Drug Discovery World

OCTOBER 16, 2023

Dr June Raine, MHRA Chief Executive, said: “Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents. The post UK regulator cuts late-stage clinical trial approval time to two weeks appeared first on Drug Discovery World (DDW).

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Agency IQ

MARCH 29, 2024

BY WALKER LIVINGSTON, ESQ 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 Discovery World

NOVEMBER 1, 2023

The post Chinese regulator approves complete long-acting HIV-1 injectable appeared first on Drug Discovery World (DDW). In ATLAS, 92.5% of participants receiving long-acting therapy and 95.5% of those receiving oral therapy remained virally suppressed at week 48. In FLAIR, 93.6% of participants receiving long-acting therapy and 93.3%

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Drug Discovery World

OCTOBER 10, 2022

The post The next steps for biopharma regulations appeared first on Drug Discovery World (DDW). Not yet a DDW member? Join now for FREE – it takes less than 2 minutes! Username or E-mail. Remember Me. Forgot Password.

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Drug Discovery World

SEPTEMBER 21, 2022

According to a study published in Cell Reports, the breast cancer cells regulate their own metastases by fuelling dissemination from the original tumour and determining routes to invade distant organs like the lungs. The post Breast cancer cells ‘regulate their own metastases’ appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MARCH 21, 2023

The In Vitro Diagnostic Regulation (IVDR) came into effect in May 2022. The regulation aims to ensure patients’ safety, provide a more transparent framework for IVDs and deliver access to innovative medical technologies.

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Science Daily: Pharmacology News

MAY 15, 2024

A recent study has found that an ion transporter protein that regulates the pH of specific brain cells can repair the blood-brain barrier and restore normal brain function after ischemic stroke.

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Drug Discovery World

MARCH 30, 2023

The post Chinese regulator approves personalised cancer vaccine trial appeared first on Drug Discovery World (DDW). These vaccines can also be designed to help elicit immunological memory for long-lasting tumour control. Hence, there is a need to increase clinical investigations in this promising area.”

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ProRelix Research

NOVEMBER 27, 2023

The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […] The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

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Perficient: Drug Development

DECEMBER 18, 2023

Legal Obligations and Regulatory Frameworks It is well-known that financial institutions operate within a complex web of laws and regulations. By streamlining processes and ensuring compliance with regulations, banks can reduce the likelihood of errors, fraud, and other operational inefficiencies that could threaten their stability.

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Agency IQ

MARCH 7, 2024

BY COREY JASEPH, MS, RAC This week, the British regulator MHRA offered a new peek into its planned medical device regulations. In the wake of Brexit, the E.U. no longer recognized products certified in the U.K., but the U.K. still needed CE-marked products.

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Drugs.com

SEPTEMBER 30, 2023

Food and Drug Administration on Friday announced that it will for the first time regulate these vital diagnostic tools. FRIDAY, Sept. 29, 2023 -- Faced with growing reports of inaccurate clinical lab tests, the U.S. Many Americans might have.

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Chemical Biology and Drug Design

JANUARY 7, 2024

The tumour killing effects of chrysophanol possible owing to its targeted regulation on mTOR. Screening by GEO software indicated that the mTOR signalling pathway is possibly regulated by chrysophanol. The beneficial effects of chrysophanol may be attribute to the targeted regulation of mTOR.

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Drug Discovery World

MARCH 17, 2023

The post Scottish regulator approves first chronic hepatitis delta virus drug appeared first on Drug Discovery World (DDW). A decision from the National Institute of Health and Care Excellence (NICE), which will provide guidance on its use across the rest of the UK, is scheduled to be made in the near future.

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Chemical Biology and Drug Design

FEBRUARY 19, 2024

However, the underlying molecular mechanism by which Icariin regulates osteogenic differentiation needs to be further revealed. The regulation of USP47 on SIRT1 was confirmed by ubiquitination detection and co-immunoprecipitation analysis. The viability of BMSCs was assessed by cell counting kit 8 assay.

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Agency IQ

MARCH 29, 2024

and national regulators. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

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Chemical Biology and Drug Design

SEPTEMBER 30, 2023

Abstract Epigenetic regulation of genes through posttranslational regulation of proteins is a well-explored approach for disease treatment, particularly in cancer chemotherapy. Structural classification and regulatory functions of histone deacetylases and their inhibitors.

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Chemical Biology and Drug Design

MARCH 8, 2024

Circ_0139658 is directly bound to miR-653-5p to regulate YY1 expression. Brucine suppressed the proliferation, migration, and invasion of RA-FLSs, and alleviated inflammation by reducing the release of pro-inflammatory factors and macrophage M1 polarization. RA-FLSs showed increased circ_0139658 and YY1 levels and decreased miR-653-5p levels.

