Welcome to the latest edition of our weekly EuroBiotech Report. This week we bring you one story from the United Kingdom and four from the 27 European Union member states it plans to leave. With the U.K. gearing up for a general election, AstraZeneca laid out what it wants from the next government as it leads the country through the Brexit process. A welcoming environment for immigrants and regulatory body aligned with the European Medicines Agency topped the wish list. On mainland Europe, Bayer positioned cancer drug copanlisib for a speedy approval by picking up priority review status at the FDA. Analysts laid into AB Science after its regulatory mishap. Vesalius Biocapital and AurorA-TT unveiled plans to invest €200 million ($223 million) in European biotechs. Vifor Pharma continued its deal spree by penning a pact with Akebia Therapeutics. And more. —Nick Taylor
AstraZeneca EVP Mene Pangalos has laid out how he wants the next government to support the United Kingdom’s life sciences sector through Brexit. The R&D leader’s wish list to U.K. politicians includes a “welcoming” environment for global talent and a local regulatory agency aligned with the European Medicines Agency (EMA).
The FDA has granted priority review status to Bayer’s copanlisib, setting the PI3K inhibitor up to speed through the regulatory process in 6 months or less. Bayer secured the privileged position on the strength of data from a midphase trial in patients with non-Hodgkin lymphoma (NHL).
Analysts have torn into AB Science over the clinical trial compliance failings identified by regulators in France. Oddo took the most extreme action by slashing its price target from €48 ($53) to €5, but even analysts with rosier assessments of AB’s situation fired off salvos at its management.
The European biotech VC sector is set to get a €200 million ($223 million) injection of capital. Well-established VC shop Vesalius Biocapital is looking to build on the success of its Ogeda exit with a €150 million fund, while new entrant AurorA-TT is putting together a €50 million pot to bankroll technology transfers in Italy.
Vifor Pharma has struck a deal to sell Akebia Therapeutics’ phase 3 oral anemia drug vadadustat through its network of U.S. dialysis centers. The deal brings together two prolific dealmakers that have both spent the past two years wheeling and dealing to improve their prospects.