The pri­or­i­ty re­view vouch­er mar­ket can be no­to­ri­ous­ly se­cre­tive, es­pe­cial­ly when com­pa­nies pur­chase PRVs and don’t dis­close where they’re plan­ning to use the ex­pe­dit­ed FDA re­views.

For Ab­b­Vie, that strat­e­gy has been plain and sim­ple so far: ex­pand block­buster Rin­voq’s la­bel as quick­ly as pos­si­ble.

Back in 2015, the Chica­go-based biotech spent an eye-open­ing $350 mil­lion on a PRV from Unit­ed Ther­a­peu­tics — more than any oth­er PRV sold ever — and used it to win ap­proval for Rin­voq as a treat­ment for adults with mod­er­ate­ly to se­vere­ly ac­tive rheuma­toid arthri­tis.

Now, the FDA said in a Fed­er­al Reg­is­ter no­tice to­day that Ab­b­Vie used an­oth­er PRV, like­ly the one it pur­chased for $90 mil­lion from Eiger Bio­Phar­ma­ceu­ti­cals in 2020, to ex­pand Rin­voq’s la­bel again in­to adults with mod­er­ate­ly to se­vere­ly ac­tive ul­cer­a­tive col­i­tis.

In­flam­ma­to­ry bow­el dis­ease is the next fron­tier for Rin­voq, which is go­ing to be one of the key ways for Ab­b­Vie to avoid a ma­jor fall fol­low­ing the launch of as many as 10 Hu­mi­ra biosim­i­lars next year.

SVB Se­cu­ri­ties an­a­lysts ex­plained in an in­vestor’s note from May that Ab­b­Vie man­age­ment “re­cent­ly up­dat­ed guid­ance to $7.5bn in 2025E sales for each Rin­voq and Skyrizi, while our 2025E es­ti­mates are $7.2bn for Rin­voq (vs. $6.1bn con­sen­sus) and $8.5bn for Skyrizi (vs. $7.6bn con­sen­sus).”

Ab­b­Vie did not im­me­di­ate­ly re­ply to a re­quest for com­ment on whether it has pur­chased oth­er PRVs too. But Big Phar­ma com­pa­nies have swal­lowed up hand­fuls of these vouch­ers, with com­pa­nies like No­var­tis (6 PRVs), Gilead (5) and As­traZeneca (4, thanks to its pur­chase of Alex­ion) win­ning or buy­ing ac­cess to 15 PRVs com­bined.

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”