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

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

AUGUST 28, 2020

The government plans to train up an army of health professionals to be ready to give the coronavirus vaccine, if and when one is shown to work. UK signs deals for 90 million virus vaccine doses. Image copyright. Getty Images. This could include pharmacists, who already deliver flu vaccines, midwives and physiotherapists.

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The Pharma Data

SEPTEMBER 21, 2020

Licensed premises such as pubs and bars will need to shut by 23:00 every night. Live: Welsh Government coronavirus update. ‘People just come out earlier’ Customers at the The Pen and Wig pub in Newport on Monday were not convinced a pub curfew would help to control the virus. What are the restrictions? in Newport.

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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.

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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.

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The Pharma Data

MARCH 25, 2022

Evusheld has the potential to provide long-lasting protection to vulnerable populations such as the immunocompromised who can’t mount an adequate response to a COVID-19 vaccine, and we’ll continue to work with governments in Europe to make Evusheld available as quickly as possible.” Evusheld was well-tolerated in the trials.

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The Pharma Data

NOVEMBER 17, 2021

AstraZeneca continues to engage with governments, multilateral organisations and collaborators to ensure broad and equitable access to the vaccine. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. 3,4,5,6,7). About AstraZeneca.

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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).

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The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. Takeda will begin distribution of Nuvaxovid doses purchased by the Government of Japan as soon as possible.

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The Pharma Data

MARCH 26, 2021

It comes at an important point in time, as governments now have more flexibility to move from inoculations in vaccination centers to a more decentralized vaccine roll-out through local doctors and general practitioners to accelerate our path out of the pandemic.”.

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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.

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The Pharma Data

AUGUST 20, 2020

“For drug licensing the onus is on the companies to go through clinical trials. Across government, action is being taken to enforce these tough regulations. SURVIVING THE VIRUS: ‘Our medical science is struggling to catch-up’ COVID-19: How are dentists coping? ” Image copyright. .

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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 29, 2021

Takeda has granted a license to HilleVax for the exclusive development and commercialization rights to its norovirus vaccine candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan, in exchange for upfront consideration, as well as future cash milestones and royalties on net sales. About HilleVax.

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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.

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The Pharma Data

MAY 6, 2021

Under the MoU framework, NOCs and their local governments are expected to coordinate the administration of vaccinations to eligible Games participants. Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide.

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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. In mid-February an investigation was launched in the nearly 300,000-member church when an asymptomatic and unknowing COVID-19 carrier attended a worship service at a Shincheonji church location.

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The Pharma Data

OCTOBER 25, 2020

The UK government’s COVID-19 Vaccine Taskforce and a contract research company called Open Orphan announced a $13 million (£10 million) plan to test investigational COVID-19 vaccines in volunteers who are then intentionally exposed to SARS-CoV-2, the virus that causes COVID-19. They will require regulatory and ethical approval.

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The Pharma Data

MAY 13, 2021

Biogen licenses a stroke drug from Japanese drugmaker TMS ( BioPharmaDive ). Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection ( FDA ). Government, Regulatory & Legal. Medtech.

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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

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. government by the end of December 2020. W911QY-20-C-0100.

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The Pharma Data

JULY 21, 2021

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.

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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.

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The Pharma Data

APRIL 27, 2021

We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent.” This brings the total number of doses to be delivered to the EU to 600 million. “We said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “To

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Agency IQ

JANUARY 12, 2024

FDA received its most recent statutory authority to collect fees through PDUFA VII on September 30, 2022, when it passed user fee reauthorization as part of the Continuing Resolution to fund the federal government. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

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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.

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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

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The Pharma Data

DECEMBER 29, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. government, Regeneron is producing approximately 300,000 doses (2,400 mg) for outpatient use under the EUA. In the U.S.

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The Pharma Data

DECEMBER 11, 2020

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

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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

SEPTEMBER 9, 2020

BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. About the Phase 2/3 Study. In the late-stage trial, Pfizer and BioNTech are studying a 30µg dose level in a 2-dose regimen among up to 30,000 participants aged 18 to 85 years. billion doses by the end of 2021.

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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

JUNE 24, 2021

This is a meaningful moment for adolescents, parents and entire families who are seeking protection from this virus and a return to normalcy,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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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.

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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. It is approved in the U.S.

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The Pharma Data

SEPTEMBER 12, 2020

Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

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