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.

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Massachusetts-based biotech Ribon Therapeutics has roped in a big name for some financial backing.

Ribon announced on Monday that Pfizer has invested $25 million into the biotech. Robert Rickert, Pfizer’s head of cancer immunology discovery, will be coming onto Ribon’s scientific advisory board. The startup will use the funds to support the development of its programs for oncology and immunology.