vaccine be Stored at Standard Freezer Temperatures?

Vaccination 111

Vaccination Vaccine Development In-Vitro 111

XTalks

NOVEMBER 9, 2020

SARS-CoV-2 Vaccines Inch Towards Regulatory Approval. Over the past month or so, investigators have been amassing data on SARS-CoV-2 candidate vaccines as quickly as possible and some of that data is making its way—ever so much more slowly—through regulatory agencies for official scrutiny.

Vaccination 105

Vaccination Vaccine Development Drugs 105

The Pharma Data

JANUARY 29, 2021

EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. The move comes after the European Medicines Agency has been criticized for not moving fast enough to vaccinate its population.

Regulation 52

Regulation Vaccination Vaccine Clinical Trials 52

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 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).

Vaccination 98

Vaccination Vaccine Regulation Development 98

BioPharma Reporter

SEPTEMBER 28, 2020

Axon Neuroscience is launching the world's first crowdfunding exercise for the development of a COVID-19 vaccine, following what it says are strong pre-clinical results for its candidate.

Vaccination 88

Vaccination Vaccine Development Regulation 88

pharmaphorum

NOVEMBER 27, 2020

AstraZeneca is to run an additional global trial to test its COVID-19 vaccine at a lower dosage, as the UK regulator begins to review trial data. Health secretary Matt Hancock has asked the UK’s regulator the Medicines and Healthcare products Regulatory Agency (MHRA) to begin its review of the vaccine.

Regulation 62

Regulation Vaccination Vaccine Trials 62

BioPharma Reporter

MARCH 11, 2021

Its ambitions are for an âall-in-oneâ vaccine against SARS, MERS-CoV and SARS-CoV-2 coronaviruses; as well as reducing vaccine development into a 100 day timeframe. The Coalition for Epidemic Preparedness Innovations (CEPI) has set out a $3.5bn plan to âdramatically reduce or even eliminate the future risk of pandemicsâ.

Vaccination 98

Vaccination Vaccine Development Regulation 98

NY Times

JULY 12, 2021

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

Vaccination 116

Vaccination Vaccine Regulation Development 116

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.

Vaccination 180

Vaccination Vaccine Contamination Compliance 180

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.

Vaccination 52

Vaccination Vaccine Development Regulation 52

Medical Xpress

MARCH 22, 2023

China has approved its first locally developed messenger RNA (mRNA) vaccine against COVID-19, its manufacturer said Wednesday, months after the relaxation of strict COVID-zero regulations sparked a surge in cases.

Vaccination 70

Vaccination Vaccine RNA Regulation 70

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.

Vaccination 121

Vaccination Vaccine Production Regulation 121

pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As The same principle applies to regulation,” she went on.

Regulation 98

Regulation Medicine Life Science Development 98

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.

Regulation 52

Regulation Vaccination Vaccine Trials 52

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.

Regulation 52

Regulation Vaccination Vaccine Sales 52

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.

Vaccination 145

Vaccination Vaccine Regulation Trials 145

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

Regulation 52

Regulation Vaccination Vaccine Trials 52

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.

Vaccination 105

Vaccination Vaccine Protein Marketing 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.

Vaccination 117

Vaccination Vaccine Bacterium Protein 117

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?

Vaccination 180

Vaccination Vaccine Branding Regulation 180

pharmaphorum

DECEMBER 10, 2020

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Both recovered after appropriate treatment. Both are recovering well.”.

Allergies 99

Allergies Vaccination Vaccine Regulation 99

BioPharma Reporter

SEPTEMBER 28, 2020

Axon Neuroscience is launching the world's first crowdfunding exercise for the development of a COVID-19 vaccine, following what it says are strong pre-clinical results.

Vaccination 52

Vaccination Vaccine Development Regulation 52

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.

Vaccination 105

Vaccination Vaccine Marketing Development 105

Drug Discovery World

DECEMBER 6, 2022

As a result of clear US Food and Drug Administration (FDA) guidelines, the leading vaccine development programmes for Covid-19 were all remarkably similar. For example, care homes could have been selected at random to receive a Covid-19 vaccine, since not all care homes could be visited at once.

Development 98

Development Drugs Vaccination Vaccine 98

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.

Vaccination 104

Vaccination Vaccine Manufacturing Regulation 104

BioPharma Reporter

AUGUST 13, 2020

CureVac files to raise upward of $200 million in Nasdaq IPO to fund clinical development of COVID-19 vaccine.

Vaccination 90

Vaccination Vaccine Development Clinical Development 90

XTalks

AUGUST 17, 2022

August is National Immunization Awareness Month (NIAM), which is marked to help raise awareness about the importance of vaccines in the protection of public health. One of the themes of this year’s National Immunization Awareness Month is “vaccines work.” Vaccination Awareness from the FDA.

Vaccination 98

Vaccination Vaccine Bacteria Development 98

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. Further, with a pandemic treaty in development, there are reasons to believe that many countries and the WHO want to see a more equitable distribution of medical products for future pandemics.

Vaccination 95

Vaccination Vaccine Production Licensing 95

pharmaphorum

AUGUST 11, 2020

Russia has become the first country in the world to approve a coronavirus vaccine, amid scepticism from international experts who have been unable to review or verify clinical data from the jab called ‘Sputnik V’ According to press reports the vaccine has been tested on one of President Vladimir Putin’s daughters.

Vaccination 98

Vaccination Vaccine Trials Clinical Development 98

pharmaphorum

FEBRUARY 8, 2021

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme.

Vaccination 83

Vaccination Vaccine Immune Response Regulation 83