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.

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The Premier Consulting Blog

NOVEMBER 6, 2024

Inhaled combination products (ICP) have emerged as a significant advancement in the treatment of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary conditions. However, these products present unique challenges from a Chemistry, Manufacturing, and Controls (CMC) standpoint.

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BioPharma Drive: Drug Pricing

JULY 5, 2023

The vaccine has a chance to become Moderna’s second approved product and could help offset declining sales for its COVID-19 shot.

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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. Twenty-six eye care products are part of the alert. MONDAY, Oct.

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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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Science Daily: Pharmacology News

JULY 27, 2023

A gene encoding a protein linked to tau production -- tripartite motif protein 11 (TRIM11) -- was found to suppress deterioration in small animal models of neurodegenerative diseases similar to Alzheimer's disease (AD), while improving cognitive and motor abilities, according to new research.

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Drugs.com

MARCH 21, 2024

THURSDAY, March 21, 2024 -- Your baby could be endangered by now-recalled Comfi Baby Infant Walkers, the Consumer Product Safety Commission (CPSC) warned Thursday.The walkers, sold on Amazon, "violate the federal safety regulations for infant.

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Drug Patent Watch

FEBRUARY 10, 2025

The current system is often fragmented, with multiple stakeholders involved in the production, distribution, and delivery of generic medications. By implementing these strategies, manufacturers, distributors, and regulators can work together to improve efficiency, reduce costs, and increase patient access to affordable medicines.

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BioPharma Drive: Drug Pricing

JULY 10, 2024

Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

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Chemical Biology and Drug Design

JANUARY 23, 2024

In this review, we summarize the structure, distribution, and biological function of UCP2 and its role in the progression of NAFLD, as well as natural products targeting UCP2 to improve NAFLD. These data suggest that UCP2 plays a role in lipid metabolism, oxidative stress, apoptosis, and even cancer.

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LifeSciVC

APRIL 24, 2024

Additionally, for illustrative reasons this is geared towards a single target / product focus vs. broader platform diligence, though many of these mental models will apply for selecting targets and indications for a platform. To impart “gain-of-function” pharmacology, consider inducing or up-regulating expression (e.g.,

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Drugs.com

AUGUST 8, 2024

8, 2024 -- That vape pen might contain something even worse than nicotine, new research warns.Tobacco companies may be trying to duck federal restrictions on vaping products by replacing nicotine with “nicotine analogs” -- related che. THURSDAY, Aug.

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Drug Patent Watch

DECEMBER 9, 2024

This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.

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Advarra

JULY 26, 2022

In order to understand the current status on cannabis and CBD research studies, it’s important to understand where each product stands. Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements. The 2018 Farm Bill.

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Drug Patent Watch

DECEMBER 11, 2024

Speed and Quality of Development and Production The speed and quality of development and production are critical considerations in selecting a CDMO. Pharmaceutical companies should evaluate a CDMOs compliance with industry standards and regulations, ensuring that they have a robust quality assurance system in place.

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Covalent Modifiers

NOVEMBER 7, 2023

Many previous studies have shown that 14-3-3 interactions with specific phosphorylated substrate proteins can be enhanced through small-molecule natural product or fully synthetic molecular glue interactions.

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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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Broad Institute

AUGUST 7, 2023

A surprising new role for a major immune regulator By Tom Ulrich August 7, 2023 Breadcrumb Home A surprising new role for a major immune regulator By Anne Trafton, MIT News August 7, 2023 Credit: RCSB Protein Data Bank A model of the human STING protein.

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BioPharma Drive: Drug Pricing

OCTOBER 6, 2023

Regulators’ holdup of the deal had stoked investor fears of greater scrutiny on M&A. In the end, Amgen agreed to requirements meant to guard against product “bundling.”

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Chemical Biology and Drug Design

JANUARY 5, 2024

The levels of adenosine triphosphate (ATP)/adenosine diphosphate (ADP) ratio, lactate production and glucose consumption were detected to evaluate glycolysis. Moreover, matrine also could regulate PDK1 expression to suppress AML progression. Besides, matrine modulated miR-495-3p/miR-543/PDK1 axis to inhibit the Wnt/β-catenin pathway.

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Agency IQ

JUNE 21, 2024

BY KIRSTEN MESSMER, PHD, RAC 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. Fill out the form to read the full article.

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H1 Blog

NOVEMBER 21, 2023

The life sciences industry, characterized by stringent regulations, vast data sets, and the critical nature of its decisions, is increasingly turning to Artificial Intelligence (AI) for solutions. However, before integrating an AI product into a life sciences workflow , it is crucial to evaluate its effectiveness and reliability rigorously.

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SCIENMAG: Medicine & Health

JUNE 14, 2023

Insulin production has, for the last 50 or so years, come with some risks to the patient. Credit: Kevin Monko Insulin production has, for the last 50 or so years, come with some […] Even so, the medication is lifesaving for the estimated 537 million adults living with diabetes worldwide, with that number expected to grow.

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FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. The MoCRA rollout, though, does not preclude that FDA may practice some regulation by enforcement if it deems such action necessary.

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FDA Law Blog: Biosimilars

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.

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Common Sense for Drug Policy Blog

OCTOBER 4, 2024

Consumer Protection and Vape Products "The 2021 review of cannabis policy found that states also have limits on ingredients that can be contained in cannabis products. Colorado has banned medium-chain triglycerides oil and polyethylene glycol oil entirely.

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Agency IQ

NOVEMBER 10, 2023

The FDA announced it intends to delay enforcement of cosmetic facility registration and cosmetic product listing requirements to July 1, 2024, from the current deadline of December 29, 2023 as required by Modernization of Cosmetics Regulation Act or MoCRA. Fill out the form to read the full article.

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. The regulations also require detailed information about each transaction involving a tableting machine, including the date, name and address, quantity, method of transfer, etc.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?

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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

APRIL 12, 2024

BY RACHEL COE, MSC Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As defined in statute, the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.”

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Fierce BioTech

FEBRUARY 12, 2025

Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement. Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement.

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Drug Patent Watch

FEBRUARY 26, 2025

However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). To draft a strong patent application, you need to understand the nuances of biologic drug development, including the production process, stability, and formulation.

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Drug Patent Watch

MARCH 4, 2025

From navigating complex regulatory landscapes to ensuring the quality and safety of your products, every step of the process requires meticulous attention to detail. It's a critical component of generic drug development, as it helps ensure that our products are safe for patients to use. But why is pharmacovigilance so important?

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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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Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. The process, from patient coordination through manufacturing and administration, is intricate, time-sensitive, and highly regulated.

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FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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