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Aug 16, 2023

AstraZeneca hit with FDA warning letter over ‘misleading’ Breztri efficacy claims

Bluebird’s lovo-cel flies closer to approval as FDA rules out advisory committee meeting

J&J, Legend's myeloma CAR-T Carvykti not slowing down in the face of new bispecific: Legend exec

Sequel plots next generation of menstrual care with FDA clearance of new tampon design

Day One jets off with Sprint’s VRK1 program for up to $316M

DOJ bashes Chamber of Commerce's lawsuit against IRA's Medicare price negotiations

Featured

AstraZeneca hit with FDA warning letter over 'misleading' Breztri efficacy claims

By Nick Paul Taylor

AstraZeneca’s promotion of Breztri Aerosphere has landed it in hot water with the FDA. The agency says an AstraZeneca sales aid made “misleading” claims about the effect of the inhaler on all-cause mortality, prompting it to send a warning letter to CEO Pascal Soriot.

11-14

Sep

Join us: Digital Pharma East

Philadelphia, PA

Bluebird’s lovo-cel flies closer to approval as FDA rules out advisory committee meeting

By James Waldron

The path to potential approval for bluebird bio’s lovo-cel has become slightly smoother after the FDA confirmed it will not be holding an advisory committee meeting before making a decision on the sickle cell disease gene therapy in December.

J&J, Legend's myeloma CAR-T Carvykti not slowing down in the face of new bispecific: Legend exec

By Angus Liu

Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option.

Sequel plots next generation of menstrual care with FDA clearance of new tampon design

By Andrea Park

It’s not often that a sequel is better than the original, but one startup developing a new approach to period products is banking on it.

Day One jets off with Sprint's VRK1 program for up to $316M

By Max Bayer

Cruising on the midstage clinical success of a brain cancer therapy, Day One Biopharmaceuticals is using the wind at its sails to bolster the back of its pipeline with a $3 million upfront deal for Sprint Bioscience's preclinical program.

DOJ bashes Chamber of Commerce's lawsuit against IRA's Medicare price negotiations

By Zoey Becker

The U.S. Chamber of Commerce last month filed a lawsuit in an attempt to hold up the IRA's price negotiations, a move the DOJ criticized in its recent motion to dismiss.

Precision, pivoting to in vivo editing, punts early-phase CAR-T to Imugene for $21M upfront

By Nick Paul Taylor

Precision BioSciences has moved quickly to partner its CAR-T cell therapy candidate. Nineteen days after confirming it planned to partner the program, the biotech has agreed to offload the asset to Imugene for $21 million upfront and much more on the back end.

Nevro’s high-frequency neurostimulation cuts diabetic neuropathy pain by 80% in 2-year study

By Andrea Park

Two years after a high-frequency version of Nevro’s neurostimulation system became the first spinal cord stimulator approved by the FDA with a specific indication to treat pain associated with diabetic neuropathy, the company has published long-term study data further backing up the regulator’s decision.

Drug pricing concerns cross party lines to become 'core value' for voters, pollsters say

By Fraiser Kansteiner

Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines, a pollster found. Two pollsters presented results from their recent survey on Tuesday.

Fierce podcasts

Don’t miss an episode

'Podnosis': The challenges with new email policies, and the importance of diverse investors and founders.

This week on "Podnosis," we take a closer look at the challenges with new email policies, and the importance of diverse investors and founders.

'The Top Line': International Left Handers Day: How handedness impacts brain research

Resources

Whitepaper

Plan for success with your process liquid and buffer preparation

Learn how process liquids and buffers impact your total cost of ownership (TCO) and how outsourcing can revolutionize your approach, ensuring quality standards and improving productivity.

Sponsored by: Thermo Fisher Scientific Process Liquid Preparation Services

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.

Sponsored by: Blue Matter, strategic consultants in the life sciences

Whitepaper

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

Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives.

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.

Sponsored by: Thermo Fisher Scientific Production Chemicals and Services

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.