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.

Vaccination 52

Vaccination Vaccine Trials Bacteria 52

Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use. 45 years ago.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

The Pharma Data

NOVEMBER 5, 2021

s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir for the Treatment of Mild-to-Moderate COVID-19 in Grown-ups With a Positive SARS-CoV-2 Diagnostic Test and Who Have at Least One Threat Factor for Developing Severe Illness. Operations Remain Under Review by Other Regulatory Authorities, IncludingU.S.

Medicine 52

Medicine Licensing Licensing Vaccination 52

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.

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

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.

Vaccination 52

Vaccination Vaccine Immune Response Licensing 52

The Pharma Data

DECEMBER 19, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”. .–( BUSINESS WIRE )– Moderna, Inc.,

Vaccination 52

Vaccination Vaccine Licensing Licensing 52

The Pharma Data

JUNE 24, 2021

today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY ® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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.

Vaccination 75

Vaccination Vaccine Regulation RNA 75

Pfizer

JANUARY 27, 2023

telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply: Sufficient information is not available to assess renal and hepatic function.

Marketing 75

Marketing Production Drugs Licensing 75

Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

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.,

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

MARCH 26, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Medicines Agency (EMA) approved storage of COMIRNATY® at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.

Vaccination 52

Vaccination Vaccine Doctors Doctor 52

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. Enter the FDA’s Center for Veterinary Medicine (“CVM”).

Drugs 59

Drugs Licensing Licensing Containment 59

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).

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 26, 2021

If Granted Marketing Authorization by the European Commission, Molnupiravir Could Be the First Oral Antiviral Medicine for the Treatment of COVID-19 in the European Union. As preliminarily blazoned, Merck has submitted an operation for Emergency Use Authorization (EUA) to theU.S.

Medicine 52

Medicine Vaccination Vaccine Development 52

The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. The terms of the EUA allow use of the vaccine while more data are gathered.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

Delveinsight

DECEMBER 15, 2020

The FTA designation will help the pharma company to advance its research and development in the NASH landscape and help its commercialization in the market. The present NASH treatment market is dominated and supported by off-label therapies. Pfizer, BioNTech COVID-19 Vaccine rolls out in a watershed moment.

Vaccination 54

Vaccination Vaccine Gene Therapy Gene 54

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.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

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.”.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. This press release features multimedia.

Vaccination 52

Vaccination Vaccine Immune Response Antibody 52

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.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

Antibody 52

Antibody Licensing Licensing Development 52

pharmaphorum

NOVEMBER 24, 2021

The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients. Getting the UK’s COVID vaccine and treatments programme ahead of schedule. Why is this important for the UK?

Life Science 97

Life Science Regulation Medicine Vaccination 97

pharmaphorum

FEBRUARY 4, 2022

The approval of Novavax’ COVID-19 vaccine in Great Britain could help the country save a “considerable amount of money” if it is used in future booster campaigns, according to the former chair of UK Vaccine Taskforce. It was also filed in the US earlier this month after development and manufacturing setbacks.

Vaccination 98

Vaccination Vaccine Protein Manufacturing 98

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.

Vaccination 45

Vaccination Vaccine Medicine Gene Therapy 45

pharmaphorum

DECEMBER 21, 2020

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

Vaccination 96

Vaccination Vaccine Doctors Doctor 96

The Pharma Data

JULY 29, 2021

Takeda Will Focus its Efforts on Dengue, Zika and Pandemic Vaccines. HilleVax), a biopharmaceutical company to develop and commercialize Takeda’s norovirus vaccine candidate. President of the Global Vaccine Business Unit, Takeda. 2 Norovirus is recognized as the leading cause of acute gastroenteritis across the age spectrum.

Vaccination 52

Vaccination Vaccine Development Clinical Trials 52

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,

Vaccination 40

Vaccination Vaccine Containment Trials 40

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.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

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.

Vaccination 52

Vaccination Medicine Vaccine Licensing 52

Drug Discovery World

AUGUST 31, 2022

Biotechnology company Moderna has filed a patent infringement lawsuit against Pfizer and BioNTech in relation to the use of its messenger RNA (mRNA) technology and Pfizer and BioNTech’s Covid-19 Comirnaty vaccine. Moderna alleges that Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty.

Vaccination 52

Vaccination Vaccine Sales RNA 52

pharmaphorum

JUNE 11, 2021

Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. The Russian Sputnik V vaccine was approved for use in India in April. That includes the more transmissible B.1.617.2

Vaccination 67

Vaccination Vaccine Licensing Licensing 67

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced today that they have submitted an amended protocol to the U.S.

Vaccination 52

Vaccination Vaccine Trials Clinical Trials 52