The Pharma Data

MARCH 26, 2021

The new data is a testament to the companies’ ongoing commitment to developing this vaccine further and collecting data in order to support broader and more flexible vaccine distribution and inoculation. From the beginning our goal was to make our vaccine broadly available to people around the world. Source link:[link].

Vaccine 52

Vaccine Doctors Pharmacy 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. Healthcare workers have been on the front lines of the fight against the virus and are an inspiration to us all.

Vaccine 52

Vaccine Long-Term Care Facilities FDA Licensing 52

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development. For more information, visit www.avantgen.com.

Licensing 52

Licensing Licensing Therapies Engineering 52

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.

Vaccine 52

Vaccine Pharmaceutical Companies Clinical Trials Virus 52

The Pharma Data

JANUARY 12, 2021

Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government’s Operation Warp Speed goals. million doses. . We are pleased to work with the U.S.

Government 52

Government Hospitals Virus Production 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.”.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

JUNE 24, 2021

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. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. g doses of the COVID-19 vaccine.

Vaccine 52

Vaccine Clinical Trials FDA Trials 52

The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. government have agreed to modify the purchase agreement of bamlanivimab alone and focus on supply of bamlanivimab and etesevimab together. It was identified from a blood sample taken from one of the first U.S.

Government 52

Government Long-Term Care Facilities Hospitals Treatment 52

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. Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 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.

Vaccine 52

Vaccine Trials Clinical Trials Small Molecule 52

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.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

The Pharma Data

MARCH 25, 2022

People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld. 14) The reduced Fc effector function aims to minimise the risk of antibody-dependent enhancement of disease – a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.(15)

Vaccine 52

Vaccine Virus Immune Response Government 52

The Pharma Data

MARCH 29, 2022

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “The EU approval represents an important milestone in our efforts to help prevent COVID-19, and we will continue to work with governments across Europe to make Evusheld available as quickly as possible. Christoph D.

Vaccine 52

Vaccine Virus Immune Response Government 52

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.

FDA Approval 52

FDA Approval FDA Vaccine Pharmacy 52

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.,

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

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.

Licensing 40

Licensing Licensing Therapies Laboratories 40

The Pharma Data

OCTOBER 25, 2020

Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. The vaccine candidate is called “spike ferritin nanoparticle” (SpFN) and uses ferritin—“attaching a certain type of spike protein to a polymerized version of ferritin,” according to the organization.

Vaccine 52

Vaccine Clinical Trials Trials Virus 52

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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

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.,

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

SEPTEMBER 12, 2020

It comes as one scientist warned the UK was “on the edge of losing control” of the virus. “There is an anticipation that everyone is going to have a big last binge, but people are starting to get fearful and a lot of licensed premises have already been clamped down on by the police,” he said.

Virus 52

Virus Government Licensing Licensing 52

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).

Treatment 52

Treatment Virus Clinical Trials Government 52

The Pharma Data

MARCH 22, 2022

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

Treatment 52

Treatment Virus Hospitals RNA 52

The Pharma Data

JANUARY 5, 2021

Telemedicine isn’t new, but the COVID-19 pandemic has really put the technology front and center, with clinics closing for certain services after state and local governments issued stay-at-home orders to help prevent the spread of the virus. In April, HHS allowed licensed pharmacists to test patients for COVID-19.

Doctors 52

Doctors Pharmacy Vaccine Licensing 52

The Pharma Data

NOVEMBER 2, 2020

By the beginning of April, over 5,000 people in the same church location had tested positive for the virus. Despite the persecution, Chairman Lee encouraged Shincheonji members who had recovered from COVID-19 to donate plasma to help with therapeutic treatments and development of a vaccine.

Trials 52

Trials Licensing Licensing Virus 52

The Pharma Data

FEBRUARY 12, 2022

Pseudovirus and authentic virus testing demonstrate that bebtelovimab retains full neutralizing activity against Omicron – currently the predominant variant in the U.S. government to supply up to 600,000 doses of investigational drug bebtelovimab for at least $720 million. About BLAZE-4.

Treatment 40

Treatment Hospitals FDA Clinical Trials 40

The Pharma Data

MARCH 22, 2021

In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. 1,200 mg IV.

Virus 52

Virus Clinical Trials Trials FDA 52

The Pharma Data

JANUARY 13, 2021

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. TNX-801 , live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

The Pharma Data

APRIL 16, 2021

government to ensure adequate supply of etesevimab to be used together with bamlanivimab. 1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. All sites in the U.S. than bamlanivimab alone, including the rapidly growing B.1.427/B.1.429

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

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.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

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.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

MAY 4, 2021

Direct Relief will allocate donations of baricitinib to low- and lower-middle-income countries (based on World Bank classification) for the treatment of hospitalized COVID-19 patients requiring supplemental oxygen, based on requests from these governments to Direct Relief. Ricks , Lilly chairman and CEO. It is approved in the U.S.

Therapies 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 52

The Pharma Data

FEBRUARY 25, 2021

FDA ACCEPTS FOR PRIORITY REVIEW PFIZER’S APPLICATION FOR TICOVAC (TICK-BORNE ENCEPHALITIS VACCINE). If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations. 1,2 If approved, TicoVac would be the first vaccine in the U.S.

FDA 52

FDA Vaccine Virus Clinical Trials 52

The Pharma Data

SEPTEMBER 6, 2021

Takeda today announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.

Vaccine 52

Vaccine Clinical Trials Government Licensing 52

The Pharma Data

FEBRUARY 14, 2022

For most of 2021, limited global vaccine supply led to huge disparities in COVID-19 vaccine access, leaving billions of people – especially in low- and middle-income countries – unprotected against serious disease and death from COVID-19. Low levels of vaccine coverage also provided the ideal conditions for new variants to develop.

Vaccine 52

Vaccine Licensing Licensing Science 52

DrugBaron

NOVEMBER 9, 2020

And yet, with interim data announced today showing a vaccine candidate from Pfizer and BioNTech to have at least 90% efficacy, it seems certain a vaccine to protect against a virus that was unknown to science a year ago will be approved in the US and Europe, before the end of 2020.

Vaccine 100

Vaccine Pharmaceutical Companies Government Pharmaceuticals 100

Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. QMSR final rule : For years, the FDA has been talking about harmonizing its Quality System Regulation with ISO 13485:2016, which it would incorporate by reference. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Clinical Trials Regulations 40