Pharmaceutical Technology

AUGUST 26, 2022

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On the same day, the FDA granted a EUA to Bavarian Nordic’s (Copenhagen, Denmark) Jynneos vaccine.

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World of DTC Marketing

SEPTEMBER 10, 2021

The government has the latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” We, as a nation, can not allow ignorance and stupidity to endanger us all. It is reckless at this point for the government not to mandate vaccination.

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Pharmaceutical Technology

AUGUST 14, 2022

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.

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BioSpace

FEBRUARY 2, 2021

The vast majority of COVID-19 vaccines on the market or in development are administered through an injection, but Vaxart is attempting to develop an oral vaccine.

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BioPharma Reporter

DECEMBER 6, 2021

Australiaâs Noxopharm has in-licensed novel RNA tech developed by Hudson Institute of Medical Research: focusing on RNA drug discovery and mRNA vaccine manufacture via Noxopharmâs subsidiary Pharmorage.

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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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pharmaphorum

NOVEMBER 23, 2021

Sanofi has bolstered its push into mRNA-based therapies with a new licensing deal – but not as might be expected with some up-and-coming biotech company. Sanofi is the first pharma company to partner with Baidu on its LinearDesign AI platform, which has been developed specifically to optimise the sequence of mRNA-based vaccines and drugs.

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Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5-adapted bivalent vaccine.

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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

MAY 7, 2021

Pfizer and BioNTech have started a rolling submission for a Biologics License Application (BLA) in the US for their COVID-19 vaccine.

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BioPharma Reporter

APRIL 13, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford, has received its first regulatory clearance.

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XTalks

NOVEMBER 8, 2023

In this episode, Ayesha talked about the FDA’s acceptance of AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. Hear more about the ad featuring the Canadian hockey icon.

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pharmaphorum

DECEMBER 6, 2022

Pfizer and partner BioNTech have launched a countersuit against Moderna in a patent despite centring on their mRNA-based vaccines for COVID-19. It also waived its rights to bring the lawsuit when it pledged not to sure other COVID-19 vaccine producers during the pandemic, according to Reuters.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

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BioPharma Reporter

JULY 19, 2021

The US Food and Drug Administration (FDA) has granted priority review designation for Pfizer and BioNTechâs COVID-19 vaccine Biologics License Application (BLA).

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BioPharma Reporter

JUNE 14, 2021

Ocugen will pursue submission of a biologics license application (BLA) in the US for the COVID-19 vaccine candidate, COVAXIN, rather than a EUA application. The company believes that the differentiated vaccine has the potential to address variants, as well as planning to undertake paediatric and booster trials.

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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. Vaccine access for a price. Tendayi Achium, labelled the response by the global community as a form of “vaccine apartheid,” a suggestion echoed by the organisation’s director general.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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pharmaphorum

MARCH 22, 2022

Bavarian Nordic has licensed rights to its respiratory syncytial virus (RSV) vaccine in China and certain other Asian markets to Shanghai’s Nuance Pharma in a $225 million deal. million tied to clinical, regulatory, and commercial milestones as well as royalties on sales if MVA-BN RSV is launched in those markets.

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XTalks

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. FluMist has been in the market since 2003 and is the only intranasal spray vaccine option against flu.

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pharmaphorum

OCTOBER 7, 2021

Moderna has said it plans to invest $500 million in a new facility for manufacturing mRNA vaccines in Africa, and has kicked off a search to find a suitable country and location. of Africans have been fully vaccinated against COVID-19, and just 15 African nations have met the agency’s objective of 10% coverage.

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pharmaphorum

NOVEMBER 24, 2020

The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot. Pfizer and Moderna’s vaccines require much lower temperatures to prevent their active ingredients from breaking down.

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NY Times

NOVEMBER 30, 2021

The new agreement makes Aspen Pharmacare the first African company to market a Covid vaccine on the continent. But it stops short of allowing Aspen to make the ingredients in the vaccine.

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NY Times

NOVEMBER 30, 2021

The new agreement makes Aspen Pharmacare the first African company to market a Covid vaccine on the continent. But it stops short of allowing Aspen to make the ingredients in the vaccine.

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Pharmaceutical Technology

OCTOBER 19, 2022

According to the deal, the worldwide rights for developing and marketing intratumoral combination treatment containing Eucure’s YH002 and two additional active ingredients of the Syncrovax therapy will be acquired by Syncromune. The post Syncromune and Eucure enter antibody licence deal appeared first on Pharmaceutical Technology.

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World of DTC Marketing

FEBRUARY 11, 2022

Pfizer has held a vaccine monopoly, blocking low-income countries from accessing its novel technology, while enriching shareholders at levels advocates for vaccine equity label “obscene.” Sure they developed a vaccine but isn’t it a moral responsibility to share it with the world? The Atlantic ). How much profit is enough?

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BioPharma Reporter

NOVEMBER 23, 2021

Vaccibody, a Norway-based pioneer in the neoantigen cancer vaccine space, has changed its name to Nykode Therapeutics, and has entered into a license and collaboration agreement with US company, Regeneron, to develop vaccines against cancer and infectious diseases.

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pharmaphorum

AUGUST 26, 2022

The rivalry between Moderna and Pfizer/BioNTech in commercialising their COVID-19 vaccines has now spilled over into the courts, in the form of a patent infringement lawsuit. ” There’s no world yet on whether a counter-suit may be in the offing. .” Lawsuits sprouting like mushrooms.

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pharmaphorum

JANUARY 7, 2021

Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped. The post Bayer joins the COVID-19 vaccine push, backing CureVac shot appeared first on.

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BioPharma Reporter

JUNE 1, 2021

Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.

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Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . VLA15 is the only Lyme disease vaccine candidate currently in clinical development. Valneva Pfizer Report Positive Phase 2 Pediatric Data for Lyme Vaccine Candidate.

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pharmaphorum

AUGUST 16, 2020

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

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Pharmaceutical Technology

AUGUST 1, 2022

Since 2020, government agencies have provided funding for expensive late-stage vaccine development and the expansion of manufacturing capacity, as well as other key pharmaceutical activities. The shift from private to public funding enabled more rapid development of Covid-19 drugs and vaccines.

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pharmaphorum

FEBRUARY 19, 2021

billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, which aims to ensure fair access across the globe. There are growing concerns about the lack of COVID vaccines available to poorer countries. Novavax has signed a deal to provide 1.1

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Pfizer

APRIL 14, 2023

Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines kimkevin Fri, 04/14/2023 - 15:38 Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines Friday, January 22, 2021 - 11:21am Share We have crossed another milestone in the fight against COVID-19.

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pharmaphorum

SEPTEMBER 8, 2022

On the strength of phase 2 data, the FDA has awarded coveted breakthrough status to Pfizer’s vaccine against Group B Streptococcus (GBS), given to expectant mothers to prevent invasive infections in newborns and young infants. The post FDA gives Pfizer’s Group B strep vaccine breakthrough status appeared first on.

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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. Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effective in a phase 3 trial.

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