Two Big Phar­ma com­pa­nies are go­ing to the mat over ge­net­i­cal­ly mod­i­fied mice in a li­cens­ing dis­pute.

Bris­tol My­ers Squibb is su­ing No­var­tis in New York over a dis­pute con­cern­ing an eval­u­a­tion, re­search and com­mer­cial­iza­tion agree­ment stretch­ing back to the late ’90s ini­tial­ly inked be­tween No­var­tis and BMS’ pre­de­ces­sor Medarex. The deal in ques­tion al­lowed No­var­tis to use Medarex’s patent­ed trans­genic mice to de­vel­op ther­a­peu­tic drugs. No­var­tis agreed to pay Medarex – and sub­se­quent­ly BMS – a roy­al­ty on sales of drugs it de­vel­oped us­ing the mice.

The agree­ment be­tween the two par­ties, ac­cord­ing to the law­suit, con­tains an ar­bi­tra­tion clause stat­ing that “the ar­bi­tra­tors shall de­ter­mine what dis­cov­ery will be per­mit­ted, based on the prin­ci­ple of lim­it­ing the cost and time which the par­ties must ex­pend on dis­cov­ery.”

In Feb­ru­ary 2019, No­var­tis be­gan pay­ing BMS roy­al­ties, un­der protest, on two drugs de­vel­oped us­ing the trans­genic mice. But even as it did, No­var­tis claimed the roy­al­ties were com­pen­sa­tion for a li­cense to ex­pired patents and there­fore un­en­force­able.

No­var­tis then filed a de­mand for ar­bi­tra­tion to re­solve the roy­al­ty dis­pute in March 2019. BMS and No­var­tis ini­tial­ly agreed to amend the agree­ment to re­solve the dis­pute through a pan­el of three neu­tral and in­de­pen­dent ar­bi­tra­tors, with BMS fil­ing an an­swer to No­var­tis’s ar­bi­tra­tion de­mand in May 2019, and the par­ties even­tu­al­ly reach­ing an agree­ment.

Af­ter the con­clu­sion of dis­cov­ery, BMS filed a mo­tion for sum­ma­ry de­ter­mi­na­tion and af­ter sev­er­al cross-mo­tions were filed, the pan­el de­nied No­var­tis’s claims and re­quests for re­lief. How­ev­er, while No­var­tis said it would file the award, it has not been signed and val­i­dat­ed.

BMS is ask­ing the court to con­firm the pan­el’s de­ci­sion and di­rect en­try of judg­ment against No­var­tis per the de­ci­sion.

Trans­genic mice are ones that have had DNA from an­oth­er source put in­to their DNA. They’re of­ten used in lab stud­ies, and have been be­hind many ap­proved drugs. Joseph Bryant, ad­junct pro­fes­sor at the In­sti­tute of Hu­man Vi­rol­o­gy at the Uni­ver­si­ty of Mary­land School of Med­i­cine told End­points News that de­vel­op­ers are like­ly watch­ing this case, as it’s a com­pli­cat­ed process.

This suit comes at a time when Greece is look­ing to hold No­var­tis ac­count­able for ac­tions that got them in trou­ble with the US gov­ern­ment.

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.

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

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.

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.”