Bris­tol-My­ers Squibb $BMY has a fresh Phase III set­back to re­port to­day on its all-im­por­tant PD-1 drug Op­di­vo. The phar­ma gi­ant says that their drug com­bined with ra­di­a­tion failed to sig­nif­i­cant­ly im­prove the over­all sur­vival rate of glioblas­toma pa­tients com­pared to a con­trol group re­ceiv­ing chemo plus ra­di­a­tion.

As usu­al, re­searchers will hold back the da­ta for a fu­ture con­fer­ence, but Check­Mate-498 is an­oth­er write-off.

“GBM is a no­to­ri­ous­ly ag­gres­sive can­cer,” notes Bris­tol-My­ers on­col­o­gy R&D chief Fouad Namouni, who ex­pressed their dis­ap­point­ment with the fail­ure.

Fouad Namouni

Op­di­vo earned $1.8 bil­lion in Q1 alone for Bris­tol-My­ers Squibb, a 19% gain over the same pe­ri­od a year ago. That’s no small ac­com­plish­ment in bio­phar­ma, but it al­so marks a sec­ond place po­si­tion be­hind an in­creas­ing­ly dom­i­nant Mer­ck — $2.3 bil­lion in Q1, up 55% — which has had far more suc­cess­es to re­port from the R&D group.

It’s un­like­ly that any of the an­a­lysts had much up­side built in for glioblas­toma, the most com­mon brain can­cer which has proven to be in­cred­i­bly dif­fi­cult to slow down. So don’t look for any dra­mat­ic stock moves. On the oth­er hand, the phar­ma gi­ant has been plagued by set­backs in the clin­ic. 

The com­pa­ny had to yank its ap­pli­ca­tion us­ing a high tu­mor mu­ta­tion­al bur­den af­ter get­ting some neg­a­tive feed­back from the FDA. Their com­bo ap­proach us­ing Yer­voy failed in non-small cell lung can­cer, and that fol­lowed a fail­ure against the stan­dard of care for sec­ond-line small cell lung can­cer. A brain can­cer flop may have been pre­dictable, but it al­so rais­es ques­tions about their R&D strat­e­gy at a time Mer­ck has been ad­vanc­ing with its chemo com­bo ap­proach.

With some key read­outs due on front­line lung can­cer, Bris­tol-My­ers is in a make-or-break po­si­tion with Op­di­vo, with an­a­lysts like Wolfe’s Tim An­der­son won­der­ing if they’re head­ed for a peak in Op­di­vo sales in 2020, fol­lowed by a flat line as com­pe­ti­tion builds around the world. That al­ready may have dri­ven their $74 bil­lion Cel­gene ac­qui­si­tion, which will shift fo­cus to a slate of 6 late-stage drugs up for an ap­proval de­ci­sion.

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.