J&J electrosurgery recall reaches Class I

Today's Big News

Jul 11, 2023

ADC puts Zynlonta study on hold after 7 patient deaths, 5 other severe adverse events


Novartis retreats from TIGIT, handing $300M candidate back to BeiGene


FDA delivers Class I label to J&J’s recall of electrosurgery pads, following patient burns


Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report


Cell death biotech BAKX dissolves in 'challenging funding environment'


Tandem crosses FDA finish line with nod for miniaturized insulin pump

 

Featured

ADC puts Zynlonta study on hold after 7 patient deaths, 5 other severe adverse events

A total of 12 severe adverse events were reported among the 40 patients enrolled in the phase 2 trial, 11 of which ADC says were not related to the treatment. The study was assessing the drug in certain patients with previously untreated diffuse large B-cell lymphoma.
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July 18-19, 2023 | Jersey City, NJ
 

Top Stories

Novartis retreats from TIGIT, handing $300M candidate back to BeiGene

Novartis may have insisted earlier this year that it hadn’t given up on anti-TIGIT checkpoint inhibitors, but, now, the Swiss Big Pharma seems to have had a change of heart.

FDA delivers Class I label to J&J’s recall of electrosurgery pads, following patient burns

The recall spans more than 21,000 Megadyne return electrode pads distributed to hospitals and surgery centers over a two-year period.

Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report

Moderna has lodged two new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, Juve Patent first reported. This adds to a complex web of ongoing mRNA patent litigation.

UPDATE: Cell death biotech BAKX dissolves in 'challenging funding environment,' ends Ipsen collab

BAKX Therapeutics, a small biotech focused on cellular life and death that boasted a partnership with Ipsen, has dissolved.

Tandem crosses FDA finish line with nod for miniaturized insulin pump

The next big thing on Tandem Diabetes Care’s technology slate is actually a very small thing. The Mobi insulin pump—its smallest device to date and, it claims, the smallest automated insulin delivery system in the world—has secured an FDA clearance.

Eisai's US CEO and Alzheimer's lead Ivan Cheung telegraphs retirement days after Leqembi's full FDA nod

Ivan Cheung, Eisai's American CEO and global Alzheimer's disease officer, will retire at the end of the month. With Cheung headed for the exit, Keisuke Naito—the 34-year-old son of Eisai’s CEO Haruo Naito—has taken up the lead Alzheimer’s mantle, the company said Tuesday.

Biopharma’s green shoots thriving in summer sun as deal activity returns

The Fed has paused rate hikes and the major indices are starting to look bullish. Could the summer sun finally be shining on the biotech industry again?

Better Therapeutics' first digital app earns FDA de novo nod in Type 2 diabetes

Better days may have finally arrived for Better Therapeutics, after the company started this year with a swath of layoffs and sustained losses.

Takeda yanks FDA filing for dengue vaccine, citing data disagreement with regulator

U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. After an ominous delay, Takeda has decided to withdraw the FDA application for its dengue vaccine candidate after the agency raised concerns about data collection.

BMS makes quickfire bets on neurodegeneration, paying $95M to exercise Evotec, Prothena options

Bristol Myers Squibb has pulled the trigger on two neuroscience options, paying Prothena $55 million for a global license to a clinical-phase Alzheimer’s disease drug candidate and handing Evotec $40 million for rights to certain late-stage discovery programs.

Regulatory tracker: Roche picks up Columvi approval in Europe

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.
 
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'The Top Line': New HIV therapies, plus this week's headlines

This week on "The Top Line," we discuss new HIV therapies, plus Humira's new biosimilar, foreign pharmaceutical investments, and the rest of the week's headlines.
 

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