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Today's Rundown

Editas brings on Sarepta CMO—for CEO swap, not the vacant CMO role
Regeneron's bid for COVID-19 drug's full approval hits snag as FDA extends review
Healthcare billionaires in 2022: From HCA's founder to a Doximity entrepreneur
Following a $600M fundraising, robot maker CMR Surgical maps out European expansion
Twist in Protagonist story as FDA seeks to rescind breakthrough nod 'based on observed malignancies'
Merck evades 'aggressive marketing' claims tied to once-dominant Zostavax shot
Hackensack Meridian, Englewood Health call off merger after legal and regulatory roadblocks
AACR: By microdosing tumors, Takeda and Presage examine how to trigger the immune system to help fight cancer
FDA urges creation of racial, ethnic recruitment plans for clinical trials
Evelo hits the brakes on atopic dermatitis drug development after phase 1 failure
Providence Health agrees to pay DOJ $22M to settle allegations over unnecessary surgeries
Akron Bio debuts new plasmid DNA plant on quest to ease regenerative medicine bottlenecks
Optum Health has raised its expectations for value-based care participation. Here's why
Boston Scientific infuses €100M into Ireland facility for carbon-neutral manufacturing

Featured Story

Editas brings on Sarepta CMO—for CEO swap, not the vacant CMO role

By Annalee Armstrong

Editas is bringing on Sarepta’s Chief Medical Officer Gilmore O’Neill, M.B., but not to fill that empty role at the gene editing biotech. He will instead replace Chairman, President and CEO James Mullen, who is taking on the executive chairman role.

Regeneron's bid for COVID-19 drug's full approval hits snag as FDA extends review

By Angus Liu

Just as Regeneron’s COVID-19 antibody combination, REGEN-COV, is sidelined in the U.S. thanks to omicron, the drug has hit a hiccup on its quest for a full FDA nod.

Healthcare billionaires in 2022: From HCA's founder to a Doximity entrepreneur

By Heather Landi

More than 200 healthcare executives, 217 to be exact, are now in the “three comma club,” as Forbes calls it, and are among the 2,668 billionaires on Forbes’ 2022 list. There are 32 American business leaders on Forbes' list who made their fortunes in healthcare. Meet 20 of this year's healthcare billionaires.

Following a $600M fundraising, robot maker CMR Surgical maps out European expansion

By Andrea Park

What’s next for a surgical robotics developer that’s been riding high after raising a monstrous £425 million last summer? According to CMR Surgical, world domination—or, at the very least, European domination.

Twist in Protagonist story as FDA seeks to rescind breakthrough nod 'based on observed malignancies'

By Nick Paul Taylor

The FDA gave Protagonist Therapeutics’ rusfertide breakthrough designation last year. Now, the agency wants to take it back “based on observed malignancies,” triggering a 30% drop in Protagonist’s stock as investors scrambled to figure out the implications of the news.

Merck evades 'aggressive marketing' claims tied to once-dominant Zostavax shot

By Fraiser Kansteiner

Early this week, a U.S. District Judge granted Merck's bid to toss claims it waged a “false and misleading” marketing campaign for Zostavax, which hasn’t been sold in the U.S. since Nov. 2020. The dismissal hinged in part on a technicality.

Hackensack Meridian, Englewood Health call off merger after legal and regulatory roadblocks

By Heather Landi

Hackensack Meridian Health and Englewood Health have given up their fight against the Federal Trade Commission and dropped their plans for a merger.

AACR: By microdosing tumors, Takeda and Presage examine how to trigger the immune system to help fight cancer

By Conor Hale

By using a device that shows how tiny amounts of drugs perform inside the body, Takeda is examining two therapies that could help break down the barriers protecting solid tumors from the body's immune system.

FDA urges creation of racial, ethnic recruitment plans for clinical trials

By Gabrielle Masson

The FDA is prioritizing diversity among clinical trial participants in the U.S., with new draft guidance aimed at boosting enrollment of participants from underrepresented racial and ethnic populations.

Evelo hits the brakes on atopic dermatitis drug development after phase 1 failure

By James Waldron

Inflammatory-disease-focused Evelo Biosciences has hit the brakes on one of its atopic dermatitis treatments after a phase 1 trial failed to demonstrate clinical benefit.

Providence Health agrees to pay DOJ $22M to settle allegations over unnecessary surgeries

By Robert King

Providence Health agreed to pay the Justice Department $22 million to settle allegations of unnecessary surgical procedures being conducted at one of its hospitals.

Akron Bio debuts new plasmid DNA plant on quest to ease regenerative medicine bottlenecks

By Fraiser Kansteiner

As cell and gene therapies, mRNA vaccines and other cutting-edge meds come into their own, developers have put a strain on the industry’s manufacturing capacity. That’s where biopharma building block outfits like Akron Bio come in.

Optum Health has raised its expectations for value-based care participation. Here's why

By Paige Minemyer

UnitedHealth Group posted its first-quarter earnings on Thursday morning, where it reported $5 billion in profit.

Boston Scientific infuses €100M into Ireland facility for carbon-neutral manufacturing