Ear­li­er this month, the FDA alert­ed the pub­lic that Pfiz­er had vol­un­tar­i­ly re­called its stop-smok­ing drug Chan­tix af­ter find­ing el­e­vat­ed lev­els of can­cer-caus­ing ni­trosamines. Now, the FDA is per­mit­ting cer­tain man­u­fac­tur­ers to tem­porar­i­ly dis­trib­ute the drug that has more than the usu­al ni­trosamine, so long as it re­mains un­der the in­ter­im ac­cept­able lim­it.

Pfiz­er pre­vi­ous­ly halt­ed dis­tri­b­u­tion of Chan­tix and pulled four lots of the drug af­ter find­ing un­ac­cept­ably high lev­els of the ni­trosamine N-ni­troso-vareni­cline in rou­tine test­ing. In guid­ance re­leased Fri­day, the FDA set an in­ter­im al­low­able lim­it for that com­pound in Chan­tix at 185 ng per mil­li­liter to help en­sure ad­e­quate sup­ply of the drug in the US.

“Agency sci­en­tists eval­u­at­ed the risk of ex­po­sure to N-ni­troso-vareni­cline at in­ter­im ac­cept­able in­take lev­els up to 185 ng per day and de­ter­mined that it presents min­i­mal ad­di­tion­al can­cer risk when com­pared to a life­time of ex­po­sure to N-ni­troso-vareni­cline at the 37 ng per day lev­el,” the FDA said in a press re­lease Fri­day.

The FDA called for pa­tients to con­tin­ue to take the med­ica­tion un­til their doc­tor pre­scribes an an al­ter­na­tive: “The health ben­e­fits of stop­ping smok­ing out­weigh the can­cer risk from the ni­trosamine im­pu­ri­ty in vareni­cline,” the re­lease said.

The re­call came just a year af­ter the FDA found high lev­els of ND­MA, an­oth­er com­mon ni­trosamine, in some ver­sions of met­formin, a pop­u­lar gener­ic di­a­betes drug. Viona Phar­ma­ceu­ti­cals was the lat­est gener­ic man­u­fac­tur­er to pull its ver­sion off shelves, re­call­ing two lots of its 750 mg ex­tend­ed-re­lease met­formin tablets in June.

Mon­day, three more lots were re­called: ET1600, with an ex­pi­ra­tion date of Jan­u­ary 2023, and both EA6080 and EC9843 with an ex­pi­ra­tion date of March 2023.

That marked the fourth ver­sion of the drug since No­vem­ber 2020 to be re­called due to re­ports of ND­MA,  which was al­so im­pli­cat­ed in re­calls of blood pres­sure drug val­sar­tan and heart­burn med Zan­tac.

Chan­tix was first ap­proved by the FDA in 2006 and is used as a pre­scrip­tion in adults who need help quit­ting smok­ing. The drug­mak­er said it is paus­ing the dis­tri­b­u­tion “out of an abun­dance of cau­tion.”

The drug is ap­proved in 80 coun­tries, but re­call no­tices have been gen­er­at­ed by Cana­di­an and Ko­re­an reg­u­la­tors. In Ko­rea, the min­istry of food and drug safe­ty has been in­ves­ti­gat­ing an­ti-nico­tine ther­a­pies that use vareni­cline as its main com­pound since June 15, ac­cord­ing to the Ko­rea Bio­med­ical Re­view.

Pfiz­er will have to test for ni­trosamine im­pu­ri­ties in all drugs that con­tain vareni­cline. The FDA has not yet list­ed the drug on the re­call por­tion of its web­site.

President Joe Biden’s attempt to roll out Covid-19 booster shots has been far from smooth sailing, and the CDC director added to the bumpiness early Friday morning.

Director Rochelle Walensky reversed a CDC advisory panel’s recommendation that boosters should not be administered to adults at risk of occupational exposure, such as teachers and health care workers. The highly unusual move came after the CDC’s Advisory Committee on Immunization Practices recommended Pfizer/BioNTech booster shots for those older than 65 and younger, high-risk adults, but voted 9-6 against allowing the shots for at-risk jobs.

In an attempt to get its house of accelerated approvals in order, the FDA is holding its second adcomm of 2021 to review cancer drugs that won accelerated approvals but failed to confirm clinical benefit in subsequent trials or have taken a long time to read those data out.

On Dec. 2, the FDA’s Oncologic Drugs Advisory Committee will review two accelerated approvals from Secura Bio’s Farydak (panobinostat), a third-line multiple myeloma drug, and Acrotech Biopharma’s Marqibo, as a third-line drug for adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia. Both drugs have been marketed for more than five years under their accelerated approvals but have recorded negligible sales in their respective indications in recent years.

Another Covid-19 vaccine has been submitted to the World Health Organization to be reviewed for emergency use listing.

Novavax’s recombinant nanoparticle protein-based candidate, made in collaboration with The Serum Institute of India, is headed to the regulators. The submission is based on the previous submission to Indian regulators. An OK from the WHO is a requirement to export doses to the COVAX vaccine sharing program.

Last year, Clovis’ PARP inhibitor Rubraca beat AstraZeneca and Merck’s blockbuster Lynparza across the finish line in prostate cancer by a matter of days. Now, the pharma partners are looking for a come-back in the first-line setting — and an interim look at Phase III data could give them the boost they need.

When administered in combination with J&J’s Zytiga (a current standard of care), Lynparza achieved a statistically significant improvement in radiographic progression-free survival in a segment of men with advanced prostate cancer, compared to Zytiga alone, AstraZeneca and Merck announced on Friday.

Senate Minority Leader Mitch McConnell, Senate Health Committee ranking member Richard Burr and other top Republicans are questioning the Biden administration’s decision to get out in front of the FDA and announce that Covid-19 vaccine boosters would be ready for administration by this week.

While Burr praised the FDA’s EUA for the boosters Wednesday evening, the Republicans earlier in the day called on White House coronavirus response coordinator Jeffrey Zients to release an updated strategy on leveraging vaccines to end the pandemic and to clarify what exactly happened with the premature announcement on the boosters.

Kunwoo Lee was a graduate student at UC-Berkeley when gene editing pioneer Jennifer Doudna — who happened to work in the same building where he studied — published a paper on CRISPR/Cas9. So he did what any aspiring bioengineer would do: He ran to her lab, and grabbed a postdoc there.

“We started really thinking about the future coming (for) gene therapy and gene editing,” he said.

Lee’s research with Doudna led him to co-found a small San Francisco-based biotech called GenEdit in 2016, the same year he graduated. After five quiet years, the team is now unveiling a $26 million Series A round with support from some big names like Eli Lilly to fund their work on one of the most pressing challenges in gene therapy: what Lee calls the “delivery problem.”