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Business Strategy

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Seagen, Astellas Data Support Broader Indication For Padcev/Keytruda Combo

With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval plus a move into first-line therapy.

Clinical Trials Business Strategies

Deal Watch: Merck KGAA Teams With AI Biotechs On Drug Discovery Efforts

Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.

Deal Watch Business Strategies

BenevolentAI Still Bullish As CEO Shields Steps Down

BenevolentAI has added Merck KGaA to its list of partners but the UK firm is looking for a new CEO after Joanna Shields decided to leave as a major restructuring continues.

Artificial Intelligence Business Strategies

Infographic: A Snapshot Of Non-Alcoholic Steatohepatitis R&D

After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

Business Strategies Drug Approval Standards

A Look Into The Future Of NASH

The liver disease is one of the hottest areas of drug development. Here are some upcoming catalysts to look out for.

Business Strategies Clinical Trials

All Systems Go At Almirall To Enter Tough Atopic Dermatitis Market With Ebglyss

Following a positive opinion from the CHMP, the Spanish company is hoping to launch its challenger to Dupixent in the EU before the end of the year.

Immune Disorders Business Strategies

A Year And A Half After Giving Up On TAK-721, Takeda Seeks Approval In EoE

The US FDA rejected TAK-721 for eosinophilic esophagitis (EoE) in 2021, requiring another study, and Takeda ended development in 2022, but in a newly accepted NDA it is seeking a short-term treatment indication.

FDA Inflammation

Seelos Forges Ahead With SLS-002, Says Primary Endpoint Miss Due To Underpowered Trial

The company blamed lack of funding for incomplete enrollment of the Phase II study in acute suicidal ideation and behavior in major depressive disorder, saying it would have reached statistical significance had it fully enrolled.

Clinical Trials Business Strategies

Novartis Drops BeiGene PD-1 Asset Tevimbra As Drug Wins Esophageal Cancer Nod In Europe

The Swiss drug maker’s decision to give back rights to tislelizumab means BeiGene goes without the potentially $1.55bn in milestone payments the companies had agreed to in early 2021.

ImmunoOncology Deals

Administrative Burden, Class-Wide Impacts Are Among IRA Pitfalls

As Medicare drug price negotiations creep closer to reality, industry leaders are turning attention to the challenges of implementation and commercial concerns.

Pricing Debate Politics

Anthos Changing Course With Factor XIa Inhibitor, Targeting Atrial Fibrillation Patients First

With a Phase II study stopped for efficacy in bleeding reduction, Anthos hopes to bring abelacimab, a dual Factor XI/XIa inhibitor to market to prevent strokes in a-fib patients and to treat cancer patients with thrombosis.

Business Strategies Clinical Trials

BioAge Looks To Tackle Diseases Of Aging, Starting With Muscle Loss

Emerging Company Profile: BioAge has Phase Ib proof-of-concept data in age-related muscle loss and is gearing up for its first Phase II study, but will need fresh cash or a partner for a potential weight loss-related muscle loss study.

Companies Clinical Trials
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