FDA Law Blog

JANUARY 3, 2024

Enter the FDA’s Center for Veterinary Medicine (“CVM”). CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). So, much like humans, pets are living longer and facing the ailments so common to old age.

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The Pharma Data

NOVEMBER 13, 2020

WHO today listed the nOPV2 vaccine (Bio Farma, Indonesia) for emergency use to address the rising cases of a vaccine-derived polio strain in a number of African and East Mediterranean countries. The emergency use listing, or EUL, is the first of its kind for a vaccine and paves the way for potential listing of COVID-19 vaccines.

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The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

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The Pharma Data

JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.

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The Pharma Data

NOVEMBER 17, 2021

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7).

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The Pharma Data

APRIL 18, 2022

Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.

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The Pharma Data

APRIL 27, 2023

This is the first time an RSV vaccine candidate for adults has gained a positive opinion, one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. There are no RSV vaccines or specific treatments currently available for older adults. Efficacy was 94.6% (95% CI, 65.9–99.9,

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The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

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The Pharma Data

MAY 6, 2021

Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.

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The Pharma Data

MAY 27, 2022

AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. Pfizer Disclosure Notice: The information contained in this release is as of September 12, 2020. View the full release here: [link].

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Pfizer

SEPTEMBER 27, 2022

We’re proud to be strengthening our capacity to develop and produce more advanced medicines that can help improve the lives of patients. The facility also plays a major role in distributing the Pfizer-BioNTech COVID-19 vaccine, serving as the center for smaller shipments and vaccination kits. COVID-19, Vaccines.

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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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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 1 Adapted Bivalent Vaccine Candidate. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 1 Adapted Bivalent Vaccine Candidate. 1 as compared to the companies’ current COVID-19 vaccine.

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The Pharma Data

NOVEMBER 20, 2020

billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date. by the middle to end of December 2020. participants are 56-85 years of age.

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The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 .–(BUSINESS WIRE)–Dec. 8, 2020– Moderna, Inc.,

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Pfizer

SEPTEMBER 27, 2022

Embodied by our “Science Will Win” campaign, Pfizer is at the forefront of the vital research being conducted to find treatments, cures and preventive medicines to the diseases that currently confound us. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted COVID-19, Vaccines.

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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. Health Canada has also published a guidance document that contains additional information for drug sponsors.

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The Pharma Data

DECEMBER 1, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. The distribution of the vaccine in the U.K.

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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

AUGUST 20, 2020

times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. Jansen, Ph.D.,

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The Pharma Data

APRIL 27, 2021

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients.

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Pharmaceutical Technology

MAY 15, 2023

Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. Its primary focus is on oncology, cardiovascular, immunology, and fibrotic therapeutic projects.

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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

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The Pharma Data

DECEMBER 23, 2020

” Dr. Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” . PLYMOUTH MEETING, Pa. , PLYMOUTH MEETING, Pa. , mg and 2.0

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The Pharma Data

NOVEMBER 9, 2020

Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-adapted bivalent vaccine. 5) AUTHORIZED USES .

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. BA HCP ISI 09JUL2020.

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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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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. The vaccine was previously made available to this age group in the U.S. Fri, 07/08/2022 - 11:48. Pfizer and BioNTech Announce U.S.

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Pfizer

JULY 8, 2022

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series.

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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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Drug Discovery World

MARCH 29, 2023

An example of the current disparity, drawn from data from the European Federation of Pharmaceutical Industries and Associations (EFPIA), can be seen in Romania, Poland or Bulgaria, where a recently approved medicine will take more than 800 days on average before it becomes publicly available compared with Germany, where that figure is 133 days 3.

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The Pharma Data

MARCH 4, 2021

Our work together demonstrates the strength of Takeda’s partnership model and our commitment to delivering transformative medicines to patients with neurological diseases.”. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. Ovid has a broad pipeline of potential first-in-class medicines.

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pharmaphorum

SEPTEMBER 18, 2020

In June 2007, AstraZeneca completed the acquisition of vaccine maker MedImmune, buying its drug-development pipeline for $15.2 In some positive news from the period, though, AstraZeneca, along with nine other biopharmaceutical companies, formed a non-profit organisation to accelerate the development of new medicines. A comeback story?

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