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Background: Gefitinib, a tyrosine kinase inhibitor, is effectively used in the targeted treatment of malignant conditions. It suppresses the signal transduction cascades leading to cell proliferation in the tumors and is now currently approved in several countries globally as secondline and third-line treatment for non-small cell lung cancer (NSCLC). Objective: This review is aimed to summarize the journey of gefitinib as an established anticancer drug for the management of various cancers. Moreover, this review will focus on the mechanism of action, established anticancer activities, combination therapy, nanoformulations, as well as recent clinical trials and patents on gefitinib Methods: The data for this review was collected from scientific databases such as PubMed, Science Direct, Google Scholar, etc. Recent patents on gefitinib granted in the last two years were collected from databases Patentscope, USPTO, Espacenet, InPASS and Google Patents. Data for the recent clinical trials were obtained from the U.S. National Library of Medicine database. Results: Recent pre-clinical and clinical studies during the period 2015-2021 demonstrating the efficacy of gefitinib were selected and summarized. Total 31 patents were granted in the year 2020-2021 concerning gefitinib. The efficacy of gefitinib against lung cancer, as well as other cancer types, including breast, prostate, colon, cervix etc., was reviewed. Conclusion: Gefitinib showed significant advantages in being more effective, safer and more stable, and the associated biopharmaceutical problems are addressed by the application of nanotechnology. The combination therapy using gefitinib and various anticancer molecules of natural and synthetic origin has shown an improved anticancer profile.

Drug recalls are essential to maintaining the safety process because the medical industry’s top objective is primarily to deliver higher-quality goods to a larger population. They do this by eliminating subpar products from the market. Drug recalls are increasing quickly as a result of increased investigation rates, the emergence of industrialization and the online era into the sector, and regulatory authorities and health experts are now focusing on more stringent regulations to prevent further recalls of faulty pharmaceutical drugs. The purpose of the present write-up is to give an overview of how drug recalls work with the help pf examples of recalls due to presence of undesired solvents and mineral residue, how they affect the pharmaceutical business, and what can be done to stop them.

Background: Several health problems, especially musculoskeletal disorders, are caused by differences in work cultures and human lifestyles around the world. While the conventional approach to treating such conditions emphasizes a balanced work-life and daily exercise, nutraceuticals have proven to be successful. Nutraceuticals are dietary compounds that help sustain cartilage metabolism homeostasis, reducing articular pain. Dietary intake of a variety of nutraceuticals is thought to be essential for controlling and, more specifically, preventing osteoarthritis and osteoporosis. Objective: The current article offers a succinct overview in which data was gathered and searched using specific key terms related to nutraceuticals, osteoarthritis, and osteoporosis that were available in public domains for analysis and evaluation. Method: The current write-up offers a concise summary of disease and its relevance as to how nutraceuticals are helpful, based on the defined findings and their interpretation. The present review also discusses the existing literature, patents, and current studies in the era of nutraceuticals for osteoarthritis and osteoporosis treatment, offering a rational basis for further investigation and research. Result: This article discusses a wide variety of nutraceuticals with possible uses for osteoarthritis and osteoporosis patients. An analysis revealed that nutraceuticals' efficacy has been established. However, further study and investigation are needed to determine their protection. Conclusion: As a result of this analysis, it was concluded that more innovation and technology transfer were required. It was also concluded that greater industry-academic collaboration was required to begin more effective research in the treatment of osteoarthritis and osteoporosis with nutraceuticals.

The pharmaceutical industry's primary concern is to provide high-quality drug products to the general public, so drug recalls play an important role in maintaining the quality system by removing defective products from the market. Pharmaceutical product recalls are increasing at an alarming rate as a result of increased inspection rates and the introduction of modernization and the digital world into the industry, raising concerns for regulatory agencies and public health to focus on more stringent regulations to control future recalls of defective drug products. This article will provide an overview of recall procedures, their impact on the pharmaceutical industry, and the various steps taken to reduce pharmaceutical recalls.

