thought leadership

JULY 1, 2024

Although this regulation applies to CTAs for gene therapy studies, it does not cover the additional requirement for a Genetically Modified Organism (GMO) application for such studies.

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Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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FDA Law Blog: Drug Discovery

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

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Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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thought leadership

JULY 2, 2024

This EU portal is established as part of the new Clinical Trial Regulation No. 536/2014 (CTR) which harmonizes and centralizes the submission and assessment of Clinical Trial Applications in the EU.

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Drug Target Review

JANUARY 5, 2024

Scientists from the Centre for Genomic Regulation and the Wellcome Sanger Institute have found the allosteric control sites in the KRAS protein, the highly sought after targets for drug development. 2014 January 3 [2023 December 19]; 39(2):91-100. This study is the first complete control map for any protein. Available from: [link]

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Drug Target Review

AUGUST 17, 2023

These antibodies are negatively regulated by the inhibitory IgG receptor, FcγRIIB (CD32B). Dogma suggests inhibition is mediated through the FcγRIIB immunoreceptor tyrosine-based inhibition motif (ITIM), negatively regulating immunoreceptor tyrosine-based activation motif (ITAM)-mediated signalling from activating FcγRs.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014.

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Drug Target Review

AUGUST 24, 2023

Prior to joining CatalYm, Christine co-founded Rigontec in 2014 where she led the company’s discovery and non-clinical development activities as Senior Vice President, Research. Cell adhesion molecules and their roles and regulation in the immune and tumor microenvironment. 2014 Nov 27;515(7528):568-71. Frontiers in Immunology.

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Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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Agency IQ

JUNE 28, 2024

FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

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Drug Target Review

FEBRUARY 28, 2024

Prior to the founding of IN8bio, from 2014 to 2017, Mr Ho was the Founder and Managing Partner at AlephPoint Capital, a private healthcare investment fund. Regulation of cutaneous malignancy by gammadelta T cells. Mr Ho has worked in the biotechnology industry for almost 20 years. J Hemotother 5(5):503-9 (1996).

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Agency IQ

JULY 12, 2024

While the policy is similar in some respects to one first created by the FDA in 2014, the latest version is considerably more detailed regarding what it will – and won’t – allow companies to do. BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products.

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A PMR is a study “that sponsors are required to conduct under one or more statutes or regulations,” whereas a PMC is a study “that a sponsor has agreed to conduct, but that are not required by a statute or regulation” (see FDA Webpage, Postmarketing Requirements and Commitments: Introduction ).

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FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here.

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Broad Institute

AUGUST 31, 2023

Through the imposition of a user-defined GRN in its architecture, GRouNdGAN simulates steady-state and transient-state single-cell datasets where genes are causally expressed under the control of their regulating transcription factors (TFs).

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Agency IQ

AUGUST 18, 2023

many types of clinical research must comply with regulations intended to protect the rights of research participants. While the FDA regulates the conduct of clinical trials which evaluate medical products , its parent department, HHS oversees the conduct of all studies that involve human subjects.

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The Pharma Data

JANUARY 27, 2021

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR). I look forward to updating the market when we have definitive clinical performance data.”. View source version on businesswire.com: [link]. Source link.

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The Pharma Data

DECEMBER 3, 2020

The new study follows a 2014 publication in The Lancet Series in Midwifery and uses the Lives Saved Tool (LiST) which models variations in deaths based on the uptake, effectiveness and impact of about 30 midwife delivered interventions.

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The Pharma Data

MARCH 11, 2021

WHO prequalification helps regulators and procurers in low and middle-income countries to identify products that meet high quality standards and are safe and suitable for their intended use. Since we launched the Global Access Program in 2014, access to innovative diagnostics solutions has improved in countries with high disease burdens.

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The Premier Consulting Blog

JUNE 26, 2023

Accelerating therapies for serious conditions: Where it began The FDA first formally articulated its thinking on expediting availability of promising new therapies in Title 21 of the Code of Federal Regulations, Section 312, Subpart E. IARC highlights rare cancers to mark Rare Disease Day 2023, February 28, 2023. Available at [link].

