NEWS

Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: 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…

January 13, 2026

AbbVie Enters PD-1×VEGF Bispecific Race with ~$5.6B Deal for Remegen’s RC148

Shots: 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.…

January 13, 2026

J&J Presents the P-Ib/II (OrigAMI-1) Trial Data on Rybrevant for Metastatic Colorectal Cancer at ASCO GI 2026

Shots: 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.,…

January 12, 2026

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Shots: 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)…

January 12, 2026

Madrigal Pharmaceuticals Broadens MASH Pipeline with Pfizer’s Ervogastat Deal

Shots: 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…

January 12, 2026

Bio Usawa Receives the Ghana FDA Approval for BioUcenta (Biosimilar, Lucentis)

Shots: The Ghana FDA has approved BioUcenta, a biosimilar version of Lucentis (ranibizumab) for diabetic macular edema, age-related macular degeneration, and diabetic retinopathy The Ghana FDA approval followed a rigorous, science-based review referencing comprehensive data previously evaluated and accepted by the EMA BioUcenta is exclusively licensed to Bio Usawa for Sub-Saharan Africa by Bioeq AG Ref: Bio Usawa | Image: Bio Usawa | Press Release Related News: CuraTeQ Biologics Reports Positive P-III study…

January 12, 2026

Phanes Therapeutics Reports P-II (TWINPEAK) Trial Data on Spevatamig + CT in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Shots: 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…

January 12, 2026

Teva and Royalty Pharma Enter Funding Agreement to Accelerate TEV-’408 Development in Vitilgo

Shots: Teva has entered into a funding agreement with Royalty Pharma to accelerate the clinical development of Teva’s TEV-’408 for the treatment of vitiligo As per the deal, Teva will receive ~$500M to support TEV-‘408 development costs, incl. $75M in R&D co-funding for a P-IIb study planned for 2026. Royalty will have an option to…

January 12, 2026

Pfizer Reports P-III (BREAKWATER) Trial Results on Braftovi (Encorafenib) Regimen for Certain Metastatic Colorectal Cancer (mCRC)

Shots: Pfizer has reported data from Cohort 3 of P-III (BREAKWATER) trial, assessing Braftovi (300mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in pts with previously untreated BRAF V600E-mutated mCRC In Cohort 3, the combination improved ORR (64.4% vs 39.2%), with 57.4% vs 34.5% achieving ≥6mos. responses; mDoR was not…

January 12, 2026

RefleXion Medical Reports the US FDA Clearance of RefleXion X2 Platform for Improved Tumor Detection

Shots: The US FDA has cleared RefleXion X2 with SCINTIX therapy for the treatment of primary & metastatic lung & bone tumors X2 platform provides a 20-fold increase in PET sensitivity, increasing detectable biological signal levels for tumor imaging & potentially broadening the population eligible for SCINTIX therapy based on imaging criteria Its wide field-of-view PET detector…

January 9, 2026

Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

AbbVie Enters PD-1×VEGF Bispecific Race with ~$5.6B Deal for Remegen’s RC148

J&J Presents the P-Ib/II (OrigAMI-1) Trial Data on Rybrevant for Metastatic Colorectal Cancer at ASCO GI 2026

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Madrigal Pharmaceuticals Broadens MASH Pipeline with Pfizer’s Ervogastat Deal

Bio Usawa Receives the Ghana FDA Approval for BioUcenta (Biosimilar, Lucentis)

Phanes Therapeutics Reports P-II (TWINPEAK) Trial Data on Spevatamig + CT in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Teva and Royalty Pharma Enter Funding Agreement to Accelerate TEV-’408 Development in Vitilgo

Pfizer Reports P-III (BREAKWATER) Trial Results on Braftovi (Encorafenib) Regimen for Certain Metastatic Colorectal Cancer (mCRC)

RefleXion Medical Reports the US FDA Clearance of RefleXion X2 Platform for Improved Tumor Detection

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