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Explore BCIQ profiles by entering a target name.
BioCentury | Oct 16, 2024
Data Byte
Trio of indications for Bimzelx among FDA’s September label expansions
Agency converts accelerated approvals of Filspari and Retevmo to full
BioCentury | Aug 30, 2024
Data Byte
Nine PDUFA dates on FDA’s agenda in September
Decision on Zevra’s arimoclomol follows positive AdCom vote
BioCentury | May 30, 2024
Product Development
Renal therapies get disease-specific
Endpoint innovation and success stories are driving a surge in renal disease drug development
BioCentury | Apr 30, 2024
Data Byte
EMA’s CHMP recommends Takeda VEGF therapy, Idorsia hypertension drug
April opinions also include earlier-line use of J&J’s Rybrevant and BMS’s Opdivo
BioCentury | Apr 12, 2024
Deals
In $4.9B Alpine deal, Vertex sees best-in-class therapy with room for label expansions
Buyer believes povetacicept can outshine others in BAFF/APRIL class, even if not first to market — and can become a pipeline-in-a-product
BioCentury | Apr 3, 2024
Data Byte
Last minute flurry brings FDA’s first-quarter NME approvals to 10
Highlights include accelerated approval of first MASH therapy; plus Merck’s disease-modifying PAH therapy and Idorsia’s antihypertensive
BioCentury | Sep 22, 2023
Data Byte
Data comp: two IgA nephropathy therapies aiming for full approval
Two drugs received accelerated approval for IgA nephropathy: one has met its confirmatory endpoint, the other is moving ahead despite miss
BioCentury | Sep 18, 2023
Product Development
Data comp: four hypertension candidates advancing in the clinic
Idorsia’s aprocitentan under review, while Mineralys and AZ prepare for Phase III trials and Alnylam runs two more Phase II studies
BioCentury | Sep 8, 2023
Deals
Sept. 7 Quick Takes: Seagen, Nurix in deal to create degrader-antibody conjugates
Plus: U.K. rejoins Horizon Europe and more from Mariana, Corteria, Noetik, CymaBay, J&J, Alnylam and BlueWhale
BioCentury | Sep 7, 2023
Deals
Idorsia’s hypertension lifeline
Swiss biotech Idorsia hopes near-term commercial opportunity for aprocitentan will spur investors to refinance the company
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