Medtronic’s HeartWare woes roll on

Today's Big News

Jan 24, 2023

Amazon Pharmacy rolls out service for unlimited generic drug prescriptions for $5 a month


The rise of venture debt and when biotechs should—and shouldn't—use it


Medtronic’s spate of HeartWare heart pump issues continues with battery recall


Novartis, in SCOTUS filing, argues it was 'wrongly deprived' of Gilenya patent after judge's retirement


How a buyer's sudden withdrawal gave Ipsen a chance to fight for Albireo 


Frosty funding forecast forces Finch to stop phase 3 trial, lay off 95% of staff and seek buyers for assets

 

Featured

Amazon Pharmacy rolls out service for unlimited generic drug prescriptions for $5 a month

Amazon's pharmacy business is rolling out a new subscription service that enables Prime members to get unlimited generic medications for a flat fee of $5 a month.
 

Top Stories

The rise of venture debt: When biotechs should—and shouldn't—use it

There's a time and a place for everything, and right now might be the time for venture debt as biotechs operate on razor-thin margins.

Medtronic’s spate of HeartWare heart pump issues continues with battery recall

After issuing near-monthly safety warnings related to its discontinued HeartWare Ventricular Assist Device (HVAD) last year, Medtronic is already continuing the trend in 2023.

Novartis, in SCOTUS filing, argues it was 'wrongly deprived' of Gilenya patent after judge's retirement

Novartis, after falling short at the federal appeals court, asked the Supreme Court to take up its Gilenya patent case. The company argues an appeals judge's retirement affected its case.

How a buyer's sudden withdrawal gave Ipsen a chance to fight for Albireo

Ipsen’s near-$1 billion deal for Albireo was among a trio of biopharma acquisitions that opened this year’s J.P. Morgan Healthcare Conference. But Ipsen only got a chance to bid thanks to a sudden withdrawal by another company, and the French pharma fought hard when the opportunity presented itself.

Frosty funding forecast forces Finch to stop phase 3 trial, lay off 95% of staff and seek buyers for assets

Finch Therapeutics is throwing in the towel. Shortly after getting its phase 3 clinical trial back on track, the microbiome biotech has decided to stop the study and seek to offload assets in the face of a frosty funding forecast and slow enrollment.

Elevance Health to acquire Blue Cross and Blue Shield of Louisiana

Elevance Health has inked a deal to acquire Blue Cross and Blue Shield of Louisiana, with the Pelican State insurer joining the Anthem Blue Cross affiliated plans.

NeuroMetrix on pins and needles as it launches revamped peripheral neuropathy test

After spending much of last year shifting resources toward an update to its DPNCheck screening device for peripheral neuropathy, NeuroMetrix is ready to reap the rewards of that investment.

Eli Lilly to pour $450M more into diabetes drug plant in North Carolina, add 100 jobs

Even though Eli Lilly has yet to begin manufacturing at its ballyhooed plant at Research Triangle Park in North Carolina, it now has plans to expand it to the tune of an additional $450 million. That’s how much more Lilly says it will pour into the facility, along with an increase of at least 100 more employees, to help meet an expected surge in demand for new Type 2 diabetes treatment Mounjaro, which the company anticipates will soon be approved to treat obesity.

J&J trims the edges of its pipeline with the company mum on timing of looming readouts

Johnson & Johnson continued to trim away at early-stage cancer prospects, culling a prostate and solid tumor asset, respectively. The decision comes as the company was quiet on the specific timing of looming 2023 readouts.

CMMI Director Liz Fowler: Expect advance primary care, total cost models to be released in 2023

CMMI aims to release three to four new advance primary care payment models this year and another model enabling states to oversee the total cost of care for Medicare beneficiaries, Director Liz Fowler shared.

Asensus expands its surgical AI vision with European approval

Asensus Surgical has secured a European approval that builds upon the machine vision capabilities of its previously greenlighted robotic surgery hardware.

Cassava claims win in open-label Alzheimer's study, but shares decline 15%

Cassava Sciences, which spent 2022 trying to prove the integrity of its Alzheimer’s disease program, is trumpeting a phase 2 win for simufilam in an open-label study—but investors aren’t convinced.
 
Fierce podcasts

Don't miss an episode

'The Top Line': Highlights from Fierce's JPM Week

This week on "The Top Line," we take you inside Fierce's JPM Week event. Listen in on snippets from a lively panel discussion on how companies will navigate the drug pricing policies the Biden administration rolled out just last year. And hear from Christine Roth, head of Bayer's oncology strategic business unit, about the company's plans to become a strong competitor in cancer.

 

Resources

Whitepaper

Reduce control arm sizes by up to 35% for Alzheimer's disease

RCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease.
Whitepaper

Quality attributes that are important for GMP-grade NTPs

What makes nucleotides suitable for current good manufacturing practices?

Whitepaper

Medical Affairs Metamorphosis V: The (R)evolution in Medical Communications

This paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series).
On-Demand Webinar

Writing the Future of Antibody Discovery Solutions

See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

Executive Summary

Scale-Up Strategies for Late-Stage Cell Therapies

Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more.

Whitepaper

Linear Compression vs. Parallel Processing: Speeding Biologics Through Development and Into Clinical Trials

Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more.

Whitepaper

Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?
Case Study

A Strategy to Standardize Process Characterization & Late Phase Development

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.

Whitepaper

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.
Whitepaper

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.
 

Industry Events

 

Upcoming Fierce Events

27-28
Feb
Arlington, VA
14-15
Mar
San Francisco, CA
20-22
Mar
West Palm Beach, FL
3-4
Apr
San Diego, CA
1-3
May
May 1-3, 2023 | Jersey City, NJ

View all events