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Today's Rundown

GAO calls for major reforms at HHS to better prepare for future health emergencies
UPDATED: Eli Lilly to plow a total of $1.5 billion into two new manufacturing plants
ResMed reaps the rewards from the 'seemingly infinite demand' following Philips' ventilator recall
Yet another delay at Amryt as EMA calls in experts to inform review of rare disease drug
Samsung buys Biogen out of biosimilar unit for $2.3B—not the whole Aduhelm headache
ConvaTec breaks into wound biologics market with $450M bid for Triad Life Sciences
Uber taps first chief medical officer for growing healthcare arm
FDA expands oversight over TG's stalled U2 cancer combo therapy, sinking shares
Eli Lilly, Incyte axe Olumiant in lupus amid eczema stalemate at FDA
Provention's med for delaying diabetes wins go-ahead for FDA resubmission
Unable to 'align' with FDA, Regeneron, Sanofi pull application for Libtayo in cervical cancer days before decision date
FDA clears Insulet’s Omnipod 5 closed-loop, tubeless insulin pump for adults and children
SoftBank leads Alto Pharmacy's $200M series E as prescription delivery unicorn doubles annual revenue

Featured Story

GAO calls for major reforms at HHS to better prepare for future health emergencies

By Robert King

The GAO is worried that longstanding issues at HHS will cause the agency to bungle future public health emergencies and calls for several reforms.

UPDATED: Eli Lilly to plow a total of $1.5 billion into two new manufacturing plants

By Fraiser Kansteiner

Eli Lilly has designs on a new biologics factory in Ireland. It's investing some $445 million in the plant, with plans to hire 300 full-time staffers once the facility is complete. Details on the work planned for the site are slim, but Lilly made a point to say the facility will support its Alzheimer's portfolio, currently led by potential Aduhelm rival donanemab.

ResMed reaps the rewards from the 'seemingly infinite demand' following Philips' ventilator recall

By Andrea Park

In the second quarter of its fiscal year 2022, which ended Dec. 31, ResMed reported a 12% surge in revenue compared to the previous year, attributing much of that growth to what CEO Mick Farrell described as the “seemingly infinite demand” resulting from the recall.

Yet another delay at Amryt as EMA calls in experts to inform review of rare disease drug

By Nick Paul Taylor

The delays keep coming at Amryt. After seeing approval decision dates for its rare skin disorder drug slip on both sides of the Atlantic late last year, Amryt has now reported a further two-month delay to the European Medicines Agency’s (EMA) decision about Oleogel-S10.

Samsung buys Biogen out of biosimilar unit for $2.3B—not the whole Aduhelm headache

By Angus Liu

A recent report from Korea buzzed a Biogen takeover by Samsung. Turns out, Samsung is indeed buying something of Biogen’s, just not the entire company that’s saddled with the Alzheimer’s drug launch trouble.

ConvaTec breaks into wound biologics market with $450M bid for Triad Life Sciences

By Andrea Park

Who says an old dog can’t learn new tricks? Nearly half a century into its lifetime, ConvaTec is still breaking new ground.

Uber taps first chief medical officer for growing healthcare arm

By Rebecca Torrence

Uber Health tapped its first chief medical officer, Dr. Michael Cantor, a long-time practicing geriatrician and healthcare executive who will leverage his clinical expertise to tackle barriers to care in older adults and vulnerable populations.

FDA expands oversight over TG's stalled U2 cancer combo therapy, sinking shares

By Kyle LaHucik

The FDA told TG Therapeutics to halt enrollment in some trials of its U2 cancer combo treatment, which includes the approved relapsing lymphoma med Ukoniq, sinking shares by 43%.

Eli Lilly, Incyte axe Olumiant in lupus amid eczema stalemate at FDA

By Fraiser Kansteiner

Lilly and Incyte are pulling the plug on Olumiant in lupus, the companies announced Friday. Likewise, Olumiant’s application in moderate-to-severe atopic dermatitis could be destined for a complete response letter, the partners warned.

Provention's med for delaying diabetes wins go-ahead for FDA resubmission

By Annalee Armstrong

Provention Bio has won the go-ahead from the FDA to resubmit its application for a therapy to delay diabetes, which has been on hold since the agency questioned whether the planned commercial product was comparable to the drug used in historical trials.

Unable to 'align' with FDA, Regeneron, Sanofi pull application for Libtayo in cervical cancer days before decision date

By Kevin Dunleavy

With a Jan. 30 target date fast approaching for approval of Libtayo as a second-line treatment in cervical cancer, Regeneron and Sanofi have voluntarily withdrawn their application. The companies and the FDA were not “able to align on certain post-marketing studies," Regeneron and Sanofi said.

FDA clears Insulet’s Omnipod 5 closed-loop, tubeless insulin pump for adults and children

By Conor Hale

Insulet will begin selling the prescription Omnipod 5 device through U.S. pharmacies, starting with an initially limited commercial release before expanding its reach.

SoftBank leads Alto Pharmacy's $200M series E as prescription delivery unicorn doubles annual revenue