Drug Discovery World

APRIL 13, 2023

In 2018, the US Food and Drug Administration (FDA) introduced a policy for accepting real-world data (RWD) and real-world evidence (RWE) in addition to traditional clinical trial data in new drug applications. This has created the foundational infrastructure and legal pathway to patient-level RWD data with an unprecedented breadth and reach.

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FDA Law Blog: Biosimilars

MAY 16, 2024

But there has been a recent string of large civil monetary settlements, some in the millions of dollars, to resolve allegations that hospitals’ non-compliance with the federal Controlled Substances Act (“CSA”) and DEA regulations allowed employees to divert staggering quantities of controlled substances.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Drug Target Review

SEPTEMBER 4, 2023

2018): Ubiquitin Proteasome pathway proteins as potential drug targets in parasite Trypanosoma cruzi, Scientific Reports. (8):8399. 2018): Insights into antitrypanosomal drug mode-of action from cytology-based profiling, PLOS Neglected Tropical disease. link] Ojewale Kayode (2018). Doi.org/10.1038/s41592-019-0614-5 Ishita, G.,

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FDA Law Blog: Biosimilars

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. The evolving upswing in NDSRI regulation is due to their link to cancer. Koblitz — We need to talk about nitrosamines.

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FDA Law Blog: Biosimilars

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Take for example FDA’s Unified Agenda announcement for ISO 13485 harmonization, which first occurred in the Spring of 2018 and was re-issued until a proposed rule was published in early 2022 (see our post here ).

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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. The first version of the plan, whose goal was reduction of use of pesticides (or “plant protection products, as the plan called them ) was unveiled in 2008 with the aim of cutting pesticide use in half by 2018.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

2018 ; Llewellyn and Tober 2010; Denham 2019 ). 2017 ; Greenway and Price 2018 ). According to Turnock ( 2020 ), most anabolics steroids in the UK are produced in domestic ‘underground labs’ (UGLs) (Coomber et al. 2014 ), and can broadly be characterised as social supply (Coomber et al. 2014 ; Begley et al. 2014 ; Begley et al.

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KIF1A

MAY 4, 2024

During her time as an undergraduate student, she conducted research on proline metabolism and its effects on ATF4 regulation. Jamie Woych Jamie received her BS in Biochemistry from SUNY New Paltz in 2018. She obtained her Bachelor’s degree in Life Sciences from Fudan University in 2023.

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FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). In fact, in 2018, FDA emphasized that leveraging the use of RWD and RWE in regulatory decision-making is “a top strategic priority for the FDA.” By Jeffrey N.

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Drug Channels

DECEMBER 17, 2020

HHS relied in part on a highly misleading ASPE study of 2018 data. Last year, Dr. Scott Gottlieb, a former FDA commissioner, argued that we shouldn’t give up on biosimilars and prematurely regulate prices. Drug pricing perceptions always seem to lag reality. Consider HHS's "Most Favored Nation" model for Medicare Part B.

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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.

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Advarra

DECEMBER 14, 2023

Advarra analysis of the FDA Inspection Observation Datasets from 2018 – 2022 shows the following causes make up 44% of all findings: Failure to Follow Investigational Plan (21 CFR 312.60) Citations for failure to follow the investigational plan contribute to over half of the failures recorded since 2018.

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Drug Discovery World

OCTOBER 9, 2023

Akin to a computer’s central processing unit, mitochondria orchestrate broad ranging processes pertaining to cellular health, including metabolism, energy, and immune regulation. Biography Bill Hinshaw joined Axcella as CEO in May 2018. In their paper, Guarnieri et al.

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The Pharma Data

MARCH 29, 2022

Today’s action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements) of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Regulation. Related Information.

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Advarra

DECEMBER 15, 2022

Policies and Regulations Affecting Single IRB Review. with compliance required beginning January 25, 2018. Health and Human Services (HHS) regulations as much as practicable, which includes sIRB requirements. Working with an sIRB remains completely voluntary in many cases. The policy doesn’t apply to foreign sites.

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Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 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.

