“A lot of companies are hurting because of the higher interest rates,” one major CEO observed recently, summing up a year which saw little headline-grabbing news on the M&A front for generic and biosimilar sponsors.

Aldeyra’s bid to rely on a single Phase III trial after an initial one failed is rejected by FDA, but firm already has a special protocol assessment under review for a trial that could provide the symptom data it says agency needs to approve the RASP modulator in dry eye. 

Confidence in growing in-house commercial capabilities has recently prompted several Chinese pharmas, including Simcere and 3SBio, to focus on obtaining domestic rights to novel drug assets developed by other China-based biotechs, rather than pursuing international deals.

Aldeyra already has a special protocol assessment under review at the FDA for a trial to provide the symptom data the agency said is needed for approval of the RASP modulator in dry eye disease.