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R&D


CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
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CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.

AstraZeneca’s Truqap Trips Up In Prostate Cancer Study

 
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The AKT inhibitor proves ineffective for metastatic castration-resistant disease in a Phase III trial.

EU Approves Tremfya In Third Indication, Ulcerative Colitis

 

J&J secures EU approval for its IL-23 inhibitor Tremfya for ulcerative colitis, its third indication in the region, amid strong competition in the sector. EU approval is also awaited for Crohn’s disease.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
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Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Business


Pfizer CEO Bourla ‘Cautiously Optimistic’ About Tariffs, Pricing Policies

 
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Bourla said the pharma industry may be able to negotiate productive solutions to Trump tariff and drug pricing concerns. He asserted anti-science views are not shared by all in the administration.

Abeona Sets $3.1m Price For Rare Skin Disorder Gene Therapy

 
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Abeona plans to offer an outcomes-based payment model for Zevaskyn, which likely will see complementary use with Krystal’s Vyjuvek in recessive dystrophic epidermolysis bullosa patients.

Another CRL Prompts Questions About Regeneron’s Regulatory Operations

 

CEO Len Schleifer explained on the company’s Q1 earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

Scrip Originals


Stock Watch: Sanofi, Merck Open Windows Into Geopolitical Risks

 
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First-quarter results season featured tariff talk but without any full-year quantitation. As tariffs and foreign exchange movements bump up against capped drug prices, profitability could suffer.

Pipeline Watch: Five Approvals And One Phase III Readout

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Executives On The Move: Ten CMOs And Three CEOs and CFOs Each Among This Week’s Changes

Recent moves in the industry include C-suite changes at Dyne Therapeutics, City Therapeutics and ProQR Therapeutics, plus Madrigal Pharmaceuticals acquires chief medical officer from Novartis.

Pipeline Watch: Eight Approvals And Three Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.