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’.

Marketing 40

Marketing Drugs Production Pharmaceuticals 40

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

FDA 59

FDA Regulations Packaging Compliance 59

Codon

AUGUST 10, 2023

Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Link Biological Networks & Mathematics →Network motifs in the transcriptional regulation network of Escherichia coli , by Shen-Orr S.S. FEMS Yeast Research (2015).

DNA 98

DNA Cell Biology Molecular Biology Engineering 98

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.

Laboratories 81

Laboratories FDA Regulations Licensing 81

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).

RNA 40

RNA Regulations 40

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. Immunol Rev.

International 98

International Regulations Therapies Clinical Trials 98

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.

Disease 59

Disease Drugs Regulations Therapies 59

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.

Molecular Biology 86

Molecular Biology Therapies Pharmaceuticals Treatment 86

Codon

AUGUST 10, 2023

Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Link Biological Networks & Mathematics →Network motifs in the transcriptional regulation network of Escherichia coli , by Shen-Orr S.S. FEMS Yeast Research (2015).

DNA 52

DNA Cell Biology Engineering Molecular Biology 52

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.

Marketing 40

Marketing Drugs Regulations 40

Drug Target Review

AUGUST 9, 2023

14 TDP-43 is a DNA and RNA binding protein that regulates the expression and splicing of several target transcripts. Stathmin-2 is one of many proteins that appear critical for the growth and stabilisation of axons, most likely by regulating the dynamics of axonal microtubules.

RNA 98

RNA Regulations Disease DNA 98

Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. When it became clear this target was not going to be met, Ecophyto II was released in 2015. Several iterations of the French Ecophyto Plan have been observed over the years.

Government 40

Government Regulations Production Marketing 40

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.,

Packaging 40

Packaging Regulations Compliance Production 40

Drug Discovery World

MARCH 6, 2024

Mutations in the dark genome affect gene regulation rather than coding, exerting a positive or negative impact on the expression of genes that may be related to disease processes. Their socioeconomic costs are measured in hundreds of billions of dollars per year.

Clinical Trials 162

Clinical Trials Pharmaceutical Companies Disease Trials 162

Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Compliance Government Science 40

Drug Discovery World

MAY 15, 2024

Currently in a Phase Ib/IIa study, it is believed to stabilise GAP-junction activity through regulation of connexin-43. IDF Diabetes Atlas: A review of studies utilising retinal photography on the global prevalence of diabetes related retinopathy between 2015 and 2018. Diabetes Res Clin Pract. 2019;157:107840.

Disease 162

Disease Treatment Therapies Pharmaceuticals 162

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.

Government 52

Government Molecular Biology Regulations Laboratories 52

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.

FDA 59

FDA Production FDA Approval Compliance 59

Drug Discovery World

OCTOBER 31, 2023

The UK’s regulator, the MHRA, has indicated support in its early-stage advice, but suggests more clinical data is also needed. These factors have made regulators reluctant to rely on NfL in benefit-risk assessments of new therapies. Barriers to widespread adoption However, not everybody is as enthusiastic as we are. Mullard, A.,

Drug Development 147

Drug Development Disease Drugs Clinical Trials 147

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.

Packaging 59

Packaging FDA Regulations Production 59

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.

FDA Approval 59

FDA Approval FDA Production Therapies 59

Agency IQ

FEBRUARY 2, 2024

What we expect the EPA to do in February In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. The Agency expects to issue a final rule later in 2023.

Regulations 40

Regulations Compliance Engineering Government 40

Drug Discovery World

MAY 11, 2023

This high level of quality control is also demanded and regulated by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which consider HCPs a critical quality attribute (CQA). 2015): 1727-1737. ” Biotechnology and bioengineering 112.9 Collins, Ben C., 2017): 1-12.

Production 130

Production Vaccine Immune Response Therapies 130

PLOS: DNA Science

APRIL 4, 2024

Fishy Regulations Lume falls under the cosmetic category at FDA and so needn’t have undergone clinical trials, because it doesn’t treat an illness or condition. If each ingredient is recognized as safe, then manufacturing complies with FDA regulations. It debuted in January 2024 , but the company has been around since 2015.

Disease 65

Disease Testimonials Production FDA 65

Drug Discovery World

DECEMBER 6, 2022

Detailed meta-data (the data about data) is a requirement of working in a regulated industry – enabling reproducibility and traceability. BMJ 2015: 350;h391. . 10 As a result, reported cumulative Covid-19 deaths reduced by 13% overnight. . For statisticians working in drug development, such ambiguity is an anathema.

Drug Development 246

Drug Development Vaccine Drugs Pharmaceuticals 246

Drug Discovery World

APRIL 20, 2023

Regulators are therefore used to seeing cognitive data as primary or secondary outcomes in clinical trials, and are familiar with the instruments and methodological nuances of such data. World Alzheimer Report 2015 The Global Impact of Dementia An Analysis of prevalence, Incidence, cost and trends.” depression). KW Miskowiak et al.,

Drug Development 246

Drug Development Clinical Trials Drugs Virus 246

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.

FDA 40

FDA Science Regulations Production 40

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.

Pharmaceuticals 40

Pharmaceuticals Small Molecule Science FDA 40

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. .

Small Molecule 52

Small Molecule Disease Immune Response Licensing 52

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.

Regulations 40

Regulations Compliance Production Government 40

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.,

International 40

International Regulations Packaging Animal Testing 40

Advarra

AUGUST 10, 2023

“I am very excited for the field because I feel like we’re beginning to get to a critical mass, where a single method or product can be deemed safe and then adapted for many uses,” said Dr. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

Drug Development 52

Drug Development Disease Engineering Therapies 52

The Pharma Data

AUGUST 8, 2020

Lilly earned Chinese rights to Tyvyt through a pact the two signed in 2015, and the drug was first approved in December 2018 in third-line classic Hodgkin lymphoma. BeiGene’s application for that indication was accepted by Chinese regulators in June. The three meds were also up for a fight in first-line squamous NSCLC.

Trials 52

Trials Pharmacy Hospitals International 52

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.

Regulations 40

Regulations Compliance Production Science 40

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.”

FDA 40

FDA Regulations Packaging Marketing 40

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.

Regulations 40

Regulations Marketing DNA Production 40

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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.

FDA 40

FDA Science Regulations Production 40