BMG Labtech

DECEMBER 20, 2024

The ACU provides a complete solution to fully and independently regulate both O2 and CO2 gas levels within the microplate reader chamber. Online corrected version: (2014) "BeerLambert law (or BeerLambertBouguer law)". References IUPAC, Compendium of Chemical Terminology, 2nd ed. the "Gold Book") (1997). the "Gold Book") (1997).

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FDA Law Blog: Drug Discovery

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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New Drug Approvals

JULY 18, 2025

21] In 2014, its oral pharmokinetics in rats was elucidated. [1] 21] In 2014, its oral pharmokinetics in rats was elucidated. [1] 22] In the same month, China’s drug regulator (NMPA) decided to fast-track the approval process, labelling it a first-in-class medication. [14] September 2014). 98 : 379–386. 2017.05.009.

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). 50,036 (Aug.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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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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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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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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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.

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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

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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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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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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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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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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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

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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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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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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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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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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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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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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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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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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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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Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S., In the E.U.,

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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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