When filing an NCE-1 application, being the first applicant to do so is not just a badge of honor; it also gives a strategic edge. The Para IV filing offers exclusive opportunities to dominate the market before competitors enter the scene. Despite this lucrative benefit, common myths persist, clouding judgment, delaying action, and costing companies…

2028 is going to be a landmark year in the pharmaceutical industry. Several blockbuster drugs, each with billion-dollar sales projections, will lose patent exclusivity, opening the door for Para IV filings. For generic and biosimilar manufacturers, this represents a great opportunity. With the right data, the right timing, and tools like NCE Grid to track…

The Promise of Healing Without Medicines Imagine a situation wherein, instead of treating diseases with medications for the rest of your life, your body could actually repair itself. That's the exciting promise of stem cell therapy, also popularly known as regenerative medicine. Stem cell therapy isn't just about treating disease—it's about giving your body the…

Clinical trial supply management (CTSM) involves all the processes, such as planning, forecasting, procurement, manufacturing, storage, and distribution of clinical trial supplies in an efficient manner. This ensures that the appropriate clinical trial supplies reach clinical trial participants at the right time and in accurate condition. CTSM is a crucial part of running clinical trials…

Blood cancer affects millions of people worldwide, creating a challenging situation. A study predicts that in 2025, 66,890 new cancer cases and 23,540 cancer deaths will occur in the United States due to leukemia.

Decentralized Clinical Trials (DCTs) have transformed how clinical trials are conducted. This makes the clinical trial process more flexible and patient-friendly. This minimizes the requirement of participants to visit a trial site frequently. DCTs use technology to manage trials at remote locations with high efficiency, effectively managing clinical trial supply at different locations.…

Comparator drugs play a pivotal role in determining the quality, efficacy, and safety of the generic drug. It acts as a standard drug that will be used to compare the generic copies. It is essential to source the right comparator drug from genuine manufacturers, as there are many challenges in this process. Comparator sourcing can…

Introduction of Drug Development Process The development of medicines is a long process that involves several steps and stages. The drug development takes approximately 10 to 15 years. This includes the time from the initial discovery of a molecule to FDA approval, covering time spent in a market release. It's not only time-consuming but…

The drug development process is quite complex, consisting of numerous steps. This includes discovering the drug, developing dosage forms,  conducting research, carrying out clinical trials, seeking approval, and commercializing the drug. Drug development processes also require adherence to authorities like the FDA (Food and Drug Administration) and EMA (European Medicines Agency). This streamlined…

Managing the storage, distribution, and supply chain of pharmaceutical products requiring special storage conditions is very crucial. This stage ensures the integrity, efficacy, and safety of pharmaceutical products for marketing, as well as products that are to be used for clinical trial supply. Efficient cold-chain management is needed for shipping pharmaceutical products from manufacturers to…