DUBLIN – The EMA’s Committee for Medicinal Products for Human Use (CHMP) diverged from the FDA on a key decision at its monthly meeting, which concluded Feb. 28. It refused to back an application from Eli Lilly and Co. for a line extension to its migraine prevention drug, Emgality (galcanezumab), which would have authorized the drug for preventing attacks during an episode of cluster headaches.

LONDON – The COVID-19 epidemic has reached a “decisive point” as the number of new cases in the rest of the world exceeded the number of new cases in China, and seven countries reported infections for the first time.

LONDON – The COVID-19 outbreak appears to be sliding toward pandemic status, with the virus spreading to four more countries and confirmed cases and deaths mounting in infection hotspots in Italy, Iran and South Korea.

DUBLIN – Meda AB’s acquisition in 2014 of the veteran Italian specialty pharma firm Rottapharm generated a €1.975 billion (US$2.2 billion) payday for the latter firm’s owners, the Rovati family. A small fraction of that amount is now being recycled into a new investment initiative, Aurora Science, which is a three-way partnership among Monza-based Rottapharm Biotech Srl (the R&D arm of the company that was not part of the Meda transaction), the Milan-based specialty pharma Italfarmaco SpA and Aurora-TT Srl, a Milan-based commercial technology transfer company.

LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.

DUBLIN – “Welcome to the conversation,” Abbvie Inc.’s head of genomic research, Howard Jacob, an early pioneer of genomics-driven medicine, told delegates during a keynote address at the Genomics Summit 2020 event Jan. 23. Ireland is very much a latecomer to that conversation and it has yet, as a country, to figure out what the shape of its contribution to the genomic era of medicine is going to be.

LONDON – A high level U.K. group, involving industry, academia, patients, health technology assessment and regulatory representatives, has set out guidelines for designing complex cancer trials and is calling for their rapid implementation to reduce clinical development timelines.

DUBLIN – Last year was yet another banner year for European biotechnology firms engaged in drug development. The sector took in $7.739 billion in equity funding in 2019, just edging past the previous high of $7.715 billion it reached in 2018. The second half of the year was a marked improvement on the first half, but that was linked to the timing of a couple of large-scale transactions.

LONDON – Following 3.5 years of uncertainty, the U.K. will be leaving the EU at 11 pm on Jan. 31, after the newly elected Conservative government finally got the withdrawal agreement bill voted through parliament on Dec. 20, by a majority of 124.