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The Pharma Data

APRIL 6, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

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Broad Institute

JUNE 14, 2023

A trailblazer in cancer research, Glimcher's research identified key transcriptional regulators of protective immunity and the origin of pathophysiologic immune responses underlying autoimmune, infectious, and malignant diseases. She is also a member of the board of trustees of the Massachusetts Health & Hospital Association.

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Drug Target Review

JULY 13, 2023

Dewpoint Therapeutics, a platform drug discovery company founded in 2018, has been at the forefront of this exciting field. As for regulatory considerations, Klein anticipates engaging in discussions with regulators to address novel aspects such as mechanism, toxicology, and dosing regimens.

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The Pharma Data

APRIL 8, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

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Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUN 28, 2023 12:13 AM EDT Regulatory background The FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) regulates pharmaceutical advertising in the U.S., The FDA regulates prescription drug advertising under 21 CFR 202.1 , Prescription drug advertisements.

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. The integration of technology in healthcare not only promises advancements but also raises concerns about security, regulation and potential disparities in access.

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Translation

JULY 13, 2022

Last year, the companies partnered with Halo to seek solutions in carbon sequestration , plant growth regulators , and mycorrhizal fungi colonization. Likens Award from the Biogeosciences section of the Ecological Society of America in 2018 for her work in the field. Valent U.S.A. She received the prestigious Gene E.

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Drug Discovery World

MARCH 29, 2023

She also does not believe that the problems with Europe’s medicines can be solved with regulation. If you measure everything on faster, I’m not sure Europe will always come out ahead.” References [link] [link] [link] [link] [link] [link] [link] [link] The post European Commission vs Big Pharma, or profit vs access?

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Drug Target Review

JULY 5, 2024

Interneuron migration is regulated by L-type calcium channels (LTCCs), encoded by the CACNA1C gene. 15(9):700-706 (2018) [link] Deshmukh V, et al. TS has been studied through the generation of “assembloids”, glutamatergic and GABAergic organoids fused together. 12(3) (2023). link] Madhavan M, et al. Nat Methods. 502:327-332 (2013).

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H1 Blog

AUGUST 30, 2023

billion in 2018 to $44.932 billion by 2023, a CAGR of 18.2 Prove & Facilitate HIPAA & FDA Compliance Another facet of healthcare cloud technology that could impact sales is compliance with HIPAA and FDA regulations. After a slow start, cloud computing in the medical field is seeing a higher rate of adoption.

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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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Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. Reneo has been working on this since before 2018. Every drug has a story: an end game.

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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.), Emerg Infect Dis. 2021;27(1):271-4.

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Vial

MARCH 15, 2024

. · Regulatory compliance : Given the global and decentralized nature of clinical studies, involving various sites and stakeholders worldwide, adhering and staying compliant with evolving international, national, and local regulations becomes increasingly challenging.

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Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. These facilities are uniquely categorized under French law so that they may be regulated with greater oversight. agricultural activity, waste processing).

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Drug Discovery World

APRIL 14, 2023

as a master regulator of prostate differentiation and cancer initiation and progression, for generating unique and reliable murine bladder and prostate cancer models, and for steadfast commitment to serving as a leader, mentor, and supporter of women in cancer research. Mak’s award lecture will be held on Sunday April 16 at 12pm ET.

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NIH Director's Blog: Drug Discovery

MAY 9, 2019

Among those taking on this ambitious challenge is a recipient of a 2018 NIH Director’s New Innovator Award, Srivatsan Raman of the University of Wisconsin-Madison.

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The Pharma Data

MARCH 1, 2022

Syndesi’s unique molecules act pre-synaptically to enhance synaptic efficiency by positively modulating the function of synaptic vesicle protein 2A (SV2A), which plays a central role in regulating neurotransmission. The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018.

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The Pharma Data

JANUARY 16, 2021

Since its launch at the end of 2018, Etta’s X-Porator F1 has been accepted and adopted by many Chinese antibody drug and IVD benchmark companies, bringing significant benefits to customers. The two parties also plan to join force further to build a rapid protein production platform aiming at producing gram-scale protein for R&D, e.

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