Drug Patent Watch

DECEMBER 11, 2024

In this article, we will delve into the key criteria for selecting a CDMO, highlighting the essential factors to consider and the importance of effective communication and cultural fit. Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO.

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Drug Patent Watch

FEBRUARY 27, 2025

Navigating the Complex World of Global Drug Patents: Strategies and Challenges Ahead As a pharmaceutical professional, you know how crucial it is to protect your innovative drug patents in the global market. But what can you do to protect your drug patent in global markets? Read the full article here: [link]

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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. PTP-PEST is considered an important drug target owing to its involvement in cancer progression and myocardial injury.

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Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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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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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).

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Drug Hunter

AUGUST 21, 2023

Obtaining adequate drug exposure in the brain is key to treating CNS diseases effectively. Recently, Dennis Koester gave us a crash course in CNS drug discovery in a Drug Hunter Flash Talk. Why Kp,uu is the Most Important Parameter in CNS Drug Discovery What Influences the Kp,uu of Drugs?

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Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

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Chemical Biology and Drug Design

JUNE 21, 2023

Hsa-miR-503-5p negatively regulates CTDSPL, suggesting its potential as a target to overcome cisplatin resistance in LUAD. Hsa-miR-503-5p bound to CTDSPL gene and promoted cisplatin resistance and malignant progression of LUAD cells by negatively regulating CTDSPL.

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Chemical Biology and Drug Design

SEPTEMBER 6, 2023

Matrine inhibits TNBC cell proliferation, migration and invasion, promotes apoptosis, and suppresses tumor growth through down-regulation of HN1 expression. Abstract The treatment of triple-negative breast cancer (TNBC) cannot meet medical needs, and it is urgent to find new drugs for intervention.

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Chemical Biology and Drug Design

SEPTEMBER 24, 2023

This finding provides new ideas for the development of drug targets for the treatment of ischemic stroke. JAS reduces IS injury by regulating microglia polarization via PASK-EEF1A1 axis. Abstract Jasminoidin (JAS) can alleviate ischemic stroke (IS) injury, but its molecular mechanism remains undefined.

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PPD

MARCH 11, 2025

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. With the new EU HTA Regulation impacting orphan medicines, navigating these pathways has become even more challenging.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Fill out the form to read the full article.

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Agency IQ

SEPTEMBER 6, 2023

A warning letter represents the FDA’s determination that a manufacturer has “ significantly violated” FDA regulations, including those related to current good manufacturing practices (CGMPs). Fill out the form to read the full article.

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Chemical Biology and Drug Design

MARCH 14, 2023

EVO regulates ovarian cancer progression through the NEAT1-miR-152-3p-CDK19 axis, which further advances the possibility of EVO as a therapeutic drug for ovarian cancer. EVO dose-dependently attenuated cell viability, induced G2/M phase arrest, and apoptosis in ovarian cancer cells.

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Agency IQ

SEPTEMBER 15, 2023

For first time, FDA releases OTC drug user fees prior to start of government fiscal year The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. Fill out the form to read the full article.

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Drug Patent Watch

FEBRUARY 26, 2025

Unlocking the Secrets to Patenting Drug Combinations: Strategies and Challenges As a pharmaceutical professional, you know how crucial it is to stay ahead of the curve when it comes to patenting innovative treatments. In our latest blog post, we dive into the strategies and challenges of patenting drug combinations.

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Policy Prescription

AUGUST 25, 2022

This past June, during a debate in the Senate Health, Education, Labor and Pensions (HELP) Committee, Senator Richard Burr (R-NC), the committee’s Ranking Member, demonstrated that he does not understand very important developments in our nation’s approach to drug regulation and safety. It was almost as if Sen. Burr insulted Italy!

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Agency IQ

JUNE 29, 2023

Industry should take note of some of the consequential changes in the final guidance, including those related to the presentation of information about control groups, which will likely apply to many drug advertisements. Fill out the form to read the full article. including direct-to-consumer advertising.

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Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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KIF1A

OCTOBER 7, 2023

In this week’s article, a multinational team of scientists investigated the genetics of patients with HSAN or a similar disorder, congenital insensitivity to pain. These molecules regulate neuronal growth and survival, and mice with insufficient KIF1A show NTRK1 transport defect and reduced pain sensitivity. SCN9A/Nav1.7:

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Chemical Biology and Drug Design

JULY 4, 2023

Acacetin, as a natural flavonoid drug, modulates the activity of JAK2/STAT3 pathway, to suppress the growth, migration, invasion and anti-apoptosis of cancer cells and block the progression of esophageal cancer. Acacetin may be a promising drug in complementary therapy of cancer treatment.

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FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

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Elrig

MARCH 25, 2025

Prof Rory Johnson, Associate Professor, University College Dublin, and Dr Shalini Andersson, Vice President Nucleic Acid Therapeutics, AstraZeneca will lead this years event focussed on drugging the undruggable.

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Agency IQ

JANUARY 12, 2024

device regulation timelines 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. New roadmap sets out U.K.

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The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

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Drug Target Review

JULY 13, 2023

Drug discovery is a complex and vital field that continually seeks to identify new therapeutic targets and develop effective treatments. In recent years, a novel approach known as condensate biology has emerged, revolutionising the way researchers think about drug discovery and development.

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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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KIF1A

JANUARY 13, 2024

This process is regulated so we end up with the right number of neurons, which we can imagine with some simplified math: If you start with one progenitor and need eight neurons, it isn’t efficient for that progenitor to make a single neuron eight times. Read the Article The post #ScienceSaturday: January 13, 2024 appeared first on KIF1A.

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Drug Target Review

DECEMBER 13, 2023

The study mentions the overlap in genes associated with Fatigue Dominant long COVID and ME/CFS, including those involved in circadian rhythm regulation and insulin regulation. The article mentions that TLR4 antagonists have been identified as potential candidates for repurposing long COVID treatment.

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Agency IQ

NOVEMBER 27, 2023

Today, more than a decade after Congress required the FDA to publish such a regulation, the FDA finalized a rule that will require direct-to-consumer drug advertisements to ensure that the “major statement” of drug risks and side effects is presented in a “clear, conspicuous, and neutral manner.”

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Common Sense for Drug Policy Blog

SEPTEMBER 9, 2023

Characteristics of a Public Health Approach to Drug Use "Among the synthesized articles, the five most frequently cited characteristics and components of a PHA were the following (also see Table 6 for illustrative quotes): "A PHA includes regulation (n=70). 5 Most articles mentioned only broad types of prevention (e.g.

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Agency IQ

MARCH 25, 2024

BY CHELSEY MCINTYRE, PHARMD FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes.

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Chemical Biology and Drug Design

APRIL 27, 2023

Synergistic inhibition of two important drug targets may lead to novel therapeutic strategies. Abstract HDM2, an E3 ubiquitin ligase, is a crucial regulator of many proliferation-related pathways. It is also one of the primary regulators of p53. This network has emerged as an important drug target.

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. This article explores the likely impact of the AI Act on software and systems used in clinical research and how it affects entities outside the EU. These risks face fewer regulations but must meet certain standards to ensure ethical use.

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