A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.

Ashvattha Therapeutics Inc. secured $69 million in a series B financing that it said will strengthen its ability to develop hydroxyl dendrimer-based medicines and accelerate efforts to advance its candidates to the clinic.

The flop that is Aduhelm (aducanumab) made itself felt in Biogen Inc.’s executive suite as CEO Michael Vounatsos is leaving the company. He had the job for five and a half years and for less than a year after the controversial Alzheimer’s treatment was approved. He will stick around until a successor is found.

The U.S. Centers for Medicare & Medicaid Services’ (CMS) decision last month restricting coverage of a class of Alzheimer’s drugs to clinical trials meeting the agency’s standards still isn’t sitting well with some lawmakers.