Nuwellis Push To Expand Aquadex Pediatric Use Backed By Real-World Evidence
Nuwellis is using real-world data to seek FDA clearance for Aquadex use in infants as small as 5kg, extending the fluid management device below its current 20kg threshold. The FDA's evolving real-world evidence framework has opened a more practical path for pediatric indications, the company said.
Medtech Insight - June 3, 2026

Foes, Not Friends: US Legislators Bristle Over US-China Deals
The growing power of China in the pharmaceutical industry has spawned new legislation aiming to increase scrutiny on US-China deals.
Scrip - June 3, 2026

ASCO: Roche’s Giredestrant Gets November FDA Date Fresh Off Data Presentations
The company is aiming for adjuvant and previously treated settings for the novel SERD and presented positive data in both at the ASCO meeting.
Scrip - June 3, 2026

Abiomed’s Impella Franchise Faces Mounting Safety Questions As FDA Issues Third Alert In Weeks
The FDA has issued a third early alert for Abiomed in as many weeks, this time over thrombus risk in 14Fr Low Profile Introducer Kits used with the Impella CP heart pump.
Medtech Insight - June 3, 2026

Good News For FcRn Class With J&J’s Imaavy Data In Lupus
Johnson & Johnson’s FcRn inhibitor nipocalimab delivered significant reduction of SLE disease activity in a Phase II study.
Scrip - June 3, 2026

Safety Concern Ends Fulcrum Program, But Other PRC2 Drug Development Continues
With Ipsen’s Tazverik pulled from the market due to secondary hematologic malignancies, the US FDA said inhibition of the PRC2 complex was too risky. Pociredir targets the EED subunit, while Tazverik targets EZH2, but so far other drugs against those targets are not impacted.
Scrip - June 3, 2026

Atherectomy Overuse In Office-Based Labs Draws Medicare Scrutiny In New Watchdog Report
With 75% of office-lab PAD procedures involving an atherectomy, an HHS watchdog flags $105m in potentially unnecessary Medicare billing.
Medtech Insight - June 3, 2026

‘There’s Going To Be A Learning Curve For Everyone’ – Mintz’s Gutman On Biosimilar Streamlining
The new streamlined US framework for biosimilars will take some getting used to, according to Sige Gutman of US law firm Mintz, who pointed to opportunities for developers to more easily “leapfrog” each other in the early stages, as well as making for a more complex landscape for originators.
Generics Bulletin - June 3, 2026

IDEAL Data Expands Gilead’s Livdelzi Evidence Into Lower-ALP PBC Population
As Livdelzi gains traction in the second-line PBC market, the IDEAL study offers Gilead an opportunity to strengthen the drug's regulatory and commercial positioning beyond its original approval population.
Scrip - June 3, 2026

ADA 2026: Can Anyone Really Challenge Lilly And Novo In Obesity?
While data for Lilly’s retatrutide and Novo Nordisk’s CagriSema will dominate, many other big pharma and biotechs will present their would-be contenders in obesity therapy in New Orleans.
Scrip - June 3, 2026

ASCO: Gedatolisib PFS Disappoints Investors, But Celcuity Eyes Standard of Care
Celcuity’s gedatolisib roughly doubled progression-free survival versus Novartis’s Piqray in PIK3CA-mutated breast cancer but the rate was lower than what was seen in an early-stage trial.
Scrip - June 3, 2026

Data Paints Complex Picture Of Cancer Patients’ AI Use
ASCO data shows that 0% of cancer patients trust AI more than doctors — but another study finds that they prefer blinded AI answers.
Medtech Insight - June 3, 2026

ASCO: Lynozyfic Shows Superiority Over Standard Treatments In AL Amyloidosis
Regeneron presented data from its Phase I/II study at the American Society of Clinical Oncology meeting, and a registrational Phase II portion of the study is ongoing.
Scrip - June 3, 2026

Daewoong’s Dupixent Deal Is ‘Important Turning Point’
Daewoong’s Chime partnership for a biosimilar to Dupixent is positioned as the starting point for a differentiated global biosimilar portfolio, using the alliance to create a “powerful foundation for our long-term biosimilar journey.”
Generics Bulletin - June 3, 2026

Teva Deal Preserves Most Of Jelmyto Patent Protection Period
Teva’s generic Jelmyto launch is to be pushed to September 2030 under a patent-litigation settlement agreement that preserves most of UroGen’s patent runway.
Generics Bulletin - June 3, 2026

Torrent On Rezdiffra Generic, Brazil Market Shift To Wegovy
Torrent is conducting Phase III trials in India for a generic to Rezdiffra as it looks for other growth levers post the success of its semaglutide franchise in India. Meanwhile, a market shift in Brazil could now lead to filing of a Wegovy-referenced semaglutide product.
Generics Bulletin - June 3, 2026

swissdamed Sets UDI Date And Registration Fees
Devices, systems and procedure packs used in Switzerland must be registered on the swissdamed database by the end of the year. Monthly fees will apply from 2027. The UDI-DI module comes into force on July 1. Meanwhile, EUDAMED’s four available modules became mandatory on May 28.
Medtech Insight - June 3, 2026

Opella: Manufacturing And Supply Chain Are Keys To Unlocking Volume Growth
Exclusive Interview: Opella's COO and executive committee member Rafik Amrane argues that a more agile, consumer-goods-style supply chain is as important to solving the industry's volume growth problem as health literacy or marketing.
HBW Insight - June 3, 2026

NICE Says All Pregnant Women With T1D Should Use ‘Artificial Pancreas’
UK HTA Body seeks to solidify ‘world leading’ position on hybrid closed loop devices, highlighting benefits for controlling glucose during pregnancy.
Medtech Insight - June 3, 2026

From Zero To Phase I: The Scramble To Arm Against Bundibugyo
Facing the largest Ebola Bundibugyo outbreak on record, CEPI, Oxford/Serum, Moderna, Gilead, Regeneron and others are racing to build a vaccine, treatment and diagnostic arsenal from scratch.
In Vivo - June 3, 2026

ASCO: Significant Survival Benefits For Iza-Bren In 2L TNBC/ESCC But Safety Issues Remain
Iza-bren demonstrated statistically significant and clinically meaningful improvements in overall and progression-free survival in second- and later-line TNBC and second-line ESCC, but a higher proportion of dose reductions due to adverse events.
Scrip - June 3, 2026

‘Building From A Strong Foundation’: Merck Lays Out Oncology Vision At ASCO
Under pressure as its top seller Keytruda nears the end of its exclusivity, Merck & Co. execs used an analyst briefing at ASCO to make the case that the company is ready to deliver on a new generation of oncology blockbusters.
Scrip - June 3, 2026