GSK: Blenrep’s Return Is Just The Start Of Our Oncology Renaissance

 

GSK’s antibody-drug conjugate looks set for a blockbuster future in multiple myeloma after an approval in the UK, and the company’s head of oncology says it is already planning for the next generation of therapies.

Novotech CEO On Flexible Trial Solutions Amid Tariff, Geopolitical Tensions

 

Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.

In Brief: Bioxodes To Take Novel Hemorrhagic Stroke Drug Into Registrational Trial

 

The Belgium-based firm will take the first-in-class drug, based on tick saliva, targets inflammation without increasing bleeding, into a Phase IIb trial is in preparation, supported by a new series B funding round.

Sanofi Spends Big In US But Offers Crumbs Of Comfort For Europe

 
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CFO François Roger tells Scrip the French drugmaker is flexible geographically on making investments but its spend in the US has risen regardless of the threat of tariffs.


Japan Market Entry: Consortium’s One-Stop Shop To Support Foreign Entrants

 
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Japanese CDMO Bushu talks about a consortium designed to provide a broad range of development services to smaller foreign firms looking to bring high-need drugs to the Japanese market.

Bristol’s Growth Plans Take A Hit As Cobenfy Fails As A Schizophrenia Add-On

 
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Cobenfy is approved as a monotherapy, but failed in the adjunctive setting when combined with generic atypical antipsychotics, giving BMS a second Phase III failure in two weeks.

Sebela’s Tegoprazan Poised For GERD Market

 

Two Phase III trials testing tegoprazan read out positively, but the potassium-competitive acid blocker will compete with Phathom’s Voquezna (vonoprazan).

Veraxa Takes SPAC Route To Develop Bispecific ADCs and T-Cell Engagers

 

The Swiss biotech firm could go public on the NASDAQ later this year, and points to other preclinical dealmaking in the space to back its strategy.


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.

Europe Pharma Heavyweights Call For Higher Drug Prices At Home

 
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Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.

MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

 
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The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.

Roche US Exports To Exceed Imports After New $50bn Investment

 

A brand new R&D center in Massachusetts and a giant manufacturing site for its future obesity drugs are among the key investments in the US.


Enhertu Takes The First-Line Throne In HER2 Metastatic Breast Cancer

 

AstraZeneca and Daiichi’s DESTINY-Breast09 trial testing Enhertu with pertuzumab versus standard of care showed a statistically significant and meaningful PFS improvement.

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
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The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Japan’s Ciconia Seeks Academic Candidates To Hatch In Global Market

 
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Japanese incubator Ciconia has just started verifying its first drug candidate with a vision of building domestic startups with globally competitive assets.

In Brief: BriaCell’s Breast Cancer Cell Therapy Boosts Survival In Phase II

 

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.


China’s Biotech Stocks Proved More Resilient Than US’s Amid Market Turmoil

 

Start-ups from China dominated the fastest-growing share prices for mid-cap biopharma companies in Q1, while the biggest decliners were mainly US firms.

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

AstraZeneca Logs Japan Growth Despite Price Cuts

 
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AstraZeneca logs growth in Japan despite a big reimbursement price cut for one of its top sellers and expects 40 approvals in the country over the next six years.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.