DrugBaron

JANUARY 8, 2021

Sarepta is no stranger to controversy, following the decision of the US regulator to approve the company’s earlier product, eteplirsen, which induces exon-skipping to improve expression of dystrophin protein in individuals who carry the mutant gene, as Exondys 51 back in 2016.

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Agency IQ

NOVEMBER 20, 2023

Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. See also Article 11 of Directive 2001/83/EC.) If the ePI is approved by the regulator, then it will be made publicly available in the ePI database.

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Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. Despite the law requiring the reporting of suspicious orders, the Gazette-Mail reported that between 2001-2012 the board received only two reports , both from Cardinal Health.

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Drug Discovery World

NOVEMBER 24, 2022

Of the total R&D investment made in the US, Europe, China and Japan, only 31% occurs in Europe, which has declined steadily from 41% in 2001. It reveals that in 2002 the US spent just $2billion more than Europe on R&D, but by 2021 that figure increased to $20billion. China has meanwhile grown its share from 1% to 8%. .

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FDA Law Blog: Biosimilars

OCTOBER 4, 2023

Engler , a 2001 decision by the Sixth Circuit Court of Appeals. According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional.

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Agency IQ

NOVEMBER 3, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. See AgencyIQ’s analysis of the proposed regulation.] wide level.

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Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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Agency IQ

DECEMBER 15, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. See AgencyIQ’s analysis of the proposed regulation here.] healthcare systems for years.

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Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

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The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

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NIH Director's Blog: Drug Discovery

MAY 9, 2013

3] vhnf1, the MODY5 and familial GCKD-associated gene, regulates regional specification of the zebrafish gut, pronephros, and hindbrain. 2001 Dec 1;15(23):3217-29. Genomics: Zebrafish earns its stripes. 2013 Apr 25;496(7446):443-4. [3] Sun Z, Hopkins N.

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The Pharma Data

JANUARY 13, 2021

175:1091-1101 (1992) 2 Karpusas, M et al., 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.,

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Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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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. The CTR replaced and expanded on the scope of the existing EU CT Directive (CTD) 2001/20/EC.

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Drug Discovery World

AUGUST 2, 2023

Recent studies have suggested that palmitoylation can regulate the expression and activity of PD-L1 6. These findings suggest that palmitoylation does not only affect cancer cells, but also plays a critical role in regulating the expression and activity of PD-L1 in the tumour microenvironment. Front Mol Biosci 2021;8:659861.

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Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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Conversations in Drug Development Trends

MAY 23, 2024

The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS). This blog delves into the key aspects of the EU regulatory space and provides insights into navigating these changes effectively.

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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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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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Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. Business: Where is the money? When it comes to something as volatile and irregular in terms of regulation as psilocybin, funding is a key component if the field is to expand and progress.

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Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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FDA Law Blog: Drug Discovery

APRIL 23, 2023

Outstanding Questions This Draft Guidance expands on the 2001 ICH E10 guidance (Choice of Control Group and Related Issues in Clinical Trials) and does a fairly thorough job describing the limitations and challenges facing sponsors seeking to use an externally controlled trial, particularly using RWD.

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Drug Target Review

SEPTEMBER 26, 2023

Ther Innov Regul Sci. 2001 Sep;24(9):517–26. Regul Toxicol Pharmacol RTP. Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, et al. Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. 2018;53(4):519–25. Rockley KL.

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Drug Target Review

FEBRUARY 28, 2024

Regulation of cutaneous malignancy by gammadelta T cells. Science 294(5542):605-609 (2001). Increased frequency of TCR gamma delta + T cells in disease-free survivors following T cell-depleted, partially mismatched, related donor bone marrow transplantation for leukemia. J Hemotother 5(5):503-9 (1996).

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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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Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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PLOS: DNA Science

APRIL 13, 2023

The first SNP map was published in 2001 and the first GWAS in 2005. A highly significant gene is PDE4B , which regulates dopamine. A GWAS can encompass millions of SNPs – a human genome has more than 10 million. SNP patterns can trace a “signature” of tendency to become dependent on a substance.

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The Pharma Data

JANUARY 10, 2021

It is a highly-selective Aurora B, CSF1R, VEGFR/PDGFR/c-Kit inhibitor, which exerts a comprehensive anti-tumor effect by simultaneously inhibiting tumor angiogenesis, inhibiting tumor cell mitosis and regulating tumor microenvironment. Chiauranib has shown pharmacological activity superior to that of other similar drugs in animal studies.

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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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The Pharma Data

OCTOBER 18, 2020

Founded in 2001, ReWalk has headquarters in the United States, Israel and Germany. ReWalk’s mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. ReWalk® is a registered trademark of ReWalk Robotics Ltd.

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Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

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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. Regulation of glucose metabolism from a liver-centric perspective. 2001 Sep;30(3):765-85. Adipose tissue regulates insulin sensitivity: role of adipogenesis, de novo lipogenesis and novel lipids. Biochem Cell Biol. N Engl J Med.

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Broad Institute

JULY 28, 2023

Future work will then examine how to regulate the accelerated rate of PNN maturation in ELS females and what prevents this from occurring in ELS males. The Sabatini Lab focuses on the development and regulation of synapses in the brain and the relationship of these processes to behavior and disease.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. A state-regulated cannabis industry better protects consumers than the illicit market or the unregulated intoxicating hemp-derived marketplace. January 29, 2024).

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Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. This result threatens the integrity of the system of federal prescription medical product regulation that has served this country well for nearly a century. That’s why Buckman Co. E.g. , Estee Lauder, Inc.

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Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. 341 (2001), is so important. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S. FDA , 727 F.

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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”). 2001) (applying Illinois law); Serpico v. at 77 (citation omitted). In United States v. Brown , 348 F.3d

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