KIF1A

JUNE 30, 2023

As families, scientists, doctors and our friends around the world navigated the challenges of 2022, the KIF1A.ORG community worked together to reach new heights. Over 162 new families from around the world joined our community since January 2022. What a year! As this community grows, so does our army of advocates and supporters.

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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

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

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

SEPTEMBER 1, 2023

EU’s PIC Regulation adds 35 new entries The European Commission’s latest update to the export and import of hazardous chemicals regulation – which implements the Rotterdam Convention on prior informed consent in the EU – includes 27 pesticides and eight industrial chemicals in the list of substances requiring export notification.

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Drug Discovery World

NOVEMBER 23, 2023

This is the latest episode of the free DDW narrated podcast, “Drug discovery trends: From regulation to embracing AI”, which covers two articles written for Volume 23 – Issue 4, Fall 2022 of DDW. They are called: From the Editor: Law and order and How AI in pharma can live up to the hype.

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The Pharma Data

MARCH 31, 2022

L’Oréal, Sanofi’s largest shareholder, has committed to a lock-up period of 1 year following the settlement of the Distribution, i.e., May 10, 2022. cash dividend per Sanofi share. For information on the tax treatment of the Distribution, shareholders are invited to read Paragraph 22.1.6 of the listing prospectus.

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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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The Pharma Data

JUNE 7, 2022

Sanofi today launches Action 2022, its global employee share ownership plan, open to 86 000 employees in 59 countries. Starting June 9 th , the shares will be offered at a subscription price of 80.21€, which is equal to a 20% discount off the average of the 20 opening prices of Sanofi shares from May 9 to June 3, 2022.

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new 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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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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Drug Discovery World

SEPTEMBER 6, 2023

It’s great to see companies like Phesi and Krystelis delivering practical solutions and services to help companies meet these new regulations quickly and effectively. In a further 2023 analysis on a subset of data from 22.4 million patients, Phesi discovered only 10.2

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.

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Agency IQ

JULY 21, 2023

New EPA regulations to sweep up lead levels in many structures The Environmental Protection Agency has announced new dust-lead hazard standards and clearance levels, which regulate levels of lead dust on floors and windowsills. New proposed EPA regulations On July 12, 2023, the EPA announced that it was reducing both the DLHS and DLCL.

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Chemical Biology and Drug Design

MAY 25, 2023

PTP1B is a negative insulin signaling pathway regulator; hence, inhibiting PTP1B increases insulin sensitivity, glucose absorption, and energy expenditure. PTP1B is a negative insulin signaling pathway regulator; hence, inhibiting PTP1B increases insulin sensitivity, glucose absorption, and energy expenditure.

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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. 2022, doi: 10.1016/S2215-0366(22)00260-7. 2022, doi: 10.1016/j.euroneuro.2022.04.004. 2022, doi: 10.1038/s41586-022-04569-5. 82–92, Jun.

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Drug Discovery World

MARCH 16, 2023

Additionally, a pledge to reform the regulation and approval of medicines, could see rapid approval for companies whose products have already gone through the US or European system and quickly open the UK as a new market.” We need regulation – but we need regulation that is focused on enabling solutions.”

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Common Sense for Drug Policy Blog

JUNE 24, 2024

The last decade has been characterized by a remarkable dynamism of change in the illicit drug market with the constant introduction of new substances synthesized to circumvent regulation. A review of synthetic cathinones emerging in recent years (2019–2022). This phenomenon has also applied to synthetic cathinones [ 4 , 5 , 6 ].

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Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. My mission is to see cannabis regulators understand basic science and to consult experienced scientists to refine regulations.

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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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Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials. This approach, together with very sparse, confirmatory PK data, for example, is discussed by Small et al. Clin Pharmacol The r.

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Drug Discovery World

JUNE 19, 2023

Anoat Therapeutics’ goal is to bring a transformative and mutation-agnostic treatment option to CF patients for whom existing therapies are not effective – for example, patients not eligible or responsive to CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulator therapies.

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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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Drug Discovery World

SEPTEMBER 9, 2022

Cancer research has been making headlines over the last seven days in the build-up to the European Society for Medical Oncology (ESMO) Congress 2022. This week’s top stories: Combination therapy halts lung cancer tumour growth in mice.

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Drug Discovery World

FEBRUARY 1, 2023

It is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estiated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 2027 1. However, the potential use of cannabis in a pharmaceutical setting is vast.

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Drug Discovery World

MAY 29, 2024

Success is a bigger pie for both sides The factors above all played a role in the deal which led to Bonum’s launch in November 2022. Our company has a platform for developing context-dependent, targeted therapies based on allosteric regulation, an extremely challenging area of science.

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Common Sense for Drug Policy Blog

DECEMBER 20, 2023

By 1972, the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) had instituted severe regulations that restricted access, said Roberts. These regulations were designed primarily to prevent methadone from being diverted to the street, he said. Washington, DC: The National Academies Press.

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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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The Premier Consulting Blog

MAY 4, 2023

billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1]. Food and Drug Administration (FDA) published in March of 2022 pertaining to ophthalmic drugs and devices, titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. 2] On April 16, 2021, the U.S.

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Drug Discovery World

OCTOBER 5, 2022

RA: How regulated is bioprinting and is there more work needed with regulators to make it more accessible? . TK: There is still groundwork to be done, and knowledge sharing and regulatory changes to make so regulations are uniform and simple enough. Volume 23 – Issue 4, Fall 2022. .

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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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FDA Law Blog: Biosimilars

APRIL 21, 2024

Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , here ). Patent Nos. Patent Nos.

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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 Discovery World

APRIL 11, 2023

The first patient was dosed in July 2022 and nine patients have been treated to date during the dose escalation phase. The Phase I/IIa study is conducted in collaboration with Lead Investigator, Mark Pennesi, Professor of Ophthalmology at the Casey Eye Institute in Oregon, US.

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Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. Read more about what the regulator plans for its database here.]

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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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