The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

MARCH 14, 2021

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. During the production of the vaccine more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories.

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The Pharma Data

NOVEMBER 13, 2020

If not enough children are immunized against polio, the weakened virus can pass between individuals and over time genetically revert to a form that can cause paralysis. If not enough children are immunized against polio, the weakened virus can pass between individuals and over time genetically revert to a form that can cause paralysis.

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The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. Kate Krav-Rude/Shutterstock.

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The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. USA) to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. . MUNICH, Germany, Jan.

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The Pharma Data

OCTOBER 26, 2020

Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus Date: Wednesday, October 28, 2020 Time: 10:30AM- 11:50AM ET.

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The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

MARCH 26, 2021

“This new storage option in Europe will help make the vaccine even more accessible to people across the continent, another important step as we continue our global fight against this virus.”. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

NOVEMBER 17, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. COVID-19 Vaccine AstraZeneca (ChAdOx1-S [Recombinant]) Summary of Product Characteristics.

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The Pharma Data

JANUARY 31, 2021

Our preclinical work at Gritstone developing our powerful prime-boost vaccine technology utilized simian immunodeficiency virus (SIV) derived antigens as model antigens, which are very similar to HIV-1. We are delighted to now advance our partnership and product candidates for the treatment of patients with HIV infection.”.

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The Pharma Data

AUGUST 28, 2020

There are also plans to strengthen the Medicines and Healthcare products Regulatory Agency (MHRA)’s powers to roll out an unlicensed vaccine rapidly if one becomes available before the new year. UK signs deals for 90 million virus vaccine doses. Oxford coronavirus vaccine triggers immune response.

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The Pharma Data

JANUARY 3, 2021

Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1). About PBGM01.

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The Pharma Data

DECEMBER 30, 2020

31, 2020 /PRNewswire/ — ImmVira Group Company (“the Company”), a biotechnology platform dedicated to the development of oncolytic virus(“OV”) and vector type approaches to create more effective and safer therapies against cancer, announced today the signing of Series C financing.

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The Pharma Data

MAY 4, 2021

Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ). WHO is closely monitoring 10 Covid variants as virus mutates around the world ( CNBC ) . WHO is closely monitoring 10 Covid variants as virus mutates around the world ( CNBC ) .

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The Pharma Data

DECEMBER 17, 2020

About casirivimab and imdevimab Casirivimab and imdevimab (formerly known as REGN-COV2 or REGEN-COV2) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

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The Pharma Data

JUNE 26, 2021

The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines.

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The Pharma Data

NOVEMBER 5, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

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The Pharma Data

DECEMBER 20, 2020

It is our continual objective to broaden our product scope, and Transcend, with its experienced management team, is a perfect foothold for us in the fast-growing market for psychedelics molecules and complements our existing pipeline of treatments. per share, with the transaction valued at $10 million. “We

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The Pharma Data

DECEMBER 28, 2020

BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumours to treat specific types of cancer.

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The Pharma Data

MARCH 11, 2021

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. About the Phase 1/2 clinical trial.

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The Pharma Data

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate.

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The Pharma Data

JULY 21, 2021

At full operational capacity, the annual production will exceed 100 million finished doses annually. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”. “We

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The Pharma Data

JANUARY 27, 2021

This approach makes Eurofins Discovery uniquely qualified to fulfill the needed studies for this innovative product. is an emerging biotechnology company engaged in the development and commercialization of next generation psychedelic products for the treatment of mental disorders. About BetterLife Pharma: BetterLife Pharma Inc.

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The Pharma Data

AUGUST 20, 2020

“For drug licensing the onus is on the companies to go through clinical trials. SURVIVING THE VIRUS: ‘Our medical science is struggling to catch-up’ COVID-19: How are dentists coping? “We can’t guarantee that the result will be easy to interpret or that it will be not misleading.” Source link.

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The Pharma Data

JANUARY 18, 2021

“Confirmation of the non-controlled status of 2-bromo-LSD is a significant first step for BetterLife to initiate our IND-enabling pre-clinical studies of our lead second-generation psychedelic product TD-0148A. BetterLife Pharma Inc.

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The Pharma Data

OCTOBER 14, 2020

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. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The research encompasses two projects.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

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The Pharma Data

JANUARY 27, 2021

– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvania’s Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. PHILADELPHIA, Jan.

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The Pharma Data

JANUARY 6, 2021

The authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. “I supply chain are expected to begin next week. About Moderna.

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The Pharma Data

DECEMBER 19, 2020

Healthcare workers have been on the front lines of the fight against the virus and are an inspiration to us all. Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. Under Operation Warp Speed, the U.S. Department of Defense contract no.

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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. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

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The Pharma Data

NOVEMBER 9, 2020

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.

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The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. .–(BUSINESS WIRE)–Jan. 12, 2021– Moderna, Inc. About Moderna.

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The Pharma Data

SEPTEMBER 12, 2020

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. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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The Pharma Data

SEPTEMBER 9, 2020

BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. 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. About the Phase 2/3 Study.

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Agency IQ

JANUARY 12, 2024

Industry wants its products reviewed quickly, efficiently and predictably. The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies that submit marketing applications to the agency for certain human drug and biological products. Without sufficient resources, the FDA is unable to do so.

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