Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Oxidation of adagrasib occurs on the methylpyrrolidine group 4. Dermavant’s tapinarof is one such friend.

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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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Agency IQ

MARCH 29, 2024

National PFAS water regulations imminent The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S.

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Drug Target Review

JULY 4, 2023

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. The first-in-class treatment for KRAS G12C-mediated non-small cell lung cancer was approved by the US FDA in 2021 and by the EMA in 2022 with orphan status and accelerated reviews.

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Perficient: Drug Development

NOVEMBER 1, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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The Strateos Blog: Drug Discovery

DECEMBER 5, 2022

The Alliance fosters pre-competitive collaboration with members working together as equals on projects that will benefit the industry as a whole—whether it is identifying the root causes of inefficiencies, working with regulators to adopt new standards, or helping researchers implement AI effectively—and more!  The

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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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KIF1A

JANUARY 13, 2024

This process is regulated so we end up with the right number of neurons, which we can imagine with some simplified math: If you start with one progenitor and need eight neurons, it isn’t efficient for that progenitor to make a single neuron eight times. Want to see more research from the Vallee Lab?

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Drug Channels

FEBRUARY 7, 2022

Hybrid Event March 28-29, 2022 | Philadelphia, PA www.informaconnect.com/drug-pricing-transparency. Don’t miss the Drug Pricing Transparency Congress on March 28-29, 2022! Drug Channels readers will save 10% off when they use promo code 22DRCH10 and register prior to March 4, 2022.*. Drug Pricing Transparency Congress.

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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. for 2020 and 5.3%

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Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

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Perficient: Drug Development

MARCH 6, 2024

In December 2022, the Department of Health and Human Services released a bulletin announcing additional compliance requirements for healthcare marketers when it comes to third-party trackers. However, full adherence to HHS guidance and HIPAA regulations is non-negotiable, so in light of recent guidance, change is completely warranted.

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Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

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Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

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Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. SB 54 established a set of recycling and source reduction targets for the state to meet by 2032.

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Agency IQ

APRIL 12, 2024

EPA releases final PFAS drinking water regulations – with five-year compliance timeline The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. Part 141 and contains the implementing regulations from the act. The SDWA is administered by the EPA at 40 C.F.R.

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Agency IQ

AUGUST 2, 2024

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.

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Agency IQ

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

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Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

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Agency IQ

MAY 3, 2024

What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. On May 29-30, the agency will host ECHA IT Days , a two-day conference held in Helsinki, Finland dedicated to all things related to information technology and chemical regulations.

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Agency IQ

MAY 28, 2024

Updates to TSCA new chemicals regulations hit OIRA for review The Office of Information and Regulatory Affairs has begun review of a final rule that will change how the EPA handles new chemical reviews under the Toxic Substances Control Act (TSCA). TSCA itself has numerous subsections focused on different aspects of chemical regulation.

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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.

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Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.

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Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. Inhibiting KDM5A, a regulator of cell proliferation, poses another interesting approach. 2022 Dec 12 [cited 2024 Sep 4];22(3):213–34. References 1.Jin Jin H, Wang L, Bernards R.

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Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

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Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. Hyman, Phelps & McNamara, P.C.’s s Faraz Siddiqui will speak on Tuesday, September 19, on Value-Based Agreements.

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Eye on FDA

OCTOBER 19, 2022

While slow out of the starting gate with emergent media opportunities, in 2022, pharma is embracing the platform in both unbranded and branded efforts. FDA’s OPDP began considering an approach to regulating social media long before Tik Tok came into being. Tik Tok was first released in 2016. That is a start.

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FDA Law Blog: Biosimilars

JULY 22, 2024

s John W.M. s John W.M.

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Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. addresses the Inflation Reduction Act of 2022.

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Drug Channels

DECEMBER 17, 2021

This week, I’m rerunning some popular posts while I prepare for today's live video webinar: Drug Channels Outlook 2022. This tale neatly summarizes why so many people hate our healthcare system—and why the average patient will have trouble benefiting from transparency regulations. See you soon! d/b/a Drug Channels Institute.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Patent Watch

DECEMBER 11, 2024

Pharmaceutical companies should evaluate a CDMOs compliance with industry standards and regulations, ensuring that they have a robust quality assurance system in place. 2022, November 29). Regulatory Compliance and Quality Assurance Regulatory compliance and quality assurance are essential aspects of CDMO selection.

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Drug Channels

JULY 18, 2022

Hybrid Event October 12-14, 2022 | Chicago, IL www.informaconnect.com/MDRP. MDRP 2022 is your chance to hear directly from the government regulators creating the rules, the industry leaders interpreting them and the manufacturer experts implementing them – You won’t want to miss it! And so much more !

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FDA Law Blog: Biosimilars

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. We have drafted a memorandum that summarizes the main provisions of this proposed rule and notes where the regulation differs from the guidances.

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biobide

NOVEMBER 20, 2023

Background on the Cosmetics industry In 2022, the value of the global cosmetics market was estimated to be worth USD 262.21 Such concerns have led to strict regulations regarding the formulation of cosmetic products. billion, with an annual growth of 4.2% projected by the year 2030.

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