By Barbara Obstoj-Cardwell. Managing editor
Regulatory events featured in last week’s news, first with US biotech major Biogen announcing that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for tofersen, a potential treatment for amyotrophic latera sclerosis (ALS), for priority review. Also, Swiss women’s health specialist ObsEva suffered a setback, as the FDA said it is seeking additional data on its NDA for linzagolix for uterine fibroids. On the M&A front, Dutch firm NewAmsterdam Pharma last week announced a merger with special purpose acquisition company (SPAC) Frazier Lifesciences. There was good news for US mRNA specialist Moderna on Friday, when it announced receiving a new contract from the US government for its COVID-19 booster jab, mRNA-1273.222, worth $1.74 billion.
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