J&J tells End­points News that a bis­pe­cif­ic an­ti­body it is part­nered on with Gen­mab for acute myeloid leukemia has been put on clin­i­cal hold af­ter pa­tients in the tri­al suf­fered se­ri­ous ad­verse events.

The drug, JNJ-63709178, tar­gets both CD3 and CD123 and was in an ear­ly stage study when the hold was in­sti­tut­ed, forc­ing in­ves­ti­ga­tors to sus­pend pa­tient re­cruit­ment, ac­cord­ing to the clin­i­cal­tri­als.gov web site. The com­plete hold, which should stop dos­ing, fol­lowed.

A spokesper­son for J&J con­firmed the news, but de­clined to say just what ad­verse events were seen in the study.

“Janssen R&D tem­porar­i­ly sus­pend­ed the study on Aug 8; the FDA put it on com­plete clin­i­cal hold ef­fec­tive Aug 16,” says the com­pa­ny spokesper­son.  “We’re work­ing with the FDA now to ad­dress rec­om­mend­ed changes to the study.  At this point, we don’t have any ad­di­tion­al de­tails to share.  We’re hop­ing to re­sume the study with ap­pro­pri­ate guid­ance from the FDA.”

News of the clin­i­cal hold was first raised in a tweet from Eval­u­ate Phar­ma’s Ja­cob Pli­eth.

Se­vere ad­verse event -> sus­pen­sion of $JNJ $GEN CD123 bis­pe­cif­ic JNJ-63709178. (H/t Nordea) $NVS $XN­CR $MGNX $CLLS pic.twit­ter.com/4q2bTAhv2d

— Ja­cob Pli­eth (@Ja­cob­Pli­eth) Sep­tem­ber 19, 2016

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations.