Tagged with USA

India In a context where even well-established, multi-billion-dollar domestic companies have received warning letters from the US FDA, quality compliance has clearly become strategically important across all layers of Indian organizations, including formulation and API companies as well as both B2B and B2C players.   My approach is extremely simple: quality…

India Dr. Letitia Robinson, Director of the US FDA India Office, provides insights into the main goals and responsibilities of the FDA in India and documents the US FDA’s collaboration efforts with its Indian regulatory counterparts. Could you introduce to our international readers the US FDA’s Office of International Programs and…

Pharma While drug developers, healthcare practitioners and patients all rejoice at the advent of a golden age of scientific advancement in medicine – symbolized by recent radical breakthroughs in all manners of domains from stem cells and CAR-T generation immunotherapy to gene tech and 3D bio-printing – it is clear that…

UK With an appetite to take the next step in its rapid development, EUSA Pharma has already established itself as a leading rare-disease and oncology biotech company in just a short period of time. Currently active in both the UK and Europe, EUSA is set to further expand internationally, notably in…

India In this exclusive interview, Binish Chudgar, vice-chairman and managing director of Intas, the largest privately-owned Indian pharmaceutical company with sales of over USD 1.7 billion during the last financial year, provides insights into the company’s growth model and M&A approach, as well as his objectives with regards to a large-scale…

Canada Canadian medtech at a glance: market value, number of companies, number of employees,export markets, spinoffs.   Key areas of expenditure in Canadian medtech: diagnostic imaging stands as the single largest therapeutic area served.   Canadian medical device export destinations; the US is far and away the largest market for Canadian…

India Umang Vohra, managing director and global CEO of Indian pharma giant Cipla, discusses the company’s ambition to grow in both the domestic and emerging markets as well as the opportunities that Cipla sees as a specialty pharmaceutical company in the US.   The opportunity to service such a vast patient…

USA Douglas Peddicord, executive director of ACRO, introduces ACRO’s mission, the evolution of the CRO space in the US and globally, and how the latest political developments are affecting the association and its members. Can you begin by introducing ACRO and its mission? “We at ACRO have always focused on advocating…

USA Janet Lynch Lambert, CEO of the Alliance for Regenerative Medicine (ARM), discusses the association’s aims and membership, the importance of creating a supportive reimbursement environment for regenerative medicine, and the huge and expanding need for education in this critical area. What was the initial inspiration behind setting up the Alliance…

USA In an exclusive interview, Stephen Ubl, President and CEO of the Pharmaceutical Researchers and Manufacturers of America (PhRMA), the association representing the leading innovative biopharmaceutical companies in the USA, discusses the onset of a new “golden era” in medicine. He goes on to discuss pricing issues, engaging in a constructive…

USA In 2016, rumours of a weakening FDA followed a disappointing 16 new drugs approved for the full year. However, since the beginning of 2017 the FDA has approved 26 drugs; double the amount of the mid-year average since 2007. “The eight oncology treatments approved by the FDA this year represent…

USA Rolando Pablos, Secretary of State of Texas, discusses Texas’s unique business-friendly environment, the significance of the life sciences sector to the state’s economy (which would be the tenth largest in the world were Texas a country), innovation, and internationalization.   Across the board we are industry agnostic, meaning that whatever…