Multi-drug resistance (MDR) developed in response to chemotherapy is one of the prominent causes of therapeutic failure. The major underlying factors that contribute to such malignancies include tumor microenvironment, genetic alterations, changes at the cellular level and most of all the heterogeneity of tumors. Recent advances in the field of oncology have prompted a mechanistic understanding of the human genome which is responsible for such alterations, upon which the therapy would be designed. Such an approach that administers drugs by targeting the molecular changes is attributed to precision medicine. Precision medicine helps design therapy as per the requirement of patients based on the sharing of similar complex tumor environments. This revolutionized approach would help in early detection, better targeting, improved patient compliance and survival along with much reduced toxicity otherwise evidenced in conventional cancer therapy. This review discusses the cause of MDR, highlighting the role of precision medicine in overcoming such critical events. Major limitations and future prospects are also highlighted.

Regular inspections are carried out to ensure system conformity by the Food and Drugs Regulatory Authority (FDA) of the United States one of the most stringent regulatory authorities in the world. The inspectors send Form 483 to the management after the inspection, detailing the inappropriate conditions. Because the FDA guidelines are difficult to comply with, a company can contravene the regulations. If any significant infringements can affect the protection, quality, effectiveness, or public health of the drug is identified, the FDA issues advice to the company. Warning Letters (WL) shall be an official notification of non-compliance with federal law within a period to be issued by manufacturer, clinician, distributor, or responsible person in the company. The delivery of a letter has a considerable impact on the company's reputation and position in the market. Inadequate WL reactions could lead to a refusal, import denial, memorandum or even conviction and order. A brief study was conducted in this document of Form 483 and WL for four years (2017–2020) on an understanding the regulatory provisions.

Cancer is a lethal disease that kills a great number of people each year. Standard treatments such as chemotherapy or radiation are only effective in a small percentage of individuals due to illness variability. Tumors can be caused by a variety of genetic factors and express a variety of proteins depending on the individual. Because of developments in high-throughput technology, there has been a flood of large-scale biological data produced in recent decades. As a result, the focus of medical research has evolved. It was a once-in-a-lifetime chance for translational research to explore molecular alterations across the entire genome. In this setting, precision medicine was developed, and the possibility of better diagnostic and treatment tools became a reality. This is especially true in the case of cancer, which is becoming more prevalent around the world. The goal of this study is to look at precision medicine technology and its applications to cancer, with a focus on children. The inherent diversity of cancer lends itself to the rapidly expanding field of precision and personalized medicine.

Changes in human lifestyles and environmental deterioration globally causes emergence of new viruses posing research challenges. Recent outburst of disease COVID-19 (nCoV19) is a recent example wherein effective management of virus using conventional medication or adopting preventive and effective diagnostic measures is a challenge. While many ongoing strategies from vaccine development to drug repurposing, are currently being investigated, a targeted approach with nanotechnology can be helpful to meet the demand for preventive and diagnostic measures. The significant results of nanotechnology in resolving better efficacy in pharmaceutical drugs is expected to be helpful in combating nCoV19 by using nanotechnology-based solutions preventive, treatment, and diagnosis. As vaccine development involves long clinical trial procedures, preventive measures such as masks, disinfectants, sanitizers, and personal protective equipment's are gaining popularity for effective management. The present write-up addresses the dire need of the nanotechnology-based solutions in present pandemic and studies of the ongoing innovation and existing patents for developing better solutions. Multiple applications of nanotechnology is expected to be helpful in preventive and diagnostic measures, immune response modulation and immunity boosters along with projecting a pathway for industry and academic researchers for addressing such pandemic.

Product registration in rest of world is a challenging task like regulated countries (US, EU & Japan) as they are not harmonized. It creates a difference in regulatory environment in Semi Regulated countries. Enormous diversity of regulatory requirements are found in this area. This region consists of mainly the countries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacific and Gulf have somewhat harmonized their regulatory environment through The Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonized regulations in their respective regions. The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care, research & development and to meet the public requirement for safe and efficacious treatments to patient in need. ICH committee has given priority to harmonize the format of reporting data for quality, safety and Efficacy in the application dossier. The commercial significance of ROW markets is increasing globally. It is crucial that pharmaceutical companies keep up-to-date with the latest regulatory developments to ensure their place on the ROW market. This paper favors the regulatory processes for gaining marketing authorization in ROW countries in terms of technical data requirement for the dossier. Keywords: ROW, ASEAN, GCC, BMR, CIS, DMF, TSE/BSE, ICH, FP