PharmExec Blog

Pharma Manufacturing Investments Reflect Key Industry Trends

Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments. Pharmaceutical Technology’s Cynthia Challener offers summary of selected investments in both small- and large-molecule manufacturing facilities during the last year.

Numerous trends in the pharmaceutical industry, and particularly in the biopharmaceutical sector, are leading to the need for smaller-capacity production facilities, which in turn is affecting the types of investments being made by pharmaceutical manufacturers. First is the shift to biologic-based drugs, which has occurred along with a dramatic increase in the productivity, mainly in terms of much higher titers, of biopharmaceutical processes. Read More »

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Google Glass — A User's Guide in Healthcare

Three medical affairs experts — Sean Turbeville, David A. Wells, and Charles Wolfus — review the capabilities of Google’s latest technology for delivering information to healthcare professionals in the field. Read More »

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Emerging Pharma Leaders: Susanne Heinzinger

Susanne Heinzinger, Executive Director of Product Strategy and Alliance Management, Achillion Pharmaceuticals.

To say that Susanne Heinzinger’s career trajectory has taken her from one spectrum of the healthcare arena to another may be an understatement. Before entering the pharmaceutical industry as a sales person, Heinzinger, who earned a Bachelor of Business Administration degree in accounting, worked as an auditor; she picked the job of auditing hospitals and home healthcare companies, mainly because she had always had an interest in the healthcare industry. Read More »

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New Products Will Force 'Radical Shift' in Hemophilia Drug Market

The hemophilia treatment landscape is to undergo a radical shift away from established short-acting therapies, beginning with the launch of Biogen Idec’s long-acting rFVIII and rFIX products this year, according to research and consulting firm GlobalData.

The GlobalData report states that the patient shares of currently marketed short-acting recombinant products will erode considerably by 2022 across seven major markets (the US, France, Germany, Italy, Spain, the UK and Japan).

Brooke Baker, Ph.D., Senior Analyst at GlobalData, says: “Biogen Idec’s new treatments have the potential to reduce the number of weekly prophylactic infusions and greatly improve patients’ convenience and quality of life. By pricing its long-acting agents, namely Eloctate and Alprolix, in line with the established short-acting recombinant factors, [the company] aims to incentivize patients to switch from their previous therapies.”

GlobalData forecasts that peak-year US sales for Eloctate and Alprolix will reach $786 million and $349 million by 2022, respectively.

More info here.

 

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Pharma's Social Media Struggles Continue

FDA has been rolling out new guidelines for using interactive media in recent months. The new guidances clarify some murky areas, but may not make online communications any easier.

FDA’s Office of Prescription Drug Promotion (OPDP) provides some useful advice in its new advisories, which were discussed further in an OPDP webinar July 10. Overall, the agency sticks to its rules requiring ads and promotional messages to be accurate, not misleading, balanced, and limited to approved uses. Because it’s very hard to get full risk information into a 140-character tweet or search engine listing, such communiqués may not fit FDA’s regulatory scheme for drugs and medical products, according to a draft guidance on using the Internet and social media platforms with character space limitations. There’s no leeway to use icons to indicate that all drugs are risky, as proposed by industry; without equal presentation of risks and benefits in a character-limited message, OPDP advises marketers to “reconsider using that platform,” especially for products with complex indications or serious risks.

Read the full version of this article here.

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