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Common Sense for Drug Policy Blog

JUNE 6, 2024

Analogous substances like post-cycle therapy drugs and human growth hormone, on the other hand, are generally produced in licit pharmaceutical laboratories in jurisdictions with more lax regulations and subsequently imported or removed from domestic pharmaceutical supply chains by illicit actors (Fink et al. 2014 ; Begley et al.

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Drug Target Review

SEPTEMBER 4, 2023

2014); Drug Discovery for Human African Trypanosomiasis: Identification of Novel Scaffolds by the Newly Developed HTS SYBR Green Assay for Trypanosoma brucei, Journal of Biomolecular Screening, Vol. 2018): Silent Information Regulator 2 from Trypanosoma cruzi is a potential target to infection control, IntechOpen. Carolina, B.M.,

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The Pharma Data

OCTOBER 25, 2020

Vatiquinone, developed from PTC’s Bio-e platform, is an investigational oral small molecule that inhibits 15-Lipoxygenase, a key enzyme that regulates oxidative stress and inflammation response pathways underpinning many neurological disease pathologies, including epilepsy. 2014; View original content: [link].

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The Pharma Data

NOVEMBER 2, 2020

2, 2020 — An experimental antibody drug that targets one of the body’s key metabolism regulators may help obese people lose weight — at least briefly. The injection drug Saxenda, approved in the United States in 2014, is an example, Ryan said. Adiponectin helps regulate blood sugar and fatty acid breakdown.

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The Pharma Data

OCTOBER 25, 2020

” This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). We have waited for this publication a long time, and now and I am excited to address its findings with our potential partners.”

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Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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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. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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The Premier Consulting Blog

NOVEMBER 20, 2023

The FDA is proposing a change to its regulations to explicitly classify In Vitro Diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), irrespective of the manufacturer being a laboratory that previously conducted business and was certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

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The Pharma Data

FEBRUARY 24, 2022

Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Source link: [link].

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Common Sense for Drug Policy Blog

JANUARY 1, 2024

million in 2014, 13 allowing for greater coverage of injection events and more opportunities for disease prevention. "By From 2005 to 2014, the SEP returned to the less restrictive 1:1 policy, after which they shifted to a need-based distribution model whereby PWID could access as many syringes as needed. in 1999 to 1.82

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The Pharma Data

JULY 27, 2021

This is the second extension of the collaboration originally established in 2014. Since 2014, the collaboration has produced more than 20 early-stage programs addressing disease states across immuno-oncology and neurodegeneration and has yielded new insights into the biology of aging. Levinson, Ph.D.,

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Agency IQ

AUGUST 23, 2024

applications) on biopharmaceutical products to regulators for review and marketing authorization throughout the region via three routes. In April 2014, the European Parliament and the Council of the European Union passed a new law ( Regulation (EU) No 536/2014 ), known as the Clinical Trials Regulation (CTR), to address this issue.

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FDA Law Blog: Biosimilars

APRIL 3, 2023

Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration, ingredients, and combinations. See our memo summarizing CMS’s regulation here. In 2014 Vanda introduced Hetlioz (tasimelteon) capsules to treat a rare sleep disorder.

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New Drug Approvals

OCTOBER 24, 2023

2014, 5, 12, 1313–1317 Publication Date:November 4, 2014 [link] APD334 was discovered as part of our internal effort to identify potent, centrally available, functional antagonists of the S1P 1 receptor for use as next generation therapeutics for treating multiple sclerosis (MS) and other autoimmune diseases. . ^ 11] SYN ACS Med.

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Agency IQ

SEPTEMBER 22, 2023

In the 1990 amendments to the CAA, Congress established both new requirements and 189 HAPs that the EPA would be required to target for regulation. On March 27, 2014 , the EPA published a finalized version of updated NESHAP standards and a residual risk and technology review for polyester polyols.

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