Drug Target Review

JULY 7, 2025

3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming. However, the last decade has seen a gradual reduction in their use, driven by tightening animal welfare regulations and scientific advances. Federal ruling on USDA primate welfare petition, 2023.

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Drug Target Review

JULY 21, 2025

These are proteins that actually do things – transcription factors that might change the regulation of different genes, proteins that can change the cell morphology.” The drug binds to the protein, and that will set off a signalling cascade, which will then lead to changes in activity of what are called effector proteins.

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Drug Target Review

APRIL 7, 2025

Involved in various physiological processes, such as vision, taste, smell, immune response and neurotransmission, GPCRs are activated by various molecules including hormones, neurotransmitters and environmental stimuli, which trigger a cascade of cellular events that help regulate bodily functions. Jones EM, et al. doi:10.7554/elife.54895.

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Alta Sciences

JULY 18, 2025

Benjamin Charron, PhD, Scientist I, Method Development, Altasciences Benjamin joined Altasciences in 2023 after developing bioanalytical sensors in academia for seven years. As a scientist, he is responsible for assay development and supporting regulated scientists for a smooth transition of the methods to a validated state.

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FDA Law Blog: Biosimilars

MARCH 24, 2025

Houck In August 2023, the U.S. Marijuana down-rescheduled to schedule III would still be regulated for legitimate medical, scientific and industrial use. By Larry K. Department of Justice subsequently conducted a separate Eight Factor Analysis and concurred with HHS rescheduling recommendation.

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New Drug Approvals

APRIL 25, 2025

Members of the PI3K family regulate cellular processes such as cell growth and proliferation, survival, remodelling, and intracellular transport of organelles. [15] Retrieved 21 September 2023. Retrieved 21 September 2023. Retrieved 21 September 2023. ^ April 2023). Retrieved 21 September 2023. 20 May 2019.

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New Drug Approvals

JUNE 22, 2025

The threonine / tyrosine protein kinase MEK plays a key role in the RAS/RAF/ MEK /ERK signaling pathway, which is frequently upregulated in a variety of tumor cell types and regulates key cellular activities including cell growth, proliferation, survival, differentiation and apoptosis. 2023 Oct 11;15(717):eade1844. min, m/z 471.2 [M+H]

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Codon

APRIL 17, 2025

Such vascular differences are governed by auxin, a plant hormone that regulates leaf venation and shape. Credit: Yamashita & Baluška (2023). The researchers also note fewer free-ending veinlets and thinner vascular networks in mimic leaves, interpreting this as evidence of active mimicry.

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PPD

JANUARY 2, 2025

And in a recent survey from the PPD clinical research business of Thermo Fisher Scientific , 34% of participants say they prefer hybrid FSP/FSO outsourcing for clinical development (up from 22% in 2023).

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The Premier Consulting Blog

APRIL 13, 2025

We remain ingrained in the regulations to ensure sponsors can optimize their programs and leverage the benefits that might be available to them via new initiatives. 6] ICH Harmonised Guideline M7(R2) (2023): Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.

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FDA Law Blog: Drug Discovery

JANUARY 30, 2025

This condition was included in the final rule for the original regulations, 21 CFR 314 Subpart H (see the December 11, 1992 Federal Register, 57 FR 58958 ) as well as when the pathway was codified in the Federal Food, Drug, and Cosmetic Act by FDAMA (21 USC 356(c)) in 1997.

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Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. For example, one can fuse a deactivated Cas9 protein to so-called “transcriptional regulators” to either activate or repress genes without directly editing the genome at all.

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Advarra

DECEMBER 17, 2024

As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners. There are many ways in which being a small biotech company, small CRO, or individual site is absolutely wonderful for this industry.

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Codon

NOVEMBER 1, 2024

bioRxiv (2023). It demands protocols, regulations, and collaborative efforts between human beings. Rather than increase the resolution of microscopy, in other words, expansion microscopy enables researchers to increase the size of the actual specimen. Credit: Shaib A.H. It involves pragmatism and cultural sensitivity.

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BioPharma Drive: Drug Pricing

JULY 18, 2025

Elevidys was approved by the FDA in 2023 as the first gene therapy for Duchenne, a genetic disorder that results in progressive muscle weakening and typically early death. While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles.

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Perficient: Drug Development

NOVEMBER 6, 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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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. 2023, November 17). 2023, October 12). 2023, June 23). References: Ellis, J. link] Societal CDMO. Societal CDMO. LGM Pharma.

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BioPharma Drive: Drug Pricing

JULY 9, 2025

In 2023, the New Jersey-based company scooped up Prometheus Biosciences for $10.8 Tsai said he doesn’t expect any risks to the deal from antitrust regulators at the Federal Trade Commission. In 2021, Merck agreed to pay $11.5 billion for Acceleron Pharma. Merck and Verona expect their transaction to close in the fourth quarter.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). How regulators will interpret and enforce its provisions may not become clear for some time. No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).

