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

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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Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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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 global ADC market is expected to continue this steep upward trajectory and is anticipated to exceed $16 Billion by 2026. Antibody drug conjugated with cytotoxic payload.

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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

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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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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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.

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Broad Institute

AUGUST 27, 2024

where she served as a director, president, and CEO prior to the acquisition of ZYCOS by MGI PHARMA in 2004. She did her postdoctoral training at Harvard University in the areas of immunology and gene regulation with Tom Maniatis and Jack Strominger. Prior to her role at MGI, she was a co-founder of ZYCOS Inc.,

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”).

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Perficient: Drug Development

FEBRUARY 22, 2024

Tesla set out in 2004 to become the first all-electric automobile manufacturer. At that time, their industry was driven by government regulations and tariffs. Nintendo continues to differentiate itself as more family-friendly with a focus on gameplay and portability. Atlas Van Lines is in the moving and relocation industry.

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The Pharma Data

SEPTEMBER 30, 2020

have all been reported to the appropriate authorities”, it would “co-operate closely with regulators” and “recommendations and learnings” had been made to staff. Circle Health Group said the “historic issues. Follow BBC West Midlands on Facebook , Twitter and Instagram.

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Pharmaceutical Development Group

AUGUST 9, 2021

Biotechnology and genomics businesses were projected to perform around one-fifth of all pharmaceutical research and development in 2004. (R&D). Many pharmaceutical goods would not have been possible without the use of biotechnologies over time.

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Codon

FEBRUARY 13, 2024

By 2004, over a dozen companies were working on developing phage products and therapies, in locations ranging from Baltimore to Bangalore, where ten years previously, there had been none. It took two years to produce the phage cocktail to standards that regulators were happy with.

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Drug Target Review

FEBRUARY 26, 2024

Our data demonstrate that the CoREST complex is a critical mediator of the distinct melanoma phenotypes, working through the regulation of both the phenotype-defining genes MITF and AXL as well as the master regulators of epithelial-to-mesenchymal transitions (EMT) and phenotype switching in melanoma and other cancers, SNAIL/SLUG/ZEB1/ZEB2.

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Drug Target Review

FEBRUARY 5, 2024

Their destructive potential and ability to secrete regulators of the function of neighbouring cells contribute to many aspects of homeostasis. Future applications The results suggest that macrophages in specific tissues throughout the body aid the direction and regulation of the cellular repair programme. Wiley Online Library.

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Broad Institute

AUGUST 2, 2023

The design of STAR leverages unique characteristics of the 2004 tsunami to provide plausibly-causal estimates of the ramifications of disasters and traumatic exposures. The 2004 tsunami was a massive tragedy, with waves of over 30m impacting the coastline. T3 is the active form of thyroid hormone.

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FDA Law Blog: Biosimilars

MAY 23, 2023

Since then, the science and legal and regulatory framework for food allergens have evolved considerably: Congress enacted the Food Allergen Labeling and Consumer Protection Act (2004) and the Food Safety Modernization Act (2011), and FDA implemented the regulatory requirements set forth in 21 C.F.R.

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The Pharma Data

APRIL 18, 2022

In August 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) was signed into law. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Source link: [link].

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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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Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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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. Dr Liu received his PhD from the Australian National University and completed his postdoctoral fellowship at Yale University.

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Agency IQ

MARCH 25, 2024

Updates from IMDRF: What’s next for the working groups At the International Medical Device Regulators Forum (IMDRF) annual meeting in Washington, DC, regulators presented updates on the work underway within all seven IMDRF working groups. The group began with regulators from Australia, Brazil, Canada, China, the E.U.,

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The Pharma Data

JULY 23, 2021

Outside Japan, the antibody combination has been authorised for emergency use or temporary pandemic use in additional territories and regions, including in the European Union, United States, India, Switzerland and Canada.

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

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Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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Broad Institute

OCTOBER 4, 2023

Cech also described his own recent research, published in Science , in which he and colleagues used an epigenetic gene-silencing complex essential for cell differentiation and often deregulated in cancers to demonstrate that RNA, in addition to serving as a messenger, regulates the process of transcription itself.

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The Pharma Data

AUGUST 1, 2021

4 Type I IFNs such as IFN-alpha, IFN-beta and IFN-kappa are cytokines involved in regulating the inflammatory pathways implicated in SLE. The Phase III trial in SLE using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis.

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Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

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The Pharma Data

MARCH 22, 2021

Earlier this year, the EMA’s Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19.

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The Pharma Data

JANUARY 13, 2021

11):1583 (2004) 6 Karpusas M, et al. 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583 Structure. 9(4):321-9. About CD40-Ligand. CD40-ligand is a protein expressed on the surface of activated T lymphocytes that mediates T cell helper function.

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Agency IQ

APRIL 19, 2024

In 2004, there were about 4.6 This category will become much more relevant once the EPA’s National Primary Drinking Water Regulation for six different PFAS comes into effect in five years, after which time these materials will be disposed of much more frequently. Aqueous film-forming foams (AFFFs).

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The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. Review will support a formal Marketing Authorisation Application.

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The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. The CHMP scientific opinion under Article 5.3 Lilly Antibody Therapies Around the World.

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New Drug Approvals

JANUARY 9, 2024

1004-1014, 2004). In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. This suggests that the CDK7 enzyme complexes are involved in multiple functions in the cell: cell cycle control, transcription regulation and DNA repair. Oct 1 5;24(20):2303-16, 2010; Blazek et al., Konig et al.,

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BMG Labtech

MARCH 8, 2023

In fact, metabolism should not be considered as a self-regulating entity that is independent of other biological pathways. Smith E, 2004, Universality in intermediary metabolism, Proceedings of the National Academy of Sciences of the United States of America. Fourth in the Cycles Review Series, EMBO Reports. 7 (3): 276–82. PMC 1456893.

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