Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

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The Pharma Data

JANUARY 25, 2021

. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. “Hexvix adds a great deal of synergy to Asieris’ strategic focus on genitourinary cancers and other diseases.

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The Pharma Data

JANUARY 13, 2021

Structure 3:1031-1039 (1995) 3 Waters J, Biocentury ; October 26, (2018) 4 NCT02273960; ClinicalTrials.gov ; “Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)”; results posted April 1, 2019, updated July 29, 2019 and accessed Jan 11, 2021 5 Ferrant JL et al., 1 Lederman, S. International Immunol. (11):1583

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New Drug Approvals

SEPTEMBER 29, 2024

gingivalis has been called a risk factor for Alzheimer’s disease ( Kanagasingam et al., 2018 ; Ding et al., gingivalis is associated with cardiovascular disease. In aged dogs with periodontal disease, ninety days of COR388 reduced oral bacterial load and gum pathology ( Arastu-Kapur et al., 2017 ; Ilievski et al.,

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The Pharma Data

AUGUST 5, 2020

A separate post hoc analysis demonstrated that nearly 9 out of 10 patients experienced no evidence of disease activity in the second year of treatment 4. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. ” These data were published in the August 6, 2020 issue of The New England Journal of Medicine.

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Agency IQ

NOVEMBER 3, 2023

Synthetic biotics have been engineered to perform a variety of functions: “ Several classes of effectors have been engineered into bacteria, including enzyme pathways that metabolize disease-causing toxins, production of protein effectors, and production of small-molecule effectors,” according to a recent article on the topic.

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The Pharma Data

NOVEMBER 2, 2020

Although the FDA did not identify any filing issues with the NDA, the Agency reiterated a position raised during the Pediatric Advisory Committee (PAC) and Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) held on May 11, 2018 recommending two-year controlled trials in different age groups. About Achondroplasia. In the U.S.,

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. This is based on FDA’s reported 2018 review of the CLIA database. [2]

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Drug Target Review

FEBRUARY 28, 2024

Human γδ TCR repertoires in health and disease. Trends Immunol 39(6):446-459 (2018). Nat Commun 9(1):1760 (2018). Normality sensing licenses local T cells for innate-like tissue surveillance. Regulation of cutaneous malignancy by gammadelta T cells. J Front Immunol 9:1409 (2018). Cells 9(40):800 (2020).

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

NOVEMBER 4, 2020

Previously they had recommended use of VASCEPA for treating patients with established cardiovascular disease. In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 Securities and Exchange Commission Regulation G. million and $8.9

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Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure. In the U.S.,

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The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. 1,2 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. About Severe Asthma Asthma is a complex and heterogeneous disease affecting an estimated 339 million people worldwide.

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The Pharma Data

DECEMBER 21, 2020

Severe asthma is a complex, heterogenous disease and many patients continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics. 2,3 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.

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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

Credit: National Institute of Allergy and Infectious Diseases, NIH A major part of NIH’s mission is to support basic research that generates fundamental knowledge about the nature and behavior of living systems. The term NME refers to molecules that are unique among regulated or approved drug products in their mode of activity.

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The Pharma Data

OCTOBER 14, 2020

2018) PLoS One. 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-102 SL is also in development for agitation in Alzheimer’s disease and alcohol use disorder (AUD).

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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The Pharma Data

FEBRUARY 4, 2021

AbbVie announced positive top-line results from the Phase 3 ADVANCE and MOTIVATE studies, which evaluated the efficacy and safety of Skyrizi (risankizumab) for induction therapy in adult patients with moderate to severe Crohn’s disease (CD). AbbVie and Frontier Medicines, Corp.,

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The Pharma Data

MAY 4, 2021

Rare Disease. The FDA action converts the 2018 accelerated approval to full approval. In March 2021, Pfizer, the Israel Ministry of Health (MoH) and BioNTech announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with BNT162b2. Internal Medicine.

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Agency IQ

MAY 28, 2024

Companies are paying for performance here, and it’s reasonable for them to expect performance” remarked Burgess, “And then we hear other discussions that the FDA wants to vastly expand its authority into licensing laboratory developed tests. If you don’t have the staff to do this, how are you going to have the staff to do that?”

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The Pharma Data

NOVEMBER 22, 2020

In 2019, women accounted for 48 percent of new infections, and in 2018, AIDS-related illnesses remained the leading cause of death for women during their reproductive years,” said Prof. In 2012, Merck licensed islatravir (4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA) from the Yamasa Corporation based in Choshi, Japan. Kenilworth, N.J.,

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The Pharma Data

DECEMBER 15, 2020

The primary endpoint of the study is the objective response rate (ORR); secondary endpoints include confirmed objective response rate (cORR), overall survival (OS), progression free survival (PFS), and disease control rate (DCR). Disease control rate (DCR). 13.2%.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Science (2018).

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Additionally, in a 2018 study, published in the journal Phytotherapy Research…. Along with the amount of estrogen-regulating DIM that he added as well. It was like the floodgates burst wide open…. And the fat just came pouring off. So what’s the fix here?

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Codon

APRIL 19, 2023

“In 2018, it was found in Myanmar.” Gene-edited bananas are not yet being grown commercially, to my knowledge, but a Dole plantation in Central America is starting field trials for a disease-resistant variety that was developed by Elo Life Systems , an American company. From Dale J. in Nature Communications (2017).

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Codon

APRIL 19, 2023

“In 2018, it was found in Myanmar.” Gene-edited bananas are not yet being grown commercially, to my knowledge, but a Dole plantation in Central America is starting field trials for a disease-resistant variety that was developed by Elo Life Systems , an American company. From Dale J. in Nature Communications (2017).

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