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Today’s Big News

Feb 14, 2025

Bristol Myers Squibb comes up short in bid to expand Opdualag in melanoma

Moderna’s norovirus vaccine trial placed on FDA hold over reported case of Guillain-Barré syndrome

Moderna shoulders $238M contract manufacturing cancellation charge in Q4

Mass firings at HHS: CDC cuts 1,300 probationary workers, reports say

Cell death biotech Kojin winds down, citing 4 funding challenges

UCB’s Bimzelx outpacing AbbVie’s Rinvoq, Skyrizi on awareness early in psoriatic arthritis launch: survey

Volta Medical’s afib AI shows gains in cardiac ablation study

Allogene’s phase 1 lymphoma data show CAR-T could ‘leapfrog’ competition: analysts

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Bristol Myers Squibb comes up short in bid to expand Opdualag in melanoma

By Kevin Dunleavy

Bristol Myers Squibb is striking out in its attempts to broaden the label of its first-in-class combo drug Opdualag. On Thursday, the company revealed that a phase 3 trial of Opdualag as an adjuvant treatment for patients with completely resected state III and stage IV melanoma did not achieve its primary endpoint.

Moderna’s norovirus vaccine trial placed on FDA hold over reported case of Guillain-Barré syndrome

By James Waldron

A trial of Moderna’s norovirus vaccine in the U.S. has been put on hold by the FDA over a reported case of neurological disorder.

Moderna shoulders $238M contract manufacturing cancellation charge in Q4

By Fraiser Kansteiner

In 2024’s fourth quarter, Moderna’s cost of sales came out to $739 million, which included a major $238 million charge tied to the cancellation of a contract manufacturing agreement toward the end of the year.

Mass firings at HHS: CDC cuts 1,300 probationary workers, reports say

By Noah Tong

The federal government is laying off thousands of health agency workers and others this week. Here's what we know so far.

Cell death biotech Kojin winds down, citing 4 funding challenges

By Gabrielle Masson

Boston biotech Kojin Therapeutics is closing its doors, citing four funding challenges and a few valuable lessons learned.

UCB’s Bimzelx outpacing AbbVie’s Rinvoq, Skyrizi on awareness early in psoriatic arthritis launch: survey

By Nick Paul Taylor

UCB’s Bimzelx is firmly on physicians’ radars, with Spherix Global Insights finding that awareness of the drug was tracking ahead of AbbVie’s Rinvoq and Skyrizi three months into its psoriatic arthritis launch. Yet, the analysis suggests UCB has work to do to turn awareness into uptake.

Volta Medical’s afib AI shows gains in cardiac ablation study

By Conor Hale

The company’s randomized clinical trial, published in Nature Medicine, tested the addition of AI-targeted heart ablations to conventional pulmonary vein isolation.

Allogene’s phase 1 lymphoma data show CAR-T could ‘leapfrog’ competition: analysts

By James Waldron

Two months after Allogene abandoned plans for its CAR-T in leukemia, analysts have suggested that fresh phase 1 data in lymphoma show the therapy can “leapfrog” the competition.

Regulatory tracker: Europe approves CSL's HAE drug, Arcturus-partnered COVID vaccine

By Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Zoey Becker,Kevin Dunleavy

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

Chutes & Ladders—Neumora overhauls C-suite after phase 3 flop

By Darren Incorvaia,Zoey Becker

After its depression candidate failed a phase 3 trial and disappointed analysts, Neumora is shaking up its leadership team. President and CEO Henry Gosebruch is leaving the company effective Feb. 14, and will be replaced as CEO by co-founder Paul Berns and as president by Joshua Pinto, Ph.D.

Otsuka breaks up with cancer candidates on strategic grounds

By Nick Paul Taylor

Otsuka has broken up with a clutch of clinical cancer candidates. The Japanese drugmaker said strategic reasons—the pharma equivalent of “it’s not you, it’s me”—underpinned the decision to ax the assets.

Inizio Evoke alums flex healthcare marketing prowess with launch of new agency

By Andrea Park

A group of former leaders from health comms giant Inizio Evoke have come together to launch Flex Marketing, a new agency catering to pharmaceutical, biotech, medtech and health tech clients.

Boston biotech Bambusa banks $90M for next-gen bispecifics

By Gabrielle Masson

Bambusa Therapeutics has raised about $90 million to build out a pipeline of next-gen bispecific antibodies targeting immunological and inflammatory (I&I) conditions.

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