Author Archives: Clark Herman

Pharma Still Doesn't Get Patient Groups

By Clark Herman | Published: January 15, 2013
A survey of 600 patient groups worldwide conducted in late 2012 revealed that perceptions of the pharmaceutical industry soured in the past year, mainly due to issues of access, pricing, patient safety and transparency. The Corporate Reputation of Pharma in 2012—the Patient Perspective compared the reputations of 29 leading pharma companies around six different [...]
Posted in Europe, Market Access, Safety, Strategy, patient education, pricing | Tagged , , | Leave a comment

R&D Trends for 2013: Data Trims, Partnerships, and Emerging Global Players

By Clark Herman | Published: January 14, 2013
The Tufts Center for the Study of Drug Development (CSDD) sees two key trends as increasingly important for pharmaceutical companies to maintain success: eliminating the bane of extraneous data and fostering collaborations with academia and multi-company consortia both as measures of reducing costs and remaining competitive by more quickly and effectively guiding medicines to market. [...]
Posted in Emerging Markets, IP, R&D, Strategy | Tagged , , | 1 Comment

The Orphan Drug Act at 30 Years: What's Next?

By Clark Herman | Published: January 8, 2013
30 years ago last week, the US Orphan Drug Act came into being, and with it, a door of possibilities opened up for patients with literally thousands of untreated diseases. The anniversary marks the beginning of a journey where medicines for rare diseases have gained a foothold in the portfolios of drug companies large and [...]
Posted in Biotech, FDA, IP, Orphan Drugs, Regulatory, Strategy | Tagged , , , , , , | Leave a comment

2012 US Drug Approvals Best in 16 Years, But will the good times last?

By Clark Herman | Published: January 3, 2013
Coming out of the blizzard of patent expirations, 2012’s total drug approvals climbed to 39, the greatest number from the FDA since 1996. The evidence is now clear that pipeline preparations laid not just within the year but within the past decade are finally yielding results.
Posted in FDA, Regulatory, compliance | 1 Comment

SEC Charges Lilly with Corruption Abroad: A Taste of Fines to Come

By Clark Herman | Published: December 21, 2012
The Securities and Exchange Commission filed charges on Eli Lilly and Co. yesterday for violations of the Foreign Corrupt Practices Act (FCPA) that allege the drug maker’s subsidiaries overseas bribed foreign officials in Russia, China, Brazil and Poland. The settlement totaled $29 million after an investigation of activities reaching as far back as 1994, assessed [...]
Posted in Emerging Markets, Global, Legal, Regulatory | Tagged | 1 Comment