Covalent Modifiers

AUGUST 2, 2025

We demonstrated that AGPAT4 is a functional regulator of tumor lineage plasticity, which correlates with enhanced metastasis and resistance to sorafenib. We identified AGPAT4 as an oncofetal protein that is abundant in embryonic stem cells and hepatocellular carcinoma (HCC) tumor cells but is low or absent in most normal tissues.

Therapies

Chemical Biology and Drug Design

NOVEMBER 13, 2024

A series of chromone derivatives were designed and synthesized. We established a NOX4 overexpression model using the NRK-49F and identified compound 14m as highly active through the assessment of intracellular ROS levels. This investigation positions 14m as a noteworthy NOX4 inhibitor, shedding light on its regulatory role in renal fibroblasts.

Regulations

The Premier Consulting Blog

OCTOBER 30, 2024

With extensive experience in manufacturing techniques and regulations, the CMC services team at Premier Consulting can help sponsors navigate the development of advanced manufacturing technologies. Contact us today to find out how we can support your program.

Regulations

Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

Clinical Development

Drug Target Review

DECEMBER 20, 2024

Regulators care a lot about controlling the Type 1 error rate of the clinical trial, Smith notes. By proving that their digital twin models can significantly reduce the number of subjects needed in clinical trials – without compromising trial integrity – Unlearn is making a compelling case for the value of AI.

Clinical Trials

Drug Patent Watch

FEBRUARY 10, 2025

By implementing these strategies, manufacturers, distributors, and regulators can work together to improve efficiency, reduce costs, and increase patient access to affordable medicines. By working together, manufacturers, distributors, and regulators can create a more efficient and patient-centric generic drug supply chain.

Drugs

Drug Patent Watch

DECEMBER 30, 2024

Pharmaceutical Regulations in Japan 2020. Freyr Solutions. 11 Must-know FAQs about the Drug Approval Process in Japan. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Retrieved from [link] Pharmaceuticals and Medical Devices Agency. Regulatory System on Generic Drugs in Japan. Retrieved from [link] Raflzadeh-Kabe, J.

Drug Development

Chemical Biology and Drug Design

FEBRUARY 3, 2025

ABSTRACT PTP-PEST (also known as PTPN12) regulates cellular signaling and transduction pathways by dephosphorylating its substrate. The invitro biochemical assays validated that J1-65 inhibits PTP-PEST activity competitively and the inhibitor binding stabilizes the protein-ligand complex.

Small Molecule

Drug Patent Watch

DECEMBER 10, 2024

” – Patheon “By possessing a deeper understanding of the regulations that apply to each step of the development and manufacturing journey, embedded CDMOs can often anticipate questions and issues that might arise and help avoid costly delays.”

Drug Development

Chemical Biology and Drug Design

AUGUST 6, 2025

Significant incremental increases in the pro-apoptogenesis Bax/anti-apoptosis Bcl ratio revealed a physiologically regulated cytotoxicity via DNA fragmentation harvested in cytolysates. Only FQs exerted comparable or superior anti-adhesion and anti-invasion activity versus the antineoplastic reference quercetin.

DNA

Drug Patent Watch

DECEMBER 11, 2024

Pharmaceutical companies should evaluate a CDMOs compliance with industry standards and regulations, ensuring that they have a robust quality assurance system in place. Regulatory Compliance and Quality Assurance Regulatory compliance and quality assurance are essential aspects of CDMO selection.

Pharmaceutical Companies

Drug Target Review

JULY 1, 2025

Unlearn’s early collaboration with regulators has helped it navigate this space effectively. We take transparency seriously, documenting every aspect of our models – from how they are trained to how they are validated in their specific context of use.

Clinical Trials

BioPharma Drive: Drug Pricing

JUNE 4, 2025

The company is one of the first to receive a “platform technology designation,” which could speed the review of certain gene therapy applications it later brings to the regulator.

Therapies

Drug Target Review

JULY 21, 2025

Developers and sponsors working on biologically derived therapies in the US can utilise the Regenerative Medicine Advanced Therapy (RMAT) designation, which regulators grant to promising regenerative therapies. The blood–brain barrier: Structure, regulation and drug delivery. Adv Drug Deliv Rev. 2020;165-166:1-14. doi: 10.1016/j.addr.2019.11.009.

Drug Development

BMG Labtech

DECEMBER 20, 2024

The amounts of critical enzyme molecules and enzyme concentrations for example may be controlled by the regulation of the rate of protein synthesis and degradation as well as the regulation of gene expression. Researchers study quorum sensing since it can directly influence how certain bacteria regulate their metabolic activities.

Regulations

Perficient: Drug Development

JANUARY 6, 2025

Legal Compliance Many countries have regulations and laws that mandate accessibility in public services, including healthcare. It sends a strong message that the healthcare facility values and respects the needs of all patients, irrespective of their disabilities.

Compliance

Perficient: Drug Development

MARCH 25, 2025

It’s about keeping your data in check, your regulators off your back, and your systems speaking the same language. Parting Thought In the end, defining a data governance structure for your bank isn’t about creating a bureaucratic nightmare.

