Drug Discovery World

JANUARY 23, 2023

Implementation of the EU Clinical Trials Regulation The way clinical trials (CTs) are conducted in the European Union (EU) underwent a major change when the Clinical Trial Regulation (CTR) EU No 536/2014 came into force on 31 January 2022.

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The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Collaborating with a team at Biogen Inc., 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583

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FDA Law Blog: Drug Discovery

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. For example, objective response rate is often used as a single-arm trial endpoint in oncology given the established understanding that tumor shrinkage rarely occurs without an intervention.”

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Drug Discovery World

AUGUST 2, 2023

Based on this data, ezurpimtrostat completed a first-in-human clinical trial for patients with advanced cancer 5 showing sustained stabilisation in heavily pre- treated patient with mild toxicity. Recent studies have suggested that palmitoylation can regulate the expression and activity of PD-L1 6. Front Mol Biosci 2021;8:659861.

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Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. However, the substance has shown promise in the field of medicine for a range of diseases and conditions, making its legality a debating point within the drug discovery industry internationally.

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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The Pharma Data

JANUARY 10, 2021

SH ) submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. SHENZHEN, China , Jan.

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Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. Regulation of cutaneous malignancy by gammadelta T cells. Science 294(5542):605-609 (2001).

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Drug Target Review

SEPTEMBER 26, 2023

Dr Rockley previously completed an MSc in Cancer Pharmacology and have experience in clinical research from an oncology clinical trial coordinator role. Ther Innov Regul Sci. 2001 Sep;24(9):517–26. Regul Toxicol Pharmacol RTP. References Blinova K, Stohlman J, Vicente J, Chan D, Johannesen L, Hortigon-Vinagre MP, et al.

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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

MAY 13, 2021

The trans-fat ban–food regulation and long-term health. 2001 Nov 16;12(16):3549-52. based weight loss intervention in adults with obesity: A randomized clinical trial. Regulation of glucose metabolism from a liver-centric perspective. 2001 Sep;30(3):765-85. Biochem Cell Biol. 2015 Oct;93(5):466-71. N Engl J Med.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). A Florida trial court, in Brookes v. at 77 (citation omitted). In United States v. Brown , 348 F.3d

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Drug & Device Law

JUNE 1, 2023

The linchpin of our proposed language, or anything similar, is – of course – the requirement that trial judges act as “gatekeepers” to preclude the admission of inadequately supported – under whatever test a particular jurisdiction applies – expert opinions. So we did it by state. Ex parte George , So.3d 3d , 2021 WL 68997, at *23 (Ala.

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Drug & Device Law

OCTOBER 20, 2023

341 (2001), is so important. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. If the results are promising, the company submits an investigational New Drug Application to FDA, explaining those results and a clinical trial plan. That’s why Buckman Co. E.g., Estee Lauder, Inc.

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Drug & Device Law

FEBRUARY 20, 2023

151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). That the product had been approved in “other countries” could not create a triable issue of fact because, even for other uses that the FDA eventually allowed, the necessary clinical trials had not been completed in 2010.

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Drug & Device Law

NOVEMBER 28, 2022

Three years ago we published a lengthy post, “ Stupid Expert Tricks ,” detailing several of the other side’s egregious attempts at passing off junk science “experts” as the real thing, along with our side’s trials and tribulations during the course of unmasking these phonies. 2001) (Kilburn); and Wade-Greaux v. 3d 179, 181-87 (D.

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Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Jones , 225 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

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Drug & Device Law

DECEMBER 30, 2022

In 2001, the Supreme Court made getting past motions to dismiss harder when it held in Buckman that plaintiffs could not recover claims predicated on violations of FDA regulations. An unfortunate fiction developed post- Buckman —particularly after Riegel v. Medtronic, Inc. Stryker Corp. , 3d 546 (7th Cir. 2022 WL 17668486, *2.

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Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. This novel duty has implications far beyond FDA-regulated products. at *31, *32. That is important. Gilead , at *67-*71.

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Drug & Device Law

NOVEMBER 9, 2023

If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. The FDA is concerned, probably with reason, about its own power.

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Drug & Device Law

SEPTEMBER 29, 2022

The biologic’s FDA-sanctioned label described reports of retinal vascular occlusion in patients who received the biologic and identified retinal vascular occlusion as an adverse event observed during clinical trials. 341 (2001). 337(a), which applies to all products regulated under the FDCA, not 21 U.S.C. Albrecht , 139 S.

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