e-Pharmatimes

FDA Approves Taletrectinib for ROS1-Positive Non-Small Cell Lung Cancer: A New Era in Targeted Cancer Therapy Introduction The Food and Drug Administration’s approval of taletrectinib marks a big step forward for lung cancer treatment. It’s especially important for patients with a rare, yet aggressive, form of lung cancer called ROS1-positive non-small cell lung cancer (NSCLC). For years, doctors faced limited options, and outcomes weren’t always good. New drugs like taletrectinib promise better results, thanks to a targeted approach that attacks cancer cells directly and spares healthy tissue. This breakthrough highlights how personalized medicine is changing the game in fighting lung cancer. Understanding ROS1-Positive Non-Small Cell Lung Cancer What is ROS1-Positive NSCLC? ROS1-positive NSCLC makes up about 1-2% of all lung cancers. It’s caused by changes in the ROS1 gene, which gets fused with other genes. This causes the cancer cells to grow fast and spread quickly. Patients...

  AstraZeneca receives approval in EU for the First-Line Treatment of Chronic Lymphocytic Leukemia for the Fixed-Duration Regimen -  Acalabrutinib in combination with Venetoclax with or without Obinutuzumab.  Introduction Chronic lymphocytic leukemia (CLL) affects thousands across the European Union each year. It’s a slow-growing cancer that starts in the blood and bone marrow, often sneaking in with few symptoms. As treatments improve, patients now have better options for managing this disease. In recent years, the focus has shifted toward fixed-duration therapies. These treatments last for a set time, unlike continuous ones that go on until the disease progresses. Calquence (acalabrutinib), a targeted drug that blocks a protein called BTK, has gained attention for its use in CLL. Now, recent approvals make it possible to use Calquence for fixed durations in the EU. This article covers the approved Calquence regimens, examines the clinical data backing their use, a...

Mexico Generic Drug Approvals and Patent Litigation: Navigating the Complex Landscape Introduction Mexico's pharmaceutical market is booming. It’s become one of Latin America's fastest-growing sectors, driven by the need for affordable healthcare. As more generics enter the market, understanding how drugs get approved and how patents are protected becomes crucial. Companies that master these rules find it easier to succeed in Mexico’s competitive environment. Staying ahead means knowing the ins and outs of both approval processes and patent battles. Mexico’s Regulatory Framework for Generic Drug Approvals Overview of COFEPRIS and Its Role The Federal Commission for Protection against Sanitary Risk, or COFEPRIS, is Mexico’s health watchdog. It makes sure medicines are safe and effective before reaching shelves. Recently, reforms have sped up approval times and simplified procedures, but challenges remain for foreign companies trying to navigate new rules. Process for Appr...

U.S. FDA Approves Third Indication of Bayer’s Nubeqa™ (darolutamide) for Advanced Prostate Cancer Patients Introduction Prostate cancer remains a major health issue for men worldwide. It’s often slow-growing, but once it advances, treatment gets more complex. Doctors need better tools to fight this disease, especially in its later stages. Now, the FDA has approved a new use for Bayer’s Nubeqa, a drug already trusted by many. This approval provides new hope for men with more aggressive prostate cancer, giving them more options and better chances to live longer. Bayer has been a leader in tackling prostate cancer, working to improve treatment and patient care. Understanding Nubeqa™ (darolutamide) and Its Therapeutic Role What is Nubeqa™ (darolutamide)? Nubeqa, known generically as darolutamide, is a medication that blocks signals telling prostate cancer cells to grow. It works by targeting androgen receptors, which fuel the growth of prostate cancer. It’s different from other drugs...

Introduction Brazil's fast-growing economy makes it a hotspot for new innovations and tech startups. Protecting ideas through patents is vital for businesses to stay competitive. As more companies seek to defend their inventions, patent disputes are becoming more common. Both local and foreign firms face these legal battles, which can be complex and time-consuming. This article offers a clear picture of how patent litigation works in Brazil. It covers legal steps, key challenges, and strategies to stand strong in IP disputes. Understanding the Brazilian Patent System Overview of Brazilian Patent Law Brazil's patent system is mainly guided by the Patent Law (Law No. 9,279/1996). This law sets rules for patent rights, duration, and scope. The National Institute of Industrial Property (INPI) manages all patent applications and registrations. In Brazil, three types of patents are recognized: inventions, utility models, and plant varieties. Each serves a different purpose and o...

  Introduction Pharmacokinetic (PK) parameters are the backbone of drug development. They tell us how a drug moves through the body — how it's absorbed, distributed, broken down, and finally excreted. These details help determine whether a drug is safe and effective. As the pharmaceutical industry grows more competitive, protecting innovations around PK parameters is more important than ever. Companies want exclusive rights to their discoveries, especially when they lead to better drugs or easier manufacturing processes. But patenting PK-related inventions is not simple. Patent disputes are common, and legal battles can slow down or block important breakthroughs. Understanding these challenges helps businesses avoid costly lawsuits and protect their research. Understanding Pharmacokinetic Parameters and Their Role in Drug Development What Are Pharmacokinetic Parameters? PK parameters include measures like absorption rate, distribution volume, metabolism speed, and excretion ...