Mark W. Schwartz

• The FDA stiff-armed Sanofi and Re­gen­eron’s rheuma­toid arthri­tis drug sar­ilum­ab, but Cana­di­an of­fi­cials were hap­py to give the drug its first reg­u­la­to­ry green light. The FDA’s CRL was point­ed to some man­u­fac­tur­ing prob­lems at Sanofi, which it’s been work­ing to over­come.  But most an­a­lysts ex­pect a near-term US ap­proval.

• Cerulean $CERU went 0 for 2 in Phase II last year, forc­ing a re­struc­tur­ing that elim­i­nat­ed half of its jobs. Now the com­pa­ny — which had $38 mil­lion in cash at the end of Sep­tem­ber — is fol­low­ing up with a look at its strate­gic al­ter­na­tives.

• South San Fran­cis­co-based Rigel Phar­ma­ceu­ti­cals has round­ed up $40 mil­lion from a fol­low-on of­fer­ing.

• Un­der in­ves­ti­ga­tion for its mar­ket­ing prac­tices, the biotech mi­cro­cap Gale­na Bio­phar­ma $GALE has boot­ed CEO Mark Schwartz.

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

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