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Today’s Big News

Jun 16, 2025

FDA's 'heavy workload' blamed for delays to KalVista's angioedema drug approval decision

Gilead lays off 36 people after axing California expansion plan

Eli Lilly's phase 1 amylin data impress analysts, pairing 11% weight loss with tolerable profile

Sarepta reports 2nd death after DMD gene therapy Elevidys, stops dosing in half of patients

South Korean biotech's GLP-1 drug scores MASH win while reducing weight

NextCure advances ADC pivot with $745M deal for Simcere's phase 1 drug

Big Pharma's 10 highest-paid CEOs of 2024

J&J ties early-stage lymphoma CAR-T to 100% response rate in 10 patients

Featured

FDA's 'heavy workload' blamed for delays to KalVista's angioedema drug approval decision

By James Waldron

KalVista Pharmaceuticals has become the latest biotech to face delays to the FDA’s decision-making, as the agency blames a “heavy workload” for pushing back a PDUFA date.

Gilead lays off 36 people after axing California expansion plan

By Nick Paul Taylor

Gilead is laying off 36 people as part of the rethink that saw it scrap plans to expand a biologics facility in California.

Eli Lilly's phase 1 amylin data impress analysts, pairing 11% weight loss with tolerable profile

By Nick Paul Taylor

Eli Lilly has shared phase 1 data on amylin analog eloralintide, impressing analysts with results that point to the potential for the drug candidate to form part of a market-leading Zepbound combination.

Precision medicine’s next frontier: unlocking the power of biospecimens

Sponsored by Thermo Fisher Scientific

Austin Read of Thermo Fisher Scientific discusses how combining biospecimens with real-world data is advancing diagnostics, treatment and the future of patient care.

Sarepta reports 2nd death after DMD gene therapy Elevidys, stops dosing in half of patients

By Angus Liu

A second patient has died following treatment with Sarepta Therapeutics’ Elevidys, raising more doubts about the Duchenne muscular dystrophy gene therapy’s safety profile.

South Korean biotech's GLP-1 drug scores MASH win while reducing weight

By James Waldron

D&D Pharmatech tested a once-weekly regimen of its dual GLP-1/glucagon receptor agonist DD01 in 67 overweight or obese patients with MASH.

NextCure advances ADC pivot with $745M deal for Simcere's phase 1 drug

By James Waldron

NextCure has ramped up its antibody-drug conjugate pivot, penning a $745 million deal for the ex-China rights to Simcere Zaiming’s phase 1-stage tumor asset.

Big Pharma's 10 highest-paid CEOs of 2024

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

The pay packages handed out for last year’s work seem to further cement a new status quo in the realm of CEO compensation, as several recently appointed pharma leaders settle into their roles and companies establish their market positions heading into the second half of the decade.

J&J ties early-stage lymphoma CAR-T to 100% response rate in 10 patients

By Darren Incorvaia

Johnson and Johnson is providing a first look at clinical data for its dual-targeting blood cancer CAR-T program.

Biogen leads Cannes Lions Pharma shortlist, with BMS, Novartis cracking Health & Wellness category

By Nick Paul Taylor

Biogen has emerged as a front-runner at the Cannes Lions International Festival of Creativity, snagging four spots on the Pharma shortlist for its work on Friedreich’s ataxia. But the biotech was absent from the Health & Wellness category, where Bristol Myers Squibb and Novartis led pharma representation.