Last week’s round-up, 16-21 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud


Biotech in Europe: A Strong Foundation for Growth and Innovation

21 Sep 2019

What makes European biotech attractive, what financing does it need to fuel growth, and what should biotech leaders and investors do to succeed?

These three questions are the focus of a recent review by McKinsey & Company. Their research has indicated that three factors make Europe’s biotech market attractive to investors: strong hot spots, research and industry expertise, and an abundance of high calibre talent. However, Europe currently lags behind the US in late-stage financing, despite the fact that European biotechs are good value for investors.

For biotech leaders to succeed, the company recommends that they work toward global competitiveness on a long-term scale, build a foundation for success before looking for investment, and target eastern funding and partnerships as well as west:


Why Isn’t Insulin a Complex Generic?

19 Sep 2019

A US Representative has asked the FDA to explain why insulin is not considered a complex generic drug.

Mike Kelly requested this information due to recent dramatic price increases in insulin. Competition is currently limited to only three follow-on insulin products, and historically insulin developers have chosen not to pursue an abbreviated new drug application (ANDA), but have instead used the 505(b)(2) application route which only partly relies on the reference product.

In response, former FDA Commissioner Scott Gottlieb has explained that, although insulin is a biologic, it was historically regulated as a drug. Therefore, the ANDA pathway was always open to developers – “the barriers to generic entrants were largely commercial and technical, not statutory”. From March 2020, any follow-on insulin products will need to be approved as biosimilars, which is expected to produce a more robust path for copies:


UK Committee Insists on Sanctions for Trial Reporting Failures

18 Sep 2019

The UK House of Commons Science and Technology Committee has called for sanctions to be imposed when clinical trial results are not reported.

The Committee was responding to an open letter from 12 patient groups and asked the Health Research Authority to take related action. The UK government and HRA already discussed a system for imposing sanctions back in February, however there was pushback and it was decided at the time that setting firmer sanctions would be premature. The HRA would first like to focus on facilitating compliance through better systems and collaboration with funders:


Male Breast Cancer: Developing Drugs for Treatment

17 Sep 2019

The FDA is encouraging the enrolment of male patients in breast cancer clinical trials, through new draft guidance.

Men have historically been excluded from trials of breast cancer drugs, as they account for less than one percent of breast cancer cases. Treatment of men with breast cancer therefore currently relies on data collected in women. To counter this and support development of labelling indications for men, the new draft guidance states that trial eligibility criteria should include both sexes. Alternatively, a scientific rationale will need to be included explaining the exclusion.

The guideline also explains that extrapolation can be used when no difference in safety or efficacy of the investigational medicinal product is expected between sexes. Conversely, further data may be necessary when the opposite applies. This can be generated through a variety of trial designs, including small single-arm trials and studies using real-world data sources. Stakeholders have until October 28th to submit related comments:


ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work

16 Sep 2019

The European Parliament’s health committee (ENVI) has renewed its call for more money to be allocated to the EMA.

ENVI made this point whilst responding to the European Union’s 2020 budget proposal. It also raised related concerns, including a lack of accounting for the additional work by the recent veterinary medicinal product regulations, which came into force in January.

In other regulatory news, the EU Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published final guidelines on benefit-risk assessments of phthalates in medical devices. France’s ANSM has also published a call for projects involving patient advisors, which would enable integration of patients’ views into decisions taken by the agency:


Image: Münzen in der Hand und Sparschweinchen auf dem Tisch, CC BY 2.0

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