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Today's Rundown

Biogen's Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises
DuPage Medical Group hit with data breach that may affect 600,000 patients
The mRNA era has arrived thanks to COVID-19. What's next in the pipeline?
JAK inhibitors from Pfizer, AbbVie and Lilly hit with dreaded FDA heart safety, cancer warnings
Fitness tech company Whoop hits $3.6B valuation after SoftBank-led funding boost
After cutting dose because of deaths, Astellas pauses gene therapy trial as new liver issue arises
Moderna reveals source of COVID-19 vaccine contamination as Japan finds yet another suspect vial
Thermo Fisher, AstraZeneca team up on multiyear companion diagnostic project for drugmaker's precision medicine pipeline
As NNU blames hospital cost cutting for labor shortage, industry groups keep the focus on COVID-19
Expect a surge in employer vaccine mandates, Willis Towers Watson survey says
Philips gets green light to begin repairing millions of recalled sleep apnea machines
COVID-19 tracker: Mesoblast's Novartis-backed drug hits FDA wall; U.S. has tossed 15M vaccine doses since March

Featured Story

Biogen's Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises

By Noah Higgins-Dunn

There's "room for surprises" when it comes to the safety of Biogen's Aduhelm because of the company's tightly controlled clinical trials, which recruited a narrower group of Alzheimer's patients compared to the treatment's FDA label, RBC Capital Markets wrote on Wednesday, citing a recent study.

DuPage Medical Group hit with data breach that may affect 600,000 patients

By Emmy Lucas

The July cyberattack of Illinois' largest independent physician group could affect 600,000 patients.

The mRNA era has arrived thanks to COVID-19. What's next in the pipeline?

By Annalee Armstrong

COVID-19 wasn’t even in the picture when mRNA was developed, but with the regulatory runway cleared, biotechs that have been working on the tech for years are ready for liftoff. Yes, Moderna and BioNTech are the rock stars in the business—launched to household name status with the COVID-19 vaccines at the end of 2020. But there's more to the pipeline than just these headliners.

JAK inhibitors from Pfizer, AbbVie and Lilly hit with dreaded FDA heart safety, cancer warnings

By Angus Liu

The safety problem for Pfizer’s arthritis drug Xeljanz has caused collateral damage across its drug class. The FDA is now requiring new heart safety and cancer warnings for Xeljanz, AbbVie’s Rinvoq and Eli Lilly’s Olumiant and is pushing back their use behind TNF blockers.

Fitness tech company Whoop hits $3.6B valuation after SoftBank-led funding boost

By Anastassia Gliadkovskaya

Whoop, which makes wearable fitness tracking technology, raised $200 million in a series F funding round as the company looks to grow internationally.

After cutting dose because of deaths, Astellas pauses gene therapy trial as new liver issue arises

By Nick Paul Taylor

Astellas’ $3 billion bet on Audentes Therapeutics has hit yet another setback. Months after getting a clinical hold lifted, Astellas has voluntarily paused a gene therapy clinical trial after a patient suffered liver problems at the lower, supposedly safer dose.

Moderna reveals source of COVID-19 vaccine contamination as Japan finds yet another suspect vial

By Kevin Dunleavy

Amid the discovery of foreign material in another vial of Moderna’s COVID-19 vaccine in Japan, the company said it has identified the source of contamination found last week. Stainless steel is the material and it was produced from friction between two pieces of metal on a Rovi manufacturing line.

Thermo Fisher, AstraZeneca team up on multiyear companion diagnostic project for drugmaker's precision medicine pipeline

By Conor Hale

Currently, more than 90% of AstraZeneca’s clinical drug candidates are based on a targeted approach, spanning its work in cancer and cardiovascular disease as well as kidney, metabolic and respiratory conditions.

As NNU blames hospital cost cutting for labor shortage, industry groups keep the focus on COVID-19

By Dave Muoio

The national nurses union said hospitals have "deliberately" failed to staff units with enough nurses, leading many to quit out of safety concerns. One hospital group's CEO responded that the union "must be experiencing a different reality than the rest of us."

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