Drug Target Review

NOVEMBER 27, 2023

Because these proteins have such a profound effect on cells, there is typically a second hurdle of regulation that needs to be overcome to make the proteins. eFFECTOR Therapeutics has developed a novel class of cancer drugs known as Selective Translation Regulator Inhibitors (STRIs), which directly target the eIF4F complex.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10

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The Pharma Data

NOVEMBER 23, 2020

Zhang, who founded Legend Biotech in 2015 as a subsidiary of parent company GenScript, a company he also co-founded, had been under residential surveillance in connection with an investigation by the Customs Anti-Smuggling Department of Zhenjiang in China since Sept. Human genetic goods are tightly regulated by the Chinese government.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

2015 ), with raw powders imported from ‘producer’ countries like China, Egypt, Greece, Thailand, Turkey, and India (Antonopoulos and Hall 2016 ; Brennan et al. 2015 : 241) suggest that some suppliers are subject to a process of normalisation due to their IPED-using peers, and thus do not view themselves as ‘real dealers’.

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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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Elrig

APRIL 11, 2024

From 2015 to 2019, he was a postdoctoral researcher in Juergen Knoblich’s lab at the Institute of Molecular Biotechnology (IMBA), Vienna, Austria where he designed advanced human brain organoids aiming to recapitulate the architecture and function of the developing brain. He is an outdoor aficionado and loves to climb the highest summits.

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Drug Hunter

AUGUST 21, 2023

The BBB is composed of specialized brain endothelial cells that regulate the distribution of molecules into and out of the brain from the blood. Unlike the endothelial BBB, the blood-cerebrospinal fluid-barrier (BCSFB) is made up of epithelial cells that similarly regulate the distribution of molecules between the blood and CSF.

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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. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

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The Pharma Data

NOVEMBER 17, 2020

In 2015, Lead Pharma partnered with Sanofi to develop and commercialize small-molecule therapies against ROR?t While the antibody responsible for immune-mediated diseases is yet to be identified, they are thought to be regulated by an aberrant immune response. Humans as well as cats and dogs can be affected. .

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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. 2015; Chevallier et al. 1 Gorman et al.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615), and concern FDA’s July 23, 2014 Accelerated Approval of NDA 205858 and NDA 206545 for ZYDELIG (idelalisib) Tablets for different uses. Patent Nos.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615. RE 44,599 and U.S. RE 44,638 and with respect to each NDA approval, See FDA Docket Nos. Earlier this month, the PTO issued a REQUIREMENT FOR INFORMATION PURSUANT TO 37 C.F.R. 1.750 with respect to the multiple PTE applications for each of U.S.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

2015 ) not only access to their client base, but also a periscope into the language, self-presentation, and culture of prospective consumers. This has potentially negative consequences for the safety of users and the regulation of the market." dwf_admin Thu, 06/06/2024 - 23:27 Source Gibbs N. Trends Organ Crime.

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Agency IQ

FEBRUARY 15, 2024

The regulation of BPA in the EU today BPA has been jointly registered (as a full registration) under REACH with over 60 registrants manufacturing or importing the substance in the tonnage band at or above 1,000,000 metric tons per year. B1) BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e.,

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Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Additional information about this stay can be found in the Notice of Stay published in the Federal Register, October 30, 2015 (80 FR 66907). Q: What is your advice for approaching the regulatory strategy?

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The Pharma Data

JULY 28, 2021

She will serve as Chair of the Board of Directors upon transformation of EUROAPI into a société anonyme , in compliance with applicable corporate governance regulations. Together, these appointments underscore the company’s strategy to further increase the diversity and cultural backgrounds of the executives leading Sanofi’s modernization.

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The Pharma Data

DECEMBER 4, 2020

Between 1989 and 2015, nearly 4,800 were diagnosed with endometriosis. But in theory, there’s an explanation, she said: Sunlight — and specifically the ultraviolet B radiation it emits — spurs the body to produce vitamin D, which is anti-inflammatory and helps regulate immune function.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Drug Target Review

AUGUST 9, 2024

Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success. 2015 Sep;26 Suppl 5:v139-51. Epub 2015 Jul 4. link] Peterson DE, Boers-Doets CB, Bensadoun RJ, Herrstedt J; ESMO Guidelines Committee. doi: 10.1093/annonc/mdv202. PMID: 26142468.

