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For the tradition-bound biopharma industry, resisting change is no longer an option

“For nearly half a century the pharmaceutical industry has lagged other industries in terms of productivity, efficiency and, some might argue, innovation,” wrote Bikash Chatterjee. “The excuse was that, as a regulated industry, any flexibility to implement improvements is limited, and compliance is of paramount importance.” Chatterjee, president and CSO of Pharmatech Associates, made these […]

Accelerating – and maintaining – drug approvals in the U.S.

Bringing a drug to market is the ultimate milestone for any pharmaceutical firm that has invested significant effort, not to mention time and resources, into developing its product. But all that work and outlay does not stop at marketing approval—this achievement must be maintained. There can be various regulatory requirements that a firm must meet […]

Advances and challenges facing the biosimilars market

The majority of the 10 top-selling drugs in 2016 were biologicals, each exceeding sales of $5 billion. With increasing pressure to reduce healthcare costs, there is a need for cheaper biologicals and thus greater demand for biosimilars, biological drugs similar to the already approved biological. The first biosimilar was approved in the EU in April […]

The challenge to stay competitive in the API industry

By the end of 2017, the worldwide demand for active pharmaceutical ingredients (APIs) is estimated to reach $92 billion, according to the European Fine Chemicals Group (EFCG).  Other analyst reports estimate the API manufacturing market to be worth more than $140 billion today and reach $186 billion by 2020. While details vary among analyst reports, […]

Disease Control in Sub-Saharan Africa: Are We Doing Enough?

Geographically comprising of 48 countries, Sub–Saharan Africa (SSA) represents the most genetically diverse region in the world, offering an imploring opportunity to tap into medical research and development.1 Without question, SSA is capable of becoming the breadbasket of the world; however this will require unification across fundamental regulatory requirements, health education, socioeconomic standards and healthcare […]