Government

Drug Target Review

JUNE 17, 2025

The dynamic behaviour of RNA transcripts, the regulation and modification of proteins, the lipid composition of membranes, the structural organisation of cells and the spatial context of tissues all play critical roles in disease progression and therapeutic response.

RNA

Science Daily: Pharmacology News

JUNE 24, 2025

These star-shaped brain cells, once thought to only support neurons, are now shown to regulate communication between brain cells and even trigger or amplify inflammatory responses. New findings spotlight astrocytes—previously overshadowed by microglia—as major players in neuroinflammation that drives depression.

Regulations

Broad Institute

MAY 21, 2025

In one study , scientists successfully targeted and labeled a rare cell that regulates sleep, opening the door to new cell type-specific treatments for sleeping disorders. The new tools were very effective at targeting specific brain cells and allowing scientists to successfully change cell activity and animal behavior in a predictable way.

Disease

Drug Target Review

JUNE 30, 2025

Lepore highlights strong early progress in oncology, immunology and metabolic diseases, where ProFound has identified novel cytokines, transmembrane tumour antigens and secreted metabolic regulators with significant therapeutic potential. And the big players are taking notice.

Disease

Chemical Biology and Drug Design

JUNE 26, 2025

In addition, network pharmacology predicts that these derivatives may have the effect of regulating the nervous system and protecting neuronal cells without violating Lipinski's Rule.

Regulations

LifeSciVC

MAY 14, 2025

Regulators may reasonably ask is a drug crystallized in orbit the same as if made on Earth? Regardless, dedicated bioproduction facilities will be essential infrastructure, but the development, validation, production, and deployment of such systems is not guaranteed. Regulatory : there is no regulatory framework for products made in space.

Science

The Pharma Data

JUNE 26, 2025

This growing body of evidence has given regulators the confidence to reduce restrictions, a decision that aligns with the evolving standard of care in oncology and cell therapy.

FDA Approval

thought leadership

JULY 24, 2025

Medical Information services are essential to ensure healthcare professionals (HCPs), patients, and regulatory bodies receive accurate, timely, and compliant information. From managing inquiries to medical writing and clinical trial support, these services are foundational to patient safety and product success.

Regulations

FDA Law Blog: Biosimilars

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product.

Pharmaceutical Companies

thought leadership

JULY 20, 2025

Recent regulatory changes, including the transition from the EU Clinical Trial Directive to the EU Clinical Trial Regulation (EU CTR) , have harmonized approval pathways, enabling Sponsors to submit a single application covering both the applicable regulatory authorities and ethics committees through the Clinical Trial Information System (CTIS).

Clinical Trials

Drug Target Review

APRIL 30, 2025

Building trust in AI – both among regulators and clinicians – will be key to unlocking its full potential in CGT, she explains. Data fragmentation remains a key challenge, as many CGT developers work in isolation, restricting the data sharing needed to strengthen AI models.

Drugs

The Pharma Data

AUGUST 1, 2025

The life sciences industry continues to face scrutiny regarding the use of animals in research, with regulators, investors, and the public pushing for more humane and scientifically valid alternatives. The 3Rs—Replacement, Reduction, and Refinement of animal testing—have become a guiding principle for responsible research.

Drug Development

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.

Drugs

PPD

JULY 18, 2025

When small and emerging companies are able to build strong, trust-based relationships with regulators, they often see benefits like reduced development risk and accelerated timelines. When teams are well prepared ahead of time, it builds credibility with regulators, and credibility is a valuable currency in the regulatory approval process.

Regulations

PPD

MARCH 11, 2025

With the new EU HTA Regulation impacting orphan medicines, navigating these pathways has become even more challenging. Securing market access and reimbursement for high-cost treatments remains a significant challenge, as regulators, HTA bodies and payer engagements demand robust evidence of clinical and economic value.

Drug Development

Drug Patent Watch

DECEMBER 9, 2024

This involves working closely with regulators to ensure that the analytical characterization and clinical trial design meet the necessary standards for approval. Collaboration with Regulatory Agencies : Collaboration with regulatory agencies such as the FDA and EMA is crucial in navigating the regulatory landscape.

Biosimilars

The Pharma Data

JUNE 24, 2025

For manufacturers, researchers, and regulators alike, this alliance represents more than a logistical convenience—it’s a blueprint for the next era of therapeutic innovation. Source link

Therapies

Broad Institute

JUNE 24, 2025

Importantly, we’ll need streamlined regulatory pathways for approving clinical trials with only a few patient participants that are founded on the principles of proportionate regulation based on current data and benefit:risk ratios.

Treatment

The Pharma Data

JUNE 25, 2025

For Novartis, the success of farabursen could represent not just a new treatment option , but a platform opportunity in using microRNA modulation for a variety of diseases where gene expression regulation plays a central role.

RNA

Covalent Modifiers

JANUARY 9, 2025

aureus serine hydrolases known as fluorophosphonate-binding hydrolases (Fphs), which regulate aspects of virulence and lipid metabolism. Therefore, there is a need for new tools to both image and treat S. aureus infections. We previously identified a group of S.

Fragment Screening