Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

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The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

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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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Agency IQ

NOVEMBER 3, 2023

Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. The regulation of dietary supplements in the U.S. a probiotic in yogurt) may be used as a dietary ingredient in a dietary supplement.”

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Codon

FEBRUARY 27, 2024

Patient YY’s neighbors quickly started to become infected, passing on the virus in turn. While the consensus that emerged among experts was that the virus spread primarily via airborne transmission , it also made use of another route: fomite transmission. Puzzled, epidemiologists sought to understand the source of the outbreak.

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Drug Discovery World

SEPTEMBER 16, 2022

One example the Cell and Gene Therapy Catapult regards as a benefit for developers in the UK is the effort the government puts in to support the industry. . The research excellence of the UK’s academic institutions, and the expertise of the Cell and Gene Therapy Catapult enable the UK to compete globally. Key comment US . “We

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Government shutdown: At present, the U.S.

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The Pharma Data

SEPTEMBER 8, 2020

Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

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The Pharma Data

SEPTEMBER 8, 2020

is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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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. The research encompasses two projects. The study led by Dr. Ilya Trakht, Ph.D., About TNX-1800. 1 Noyce RS, et al. 2018) PLoS One. 13(1):e0188453.

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The Pharma Data

NOVEMBER 9, 2020

TScan Therapeutics announced the signing of a research license and option agreement with QIAGEN to develop T cell-based laboratory tests for detecting prior exposure to the novel coronavirus, SARS-CoV-2, using discoveries from TScan’s high-throughput TCR/Target discovery platform. The data suggest a 90% efficacy rate for the vaccine.

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Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. government funded a massive effort: To sterilize millions of screwworms , initially with hospital x-ray machines, and air drop them over Florida, Texas, and elsewhere. And it’s true, but only in an incomplete way.

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Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. government funded a massive effort: To sterilize millions of screwworms , initially with hospital x-ray machines, and air drop them over Florida, Texas, and elsewhere. And it’s true, but only in an incomplete way.

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The Pharma Data

NOVEMBER 9, 2020

. “The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most.” government’s allocation program.

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The Pharma Data

NOVEMBER 9, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Amgen’s business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

DECEMBER 21, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Amgen’s business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

OCTOBER 29, 2020

We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible. ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan.

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Codon

MAY 2, 2023

But the technology has already been licensed to a crop pest control company, called AgraGene , and initial experiments in the lab seem promising. But it took years for them to get EPA approval, because nobody in government had any idea who should regulate this niche technology. Cases of dengue and Zika will slowly fall.

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Codon

MAY 2, 2023

But the technology has already been licensed to a crop pest control company, called AgraGene , and initial experiments in the lab seem promising. But it took years for them to get EPA approval, because nobody in government had any idea who should regulate this niche technology. Cases of dengue and Zika will slowly fall.

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The Pharma Data

APRIL 26, 2021

billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. These are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both prophylactics and treatments. Free cash flow¹ of USD 1.6 Tislelizumab.

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The Pharma Data

MAY 4, 2021

Panzyga (immune globulin intravenous [human] ifas 10% liquid preparation) — In February 2021, Pfizer announced that the FDA approved the supplemental Biologics License Application (sBLA) for Panzyga to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP).

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The Pharma Data

MAY 4, 2021

. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ). EU regulator begins real-time review of first Chinese COVID-19 vaccine ( Reuters ) ( EMA ). Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ).

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The Pharma Data

DECEMBER 16, 2020

Recombinant monoclonal antibodies are designed to enhance the immune system’s ability to regulate cell functions. There is no other way, we need to establish herd, and it only comes about allowing the non-high risk groups expose themselves to the virus. government in September. have zero to little risk….so

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Drug & Device Law

JULY 31, 2023

Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. So far, the would-be liability expanders haven’t done very well. 1145, 1165 n.135

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