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.

Generation Bio is looking to move the field of gene therapy into the future, and thinks it has a manufacturing process in place that will allow enough scale for broad disease indications. Now, all it needs is a plant to put those large-scale ambitions into action.

Generation signed a lease on a new 104,000-square-foot facility in Waltham, MA, set to become operational in 2023. The facility will be available for preclinical and clinical development for its lead hemophilia A program.

It’s been a quiet few weeks for one of the busiest CDMOs out there, but Catalent broke its lull with the announcement of two partnerships this week.

Curtana Pharmaceuticals, an Austin, TX-based preclinical company, announced a partnership with the manufacturer Thursday to make CT-179, its drug therapy for glioblastoma, medulloblastoma and other brain cancers.

CT-179 is a selective small molecule inhibitor of LIG2, a transcription factor essential to early brain development but often not expressed in adult brain cells. The development will take place at Catalent’s San Diego facility.

Generate Life Sciences is the largest private newborn stem cell biorepository, and with the announcement of its own in-house manufacturing facility, the company is looking to grow its regenerative medicine pipeline.

Generate has established a facility in La Jolla, CA, to provide end-to-end manufacturing for newborn stem cell biologics. The site will allow Generate to evolve as it adds a personalized therapeutics developer to its current business model. The new site has been designed to harness mesenchymal stem cells from the tissue of the umbilical cord.

The FDA has freed up yet another batch of J&J Covid-19 vaccines that were held up due to contamination at Emergent’s Baltimore Bayview plant.

In a letter addressed to J&J’s North American Regulatory leader Ruta Walawalkar, the agency re-issued emergency use authorization to one more batch on July 13. That will free up another 10 million doses Bloomberg reports.

“I am waiving Current Good Manufacturing Practice requirements for this batch, and only this batch, for the duration of this EUA,” the letter, signed by director of vaccines and research Marion Gruber, says. “This concurrence does not add any other batches manufactured at this facility to the EUA at this time and does not add the facility itself to the EUA at this time, nor does the EUA cover vaccine manufactured by combining this batch with different batches of drug substance that are not authorized explicitly under this EUA.”

The team at Cellares hopes that its Cell Shuttle is the future of end-to-end cell therapy manufacturing. On Wednesday, the company announced that one more company has signed up to work alongside it.

Poseida has signed on to provide therapies for the Cell Shuttle, a portable factory Cellares hopes will disrupt the expensive and logistically complicated cell therapy manufacturing process. The company is the third to ink a deal with Cellares, which is based out of South San Francisco, CA. Cellares has already has been collaborating with PACT Pharma and the Fred Hutchinson Cancer Research Center.

Riding science out of Dario Campana’s famed lab in Singapore, West Coast biotech Nkarta has been a high-profile entry into the race for the industry’s first natural killer cell-based therapy. The biotech, miles away from a potential approval, is doubling down on its own ambition and setting up a manufacturing facility of the future far in advance.

Nkarta has signed a lease on an 88,000-square-foot facility in South San Francisco that will act as the biotech’s new headquarters as well as the home of its commercial manufacturing operations, the company said Wednesday.