GE flattened by recall of 1,200-pound scanners

Today's Big News

Feb 16, 2023

GSK vaccine R&D head touts consistency of RSV data but is mum on restarting maternal trial


Ahead of next month’s FDA decision, Emergent aces AdComm for over-the-counter Narcan nod


GE HealthCare lands Class I recall for 1,200-pound scanners at risk of falling onto patients


On hunt for better gene med delivery, Aera exits stealth with $193M and Alnylam vet at helm


Flagship’s Pioneering Medicines to carve a new drug discovery path with Charles River’s AI


Seagen's growth drivers are 'firing' and still have room to run, analyst says

 

Featured

GSK vaccine R&D head touts consistency of RSV data but is mum on restarting maternal trial

GSK's head of vaccine R&D, Phil Dormitzer, is confident that the company has posted pack-leading data for its RSV vaccine, as it nears the finish line of the regulatory race. But he wouldn't commit to restarting trials testing the shot in maternal women after a phase 3 study was halted a year ago.
 

Top Stories

Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod

At a meeting of the agency’s Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees, the FDA’s panel of 19 independent experts voted unanimously in favor of an over-the-counter nod for Emergent BioSolutions’ opioid overdose reversal drug Narcan.

GE HealthCare lands Class I recall for 1,200-pound scanners at risk of falling onto patients

GE HealthCare has begun a recall of several models of its nuclear medicine imaging systems that were found to be at risk of collapsing while in use, potentially crushing or trapping a patient underneath.

On hunt for better gene med delivery, Aera exits stealth with $193M and Alnylam vet at helm

A biotech led by a 20-year Alnylam vet has emerged with $193 million in hand and hopes of unlocking genetic medicine’s fullest potential.  

Flagship’s Pioneering Medicines to carve a new drug discovery path with Charles River’s AI

A year after Charles River Laboratories teamed up with artificial intelligence developer Valo Health to build an AI-powered drug discovery and development platform, the contract research organization is putting that tech to work.

Seagen's growth drivers are 'firing' and still have room to run, analyst says

In his first earnings presentation as new CEO of Seagen, David Epstein had lots of good news to share. And at least one analyst liked what he heard from the former Novartis oncology chief, saying the biotech’s “growth drivers are firing.”

After several flops, Merck exec stands by aggressive Keytruda prostate cancer program

Prostate cancer is giving Merck & Co.’s seemingly unstoppable Keytruda a hard time. But even after three pivotal trial flops in less than a year, clinical development lead Scot Ebbinghaus still thinks Merck made the right decision to go aggressive on its phase 3 program back in 2019.

ASCO GU: Pfizer touts Talzenna's strong showing in PARP prostate cancer battle with AstraZeneca, J&J

Pfizer may be the last major oncology player to put a wager on a PARP inhibitor in prostate cancer, but the New York pharma appears to have a winning regimen, partly thanks to its Astellas-partnered stalwart Xtandi.

Insulet doubles down with another $25M automated insulin delivery tech buy

In its second such deal in as many days, Insulet has put down another $25 million to acquire technology used in automating insulin delivery.

Fierce Biotech Layoff Tracker 2023: Chimera cuts 40% of staff amid funding challenges; Layoffs hit a third of Talaris' team

We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech.
 
Fierce podcasts

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'Podnosis': health record errors and postpandemic telepsychiatry

In this week's episode of "Podnosis," we talk about what can be done to reduce errors in health records. We also discuss what telemedicine companies—in particular telepsychiatry firms—will face with the looming end of the public health emergency.

 

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Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

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Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial.
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Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.
 

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