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FDA Law Blog: Biosimilars

NOVEMBER 19, 2024

But shedding regulators in sensitive areas like drug manufacturing—even in the era of influencer-driven medicine—can lead to compromises in safety and efficacy, especially when FDA is already facing a massive inspectional backlog. Over that time the number of vacancies has steadily grown, from 25 in 2021 to 73 in 2023. Kennedy, Jr.,

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FDA Drugs Government Regulations 52

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. Gibbs — On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr.,

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FDA Law Blog: Biosimilars

JUNE 1, 2025

Senator Dick Durbin (D-IL) expressed concerns over the agencys ability to regulate direct-to-consumer (DTC) prescription drug advertisements following recent workforce reductions. By Charles D. Snow & Dara Katcher Levy In a recent letter to FDA Commissioner Dr. Martin Makary, U.S.

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Perficient: Drug Development

NOVEMBER 15, 2024

election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. Strict regulations around HIPAA, PHI, and PII create significant barriers, making it difficult to adopt off-the-shelf AI solutions from fields like commerce or digital experience.

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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.

Regulations 52

Regulations Compliance Production Marketing 52

FDA Law Blog: Biosimilars

MAY 23, 2025

Newberger Last week, FDA published a Request for Information (RFI) ( here ) seeking input from the public on its efforts to to identify and eliminate outdated or unnecessary regulations. As FDA stated in guidance in 2023, newer devices should be compared to the benefits and risks of more modern technology.

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Perficient: Drug Development

NOVEMBER 15, 2024

election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. Strict regulations around HIPAA, PHI, and PII create significant barriers, making it difficult to adopt off-the-shelf AI solutions from fields like commerce or digital experience.

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The Pharma Data

JUNE 24, 2025

reduction in Scope 1 and 2 greenhouse gas (GHG) emissions compared to 2023, and an 18.8% These frameworks ensure that stakeholders—from investors and employees to customers and regulators—have consistent and comprehensive access to data on Baxter’s ESG performance. In 2024, the company reported a significant 13.5%

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Drugs.com

SEPTEMBER 30, 2023

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

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New Drug Approvals

JULY 18, 2025

China Patent CN 115960147, 2023. (10) 22] In the same month, China’s drug regulator (NMPA) decided to fast-track the approval process, labelling it a first-in-class medication. [14] In July 2022, China’s drug regulator granted conditional approval for it to be used to treat COVID-19, following a local phase III trial. [6]

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Drugs.com

SEPTEMBER 1, 2023

1, 2023 -- Nursing homes will soon have to meet federal minimum staffing requirements, the U.S. FRIDAY, Sept. Department of Health and Human Services (HHS) announced Friday. Establishing minimum staffing standards for nursing homes will improve.

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Drugs.com

OCTOBER 25, 2023

25, 2023 – Federal regulators are investigating a salmonella outbreak linked to packaged, diced onions that has sickened at least 73 people across 22 states. WEDNESDAY, Oct. Fifteen of the illnesses were so bad that people required.

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Drugs.com

OCTOBER 20, 2023

20, 2023 -- CVS Health plans to pull cold medications that contain phenylephrine from its store shelves after federal regulators determined recently that the decongestant doesn’t work. FRIDAY, Oct. Oral phenylephrine is an active ingredient.

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Drugs.com

OCTOBER 27, 2023

27, 2023 -- Federal regulators have sent warning letters to two companies for illegally selling probiotic products for use in preterm infants. FRIDAY, Oct. Food and Drug Administration also sent a letter to health care providers warning of.

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Drugs.com

OCTOBER 31, 2023

30, 2023 -- Federal regulators are warning consumers to stop using eyedrops and gels from several major brands after finding unsanitary conditions in a manufacturing plant. MONDAY, Oct. Twenty-six eye care products are part of the alert.

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Drugs.com

OCTOBER 10, 2023

9, 2023 -- Flavoring added to small, cheap cigars is making these the second-most popular tobacco product among youth, a new report shows. The report comes as federal regulators prepare to bar flavored cigars. MONDAY, Oct. They are marketed with.

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Covalent Modifiers

MARCH 1, 2024

CHANG Science 2023 382, 6670 DOI: 10.1126/science.abp9201 INTRODUCTION One-carbon metabolism manages cellular carbon pools by detoxifying highly reactive carbon species, such as aldehydes, and diverting their carbon toward the biosynthesis of useful products, including amino acids and nucleotides. DINGLER, CHRISTOPHER L. GARCIA-PRIETO MIA C.

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Drugs.com

JULY 13, 2023

TUESDAY, July 11, 2023 -- The European Medicines Agency is investigating concerns that popular weight-loss drugs like Ozempic and Saxenda may be linked to suicidal thoughts and thoughts of self-harm. Three case reports from Iceland spurred the.

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