Bio-IT World: Next Generation Sequencing

next generation sequencing

Bio-It World Expo 2015 Joins the Major Forces in Pharma to Advance analytical tools and methods to address Industry-wide Challenges with ever increasing NGS Data. (more…)

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Ibrance: First-in-Class CDK 4/6 Inhibitor Approved in Breast Cancer

ibrance

Pfizer has won the race to get the first CDK inhibitor to market with the approval of Ibrance last month; however, competition in this market segment for breast cancer is set to intensify with potential new CDK inhibitors, including Eli Lilly’s abemaciclib (LY-2835219) and Novartis’s ribociclib (LEE -011) expected to reach the market in the near term. (more…)

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Chagas Disease: Few Novelties in the Pipeline for a Disease Affecting Millions

Chagras

Chagas disease, or American trypanosomiasis, is a chronic, systemic infection caused by the protozoan parasite Trypanosoma cruzi, a single-cell flagellate that is transmitted to animals and humans via the bite of triatomine insects, also known as “kissing bugs.” It is named after the Brazilian physician Carlos Chagas, who first described both the disease and its transmission cycle in 1909. The disease is endemic throughout much of Mexico, Central America and South America, where it appears to have been present since the earliest human civilizations. The economic burden of Chagas in these underdeveloped countries is substantial. In Colombia alone, WHO estimates that the annual cost of medical care for all patients with the disease was approximately USD 267 million in 2008. (more…)

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More Learning, Less Lecturing: ACC Annual Scientific Session 2015

ACC

“More learning, less lecturing”. Following this philosophy the 64th Annual Scientific Session and Exposition of the American College of Cardiology (ACC.15) took place in sunny San Diego, bringing together 13,500 professional attendees and key opinion leaders from 128 countries. This year’s meeting covered 11 different clinical learning pathways, including heart failure and cardiomyopathies, arrhythmias, clinical electrophysiology, valvular heart diseases and non-invasive imaging. (more…)

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DCAT Week 2015: Value Creation through Strategic and Collaborative Sourcing

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The quality and safety of drug products and the ingredients they contain is of utmost importance in the supply of medicines. The industry as a whole is addressing quality issues and working to mitigate risks in an ever-changing business environment. As global supply chains become increasingly complex, industry leaders in sourcing, procurement and supply management must rise to the challenge of delivering value and growth while faced with greater cost pressures. (more…)

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GMP Compliance: An Ounce of Prevention

GMP

The term Good Manufacturing Practices (GMPs) refers to guidelines spelled out by regulatory agencies that oversee the production and sale of any products consumed by humans, including drug products and active pharmaceutical ingredients (APIs). These regulations contain the minimum requirements necessary to assure that the strength, quality and purity of drug products meet the appropriate standards. While GMPs have been the benchmark of pharmaceutical manufacturing safety standards in regulated markets for decades, perhaps at no time previously have these guidelines been more at the forefront of industry discussion than they are today. (more…)

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The 505(b)(1) and 505(b)(2) Application Process in the US

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A dwarf standing on the shoulders of a giant can see farther than a giant himself, the old adage says to highlight the importance of discovering by building on previous discoveries. This is particularly true for US manufacturers of drugs, who are more and more relying on previous findings to obtain approval for a modification of an existing reference drug, such as a new indication for use, a new dosage form, a new formulation, or a new combination. (more…)

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DCAT Week 2015 Biopharmaceutical Forum: Opportunities, Trends, and Supply Chain Development in Biopharmaceuticals

DCAT Week

DCAT Week ’15, organized by the Drug, Chemical & Associated Technologies Association (DCAT), a non-profit global business development association for the pharmaceutical manufacturing industry, offered educational sessions around several industry topics. This year’s biopharmaceutical forum brought together nearly 100 attendees from varied segments of the industry and provided a look into some of the trends and opportunities in the biotech arena. Speakers included industry analysts and manufacturers of biologic drugs, who provided insight into where current development investment is taking place, along with considerations to take into account when building out supply chains for these complex products. (more…)

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DCAT Week 2015: Utilization & Impacts of Quality Metrics

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During the third week of March, New York City played host to DCAT Week ’15, organized by the Drug, Chemical & Associated Technologies Association (DCAT), a non-profit global business development association for the pharmaceutical manufacturing industry. On Tuesday March 17th, over 100 attendees took time out from a busy week of meetings and networking to attend a conference session focused on quality metrics. (more…)

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Drugs to Watch in 2015

drugs to watch

In January 2014, Thomson Reuters Cortellis Competitive Intelligence named three drugs to watch that were expected to enter the market that year and make sales of over $1 billion within five years. All three entered the market as anticipated, and although the Cortellis Consensus sales forecasts have fluctuated over the course of the year, all of the drugs are still forecast to be $1 billion-plus blockbusters. (more…)

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