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Ian Schofield

Edinburgh, U.K
Ian Schofield has been writing on issues affecting the pharmaceutical and biotech industry since the mid-1980s, specialising in EU and global policy and regulatory affairs.  As well as writing, editing and commissioning articles for Pharma Intelligence, Ian works for the Ask the Analyst service, providing tailor-made answers to questions posed directly by clients. He has a degree in modern languages from the University of Bath. Outside the realm of work, Ian plays guitar in a traditional music group and also enjoys a touch of cycling and gardening. He lives by the seaside about three miles from the centre of Edinburgh.
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Latest From Ian Schofield

AB Science Asks For Re-examination After EMA Rejects Masitinib For Mastocytosis

The EMA’s main scientific committee, the CHMP, has rejected AB Science’s potential mastocytosis drug masitinib, but the company has asked for a re-examination of the decision on a number of grounds, including the fact that it has implemented GCP corrective actions and that updated information shows the product to have “acceptable” long-term safety.

Drug Review Compliance

All Set For EU Approval: First Biosimilar Humalog And Three More Rituximabs From Celltrion

The European Medicines Agency has given the thumbs-up to Insulin lispro Sanofi, the first biosimilar version of Lilly’s diabetes drug Humalog. It has also green-lighted three more biosimilar rituximab products from Celltrion, which already has EU approval for one version of the originator product, Roche’s MabThera.

Biosimilars Approvals

High Rejection Rate of Proposed Brand Names On EMA Radar

In March, the number of proposed new drug brand names rejected by the European Medicines Agency exceeded those that were accepted. A dedicated group at the agency is to look into the problem at a meeting with stakeholders on June 1.

Trademarks Europe

On The Rise In The EU: New Drug Applications, Conditional Approval Recommendations

Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.

Approvals Drug Review

‘Excessive Pricing’ Inquiry Widens As EC’s First Antitrust Price Probe Targets Aspen Pharma

The litany of complaints against pharmaceutical companies for imposing “excessive” prices on generic drugs is growing after the European Commission decided to pursue Aspen Pharma over price rises imposed on a range of anticancer products it acquired from GSK.

Europe Generic Drugs

‘Excessive Pricing’ Inquiry Widens As EC’s First Antitrust Price Probe Targets Aspen Pharma

The litany of complaints against pharmaceutical companies for imposing “excessive” prices on generic drugs is growing after the European Commission decided to pursue Aspen Pharma over price rises imposed on a range of anticancer products it acquired from GSK.

Pricing Strategies Europe
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