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'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.
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.
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.
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.
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.
Two Phase III trials testing tegoprazan read out positively, but the potassium-competitive acid blocker will compete with Phathom’s Voquezna (vonoprazan).
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 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.
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.
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.
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.
AstraZeneca and Daiichi’s DESTINY-Breast09 trial testing Enhertu with pertuzumab versus standard of care showed a statistically significant and meaningful PFS improvement.
The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.
Japanese incubator Ciconia has just started verifying its first drug candidate with a vision of building domestic startups with globally competitive assets.
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.
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.
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 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.
BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.