J&J AFib catheters get zero X-ray nod

Today's Big News

Aug 4, 2023

Lilly pressures Blueprint further with positive Retevmo trial in newly diagnosed lung cancer


2nd time unlucky for Mesoblast as FDA rejects cell therapy again, sinking shares


Ditch the lead aprons: FDA approves J&J AFib catheters for use without X-ray fluoroscopy


After tornado, Pfizer puts Rocky Mount meds on emergency ordering list to thwart hospital shortages


UPDATED: Amgen's tarlatamab BiTEs at small cell lung cancer in brief readout

 

Featured

Lilly pressures Blueprint further with positive Retevmo trial in newly diagnosed lung cancer

In their ongoing RET inhibitor rivalry, Eli Lilly is pulling further ahead of Blueprint Medicines, even as the latter company is being abandoned by Roche.
11-14
Sep
Philadelphia, PA
 

Top Stories

2nd time unlucky for Mesoblast as FDA rejects cell therapy again, sinking shares

Mesoblast’s second attempt to win over regulators to its off-the-shelf cell therapy has had no more success than the first try, sinking the Australian biotech’s stock.

Ditch the lead aprons: FDA approves J&J AFib catheters for use without X-ray fluoroscopy

Johnson & Johnson MedTech's Biosense Webster division has secured a broad approval from the FDA that enables several of its atrial fibrillation treatments to be used without real-time radiation.

Amgen's hyped Humira biosimilar fritters away its exclusivity advantage

When Amgen launched the first biosimilar to compete with AbbVie’s Humira in the U.S., the company looked forward to six months of exclusivity in competing one-on-one against the immunology powerhouse. But Thursday, Amgen reported second-quarter sales of just $19 million for Amjevita, a 63% drop sequentially.

After tornado, Pfizer puts Rocky Mount meds on emergency ordering list to thwart hospital shortages

In a bid to thwart shortages of critical drugs, Pfizer is relegating certain products made in Rocky Mount, North Carolina, to its emergency ordering list. The move comes after a tornado hit the company's injectables facility late last month, creating questions about potential supply disruptions.

UPDATED: Amgen's tarlatamab BiTEs at small cell lung cancer in brief readout

One of Amgen's top BiTE molecules continues to inch forward after the company posted a brief phase 2 readout Thursday. The trial update included no new data, but Amgen said tarlatamab posted better safety and efficacy data than it produced in phase 1.

Gilead, building out its oncology group, expects $3B from Trodelvy, Tecartus and Yescarta this year

The company is sticking to its ambitions of pulling a third of its revenue from its oncology portfolio by 2030. This year, the company expects $3 billion to come from its cancer trio of Trodelvy, Tecartus and Yescarta.

PacBio picks up speed with first short-read sequencer shipments, plus a new acquisition

The DNA sequencing developer has begun shipping its first short-read hardware—while simultaneously announcing a new deal to boost those capabilities in the future.

Voyager Therapeutics adds anti-amyloid gene therapy to Alzheimer's pipeline

The company is tripling down on its Alzheimer’s franchise, rounding out its tau-focused pipeline with a gene therapy aimed at amyloid-beta plaques.

Chutes & Ladders—Peter Marks has no immediate plans to leave the FDA

CBER chief Peter Marks doesn't have any plans to leave the FDA—yet. Anthony Fauci's replacement at NIAID has been founf. Jamie Rubin takes CFO role at Boundless after EQRx stint.
 
Fierce podcasts

Don't miss an episode

'The Top Line': How to support patients during a drug shortage, plus this week's headlines

This week on "The Top Line," we discuss how to support patients during the cancer drug shortage, plus this week's headlines.
 

Resources

Whitepaper

Key Drivers of Sales Force Strategy in Oncology

In oncology, traditional methods for determining sales force size & structure are no longer appropriate. This paper describes the multiple drivers of sales strategy in oncology markets today.
Whitepaper

Five ways to get the most from your lab and manufacturing facilities

Leading facilities practices and technologies can help improve the productivity of your research and manufacturing operations—and accelerate the journey from laboratory to saving lives.
Research

Reduce chemical lead times with just-in-time delivery

Learn how the right chemical inventory strategy helped save a mid-size CDMO millions of dollars while securing a stable supply of products with just-in-time delivery.
Webinar

Novel Antibodies for the Characterization of CAR-T Cells

Download this webinar to learn how to avoid pitfalls when characterizing CAR-T cells in your development workflow, how to save time by using one antibody to examine your entire panel of CARs, and more.
Whitepaper

Improving the Patient Experience Through Research-Driven Design

Learn more about the current challenges and issues that eClinical technology providers are facing.
 

Industry Events

 

Upcoming Fierce Events

11-14
Sep
Philadelphia, PA
13
Sep
Philadelphia, PA
19-21
Sep
Virtual Event
26-28
Sep
Philadelphia, PA
5-6
Oct
San Diego, CA

View all events