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Drug Discovery World

SEPTEMBER 27, 2023

The post UK regulator gives green light to combination for multiple myeloma appeared first on Drug Discovery World (DDW).

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Agency IQ

JANUARY 12, 2024

To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. has done.

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Chemical Biology and Drug Design

JULY 26, 2023

Sino suppressed GC cell proliferation, migration, invasion, and promoted apoptosis via regulating the circTRPM7/miR-145-5p/PBX3 axis. Circular RNA (circRNA) is an important regulator of gastric cancer progression. However, it is not known whether Sinomenine mediates gastric cancer processes by regulating circRNA-related pathways.

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ProRelix Research

DECEMBER 14, 2023

The European Medicines Agency (EMA) coordinates the European […] The post EMA Pharmacovigilance Regulations Updates appeared first on ProRelix Research. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

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ProRelix Research

FEBRUARY 12, 2023

Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused […] The post Clinical Trial Regulations in the United States appeared first on ProRelix Research.

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PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.

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Agency IQ

MARCH 1, 2024

and national regulators. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

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Chemical Biology and Drug Design

JANUARY 24, 2024

From result of network analysis, the possible underlying mechanism of YH complex was closely related with the “regulation of hair cycle” and “apoptosis signaling pathway.” In summary, YH complex regulated hair development cycle by inhibiting the androgenic-apoptotic axis in AGA.

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Chemical Biology and Drug Design

JULY 13, 2023

Coptisine inhibits the malignancy of BC cells via regulating XPO1. In summary, COP represses the malignant biological behaviors of bladder carcinoma cells and regulates XPO1 expression, which is promising to be a complementary drug for bladder carcinoma treatment.

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FDA Law Blog: Biosimilars

JANUARY 28, 2024

Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. By Jeffrey N. Gibbs & Steven J.

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Chemical Biology and Drug Design

NOVEMBER 1, 2023

Kaempferol exerted antioxidant effects in AR-DOR by inhibiting Hsp90 to up-regulate Nrf2. The results showed that HSP90 was predicted to have high affinity with kaempferol, and its expression was inhibited by kaempferol, while the expression of NRF2, the target of HSP90, was up-regulated by kaempferol.

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FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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Drug Discovery World

APRIL 25, 2023

The post UK regulator approves ‘one the most significant advances in CLL treatment’ appeared first on Drug Discovery World (DDW).

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Chemical Biology and Drug Design

JANUARY 23, 2024

Matrine inhibits the growth and metastasis of hepatocellular carcinoma by regulating the ELAVL1/RBM3-mediated Wnt/β-catenin signaling pathway. Moreover, ELAVL1 might bind with RBM3 to positively regulate the stability of RBM3 mRNA. Nevertheless, the anti-tumor molecular mechanism of Martine in HCC is still not fully revealed.

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Chemical Biology and Drug Design

MARCH 8, 2024

Besides, SSD (4 μM) treatment could significantly up-regulate the cell viability and marker expression of PP-induced astrocytes. PP treatment (1 mM) induced cell injury by significantly reducing the viability of astrocytes and expression of cellular markers. SSD treatment (4 μM) had no toxicity to astrocytes.

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FDA Law Blog: Biosimilars

MARCH 10, 2024

Hyman, Phelps & McNamara Director Larry Houck will participate as a panelist focusing on this timely topic at the Food and Drug Law Institute’s (“FDLI’s”) Legal and Practical Issues in Cannabis Regulation Conference next month. The conference, held in Washington, D.C., April 4th and 5th, is an in-person and virtual event.

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Agency IQ

MARCH 15, 2024

The newly released draft regulations, statement of reason and regulatory impact assessment all point to the wide-reaching implications that the rule will have for a variety of industries across the state.

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Chemical Biology and Drug Design

JANUARY 24, 2024

Baicalin alleviates OGD/R-induced SK-N-SH cell apoptosis, inflammation, and ferroptosis in vitro, and brain injury in MCAO mice in vivo, via the regulation of miR-556-3p/ACSL4 pathway. In conclusion, BCL alleviated OGD/R-induced SK-N-SH cell injury and relieved brain injury in MCAO mice by regulating miR-556-3p/ACSL4 axis.

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Agency IQ

APRIL 12, 2024

BY WALKER LIVINGSTON, ESQ The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. The finalized rule includes new individual limits for some PFAS and gives water systems five years to be able to comply with the drinking water contaminant levels.

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