AMSTERDAM – As the Chinese ecosystem continues to evolve with an increasing focus on innovative drugs and a rapidly changing regulatory environment, American and European biopharma executives have kept a keen but wary eye on the possibilities.

2017 was recorded as the second highest financings year for the biopharmaceutical industry. High enthusiasm was demonstrated among investors who funneled about two-thirds of the money through public offerings.

Drug pricing pressures, regulatory uncertainty and sizeable financings opportunities all may have contributed to an M&A slowdown in 2017 that left the biopharmaceutical industry with the lowest value of completed deals in four years and the lowest number of deals in three.

January set a new record for biopharmaceutical public financings tracked over the last 18 years, with a more than 20 percent increase in the value of follow-on offerings over the second highest January three years ago.

Last year, there were 1,015 biopharmaceutical deals recorded by Cortellis Deals Intelligence, with projected values at signing of $80.89 billion. This total represented a slight 3 percent drop on the deal totals calculated in 2016, and a 24 percent decline over 2015, despite the fact that the deal volume was 24 percent and 12 percent higher than the 2016 and 2015 volumes, respectively. 

If ever a statement was made, it was made in 2017 by the FDA with a record number of approvals that dwarfed last year's numbers in every aspect. The most dramatic change was seen through a doubling of the new molecular entities (NMEs) approved, as well as a 37 percent increase in orphan drug approvals. BioWorld reported on the approval of 46 NMEs, in contrast with 2016's 22 NMEs approved. (See BioWorld Insight, Jan. 2, 2017.)

Although the number of complete response letters (CRLs) issued by the FDA to biopharmaceutical companies in 2017 dipped by 23 percent compared to the prior year, extensive planning and robust studies once again offered no foolproof promise of commercial glory.

Although the number of complete response letters (CRLs) issued by the FDA to biopharmaceutical companies in 2017 dipped by 23 percent compared to the prior year, extensive planning and robust studies once again offered no foolproof promise of commercial glory.

PHILADELPHIA – A growing number of therapeutics, upon showing signs of early efficacy, are moving directly into seamless registration trials, replacing the age-old phase I, II and III continuum, speeding the time to approval and potentially reaching ill patients faster.

PHILADELPHIA – Understanding the evolution of cancer and discovering the most specific, immunogenic targets are crucial prerequisites for the discovery of effective therapeutics, especially when tumors continually evade immune surveillance.