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

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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FDA Law Blog

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. 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

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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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

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

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). Today, the U.S. Solomon, D.V.M.,

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Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Disclosure Notice The information contained in this statement is as of January 27, 2023.

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Pfizer

AUGUST 11, 2022

Pfizer sold Zantac only between 1998 and 2006, and the withdrawal of Zantac products from the market in 2019 and 2020 did not involve any Pfizer products. The information contained in this statement is as of August 11, 2022. COVID-19, Vaccines. 1 Adapted Bivalent Vaccine Candidate. COVID-19, Vaccines. 07.19.2022.

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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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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. Bayer holds further options to become Marketing Authorization Holder in other markets outside of Europe.

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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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XTalks

AUGUST 3, 2021

The National Council of Negro Women (NCNW) filed a lawsuit last week asking courts to make Johnson & Johnson create equally targeted “corrective marketing,” and/or fund outreach efforts warning Black women and their families about the risk of ovarian cancer associated with its product.

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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

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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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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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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pharmaphorum

JANUARY 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. Add to this the fact that the world missed the WHO targets for global vaccination by the end of 2021 and will likely continue to miss targets in 2022.

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The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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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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pharmaphorum

JANUARY 27, 2021

The approval and roll out of the COVID-19 vaccines have put the spotlight on clinical trials. is a phrase I’ve seen repeatedly on social media over the past few weeks, especially when the news broke of the Medicines and Health Products Regulatory Agency’s speedy approval of the Pfizer-BioNTech COVID-19 vaccine in the UK.

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Pharma in Brief

JANUARY 24, 2021

The industry was among the heroes of 2020, developing, commercializing and distributing drugs, vaccines, and personal protective equipment to deal with COVID-19 at remarkable speeds. The year saw the first trials and decisions in actions under the new Patented Medicines (Notice of Compliance) Regulations ( PM(NOC) Regulations ).

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The Pharma Data

JANUARY 17, 2021

Outlook The prevalence of COVID-19 across the globe has increased substantially since the trading update provided in November and Genus expects there will continue to be some challenges for our customers and employees for the remainder of our financial year, despite the prospect of better conditions as vaccines are being made available.

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WCG Clinical

NOVEMBER 20, 2023

Insufficient Regulatory Status Information The first category includes missing or insufficient regulatory status information about the test article utilized such as: drugs, vaccines, biologics, medical devices, combination products, dietary supplements, or human cells, tissue, and cellular and tissue-based products (HCT/Ps). a) (1) to (4).

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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

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

MARCH 3, 2021

Nally, chief marketing officer, is scheduled to participate in the Barclays Global Healthcare Conference on March 9, 2021 at 1:50 p.m. KENILWORTH, N.J.–(BUSINESS BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Michael T. About Merck.

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FDA Law Blog

SEPTEMBER 10, 2023

Interventional studies are generally clinical investigations under the regulations and thus require an IND under 21 C.F.R. § The COVID-19 vaccines were initially authorized under EUAs, but their approvals do not appear to have been based on RWE. Does this offer the potential to use RWE for an initial approval?

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The Pharma Data

DECEMBER 4, 2020

Britain First to Approve Emergency Use of Pfizer’s COVID vaccine. Britain became the first Western country to allow emergency use of a coronavirus vaccine on Wednesday, approving Pfizer’s candidate in the race to inoculate millions of people around the globe.

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The Pharma Data

DECEMBER 3, 2020

.” Britain First to Approve Emergency Use of Pfizer’s COVID vaccine. Britain became the first Western country to allow emergency use of a coronavirus vaccine on Wednesday, approving Pfizer’s candidate in the race to inoculate millions of people around the globe.

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The Pharma Data

MAY 15, 2021

Sam Hansen is a pen name used for marketing purposes and to protect the author’s identity. Please read the CLICKBANK client contract and all accompanying CLICKBANK policies to ensure your compliance with all applicable policies, rules and regulations. Any likeness to a real Sam Hansen living or dead is entirely coincidental.

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The Pharma Data

MAY 14, 2021

Brad Cameron is a pen name used for marketing purposes and to protect the author’s identity. Please read the CLICKBANK client contract and all accompanying CLICKBANK policies to ensure your compliance with all applicable policies, rules and regulations. Any likeness to a real Brad Cameron living or dead is entirely coincidental.

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The Pharma Data

JANUARY 29, 2021

Once extensively validated, MedMira’s neutralizing antibody test can effectively pinpoint the antibodies with the blocking capability, thus, potentially, serving as a powerful tool for the qualitative assessment of the antibody status pre- and post-vaccination, as well as providing insights into one’s immunity to SARS-CoV-2. About MedMira.

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The Pharma Data

FEBRUARY 25, 2021

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. About Merck.

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