FDA clears J&J’s Impella heart pumps for kids

Today’s Big News

Dec 12, 2024

ICER calls out Gilead, J&J, Novartis and more in latest report on 'unsupported' price increases


iTeos deprioritizes cancer candidate despite 'encouraging' phase 2 data


FDA expands use of J&J’s Impella heart pumps to pediatric patients


Corcept shows how excess cortisol might be pulling the strings in Cushing syndrome awareness campaign


SABCS: Under siege from competitors, Pfizer's Ibrance scores in double-positive breast cancer


Industry M&A volume declined 8% this year compared to '23: PwC


Multiomics startup Pleno raises $25M for commercial launch, plucks new CEO from Illumina

 

Featured

ICER calls out Gilead, J&J, Novartis and more in latest report on 'unsupported' price increases

The U.S. watchdog is taking several pharma majors to task over what it says are "unsupported" price increases. But many of the companies have been quick to hit back against ICER’s findings.
 

Top Stories

iTeos deprioritizes cancer candidate despite 'encouraging' phase 2 data

Despite “encouraging” new data, iTeos Therapeutics is dropping a midstage cancer asset to focus on other programs, a move that will bring the biotech's clinical pipeline down to two investigational meds.

FDA expands use of J&J's Impella heart pumps to pediatric patients

The agency expanded its previous premarket approvals for the catheter-based Impella 5.5 and CP pumps developed by Abiomed for children weighing at least 30 kilograms and 52 kilograms for each model, respectively.

Corcept shows how excess cortisol might be pulling the strings in Cushing syndrome awareness campaign

Over a decade into selling Korlym to treat endogenous hypercortisolism, also known as Cushing syndrome, Corcept Therapeutics is launching its first-ever direct-to-consumer campaign raising awareness of the condition and screening options.

SABCS: Under siege from competitors, Pfizer's Ibrance scores in double-positive breast cancer

While under competitive pressure from Novartis and Eli Lilly, Pfizer can tally up a unique trial win for its Ibrance in a niche breast cancer population.

Industry M&A volume declined 8% this year compared to '23: PwC

Though M&A deal value and volume both declined in biopharma in 2024 compared to the year prior, PwC analysts still believe 2025 will be an active year for the sector.

Multiomics startup Pleno raises $25M for commercial launch, plucks new CEO from Illumina

Pleno plans to launch its Raptor benchtop analyzer early next year, and it's poached Illumina's Vik Vaz to lead its commercialization.

Ex-NFL stars 'Gear Up' with CDC for colorectal cancer screening push

Ex-NFL players and the CDC are about to “Gear Up Against Cancer,” kicking off a campaign that will see former footballers use their star power to raise awareness about screenings.

After M&A rumors sparked stock volatility, Bausch + Lomb confirms it's exploring a sale

Bausch + Lomb has issued a statement saying that its board had authorized “management and its advisors to explore a potential sale, which is one of several options being explored to complete a full separation” from its parent, Bausch Health Companies. The statement came at the request of the Canadian Investment Regulatory Organization (CIRO), which wanted an explanation for the recent volatility in the company’s stock.

Evotec, Novo Nordisk's drug discovery accelerator debuts first 3 projects, adds 5 partners

LAB eN2, the drug discovery accelerator launched by Evotec and Novo Nordisk in September 2023, has unveiled its first three projects and launched an expansion featuring five new academic partners.

CRO Ora showcases key role music plays in the blind community

Ora has unveiled the next phase of its collaboration with the blind community, releasing a series of short films about the work of the Academy of Music for the Blind.

Lonza plans to shed capsules business, simplify operating structure in push to become 'pure-play' CDMO

Lonza unveiled a restructuring strategy under which the company will reorganize its CDMO business. Notably, Lonza aims to hive off its capsules and health ingredients business “at the appropriate time," the company said.

Tenpoint, Visus merge in effort to push presbyopia-correcting eye drop over FDA finish line

Eye-focused biotechs Tenpoint Therapeutics and Visus Therapeutics are joining forces, setting their sights on filing a new drug approval application next year for a presbyopia-correcting eye drop.

PeptiDream’s macrocyclic peptides preserve muscle mass in mice given semaglutide

PeptiDream, the Japanese biopharma with a penchant for deal-making, has a new bargaining chip in hand in the red-hot obesity space. The firm’s oral macrocyclic peptides preserved lean muscle mass in mice given the weight-loss drug semaglutide.
 
Fierce podcasts

Don’t miss an episode

What can we learn from 2024’s biotech IPOs?

This week on "The Top Line," we explore the biotech IPO market rebound and ask: Is the momentum here to stay?
 

Resources

Whitepaper

Building a “Best Practice” R&D Organization in Biopharma

We interviewed 14 R&D biopharma leaders on the critical success factors for building a Best Practice R&D organization. This report shares what we learned.
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Single Cell RNA Profiling FFPE Tissue

Explore the robust cross-platform agreement between scRNA-seq and bulk RNA-seq, ensuring consistent and reproducible data on immune cell presence.
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Straight to Market in an Autoinjector

The use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors.
Whitepaper

Planning for success in cell-based manufacturing

Learn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes.
 

Industry Events

On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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