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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

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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.

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.

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