J&J proposes $8.9B talc settlement

This Week

Apr 7, 2023

In Teva vs. GSK skinny label feud, Biden admin urges Supreme Court to weigh in


Lilly's early data on next-gen Alzheimer's drug show 'robust' amyloid reduction but a familiar adverse event


David Liu's lab shows new base editing SMA therapy could lead to a one-time therapy


J&J proposes $8.9B talc settlement deal but some plaintiffs decry 'woefully inadequate' offer


How much does a biotech pay? Community-generated data tool gives a peek at industry's salaries


FDA grants medical device clearance to Snoo robotic baby bassinet


Ahead of Pfizer buyout, Seagen's Padcev gains Keytruda combo nod in first-line bladder cancer


Sumitomo Pharma tidies up 7 units into one combined US entity in spring cleaning


In $2.6B cell and gene therapy expansion, Sartorius buys viral vector specialist Polyplus


Gaps in public info on cancer drugs and 'potentially misleading' details spur call for regulatory actions

 

Featured

In Teva vs. GSK skinny label feud, Biden admin urges Supreme Court to weigh in

The Biden Administration’s solicitor general, Elizabeth Prelogar, told the Supreme Court that the case is a “suitable vehicle” to address the argument over skinny labels.
 

Top Stories

Lilly's early data on next-gen Alzheimer's drug show 'robust' amyloid reduction but a familiar adverse event

Eli Lilly’s up-and-coming Alzheimer’s disease treatment remternetug seems to have resulted in an early, dose-dependent reduction in amyloid plaques during a small phase 1 study. But the therapy also ran into a common side effect for the anti-amyloid monoclonal antibody class—although it is early days for the data.

David Liu's lab shows new base editing SMA therapy could lead to a one-time therapy

The lab of gene editing pioneer David Liu is out with new research touting the potential of base editing to bolster existing spinal muscular atrophy treatments. The researchers said that when combined with an FDA-approved treatment, therapeutic benefits were significantly extended.

J&J proposes $8.9B talc settlement deal but some plaintiffs decry 'woefully inadequate' offer

After already spending billions to defend itself against claims its talc products cause cancer, J&J is moving to end the litigation altogether. But lawyers for some plaintiffs have said the offer is "woefully inadequate."

How much does a biotech pay? Community-generated data tool gives a peek at industry's salaries

A new community-generated data resource from Pillar VC, the Founder-led Biotech Summit and compensation analysis firm Pave seeks to take the guesswork out of the process by summarizing salary ranges from 90 companies.

FDA grants medical device clearance to Snoo robotic baby bassinet

Already popular with the parents of newborns, the makers of the Snoo motorized bassinet hope it will become the favored choice among hospitals and, perhaps one day, insurance providers.

Ahead of Pfizer buyout, Seagen's Padcev gains Keytruda combo nod in first-line bladder cancer

While Merck & Co.’s Seagen buyout wasn't fated to be, the companies’ clinical courtship in cancer has blossomed into a swift approval at the FDA.

Sumitomo Pharma tidies up 7 units into one combined US entity in spring cleaning

Sumitomo Pharma is doing a little bit of spring cleaning to bring a handful of biopharma units under one consolidated company to be named Sumitomo Pharma America.

In $2.6B cell and gene therapy expansion, Sartorius buys viral vector specialist Polyplus

In the latest example of biopharma's ongoing investment in cell and gene therapy production, Sartorius has agreed to acquire French viral vector expert Polyplus for $2.6 billion. But there are some signs of cooling in the field.

Gaps in public info on cancer drugs and 'potentially misleading' details spur call for regulatory actions

Drugmakers are failing to provide Europeans with the information to understand the benefits and harms of oncology medicines. That is the headline finding of a paper published in The BMJ, which found patient information leaflets routinely lack details that could support informed decision making.
 
Fierce podcasts

Don't miss an episode

'The Top Line': Humira's patent cliff and 2023's other big patent expirations, plus this week's headlines

This week on "The Top Line," we discuss how this year is chock-full of blockbuster drugs headed for the patent cliff, besides the well-known patent cliff for AbbVie's Humira. We also cover Johnson & Johnson's talc settlement offer and more of this week's top headlines.
 

Resources

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Accelerated Approval Pathways Pose Commercialization Risk

Accelerated approval pathways create an additional layer of complexity in the chaotic oncology marketplace, leaving manufacturers of all sizes seeking a new commercialization model for launch success.
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The Hematopoietic Colony Forming Cell (CFC) Assay for Drug Safety and Toxicity

The preclinical hematotoxicity screening method that helps clients eliminate bad players earlier in the drug development process
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Accessing and Analyzing Relevant Content in Today’s Information Chaos – R&D Challenges and Opportunities

We’ve identified four must-have tools to manage today’s scientific information chaos. How many are you utilizing?
Research

Three Considerations to Expand Physicians’ Bandwidth and Improve Real-World Safety Reporting

The current real-world safety reporting process is too burdensome for most HCPs – how can technology help?
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Blueprint for Commercializing Cell and Gene Therapies

How advanced medicines commercial readiness differs and the resources needed to maximize potential.
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Coming to America: Keys to Success for ex-US Digital Health Companies Entering the US Market

This paper outlines an approach that digital health / therapeutics companies can use when developing a go-to-market strategy for the complex US market.
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Plan for scalable process liquid and buffer preparation

Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation.
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Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
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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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