A non­prof­it ad­vo­ca­cy group has filed a com­plaint with the FDA ac­cus­ing No­vo Nordisk of lin­ing up pro­mo­tion­al ma­te­r­i­al for its weight loss drug We­govy that mas­quer­ad­ed as a CBS news seg­ment.

The com­plaint filed by the Physi­cians Com­mit­tee for Re­spon­si­ble Med­i­cine on Thurs­day takes is­sue with a 13-minute seg­ment of a 60 Min­utes episode that aired on Jan. 1, fea­tur­ing two Boston-area doc­tors who’ve con­sult­ed for No­vo Nordisk.

While CBS cit­ed No­vo Nordisk as an ad­ver­tis­er on the broad­cast, the Physi­cians Com­mit­tee ar­gues that the seg­ment vi­o­lates the FDA’s “fair bal­ance” re­quire­ments for ad­ver­tise­ments, and urges reg­u­la­tors to re­quire that the seg­ment be with­drawn and that No­vo is­sue cor­rec­tive ad­ver­tis­ing.

“Al­though it was in­clud­ed dur­ing a reg­u­lar­ly sched­uled episode of CBS’s pop­u­lar se­ries 60 Min­utes, the We­govy pro­mo­tion meets the de­f­i­n­i­tion of an ad­ver­tise­ment,” the com­plaint states. “No med­ical ex­perts who were not paid by No­vo Nordisk ap­peared, nor did the pro­mo­tion dis­cuss al­ter­na­tive prod­ucts or ap­proach­es to ad­dress obe­si­ty.”

The group al­so takes is­sue with words used to de­scribe the drug dur­ing the seg­ment, in­clud­ing “safe,” “fab­u­lous,” and “ro­bust.”

We­govy was ap­proved in June 2021 as a once-week­ly in­jec­tion for chron­ic weight man­age­ment in adults. It con­tains the same med­ica­tion, semaglu­tide, as the com­pa­ny’s type 2 di­a­betes drug Ozem­pic, just at a high­er dose. In a fol­low-up episode, one of the doc­tors re­turns to ex­plain how We­govy and Ozem­pic work.

No­vo Nordisk has de­nied the al­le­ga­tions. The com­pa­ny said in an email to End­points News:

No­vo Nordisk did not pro­vide any pay­ment or spon­sor­ship to CBS 60 Min­utes for their re­port­ing on obe­si­ty as part of a news seg­ment that aired on Jan­u­ary 1, 2023, and we did not con­trol any of the con­tent or have any role in iden­ti­fy­ing or se­lect­ing the doc­tors and pa­tients fea­tured in the news seg­ment.

No­vo Nordisk had halt­ed We­govy pro­mo­tions back in March on the heels of sup­ply is­sues but said in No­vem­ber that it planned a “broad com­mer­cial re-launch” in the new year.

Last month, the com­pa­ny re­port­ed a short­age of Ozem­pic caused by “in­cred­i­ble de­mand cou­pled with over­all glob­al sup­ply con­straints.” While No­vo de­clined to con­firm whether the short­ages are due to off-la­bel use of Ozem­pic for weight loss, it did ac­knowl­edge that some providers may be pre­scrib­ing the drug for such use. The is­sue is ex­pect­ed to be re­solved by ear­ly 2023, ac­cord­ing to a re­cent­ly up­dat­ed re­port by the Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists. 

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.