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The Pharma Data

MARCH 27, 2021

11 Like human GLP-1, Saxenda ® is believed to work in areas of the brain involved in appetite regulation, including the hypothalamus. Since launch in 2015, more than 1.5 Saxenda ® (liraglutide 3.0 million patients have been treated with Saxenda ® globally.

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Drug Target Review

JANUARY 5, 2024

and the work reported in: Bosch DE, Jeck WR, and Siderovski DP ‘Self-activating G protein alpha subunits engage seven-transmembrane regulator of G protein signaling (RGS) proteins and a Rho guanine nucleotide exchange factor effector in the amoeba Naegleria fowleri.’ NIH R01 DA048153 (to D.P.S.), T he Journal of biological chemistry.

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Drug Target Review

OCTOBER 17, 2024

By definition, the do-not-eat-me signal refers to phagocytosis of tumour cells by macrophages, although we and others have shown that the CD24/Siglec-10 pathway also regulates the function of T cells and NK cells.

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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

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Agency IQ

NOVEMBER 10, 2023

BY ALEXANDER GAFFNEY, MS, RAC | NOV 9, 2023 6:35 PM CST Background on CDER’s Office of Pharmaceutical Quality (OPQ) CDER’s Office of Pharmaceutical Quality became operational in January 2015, making it a still relatively recent addition to the agency.

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Agency IQ

AUGUST 11, 2023

Given this significance, it’s worth analyzing its chaotic regulatory history, examining the implications of the risk assessment document itself, and projecting how this controversial active substance is likely to be treated by EU regulators going forward. and EU, however, have diverged from this conclusion.

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DrugBank

JUNE 27, 2023

14 As an unbiased method for genetic variant detection, GWAS holds the promise of identifying new genes and gene regulation mechanisms underlying a variety of conditions, including complex diseases. whitehouse.gov [link] (2015). Nature 526 , 68–74 (2015). Precision Medicine from a Public Health Perspective. Waeber, G. &

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Drug Target Review

OCTOBER 3, 2024

3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. 2015 May;521(7552):274–6. Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval. www.science.org.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. Four comments were submitted to the docket established for the 2015 Petition.

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Agency IQ

MARCH 7, 2024

As stated by the FDA , the proposed HFP will allow the agency to truly fulfill the vision laid out in the FSMA, “elevate the importance of nutrition to help reduce diet-related diseases,” and leverage existing partnerships and new technologies so as to “more effectively regulate and uphold safety of the nation’s food supply.”

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The Pharma Data

AUGUST 5, 2020

Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015 8. December 21, 2015. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Comparison of the B-Cell recovery time following discontinuation of anti-CD20 therapies. Accessed June 17, 2020.

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The Pharma Data

OCTOBER 21, 2020

headquartered in Woburn, MA, was founded in 2015 to develop the next generation of oncolytic immuno-gene therapies for the treatment of cancer. About Replimune Replimune Group, Inc.,

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The Pharma Data

MARCH 13, 2021

” Discussions with regulators are ongoing and an update on the TRAILBLAZER clinical trial program will be provided on a webcast on Monday, March 15 at 10:30 AM EDT including an update on the ongoing TRAILBLAZER-ALZ 2 trial. In the US alone, there was an increase of 8 million new caregivers from 2015 to 2020 5.

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Agency IQ

JANUARY 19, 2024

WALKER LIVINGSTON, ESQ | JAN 17, 2024 8:30 PM CST Background: Clean Air Act and NAAQS Under the Clean Air Act (CAA), the Environmental Protection Agency (EPA) must issue a cornucopia of air quality-related regulations to protect the environment and public health of the country. BY PATRICIA ISCARO, ESQ.,

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Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. The FDA sought input on these criteria from the PCAC in 2015 and again in 2016. Now, the proposed list is out, and its limited length may be a surprise to stakeholders.

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The Pharma Data

DECEMBER 15, 2020

Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane ® ) in combination with gemcitabine for first-line treatment in 2013 and Onivyde ® in combination with fluorouracil and leucovorin for second-line treatment in 2015. About BioLineRx BioLineRx Ltd.

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The Pharma Data

NOVEMBER 9, 2020

Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 2015; 15: 57-65. Amgen’s business may be impacted by government investigations, litigation and product liability claims. J Allergy Clin Immunol.

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