FDA warns of saline recall fallout

Today’s Big News

Feb 26, 2024

J&J to shut down massive Bay Area R&D facility less than 18 months after opening it


With global expansion planned, Krystal lays out blockbuster ambitions for topical gene therapy


FDA warns on widened fallout of Nurse Assist’s saline, sterile water recall


Biotech's top money raisers of 2023


Amgen boots up Ohio 'smart facility' where it plans to employ 400—and a trio of robots, too 


Virtual Incision pinches de novo clearance for its MIRA miniaturized surgical robot

 

Featured

J&J to shut down massive Bay Area R&D facility less than 18 months after opening it

Johnson & Johnson is closing a nearly 200,000 square-foot R&D outpost in Brisbane, California, less than 18 months after it opened, according to multiple sources familiar with the decision.
 

Top Stories

With global expansion planned, Krystal lays out blockbuster ambitions for topical gene therapy

In its first six months of commercial availability, Krystal's topical gene therapy Vyjuvek raked in more than $50 million. Now, the company is looking toward bringing the drug to Europe and Japan and testing a new eye-drop formulation.

FDA warns on widened reach of Nurse Assist’s saline, sterile water recall

About three months after first alerting patients and healthcare providers to Nurse Assist’s voluntary recall of several of its sodium chloride irrigation and sterile water products, the FDA is now highlighting the broad reach of the recall.

Biotech's top money raisers of 2023

While there wasn't another $3 billion private financing in 2023, it doesn't mean there wasn't plenty of money flowing.

Amgen boots up Ohio 'smart facility' where it plans to employ 400—and a trio of robots, too

Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” Dubbed “Amgen Ohio,” the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the “latest innovation and technology."

Virtual Incision pinches de novo clearance for its MIRA miniaturized surgical robot

The MIRA system is small enough to fit in a standard surgical tray, weighing only two pounds. With a camera and two robotic arms, it is designed to be placed entirely inside the patient’s abdomen and to conduct its work through a single cut in the navel.

As part of new focus, Denali reorganizes and sends staff packing

As Denali Therapeutics narrows in on large molecule biotherapeutics, the company is reorganizing, laying off an undisclosed number of workers and sending some to a new small molecule spin-out.

BeiGene grows global workforce by 1,000+ as Brukinsa surges, Tevimbra launches outside China

The chilling wind of the biotech winter has apparently spared BeiGene. While layoffs have been commonplace in the industry, BeiGene employed 1,400 more people at the beginning of 2024 than it did a year ago.

Philips puts forward fiber-optic, X-ray-free surgical navigation system

The company announced its LumiGlide system helped guide minimally invasive procedures, with a first focus on operations to repair aortic aneurysms.

Novo Nordisk sticks down $1.46B in biobucks for molecular glues with California biotech

Novo Nordisk is getting sticky, coming together with Neomorph in a new licensing pact worth up to $1.46 billion across multiple molecular glue targets.

FDA clears pulse ox-analyzing AI from EnsoData to diagnose sleep disorders

A new AI algorithm may be able to replace the bulky and often expensive equipment typically used to produce accurate diagnoses of sleep disorders.

Sanofi CEO Hudson takes another small dip in pay to €10.57M

For the third straight year, Sanofi CEO Paul Hudson has seen a slight dip in his compensation. For 2023, Hudson will receive 10.57 million euros ($11.44 million) in total pay, according to the company’s annual filing.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Breaking down Eli Lilly’s ESG formula

This week on "The Top Line," we explore the impact of environmental, social, and governance measures, commonly known as ESG, on the pharmaceutical industry. Fierce Pharma's Fraiser Kansteiner engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights and discuss Lilly's specific ESG initiatives.
 

Resources

Whitepaper

The Oncology Market – 2023 Year in Review

This paper offers a detailed review of key events and developments in the oncology market during 2023.  It’s a helpful “status report” that informs how the market is likely to evolve in 2024. It covers, vaccines, radiopharmaceuticals, ADCs, CAR-Ts, bi-specifics, & more.

Whitepaper

Developing and Manufacturing Drugs with HPAPIs

Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient.

 

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