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Today's Rundown

Bluebird Bio has 'doubts' about continuing to do business through 2022, announces CFO resignation
Astellas gets safety win for phase 3 menopause drug, setting up US, EU filings
Fierce Medtech's 2021 Fierce 15
CVS invested $185M in housing last year. Here's where those funds went
Gilead drops unclear win for key Trodelvy breast cancer trial, poking holes in CEO’s oncology plan
AstraZeneca tacks on another $100M to wrap up over-budget R&D center
GoodRx picks up vitaCare Prescription Services in $150M deal to expand pharmacy services platform
Microsoft closes $19.7B Nuance acquisition after EU, UK antitrust probes
Hennepin Health accused of 'deeply rooted' racism following blackface, 'excited delirium' incidents
In ultrafast FDA nod, Bristol Myers' Opdivo catapults I-O therapy to pre-surgery lung cancer with first glimpse of key data
Death in Alpine's Keytruda combo trial triggers clinical hold, raises specter of earlier tragedy
Be ‘recall ready’: FDA asks companies to take potentially harmful products off the market faster

Featured Story

Bluebird Bio has 'doubts' about continuing to do business through 2022, announces CFO resignation

By Kevin Dunleavy

After updating the status of three promising gene therapies in its fourth-quarter and 2021 earnings report, bluebird bio illuminated its dire financial situation, saying that its cash needs “raise substantial doubt about its ability to continue to do business this year. The company also announced the departure of chief financial officer Gina Consylman, whose duties will be picked up by chief business officer Jason Cole.

Astellas gets safety win for phase 3 menopause drug, setting up US, EU filings

By Annalee Armstrong

Astellas Pharma has shown its menopause medicine is safe, teeing up regulatory filings in the U.S. and EU—but analysts aren’t sure whether fezolinetant will find a market once approved.

Fierce Medtech's 2021 Fierce 15

By Conor Hale,Andrea Park,Heather Landi,Rebecca Torrence,Kyle LaHucik,Max Bayer

In one way or another, the Fierce 15 has always been about celebrating those who are finding new ways of doing things. This year's 10th annual selections stand out from the pack because they are working to build new ways to approach the day to day.

CVS invested $185M in housing last year. Here's where those funds went

By Paige Minemyer

CVS Health invested $185 million in affordable housing last year, the healthcare giant announced.

Gilead drops unclear win for key Trodelvy breast cancer trial, poking holes in CEO’s oncology plan

By Angus Liu

Gilead Sciences has a lot of its oncology ambitions riding on Trodelvy’s success beyond its existing approvals. While investors have been waiting with bated breath for results from a breast cancer trial to gauge the drug’s potential, Gilead’s new announcement isn’t giving them too much confidence in CEO Daniel O’Day’s big cancer plans.

AstraZeneca tacks on another $100M to wrap up over-budget R&D center

By Max Bayer

AstraZeneca is budgeting another $100 million in 2022 to wrap up work on its R&D center in Cambridge, U.K. The addition brings the total costs of the over-budget and overdue research hub to $1.3 billion.

GoodRx picks up vitaCare Prescription Services in $150M deal to expand pharmacy services platform

By Heather Landi

GoodRx is scooping up vitaCare Prescription Services from TherapeuticsMD to beef up its growing pharma manufacturer solutions business.

Microsoft closes $19.7B Nuance acquisition after EU, UK antitrust probes

By Andrea Park

Nearly a full year after first announcing its intent to acquire Nuance Communications, Microsoft has finally closed the $19.7 billion buy.

Hennepin Health accused of 'deeply rooted' racism following blackface, 'excited delirium' incidents

By Dave Muoio

Resurfaced photos and a doctor's work with local police have drawn criticism from employees, a union and a county commissioner who also serves on the integrated system's board.

In ultrafast FDA nod, Bristol Myers' Opdivo catapults I-O therapy to pre-surgery lung cancer with first glimpse of key data

By Angus Liu

When lots of regulatory priorities are given to COVID-19 during the pandemic, the FDA has introduced Opdivo as the first pre-surgery therapy for early-stage non-small cell lung cancer, with an ultrafast approval within the same week of accepting its application.

Death in Alpine's Keytruda combo trial triggers clinical hold, raises specter of earlier tragedy

By Nick Paul Taylor

A patient has died in a clinical trial that is testing Alpine Immune Sciences’ davoceticept in combination with Merck’s Keytruda. The death in the study of adults with advanced malignancies triggered a partial clinical hold—and raised the specter of an earlier tragedy.

Be ‘recall ready’: FDA asks companies to take potentially harmful products off the market faster