PharmExec Blog

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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60 Years of Pharma Regulation in Europe

European regulation of pharmaceuticals has, since the foundation of the European Union around 60 years ago, been a story of medicines being controlled in a collaboration between regulators at the EU and national levels.

In recent years, this collaboration has been extended to involve not just the regulators themselves but also other stakeholders such as large, medium and small pharmaceutical companies, prescribers and patients.

A major objective of the European pharmaceutical legislation, particularly at the EU level, has been to support the competiveness of the European pharmaceutical industry. This aim has become more urgent with the industry coming under pressure from globalization. \

In this special Pharmaceutical Technology Europe feature, Sean Milmo looks at the key events and controversies in European drug regulation over the last 60 years.

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Biosimilar Development in Europe: Ten Years On

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, in the light of its experience.  

In this special Pharmaceutical Technology Europe feature, Fiona Greer looks at what the future holds for biosimilars in Europe.

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