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Editor's Note: The PM Tracker newsletter will not publish Monday, May 30, in observance of the Memorial Day holiday. Enjoy your weekend, and we'll be back in your inboxes on Tuesday, May 31.

Today's Rundown

ASCO: Mirati cedes to Amgen's Lumakras on durability in tight KRAS battle
Abbott’s imaging catheter recall hit with FDA’s Class I designation
Senate Finance Committee details telehealth 'Bill of Rights' for mental health care services
ASCO: J&J, Legend reveal more CAR-T data and a look at Carvykti for earlier myeloma in a difficult population
Iovance sinks 50% as pivotal cell therapy data disappoint investors, but approval plan pushes ahead anyway
Cleveland Clinic reports $283M loss, deferred care and high expenses in Q1 2022
Mayo Clinic, Janssen AI to detect pulmonary hypertension scores FDA breakthrough nod
Moderna CEO pledges to donate most of his $4B fortune: Bloomberg
Addex's eyelid data fail to make clear case for spasm expansion
ASCO: Seagen, Takeda think Adcetris can become a force as a lymphoma combo drug
AWS for Health launches accelerator with a focus on health equity startups
'The Top Line' podcast: How biopharma is tackling the monkeypox outbreak, insight on nominations for our Fierce 15 list, plus this week's headlines

Featured Story

ASCO: Mirati cedes to Amgen's Lumakras on durability in tight KRAS battle

By Annalee Armstrong

Mirati seems to have gotten what it needed in terms of efficacy for its KRAS inhibitor, notching an objective response rate of 43% in non-small cell lung cancer, compared to Amgen’s 37% for its already approved med Lumakras. But the problem lies with how long the effect lasts. On that measure, Amgen appears to have taken the win.

Abbott’s imaging catheter recall hit with FDA’s Class I designation

By Andrea Park

The recall covers more than 14,500 Dragonfly OpStar imaging catheters that had been distributed around the world, including 4,800 that were sold in the U.S. alone.

Senate Finance Committee details telehealth 'Bill of Rights' for mental health care services

By Robert King

The Senate Finance Committee released details on what telehealth flexibilities should be made permanent as part of an effort to increase mental health coverage.

ASCO: J&J, Legend reveal more CAR-T data and a look at Carvykti for earlier myeloma in a difficult population

By Angus Liu

Johnson & Johnson and Legend Biotech showed that their closely watched CAR-T therapy, Carvykti, sustained an effect in heavily pretreated multiple myeloma patients and shrank tumors when given earlier in a population with otherwise unyielding disease.

Iovance sinks 50% as pivotal cell therapy data disappoint investors, but approval plan pushes ahead anyway

By Nick Paul Taylor

Iovance Biotherapeutics trumpeted a 29% response rate and a 10.4-month median duration of response in a pivotal advanced melanoma trial of its tumor-infiltrating lymphocyte candidate—and saw its stock plummet almost 50% on an unfavorable comparison to earlier data.

Cleveland Clinic reports $283M loss, deferred care and high expenses in Q1 2022

By Dave Muoio

A -3.4% operating margin and heavy investment losses places Cleveland Clinic right in line with other nonprofit systems buffeted by the omicron surge.

Mayo Clinic, Janssen AI to detect pulmonary hypertension scores FDA breakthrough nod

By Andrea Park

A new artificial intelligence algorithm may be the key to slashing the drawn-out period between when pulmonary hypertension symptoms first arise and a definitive diagnosis is reached.

Moderna CEO pledges to donate most of his $4B fortune: Bloomberg

By Eric Sagonowsky

Moderna's efforts to develop, manufacture and market its massively successful COVID-19 vaccine have made CEO Stéphane Bancel a billionaire. Eventually, the helmsman plans to give away most of his fortune, he told Bloomberg.

Addex's eyelid data fail to make clear case for spasm expansion

By Nick Paul Taylor

Addex Therapeutics’ attempt to expand use of dipraglurant into muscle spasms has stumbled at the first hurdle. A phase 2a clinical trial of the mGluR5 negative allosteric modulator has delivered “inconclusive” data in an eyelid disorder, raising doubts about a broader push beyond Parkinson’s disease.

ASCO: Seagen, Takeda think Adcetris can become a force as a lymphoma combo drug

By Kevin Dunleavy

During the American Society of Clinical Oncology (ASCO) conference, Seagen and Takeda presented trial data that show Adcetris could become at growing force in the treatment of various forms of lymphoma.

AWS for Health launches accelerator with a focus on health equity startups

By Anastassia Gliadkovskaya

For- or nonprofit U.S.-based startups with existing customers and revenue looking to use AWS services and focused on solving health equity challenges will be considered, the company said.

'The Top Line' podcast: How biopharma is tackling the monkeypox outbreak, insight on nominations for our Fierce 15 list, plus this week's headlines

By Teresa Carey

This week on "The Top Line," we discuss the new monkeypox outbreak, what the treatment options are and why health officials don’t seem concerned. We also talk about Dexcom's potential megamerger with Insulet, the upcoming ASCO meeting and the week's other big headlines. Plus, we have a special announcement about the prestigious Fierce 15 competition.