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FDA has granted 510(k) clearance to MiniMed Go app, powering the MiniMed Go Smart MDI system that integrates the InPen smart insulin pen with Abbott’s Instinct glucose sensor for diabetes management; commercial launch expected in spring of 2026
The MiniMed Go system is cleared for people with insulin-requiring type 1 & type 2 diabetes…
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BMS reported topline P-III (SCOUT-HCM) trial data evaluating Camzyos (mavacamten) in 44 adolescents (12 to <18yrs.) with symptomatic oHCM, comprising a 28wk. PBO-controlled phase, an ongoing 28wk. active-treatment phase, & a 144wk. open-label LTE
Trial met its 1EP, showing reduced Valsalva LVOT gradient at Wk. 28, & achieved statistical significance across multiple 2EPs, incl.…
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SciNeuro has entered into a global licensing & collaboration deal with Novartis to advance its amyloid beta-targeted antibody program for Alzheimer’s disease
The program has identified de novo antibody candidates using SciNeuro’s blood–brain barrier shuttle tech, with Novartis leading global development & commercialization after collaboration on early development
As per the deal, SciNeuro will…
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The US FDA has accepted the NDA of Merck KGaA's Pimicotinib (PO) for the systemic treatment of adults with TGCT following NMPA approval
NDA was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which Part 1 randomized 94 pts…
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RemeGen has granted AbbVie exclusive rights to develop, manufacture, & commercialize RC148 outside of the Greater China
In return, RemeGen will receive $650M upfront, ~$4.95B in development, regulatory, & commercial milestones, with tiered, double-digit royalties on sales in AbbVie’s licensed areas
RC148 is a PD-1/VEGF-targeted bispecific antibody that is being developed as a monotx.…
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As 2025 wrapped up, the final quarter made one thing clear: biopharma is doubling down on scale, science, and speed. From October to December, the industry saw a surge in high-value M&A and strategic collaborations, with companies racing to strengthen pipelines across neuroscience, oncology, metabolic diseases, and next-generation platforms
The quarter was led by…
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J&J has reported longer follow-up results from Cohorts D & E of the P-Ib/II (OrigAMI-1) trial assessing Rybrevant (amivantamab-vmjw; IV) ± FOLFOX/FOLFIRI in pts with RAS/BRAF wild-type mCRC
At mFU of 16mos., Rybrevant + FOLFOX (n=20) or FOLFIRI (n=23) achieved a cORR of 51%, with early responses & median time to first response of 8.3wks.,…
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The EC has approved Sanofi's Teizeild (Tzield outside the EU) to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regions
Approval was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32)…
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Madrigal has entered into an exclusive global license agreement with Pfizer for ervogastat (PF-06865571; PO) to treat metabolic dysfunction-associated steatohepatitis (MASH)
As per the deal, Madrigal will receive an exclusive global license to develop, manufacture & commercialize ervogastat & 2 additional early-stage MASH assets, paying Pfizer $50M upfront with further milestone payments & net…
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The P-I/II (TWINPEAK) trial data assessed spevatamig alone & in combinations to treat advanced gastric, GEJ, pancreatic ductal or biliary tract adenocarcinomas in the US
As of Dec 12, 2025, 107 pts received spevatamig alone or in combination; 42 with 1L mPDAC were treated with spevatamig + GnP, with spevatamig (2mg/kg, QW) data presented…

