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Editor’s Note: We will not publish on Monday in observance of Presidents Day, but we’ll be back in your inboxes on Tuesday, February 22. Have a great weekend!

Today's Rundown

Atara, Memorial Sloan Kettering investigating patient death in phase 1 mesothelioma CAR-T study
Bayer hikes Nubeqa's peak sales to more than €3B on prostate cancer data, teeing up new 3-way battle against Pfizer-Astellas, J&J
FDA hands down Class I rating to Vyaire Medical's ventilator recall
Community Health Systems signals less contract labor, more volume recovery in the coming months
GSK, in close race with Pfizer, slams brakes on phase 3 maternal RSV vaccine program over safety signal
FTC deadlocked on whether to study PBM contracting practices such as DIR fees
Recipharm, working on Moderna's COVID vaccine, boosts biologics presence with Arranta Bio, Vibalogics buyouts
'Early stage': Majority of biotechs don't disclose ESG practices, but most plan to in near term
InfraScan wins FDA OK for its handheld brain bleed detector for children
FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data
Beta Bionics raises $57M to bring its artificial pancreas to the FDA
Why L.A. Care Health Plan is offering providers financial incentives to boost COVID vaccination rates
Fierce Pharma Asia—Lilly, Innovent's I-O implications; Novartis' India job cuts; Moderna's Asia expansion

Featured Story

Atara, Memorial Sloan Kettering investigating patient death in phase 1 mesothelioma CAR-T study

By Kyle LaHucik

Atara Biotherapeutics said a patient in an early-stage study of its CAR-T cell therapy has died. The biotech and the study sponsor are evaluating "the extent of the relationship" of the death to the treatment.

Bayer hikes Nubeqa's peak sales to more than €3B on prostate cancer data, teeing up new 3-way battle against Pfizer-Astellas, J&J

By Angus Liu

Bayer has spelled out an even more bullish estimate for Nubeqa's blockbuster potential, thanks to a trial win in a new prostate cancer frontier for the androgen receptor inhibitor. But the German drugmaker still faces an uphill fight against two formidable incumbent players.

FDA hands down Class I rating to Vyaire Medical's ventilator recall

By Andrea Park

So far, no deaths have been reported in connection with the software flaw, but the FDA has received 18 complaints and reports of seven injuries linked to the issue.

Community Health Systems signals less contract labor, more volume recovery in the coming months

By Dave Muoio

Even with six fewer hospitals, CHS logged a 3.7% year-over-year increase in net operating revenues and closed out its fiscal year with higher same-store patient volumes.

GSK, in close race with Pfizer, slams brakes on phase 3 maternal RSV vaccine program over safety signal

By Nick Paul Taylor

GlaxoSmithKline has slammed the brakes on its pivotal maternal respiratory syncytial virus (RSV) vaccine program after a safety assessment, potentially handing an advantage to Pfizer in a close race to market.

FTC deadlocked on whether to study PBM contracting practices such as DIR fees

By Robert King

The FTC deadlocked on whether to initiate a study into contracting practices of the PBM industry, despite fervent lobbying from pharmacists.

Recipharm, working on Moderna's COVID vaccine, boosts biologics presence with Arranta Bio, Vibalogics buyouts

By Fraiser Kansteiner

Recipharm picked up Arranta Bio and Vibalogics in a two-pronged bid to beef up in biologics. Arranta specializes in microbiome therapeutic products and mRNA clinical production, while Vibalogics focuses on the production of oncolytic viruses, viral vaccines and gene therapies.

'Early stage': Majority of biotechs don't disclose ESG practices, but most plan to in near term

By Kyle LaHucik

The biotech industry has not caught the ESG bug that has swept across C-suites in recent years as part of the broad push for corporate social responsibility, according to a survey and review from life sciences law firm Fenwick.

InfraScan wins FDA OK for its handheld brain bleed detector for children

By Andrea Park

More than a decade after InfraScan’s technology was initially approved by the FDA to detect hematomas on the brains of adult patients with head injuries, the agency has granted an expansion of the Infrascanner’s indication to include pediatric cases, too.

FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data

By Nick Paul Taylor

BioMarin Pharmaceutical faces a long clinical hold on its phenylketonuria (PKU) gene therapy trial. After stopping the trial over tumors in mice, the FDA has asked BioMarin to run additional nonclinical studies that are expected to take “several quarters” to assess the risk of BMN 307.

Beta Bionics raises $57M to bring its artificial pancreas to the FDA

By Conor Hale

Beta Bionics has secured $57 million in funding shortly after wrapping up a pivotal clinical trial of the device in people with Type 1 diabetes.

Why L.A. Care Health Plan is offering providers financial incentives to boost COVID vaccination rates

By Anastassia Gliadkovskaya

The program has the potential to reach up to 80,000 L.A. Care members. Certain providers will be eligible for the incentive for each member that gets their first dose from now until April 30.

Fierce Pharma Asia—Lilly, Innovent's I-O implications; Novartis' India job cuts; Moderna's Asia expansion