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 Discovery World

JULY 23, 2024

Importantly, only a small fraction of the human genome codes for proteins; the majority (~ 98%) consists of non-coding DNA, which plays a critical role in gene regulation, cellular identity, and disease susceptibility. Nature 2014:1-6. The support of human genetic evidence for approved drug indications.

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FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

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New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of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

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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Drug Target Review

OCTOBER 17, 2023

The liver is an essential organ that has a variety of crucial functions in the body, including metabolising nutrients, storing energy, regulating blood sugar levels and detoxifying and removing harmful substances. This promotes tumour growth by regulating the expression of metabolic genes. References 1 Krafts K, Ray SD, Yang N.

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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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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

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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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

Treatment 40

Treatment Government Regulations Disease 40

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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Drug Discovery World

SEPTEMBER 26, 2022

Improvements in technology and changes to worldwide regulations in life sciences has led to an increase in the availability of clinical data. Remote trials, wearable devices and advancements in genomic sequencing means that clinical data is now more abundant than ever and is only set to grow. .

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Agency IQ

MAY 10, 2024

But the advice went beyond the specific instance of the reclassification regulation to suggest that the regulator needs to ensure its feedback mechanisms are robust and thorough. In early 2023, the Ombudsman received a complaint on the European Commission’s reclassification regulation on brain stimulation devices.

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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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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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Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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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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Packaging FDA Regulations Production 59

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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Laboratories FDA Clinical Development Regulations 52

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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Treatment Therapies Clinical Development Cell Biology 98

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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FDA FDA Approval International Pharmacokinetics 57

Agency IQ

AUGUST 11, 2023

Consequently, the 1989 asbestos regulation only bans new uses of asbestos in products that would be initiated “for the first time” after 1989 and flooring felt, rollboard, and corrugated, commercial, or specialty paper. Some of these were included in the 2014 IRIS LAA assessment. EPA, 947 F.2d 2d 1201 (5th Cir.

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Production Regulations Disease 40

Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials. Neonates also have an increased amount of CSF and immature myelination 3.

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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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Regulations Disease Marketing 40

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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Disease Laboratories Treatment Virus 52

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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Nurses International Doctors Regulations 52

Drug Discovery World

NOVEMBER 24, 2022

The number of ATMP trials conducted in the US and Asia-Pacific region grew by 70% and 67% respectively from 2014-21, while Europe remained stagnant. . ATMP clinical trial activity is twice as high in the US and almost three times as high in China than in Europe. Overall clinical trial activity in the region is also on the decline.

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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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FDA Approval FDA Treatment Hospitals 52

Agency IQ

JUNE 26, 2023

Because CDx are diagnostic devices, they are not considered part of a combination product but are regulated separately as medical devices. As the 2014 definitions document states (footnote 6): “Uses of diagnostic devices that are suggested but not required in therapeutic product labeling are not considered essential.””

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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.,

Disease 52

Disease Science Production Therapies 52

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].

Clinical Trials 52

Clinical Trials Trials Small Molecule Regulations 52

Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

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Clinical Trials Clinical Research Trials Hospitals 52

The Pharma Data

JUNE 28, 2021

When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. About Vericiguat Vericiguat 2.5 in the U.S.

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Clinical Trials Treatment Disease Production 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. RE 44,599 and RE 44,638 were submitted nearly ten years ago (a point not lost on Gilead as noted below), on September 17, 2014 (Docket Nos. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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The Pharma Data

MARCH 3, 2022

In 2014, Shalev’s UAB research lab reported that verapamil completely reversed diabetes in animal models, and she announced plans to test the effects of the drug in a human clinical trial. The suggestion that verapamil might serve as a potential Type 1 diabetes drug was the serendipitous discovery of study leader Anath Shalev, M.D.,

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The Pharma Data

DECEMBER 15, 2020

This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). All in all, this contributes to Lipidor’s ability to more rapidly develop and commercialize ever more competitive drug candidates. CONTACT: For more information, please contact.

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The Pharma Data

OCTOBER 26, 2020

” 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 (EU) No 596/2014 until the release of this announcement. Enquiries: Hemogenyx Pharmaceuticals plc. .

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