
BioSpace
1w ago·21m
AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more
This year has been partly defined by a return to M&A. In the first quarter of 2026, biopharma spent nearly $47 billion in acquisitions across 19 deals, and this week, AbbVie notched another one for the second quarter, scooping up Apogee Therapeutics and its IL-23 blocker for atopic dermatitis for around $10.9 billion. The deal follows GSK’s $10.6 billion Nuvalent Bio acquisition earlier this month.
These deals come as several big pharmas face patent cliffs. Sanofi, for example, will lose patent protection on Dupixent in 2031. New CEO Belén Garijo made a major play to build out Sanofi’s pipeline this week, announcing that Xaira veteran Paulo Fontoura will step in as R&D chief as Houman Ashrafian exits.
Another key trend over the past 18 months has been regulatory uncertainty. This trend continues, with both uniQure and REGENXBIO announcing FDA reversals for their gene therapies for Huntington’s disease and Hunter syndrome, respectively. Both companies will submit for approval of their products—a first submission for uniQure and a resubmission for REGENXBIO—in the third quarter, after the agency, under the leadership of acting commissioner Kyle Diamantas, deemed their current data sufficient.
Also at the FDA, a policy memo on the agency’s consideration of Sanofi’s Commissioner’s Priority Review Voucher for type 1 diabetes drug Tzield threw more fire on the CNPV program, which has already been mired in controversy. And the agency debuted an investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months.
For a special treat, we heard from BioSpace Managing Editor Jef Akst and Senior Editor Annalee Armstrong who are currently in San Diego enjoying BIO 2026.
And finally, on the Eli Lilly front, a new report from Evaluate projects that the company’s weight loss franchise will account for nearly half of the total sales of the top 10 drugs in 2032. But Lilly isn’t resting on this envisioned success: the juggernaut is one of two companies circling Sangamo’s assets as the biotech files for bankruptcy.
These deals come as several big pharmas face patent cliffs. Sanofi, for example, will lose patent protection on Dupixent in 2031. New CEO Belén Garijo made a major play to build out Sanofi’s pipeline this week, announcing that Xaira veteran Paulo Fontoura will step in as R&D chief as Houman Ashrafian exits.
Another key trend over the past 18 months has been regulatory uncertainty. This trend continues, with both uniQure and REGENXBIO announcing FDA reversals for their gene therapies for Huntington’s disease and Hunter syndrome, respectively. Both companies will submit for approval of their products—a first submission for uniQure and a resubmission for REGENXBIO—in the third quarter, after the agency, under the leadership of acting commissioner Kyle Diamantas, deemed their current data sufficient.
Also at the FDA, a policy memo on the agency’s consideration of Sanofi’s Commissioner’s Priority Review Voucher for type 1 diabetes drug Tzield threw more fire on the CNPV program, which has already been mired in controversy. And the agency debuted an investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months.
For a special treat, we heard from BioSpace Managing Editor Jef Akst and Senior Editor Annalee Armstrong who are currently in San Diego enjoying BIO 2026.
And finally, on the Eli Lilly front, a new report from Evaluate projects that the company’s weight loss franchise will account for nearly half of the total sales of the top 10 drugs in 2032. But Lilly isn’t resting on this envisioned success: the juggernaut is one of two companies circling Sangamo’s assets as the biotech files for bankruptcy.
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