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Today's Rundown

Pfizer to become $100B behemoth next year thanks to COVID-19 drug and vaccine: analyst
Major insurers won't pay for Biogen's Alzheimer’s drug until they get more proof that it works: Bloomberg survey
AstraZeneca, after years of delays and spiraling costs, opens Cambridge R&D site. Will the bet pay off?
FDA, working to tackle pandemic inspection backlog, struggles with foreign oversight and site visits for new drugs
Data manipulation expert Elisabeth Bik compares the tales of 2 accused biotechs: Cassava and Athira
Medtronic's surgery robot rollout hits supply chain speed bumps
White House unveils $1.5B investment to train more than 22,700 new healthcare providers
Sanofi coughs up $180M to settle Pompe disease royalty payment dispute
Rafael resets after phase 3 flop, parting ways with 5 execs and reinstating telecom tycoon as CEO
Cardiologs scores pediatric heart AI diagnostic clearance from FDA ahead of Philips buyout
Epic's sepsis algorithm may have caused alert fatigue with 43% alert increase during pandemic

Featured Story

Pfizer to become $100B behemoth next year thanks to COVID-19 drug and vaccine: analyst

By Angus Liu

The COVID-19 pandemic is creating a $100 billion pharma goliath. Pfizer’s revenue could reach $101.3 billion in 2022, with major contributions coming from its BioNTech-partnered COVID vaccine and antiviral drug Paxlovid, one analyst estimates.

Major insurers won't pay for Biogen's Alzheimer’s drug until they get more proof that it works: Bloomberg survey

By Robert King

A Bloomberg survey of 25 major insurers found that none of the payers believe it's medically necessary to cover a controversial Alzheimer's drug made by Biogen.

AstraZeneca, after years of delays and spiraling costs, opens Cambridge R&D site. Will the bet pay off?

By Nick Paul Taylor

Five years late and 200% over budget, AstraZeneca has finally formally unveiled the Cambridge, U.K., site that is at the heart of its R&D strategy.

FDA, working to tackle pandemic inspection backlog, struggles with foreign oversight and site visits for new drugs

By Fraiser Kansteiner

More than a year and a half into the COVID-19 pandemic, the FDA has started to right the ship on the pace of its domestic drug manufacturing inspections. Still, the agency continues to struggle with oversight of foreign plants, and a growing number of new drug applications are facing delays, a report shows.

Data manipulation expert Elisabeth Bik compares the tales of 2 accused biotechs: Cassava and Athira

By Annalee Armstrong

Fierce Biotech caught up with one of the scientists who spotted irregularities in Cassava’s research after the issue was flagged in a citizens petition to the FDA.

Medtronic's surgery robot rollout hits supply chain speed bumps

By Conor Hale

On a quarterly earnings call with investors, Martha described the launch as currently holding in a “limited-release phase.”

White House unveils $1.5B investment to train more than 22,700 new healthcare providers

By Dave Muoio

American Rescue Plan-funded investments will yield "the largest field strength in history" for the National Health Service Corps, Nurse Corps and the Substance Use Disorder Treatment and Recovery Program, according to the White House.

Sanofi coughs up $180M to settle Pompe disease royalty payment dispute

By Angus Liu

As Sanofi's Pompe disease franchise fuels its growth in rare diseases, the company has inked a $180 million settlement related to a license for a key medicine.

Rafael resets after phase 3 flop, parting ways with 5 execs and reinstating telecom tycoon as CEO

By Nick Paul Taylor

Rafael Holdings is clearing out its C-suite. Weeks after the failure of its lead cancer drug, Rafael has disclosed the planned departures of five executives as it adapts to life without a near-approval asset.

Cardiologs scores pediatric heart AI diagnostic clearance from FDA ahead of Philips buyout

By Conor Hale

Philips’ latest M&A target, French artificial intelligence developer Cardiologs, received a new FDA clearance that expands the use of its cardiac diagnostic platform into pediatrics. It will be used to identify potential irregular heartbeats among electrocardiogram recordings.

Epic's sepsis algorithm may have caused alert fatigue with 43% alert increase during pandemic

By Rebecca Torrence

A new JAMA Network Open study found that Epic's sepsis warning system may have burdened providers during the pandemic with a deluge of alerts, with the number of alerts increasing 43% in the three weeks after the hospitals' first cases of COVID-19 even as total patient volumes decreased.

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