pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. Good news for everyone the Oxford vaccine trials are back up and running. We will back our scientists to deliver an effective vaccine as soon as safely possible [link].

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Pfizer

APRIL 26, 2023

Albert Bourla Every day, I am asked about how Pfizer and our partners at BioNTech will distribute our COVID-19 vaccine now that it has begun to be authorized by regulators in different countries. But the underlying question is always the same: How will Pfizer and BioNTech ensure a seamless distribution of our vaccine?

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pharmaphorum

DECEMBER 7, 2020

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Health secretary Matt Hancock reportedly came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Continued authorization for COVID-19 drugs.

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pharmaphorum

NOVEMBER 30, 2020

The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. The vaccines can only be kept in a fridge for up to five days before being administered, although Pfizer has designed a “pizza box” style transportation container.

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XTalks

AUGUST 16, 2022

Health regulators in the UK have become the first in the world to approve Moderna’s next generation COVID-19 vaccine booster that includes targeting of the Omicron variant. The primary series of Moderna’s COVID vaccine remains at two doses. Related: Menarini Diagnostics’ New COVID-19 Test Detects Variants Including Omicron.

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Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity. The process eliminates the disadvantages of conventional drying methods or freezing.

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The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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The Pharma Data

MARCH 18, 2021

Today the Medicines Health Regulatory Authority (MHRA) and European Medicines Agency (EMA) reaffirmed the benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks. Furthermore, there was no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.

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The Pharma Data

AUGUST 31, 2020

Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. We are deeply committed to providing global access to our SARS-CoV-2 vaccine candidate.

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The Pharma Data

MARCH 14, 2021

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine. COVID-19 Vaccine AstraZeneca , formerly AZD1222.

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The Pharma Data

DECEMBER 30, 2020

The United Kingdom authorized AstraZeneca ’s COVID-19 vaccine on Wednesday, but it could be April at the earliest before the drug will likely be administered in the United States, Operation Warp Speed’s chief said. Those concerns have pushed back expected Emergency Use Authorization (EUA) of the AstraZeneca vaccine by two months.

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. There were no serious adverse safety events.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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The Pharma Data

AUGUST 5, 2020

Government for 100 Million Doses of Investigational COVID-19 Vaccine. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. Johnson & Johnson Announces Agreement with U.S.

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pharmaphorum

JULY 9, 2021

The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of heart inflammation. . Myocarditis is generally the result of a viral infection, so could be unrelated to the mRNA vaccines, particularly as neither of them contain any live virus.

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The Pharma Data

MARCH 5, 2021

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway. Disclaimer.

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The Pharma Data

NOVEMBER 16, 2020

We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

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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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The Pharma Data

OCTOBER 22, 2021

At least 24 million doses of the mRNA-based vaccine will be filled in 2022 into vials under sterile conditions at Novartis Technical Operations state-of-the-art facility in Ljubljana, Slovenia New agreement follows earlier supply agreement for the fill and finish of more than 50 million doses in 2021 at the Novartis Stein site in Switzerland.

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The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

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Pfizer

AUGUST 11, 2022

The information contained in this statement is as of August 11, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. . COVID-19, Vaccines. 1 Adapted Bivalent Vaccine Candidate. COVID-19, Vaccines.

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, NEW BRUNSWICK, N.J.,

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The Pharma Data

MARCH 2, 2021

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today it has entered into multiple agreements to support efforts to expand manufacturing capacity and supply of SARS-CoV-2/COVID-19 medicines and vaccines. Department of Health and Human Services (HHS), will provide Merck with funding of up to $268.8 About Merck.

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The Pharma Data

OCTOBER 19, 2020

.–( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. among adults 65 years of age or older.

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XTalks

NOVEMBER 28, 2023

In the US, the regulation of food products, including the ban on certain items, falls primarily under the jurisdiction of two key agencies: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). They are banned because they contain non-edible items, posing a risk, particularly to children.

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The Pharma Data

DECEMBER 2, 2020

2, 2020 – Britain became the first Western country to allow emergency use of a coronavirus vaccine on Wednesday, after approving Pfizer’s candidate in the race to inoculate millions of people around the globe. But there are daunting obstacles to the vaccine’s delivery to the masses. WEDNESDAY, Dec.

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. billion doses by the end of 2021.

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The Pharma Data

JANUARY 6, 2021

Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate CVnCoV. “The need for vaccines against COVID-19 is enormous. “We are highly committed to making our capabilities and networks available to help end this pandemic.”

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The Pharma Data

OCTOBER 28, 2020

OSAKA, Japan–( BUSINESS WIRE )– Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), announced today that it will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan. President of the Global Vaccine Business Unit, Takeda.

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FDA Law Blog

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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The Pharma Data

DECEMBER 30, 2020

Becomes First Country to Approve Covid-19 Vaccine From Oxford-AstraZeneca. Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. More Dangerous Mouthwashes and Hand Sanitizers Recalled. Shane Erickson Inc.

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Pfizer

APRIL 14, 2023

I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine.

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Drug Discovery World

JANUARY 11, 2024

Patients affected by the disease are found to also experience an imbalance of glutathione regulation, which is important for liver detoxification. Co-lead Principal Investigator, Dr Julien Baruteau (UCL Great Ormond Street Institute of Child Health), said: “mRNA has revolutionised the field of vaccines during the Covid-19 pandemic.

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