NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

Most have focused on patents specifically licensed to pharmaceutical companies from academic institutions, where the vast majority of basic biological research takes place in America, most of it supported by NIH. 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

JANUARY 24, 2021

On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. The FTD is designed to make important new drugs accessible to patients faster.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Compass has studied psylocibin for PTSD in an open-label, Phase 2 setting.

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Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

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The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2018; 9: 1595. 2018; 10 (1): 34–45. 2018; 3: 60-9. Tezepelumab was very well tolerated in patients with severe asthma.

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The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. Adv Studies Pharm.

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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. In fact, CDER received a perfect 100% for meeting PDUFA dates for novel drugs in 2013, 2017, 2018 and 2020.

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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. 1 Noyce RS, et al. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

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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 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. In the U.S., About BioMarin.

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The Pharma Data

DECEMBER 15, 2020

In 2018, approximately 450,000 individuals globally were diagnosed with this condition, 55,000 of them in the US; and the incidence of pancreatic cancer is expected to continue to increase. About Pancreatic Cancer Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. Its incidence rate in the US is estimated at 3.2%

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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2018; 9: 1595.

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The Pharma Data

FEBRUARY 4, 2021

Imbruvica was approved as a monotherapy for WM in 2015 and as a combination therapy with rituximab in 2018 based on the iNNOVATE primary analysis. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties.

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New Drug Approvals

SEPTEMBER 29, 2024

2018 ; Ding et al., According to a company press release and a poster presentation at the 2018 CTAD conference, healthy adults received 25, 50, or 100 mg COR388 or placebo every 12 hours for 10 days; AD patients took 50 mg or placebo every 12 hours for 28 days. Epub 2018 Oct 3 PubMed. Epub 2018 Jan 30 PubMed.

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The Pharma Data

JANUARY 12, 2021

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. Market Abuse Regulation (MAR) Disclosure. Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation No 596/2014 until the release of this announcement.

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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. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Codon

APRIL 19, 2023

“In 2018, it was found in Myanmar.” This fruit is discarded more than any other food in grocery stores, according to a 2018 study from Sweden. This gene is regulated, in turn, by a small arsenal of other proteins from the MaMADS family. ( The race is on to make a resistant Cavendish using gene-editing tools. .”

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Codon

APRIL 19, 2023

“In 2018, it was found in Myanmar.” This fruit is discarded more than any other food in grocery stores, according to a 2018 study from Sweden. This gene is regulated, in turn, by a small arsenal of other proteins from the MaMADS family. ( The race is on to make a resistant Cavendish using gene-editing tools. .”

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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. 75% of all bladder cancer cases occur in men.

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Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. PharmaDrug Inc.

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The Pharma Data

NOVEMBER 4, 2020

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. 6 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018. million and $8.9

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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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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. Science Robotics (2018).

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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

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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Agency IQ

NOVEMBER 3, 2023

Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway. The regulation of dietary supplements in the U.S.

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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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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. What does it mean for FDA staff?

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The Pharma Data

MAY 4, 2021

The FDA action converts the 2018 accelerated approval to full approval. 7) BNT162b2 has not been approved or licensed by the U.S. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. If approved, TicoVac would be the first vaccine in the U.S.

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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. And so, there was a lot of debate about that back in 2017 and 2018 , when they were considering these trials in the first place. Ultimately, I don't think that they are mutually exclusive.

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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.

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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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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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BMG Labtech

FEBRUARY 24, 2025

Protein nitration is one example that takes place on tyrosine residues which can have important consequences for the regulation of biological processes. 3 in this blog adapted from this reference under license CC-BY 4.0. 2018 Aug 29;9(1):3505. 4 in this blog adapted from this reference under license CC-BY 4.0. Nat Commun.

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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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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2018), rejected a purported duty to modify an electronic product component to disable product use while the user was driving. Ocwen Loan Servicing, LLC , 2018 WL 6599901, at *5 (D. 2018), cert. Brown , 348 F.3d

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