The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure.

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The Pharma Data

JANUARY 8, 2021

For example, pharmaceutical regulatory bodies are working tirelessly to fast track the approval of vaccines to treat Covid-19, doctors are now better prepared to handle patients with coronavirus and testing is becoming faster and more accessible. The New Year brings new hope as UK regulators approve Oxford vaccine for emergency use.

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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

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

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 24, 2021

per cent of healthy Canadians had been exposed to SARS-CoV-2, the virus causing COVID-19. We have no choice but to keep up public health measures until vaccine-induced immunity grows substantially.”. As more Canadians are vaccinated, we will start seeing a significant increase in the proportion of the population with antibodies.

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The Pharma Data

OCTOBER 29, 2020

Government to Cover COVID-19 Vaccine, Treatments. Insurance rules that will grant every American free access to COVID-19 vaccines when they are approved were issued by the government on Wednesday, the Associated Press reported. The regulations take effect immediately, the AP said. The rules, from the U.S.

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The Pharma Data

JANUARY 24, 2021

(NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110.

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The Pharma Data

MAY 13, 2021

CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 ( NYTimes ) ( Reuters ) ( STAT ). US CDC finds more clotting cases after J&J vaccine, sees causal link ( Reuters ) ( NBC ) ( NYTimes ). Covid vaccines may not protect people with immune disorders. In Focus: US.

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The Pharma Data

OCTOBER 19, 2020

The refusal to share data or even basic information about the study and the pause comes on the heels of a recent and widely-touted joint pledge of prudence and caution on vaccine trial safety by nine drug companies, including J&J, working on COVID 19 vaccines. Since the beginning of the pandemic, COVID-19 has infected 40.3

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The Pharma Data

DECEMBER 4, 2020

And I think we’ll see a significant reduction” in the virus, Biden told CNN. Britain First to Approve Emergency Use of Pfizer’s COVID vaccine. And it has stirred up a global debate about how to balance the dire need for a vaccine against the importance of looking for clear signs that a vaccine is safe.

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The Pharma Data

DECEMBER 3, 2020

Though coronavirus cases have exploded recently, with new infections topping 1 million a week, a far smaller proportion of people who get the virus now are dying from it. ” Britain First to Approve Emergency Use of Pfizer’s COVID vaccine. But there are daunting obstacles to the vaccine’s delivery to the masses.

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The Pharma Data

JULY 23, 2021

In December 2020, Chugai obtained development and exclusive commercialisation rights in Japan from Roche, and is working with the Japanese government to ensure an appropriate and timely supply of Ronapreve. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work. About Ronapreve (casirivimab and imdevimab).

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The Pharma Data

MAY 27, 2022

.’ This groundbreaking initiative aims to provide all of Pfizer’s patented, high-quality medicines and vaccines available in the U.S. “As we learned in the global COVID-19 vaccine rollout, supply is only the first step to helping patients. or the European Union on a not-for-profit basis to 1.2

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

SEPTEMBER 20, 2020

Covid restrictions in England will get tougher if rules are not followed, Matt Hancock has warned, as the government introduces £10,000 fines for people who fail to self-isolate. The government’s scientific advisers have suggested as many as four out of five people who should be self-isolating bend or break the rules.

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The Pharma Data

MARCH 22, 2021

Earlier this year, the EMA’s Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work.

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The Pharma Data

SEPTEMBER 22, 2020

In the House of Common, the Prime Minister told MPs: “We always knew that while we might have driven the virus into retreat, the prospect of a second wave was real. How far is it prepared to go to contain the virus? ” He also confirmed that office workers were being asked to work from home once again, if possible.

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The Pharma Data

OCTOBER 22, 2020

The twenty-sixth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on the international spread of poliovirus was convened and opened by the WHO Deputy Director-General on 14 October 2020 with committee members attending via video conference, supported by the WHO Secretariat.

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The Pharma Data

JANUARY 13, 2021

The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix’s lead vaccine candidate, TNX-1800 , is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response.

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The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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Agency IQ

NOVEMBER 3, 2023

Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. The regulation expanded EMA’s mandate to monitor and mitigate shortages, as well as establish lists of critical medicines during major events that affect public health. [See wide level.

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The Pharma Data

SEPTEMBER 8, 2020

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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The Pharma Data

DECEMBER 3, 2020

Today, transplant patients who do not respond or experience adverse events related to existing therapies may be at higher risk for complications from the virus, including transplant failure and death. 3 CMV is a ubiquitous virus that typically resides latent and asymptomatic in the body but reactivates during periods of immunosuppression.

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The Pharma Data

DECEMBER 30, 2020

30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. This is the first authorisation for this vaccine.

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The Pharma Data

DECEMBER 18, 2020

COVAX now has agreements in place to access nearly two billion doses of several promising vaccine candidates, and laid the groundwork for further doses to be secured through contributions from donors. billion donor-funded doses of approved vaccines in 2021 to the 92 low- and middle-income economies eligible for the COVAX AMC.

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The Pharma Data

APRIL 28, 2021

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Globally, infectious diseases are responsible for more than 8.4 For more than 170 years, we have worked to make a difference for all who rely on us.

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Agency IQ

NOVEMBER 3, 2023

Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. The regulation of dietary supplements in the U.S. According to the FDA, a recombinant LBP is distinctive from a standard LBP.

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The Pharma Data

JUNE 18, 2021

Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay. Some people have died from these infections. Are pregnant or plan to become pregnant.

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The Pharma Data

OCTOBER 14, 2020

Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. CHATHAM, N.J., About TNX-1800. 1 Noyce RS, et al.

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The Pharma Data

OCTOBER 28, 2020

government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. government will accept the vials of bamlanivimab if it is granted an Emergency Use Authorization (EUA) by the U.S. Supply agreements with governments – such as this one with the U.S.

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Codon

MARCH 7, 2024

Because, as it had been so eloquently and so hopefully stated, ‘If it takes a village to raise a child, it takes thousands of villages, cities, governments, laboratory and social scientists, and donors, committed and working together, to traverse the last mile required for disease eradication. This is why you need vaccines and cures.

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The Pharma Data

FEBRUARY 22, 2021

Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay. Some people have died from these infections. Are pregnant or plan to become pregnant.

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The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. Review will support a formal Marketing Authorisation Application.

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Drug Discovery World

SEPTEMBER 16, 2022

One example the Cell and Gene Therapy Catapult regards as a benefit for developers in the UK is the effort the government puts in to support the industry. . BioMed Realty, a prominent life sciences real estate provider, acquired a 7.5-acre Key comment US . “We We can’t discount the terrific momentum happening on this front in the US.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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The Pharma Data

NOVEMBER 9, 2020

Testing Therapies, Antivirals and Vaccines. CureVac NV , located in Tübingen, Germany, published detailed interim Phase I data of its COVID-19 vaccine candidate, CVnCoV. With the entire world watching, Pfizer and BioNTech released very promising interim data from the Phase III COVID-19 vaccine trial. Other Industry News.

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