Archive for the 'Uncategorized' Category

US Still Strong but Europe Waning in Life-Sciences Investment

Amy RitterA newly released report from Jones Lang LaSalle, a financial and professional services firm specializing in real estate services and investment management, looks at the world in terms of life-sciences investment, and finds some not-so-surprising trends over the past 10 years. The report ranked areas of the world according to how much direct investment they received in life sciences, and compared the rankings made between 2003–2006 with those made between 2007–2010. Those time periods were chosen to represent periods before and after the world-wide economic slowdown. Not surprisingly, on both lists, the US was number one, with Ireland, China, and Singapore also in the top 5 in both analyses. However, there have been some changes over the past few years. Puerto Rico, which ranked number 8 on the 2003–2006 list, failed to make the top 10 ranking in the 2007–2010 list. And Canada and Brazil, two non-European countries, replaced Sweden and France as top 10 recipients of life-sciences investments. India, ranked at number 9 in the 2003–2006 analysis, moved up to number 4 in the more recent ranking. Read more »

GSK CEO Knighted

Stephanie Sutton Pharm Tech EuropeFirst of all, I wish all of you a very happy new year! The pharma industry and its workers have been through a lot of hardships in recent times with huge job losses, eroding profits and drying pipelines. A lot of gloomy predictions have been made about 2012 (including ongoing economic woes and the end of the world) but let’s hope that this year finally brings good times for pharma as it seems that the industry is well overdue for a successful year.

For Andrew Witty, the CEO of British pharma giant GlaxoSmithKline, the year is definitely off to a good start after he was knighted for services to the UK economy and pharmaceutical industry. Sir Andrew as he will now be known received the royal recognition in the UK’s 2012 New Year’s Honours List. Almost 1000 people received awards of varying kinds.  Read more »

Show Us the Data

Amy RitterIf a clinical trial is run, but the results are never published, what benefit is there to patients, physicians, or the public? Read more »

FDA Inches Towards a Biosimilar Approval Pathway

Amy RitterThis week’s announcement of a public meeting to discuss a user fee structure for biosimilars marks another step towards implementation of the Biologics Price Competition and Innovation Act of 2009, which mandates that FDA establish an approval pathway for biosimilars. The question on everyone’s mind regarding the definition of a biosimilar has yet to be answered, but the fee announcement and the accompanying proposed review of performance goals and procedures provides some welcome information about what the approval process will look like. Read more »

These Coupons Are No Bargain

Amy RitterTo lower costs and encourage the use of generics, most insurance programs have a tiered copay system, where the consumer is free to choose a more expensive drug covered under the plan, but must shoulder some of the extra cost in the form of higher copays. To recapture market share for branded drugs from generic competition, drug companies offer consumers incentives in the form of rebate coupons. Consumers who buy their drugs though private insurance are reimbursed for the copay on a branded drug to bring the copay cost near to, or in some cases lower than, that for the generic competition. A report released this week by The Pharmaceutical Care Management Association (PCMA) takes aim at this practice, claiming that it will raise health care costs for employers, unions, and state governments by as much as $32 billion. Read more »

Coordinated Global Health Efforts Pay Off for Malaria

Angie Drakulich PharmTech editorThe malaria vaccine candidate RTS,S is looking even more promising, according to preliminary clinical trial results published in the New England Journal of Medicine . Early data from a large-scale Phase III trial conducted in seven African countries show that the vaccination regimen “can reduce the risk of clinical malaria by more than half in African children aged five to 17 months during the 12 months after vaccination.” Read more »

Who’s Making the Most Money?

Everyone wants to know what their equivalents in the market are making, whether they are a QA professional, a lab chemist, a supply-chain manager, a procurement officer, a division leader, or even a CEO. But salaries aren’t all that make job satisfaction possible. Factors such as proper staffing, level of outsourcing, mergers and acquisitions, training, benefits, company culture, and more contribute to one’s willingness to stay put–or seek other employment. We’d like to know what’s going on in your field, so please take our annual employment survey. The results will be reported in the December print issue of Pharmaceutical Technology and Pharmaceutical Technology Europe.

PDA-FDA: Common Questions about CMOs and Regulatory Responsibility

Angie Drakulich PharmTech editorThis morning’s session at the PDA-FDA Joint Regulatory Conference in Washington, DC, honed in on common CMO-based questions about regulatory expectations, corporate responsibility, and sub-suppliers. Several audience members wanted to know what the agency has in mind in this area of contract manufacturing. Read more »

PDA-FDA: What’s New in Regulatory Inspections

Angie Drakulich PharmTech editorSeveral things are changing in regulatory inspections in the US and industry should be prepared. Zena Kaufman, division vp of global pharmaceutical operations at Abbott, highlighted what’s new in domestic inspections at the PDA-FDA 2011 Joint Regulatory Conference taking place this week in Washington, DC. Read more »

Compliance is Focus of Upcoming PDA-FDA Meeting (Podcast)

Angie Drakulich PharmTech editorIn just a few weeks, the PDA-FDA Joint Regulatory Conference is taking place in Washington, DC. Between 800 and 1000 attendees are expected, including good representation from FDA. I spoke with Susan Schniepp, co-chair of the meeting, vice-president of quality for OSO Biopharmaceuticals, and a member of PharmTech’s Editorial Advisory Board, to see what participants can expect this year. Read more »

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