| 02.25.25 | Emalex eyes approval filing after ph. 3 Tourette win; Compounders sue FDA again after semaglutide shortage ends

Laden...

15 uren geleden

Html
Tekst

PM Tracker

Webinar: Early Commercial Planning: Mitigate Patient Access Challenges for Cell and Gene Therapies

Thursday, March 6, 2025 | 11am ET / 8am PT

While cell and gene therapies offer fresh hope to patients with serious and debilitating diseases, the process of getting to market and enabling patient access is far from simple. Don’t miss this opportunity to hear industry experts weigh in on commercial planning strategies to optimize patient access at launch. Register now to secure your spot!

Today’s Big News

Feb 25, 2025

Emalex dopamine blocker stops Tourette syndrome relapse in phase 3 win

Compounders sue FDA again over declaring end of shortage for Novo's semaglutide

Tandem Diabetes Care insulin-dosing algorithm nets FDA clearance for Type 2 diabetes

Grail goes ‘Grey’s’: Actor Kate Walsh joins awareness campaign for multi-cancer early detection testing

Eli Lilly makes Zepbound vials cheaper for self-paying patients

Takeda fronts $46M for 2nd small molecule collab with BridGene

FDA updates Boston Scientific’s Accolade pacemaker recall, reporting 832 injuries

Webinar: Applying Technology Advancements to Overcome Challenges in Clinical Trials

Tuesday, March 11, 2025 | 11am ET / 8am PT

In the world of clinical trials, where precision and compliance are critical, the role of technology is more important than ever. Join us to learn how to harness the latest innovations for driving efficiencies and more streamlined experiences for patients. Register now to take a deep dive into the most pressing challenges in clinical trials today!

Featured

Emalex dopamine blocker stops Tourette syndrome relapse in phase 3 win

By Darren Incorvaia

Emalex Biosciences’ dopamine blocker led to fewer patients with Tourette syndrome relapsing in a phase 3 trial, setting the stage for the Chicago-based firm to submit the drug candidate for approval later this year.

Compounders sue FDA again over declaring end of shortage for Novo's semaglutide

By Kevin Dunleavy

Compounding pharmacies aren’t surrendering their ability to create cheaper knockoff versions of Eli Lilly and Novo Nordisk’s weight loss drugs without a fight. The Outsourcing Facilities Association and a Texas-based compounder have filed a lawsuit against the FDA in U.S. District Court in Fort Worth for declaring the shortage over for Novo's semaglutide.

Tandem Diabetes Care insulin-dosing algorithm nets FDA clearance for Type 2 diabetes

By Conor Hale

Tandem Diabetes Care has secured a new FDA clearance for its insulin dose-calculating algorithm, opening up its use to adults with Type 2 diabetes.

Grail goes ‘Grey’s’: Actor Kate Walsh joins awareness campaign for multi-cancer early detection testing

By Andrea Park

Blood test maker Grail has recruited ‘Grey’s Anatomy’ star Kate Walsh to join a campaign focused on encouraging Gen Xers to get tested for cancer as early as possible.

Webinar: Unlocking the Power of Softgels in Drug Lifecycle Management

Tuesday, March 11, 2025 | 11am ET / 8am PT

Softgels have emerged as a versatile dosage form, yet they are often overlooked. This webinar will explore the role of softgels in both early-stage and post-approval lifecycle management strategies. Learn about key considerations for launching with softgels, opportunities for post-approval switches to or from softgels, and how softgels compare to other dose forms. Register now.

Eli Lilly makes Zepbound vials cheaper for self-paying patients

By Zoey Becker

The company is adding higher-dose Zepbound options to its online pharmacy and trimming costs for its lower-dose options by $50.

Takeda fronts $46M for 2nd small molecule collab with BridGene

By James Waldron

Takeda has returned to BridGene Biosciences for another small-molecule collaboration—this time focused on immunology as well as neurology.

FDA updates Boston Scientific’s Accolade pacemaker recall, reporting 832 injuries

By Conor Hale

In addition to the previously disclosed two deaths, the FDA said in its February 21 update that the issue has also been linked to 832 patient injuries.

J&J takes Samsung Bioepis to court over claims Korean company breached Stelara biosim settlement

By Fraiser Kansteiner

As Stelara biosimilars gradually make their way on to the U.S. market, Johnson & Johnson has accused one early adopter—Samsung Bioepis—of violating the settlement that paved the way for the launch of its biologic copycat earlier this week. The alleged breach of contract has prompted J&J to take the matter to court.

Repare unveils scale of layoffs with 75% of staff and chief medical officer heading for exit

By James Waldron

For the last six weeks the shadow of potential layoffs has hung over Repare Therapeutics’ employees. Monday, staff learned that three-quarters of them are heading for the exits.

In $4.1B deal, Thermo Fisher buys 3M spinoff's filtration unit to beef up bioproduction

By Angus Liu

On the heels of a move to reduce its viral vector manufacturing workforce, Thermo Fisher is beefing up its biologics production business through a $4.1 billion acquisition.

Kiniksa adds to Sjögren’s exodus with trial termination, axes AstraZeneca asset

By Nick Paul Taylor

Kiniksa Pharmaceuticals is stopping development of a midphase autoimmune asset and returning a drug candidate to AstraZeneca as it doubles down on its cardiovascular disease pipeline.

Fierce podcasts

Don’t miss an episode

What were the biggest clinical trial flops of 2024?

This week on "The Top Line," we dive into several of the biggest failures in clinical-stage drug development last year and discuss what the biopharma industry can learn from these setbacks.

A heartwarming review of cardiovascular news, most-loved stories

How do certified community behavioral health clinics work?

Webinar: Pharmacy Considerations for Early Phase Trials

Tuesday, March 4, 2025 | 2pm ET / 11am PT

Learn expert strategies for overcoming the unique challenges of early phase clinical trials, from preparing investigational products to maintaining blinding and sourcing controlled substances. This webinar provides actionable insights to optimize pharmacy activities and ensure trial success. Register now.