All News

Cleveland Clinic's Pick of Top 10 Advances for 2015.

The pharmaceutical and biotechnology industries, like all industries, are facing industry-specific changes coupled with disruptive events in the external global environment.

The innovation debate (Why isn’t there more or it? How much should we pay for it? Just what is it anyway?!) remains a lively one in the UK. Lord Saatchi’s Medical Innovation Bill is just one part of this debate.

The battle against hepatitis C (HCV) is a relatively new, and highly dynamic, one.

“Only those who risk going too far can possibly find out how far they can go,” said T.S. Elliot. Cancer Research UK (CRUK) followed this advice when it decided to have its Center for Drug Development (CDD) adopt a risk-based monitoring (RBM) approach across its entire portfolio of clinical trials.

I can’t help imagining the cocktail party of 2018 as a scene from one of those a low-budget sci-fi film aired late at night. Imagine: A living room packed with people too busy to chat with each other as they balance their drinks with one hand and monitor their sleeves of devices and smartphones with the other - emailing, texting checking their wearable ECGs (electrocardiograms); glucose monitors and even insulin pumps.

The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes.

Shire plans to relocate more than 500 positions to Massachusetts from its Chesterbrook, PA, site and establish Lexington, MA, as the company’s US operational headquarters.

The Tufts University Center for the Study of Drug Development (CSDD) released its latest research on the costs and timeframes required for launching a new drug.

The European Medicines Agency (EMA) has published its revised policy on handling declarations of interests for scientific-committee members and experts.

CytRx announced on Tuesday that FDA gave notice of a partial clinical hold for trials for its oncology candidate aldoxorubicin.

The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation’s leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace.

A cool $2.6 billion is the going rate to develop and gain market approval for a drug, according to the recent study by the Tufts Center for the Study of Drug Development (CSDD).

The pharmaceutical market is beginning to show signs of stability, with a review of 30 leading companies highlighting combined revenues of $718.7 billion in 2013, down just 0.2% from 2012, according to GlobalData.

While flipping through my emails recently, I froze before an image that appeared on my screen. An old Rx colleague had sent me a graph, mapping out the 2014 U.S. sales achieved by Gilead’s Hep C drug, Sovaldi. It was stunning.

Peter O’Donnell’s recent Applied Clinical Trials blog, ‘Who’s in charge of Medicines in Brussels?‘, has been overtaken by history, with the departure of Guido Rasi from his post of Executive Director of the European Medicines Agency.

In response to a letter the European Medicines Agency received from the European Ombudsman on Oct. 27, 2014, the agency is clarifying its policy on commercially confidential information.

Johnson & Johnson completed the acquisition of Alios BioPharma, a privately held clinical-stage biopharmaceutical company focused on developing therapies for viral diseases, for a total purchase price of approximately $1.75 billion in cash.

Merck KGaA CEO Stefan Oschmann spoke last week in New York as he accepted the two-year role as president of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the R&D industry’s global trade group based in Geneva.

The past decade has seen considerable growth in the Indian pharmaceutical industry. The country has emerged as a key supplier of high quality and affordable medicines not only to the developing world, but also to developed economies.

The Brazilian economy is being impacted by internal and external factors, and forecast figures are being quickly revised downwards. Market research released by Brazil’s Central Bank revised average analysts’ projections for economic growth in 2014 down to 0.70% from 0.90% four weeks earlier(1).

While emerging markets continue to represent a new channel of demand for pharmaceutical products, manufacturers have quickly realized that significant attention must still be given to more established markets, such as Germany.

The growing insistence on making healthcare more patient-centered - Europe is currently awash with declarations of intent along those lines - is generating a new level of interest in helping patients (or even citizens) to meet the expectations that the new orthodoxy is creating.

The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.

The Cleveland Clinic once again ended its Medical Innovation Summit with a list of 10 advances voted most likely to have a major impact on improving patient care in 2015.

Israel’s pharmaceutical market value will increase from approximately $1.9 billion in 2013 to $2.34 billion, a compound annual growth rate of 2.8%, by 2020, says UK research and consulting firm GlobalData.

We hear it all the time these days: research processes have to undergo transformative changes in order for research organizations to thrive-or even survive. Controlled clinical trials take too long and cost too much. Regulatory review is blocking innovation.

So now we know who is to do what on health issues in the new European Commission. Or do we?