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Today’s Big News

May 7, 2024

‘Remarkable interest’: Madrigal touts early launch progress for first MASH drug Rezdiffra despite VA hurdle


Lilly gets a date with FDA to discuss Alzheimer's med donanemab


Nominations for Fierce Biotech's 2024 Fierce 15 are now open!


Vertex's Casgevy launch progresses as CF business posts impressive growth 


A surprise leader for April's largest TV drug ad spender as Otsuka, Lundbeck knock AbbVie from its perch 

 

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‘Remarkable interest’: Madrigal touts early launch progress for first MASH drug Rezdiffra despite VA hurdle

With $1.1 billion cash on Madrigal Pharmaceuticals’ balance sheet, CEO Bill Sibold believes the company can “fully resource” the launch of Rezdiffra, the first FDA-approved therapy for fatty liver disease.
 

Top Stories

Lilly gets a date with FDA to discuss Alzheimer's med donanemab

Mark your calendars: Eli Lilly will come before the FDA’s advisory committee to discuss Alzheimer’s disease medicine donanemab June 10.

Nominations for Fierce Biotech's 2024 Fierce 15 are now open!

Fierce 15 is here! Nominations are open now in search of the best and brightest in biotech.

Vertex's Casgevy launch progresses as CF business posts impressive growth

As of mid-April, Vertex said it had collected 5 patients' cells for eventual treatment with sickle cell disease therapy Casgevy. That puts Vertex ahead of its gene therapy rival bluebird bio, which recently said it had collected just one patient's cells for its own SCD treatment Lyfgenia.

A surprise leader for April's largest TV drug ad spender as Otsuka, Lundbeck knock AbbVie from its perch

Otsuka and Lundbeck’s atypical antipsychotic Rexulti has taken the crown away from AbbVie as the largest TV drug ad spender in April, according to the latest data out from real-time ad trackers iSpot.TV.

Zenas adds $200M series C to reach a bucket of key readouts for lead monoclonal antibody

Zenas BioPharma has raised a $200 million series C to fund further clinical development of its lead autoimmune treatment. The company expects four mid-to-late-stage readouts before 2026.

Krystal Biotech touts topical gene therapy uptake, plots overseas launches

The topical gene therapy has pulled in nearly $100 million during its first three quarters on the U.S. market. Meanwhile, Vyjuvek is currently under review in Europe, and a filing in Japan is planned for later this year.

FDA advisers to weigh first psychedelic therapy in early June

Lykos Therapeutics’ MDMA-assisted therapy is charting yet another first in the psychedelic field: an FDA advisory meeting. 

Outset Medical rebounds on new FDA clearance for dialysis cart

Outset Medical has resumed distributing its portable dialysis machine after halting sales last summer, now that it’s obtained a necessary green light from the FDA.

Kenvue maps out hundreds of layoffs as service pact with J&J winds down

Kenvue’s board of directors on Monday approved a plan to cut 4% of the company’s global workforce. The J&J spinoff employed about 23,000 staffers at the end of last year, so the layoff initiative could affect some 920 workers. 

Vertex files FDA approval ask for next-gen cystic fibrosis candidate, resumes diabetes cell therapy trial

Vertex Pharmaceuticals is ahead of schedule, filing a new drug application for its next-gen cystic fibrosis (CF) treatment, dubbed vanza triple.
 
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A closer look at 2023's top biopharma deals and what lies ahead

This week on "The Top Line," we're diving into the details of the spree of big-money biopharma deals in 2023 and examining what that means for this year.
 

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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.
 

Industry Events

Drug Development Boot Camp® VIRTUAL | Spring 2024

April ‌10-11, ‌2024

On Helix

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

 

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