New Products
Vertex, Bristol Myers and Regeneron updated investors on launches underway, while Sanofi CEO Paul Hudson assured investors on the late-stage pipeline.
Sun launches tildrakizumab, its star psoriasis therapy in India seven years after US FDA approval at what’s seen as a carefully calibrated price point. Can it ruffle entrenched products like secukinumab?
If approved, VER-01 would be the first cannabinoid-based therapy for chronic low back pain.
With the help of a purchased priority review voucher, the drug looks likely to become the first aldosterone synthase inhibitor to receive regulatory authorization, ahead of Mineralys' lorundrostat.
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.
The agency’s approval of Imfinzi combined with chemotherapy makes it the only immunotherapy for perioperative gastric and gastroesophageal cancers.
US FDA approval of the intrathecal formulation of Zolgensma means many more patients with spinal muscular atrophy will be eligible for the gene therapy.
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.
The US FDA’s accelerated approval makes sevabertinib the second drug for that patient segment after BI’s Hernexeos, which won accelerated approval in August.
Novartis has projected 5%-6% sales growth through 2030 on the back of strong performances for some anticancers, even as MFN pricing and IRA negotiations loom.
Redemplo is Arrowhead’s first commercial product, and the drug will enter a competitive market. Arrowhead and Ionis have taken different pricing paths, however.
Five-year Agamree data shows the novel steroid is a safer and equally effective treatment to standard of care deflazacort or prednisone, the Swiss biotech argues.
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.
The US FDA approved the menin inhibitor for NPM1-mutant relapsed/refractory acute myeloid leukemia.
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.
Do US FDA’s efforts at simplifying the biosimilar pathway create more competition and threaten Aurobindo Pharma's return on investments? Management speaks on this, biosimilar filing plans and deal strategy at the Q2 FY26 earnings call
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.
Boehringer’s PDE4B inhibitor Jascayd was approved for IPF in China on Oct. 22, marking its second nod globally soon after the US. The German firm discusses with Scrip the opportunities and challenges in this market.
After yet another regulatory setback in its quest to bring Vafseo to non-dialysis dependent kidney disease patients in the US, Akebia said it would no longer conduct a planned Phase III trial for the commercially important population.
Other drugs could soon follow Cosentyx which will be made available at a 55% discount off list price beginning Nov. 1.