It’s been six months since the last in­ci­dent, but 2021 end­ed with the tal­ly re­set­ting back to “ze­ro days.”

Viona Phar­ma­ceu­ti­cals is re­call­ing 33 lots of met­formin hy­drochlo­ride af­ter find­ing traces of ND­MA, a known prob­a­ble hu­man car­cino­gen with can­cer-caus­ing po­ten­tial. It’s a much larg­er re­call than the two lots of 750 mg ex­tend­ed-re­lease tablets it re­called in June.

Met­formin is used to help im­prove glu­cose con­trol in adults with type 2 di­a­betes, and is pack­aged in bot­tles of 100 tablets. The drug can be iden­ti­fied by its cap­sule-shaped, un­coat­ed off-white col­or tablets that fea­ture a “Z” and a “C” on one side and “20” on the oth­er.

The fol­low­ing lots are be­ing re­called:

1. M008130 – 06/2022
2. M008131 – 06/2022
3. M008132 – 06/2022
4. M008133 – 06/2022
5. M010080 – 07/2022
6. M010081 – 07/2022
7. M011029 – 08/2022
8. M011030 – 08/2022
9. M011031 – 08/2022
10. M011032 – 08/2022
11. M011304 – 08/2022
12. M013394 – 09/2022
13. M013395 – 09/2022
14. M013396 – 09/2022
15. M013966 – 09/2022
16. M013967 – 09/2022
17. M100831 – 12/2022
18. M100832 – 12/2022
19. M100833 – 01/2023
20. M100834 – 01/2023
21. M101267 – 01/2023
22. M102718 – 01/2023
23. M102719 – 01/2023
24. M102720 – 01/2023
25. M102721 – 01/2023
26. M102722 – 02/2023
27. M104172 – 02/2023
28. M104173 – 02/2023
29. M104174 – 02/2023
30. M104175 – 02/2023
31. M104176 – 02/2023
32. M105889 – 03/2023
33. M105890 – 03/2023

ND­MA has can­cer-caus­ing po­ten­tial, and is some­times found in meats, dairy prod­ucts and veg­eta­bles. Is­sues with the car­cino­gen have plagued the man­u­fac­tur­ing in­dus­try in the last few years.

Last Jan­u­ary, Nos­trum Lab­o­ra­to­ries twice vol­un­tar­i­ly re­called its gener­ic met­formin. In No­vem­ber 2020, a batch of 500 mg tablets were re­called for the same rea­son.

More re­cent­ly, in June, Pfiz­er yanked its ground­break­ing an­ti-smok­ing drug Chan­tix off of the shelves and halt­ed dis­tri­b­u­tion. June, Ju­ly, Au­gust and Sep­tem­ber all saw lots of the drug re­called by Pfiz­er for con­t­a­m­i­na­tion by ni­trosamine, an­oth­er known car­cino­gen, or ND­MA. Lots were dis­trib­uted in the US, US Vir­gin Is­lands and Puer­to Ri­co from May 2019 to Sep­tem­ber 2021.

Of­fi­cials at Pfiz­er orig­i­nal­ly said the drug­mak­er be­lieved the ben­e­fits of the an­ti-smok­ing drug out­weigh any po­ten­tial risk of ex­po­sure to ni­trosamines or ND­MA, and that those who have been tak­ing it should con­tin­ue to do so. It stuck by that mantra, but a lat­er an­nounce­ment fea­tured ex­ten­sive in­for­ma­tion about how to re­turn the dis­trib­uted batch­es and stop fur­ther dis­tri­b­u­tion.

Since No­vem­ber 2020, there have been two ad­di­tion­al drugs re­called be­cause of re­ports of ND­MA. In 2018, blood pres­sure drug val­sar­tan was pulled for the same rea­son.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

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.