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NEWS

PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia

Shots: The US FDA has accepted sBLA of ropeginterferon alfa-2b-njft for the treatment of adults with essential thrombocythemia, with a PDUFA target action date of Aug 30, 2026 sBLA is supported by the statistically significant and clinically meaningful data from the P-III (SURPASS-ET) trial as well as North American P-IIb (EXCEED-ET) trial  Ropeginterferon alfa-2b-njft received…
January 14, 2026

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NEWS

Zonsen PepLib Biotech Grants Novartis Global License for Radioligand Therapy Asset with $50M Upfront

Shots: Zonsen PepLib Biotech has entered into a worldwide license agreement with Novartis for an undisclosed peptide-based radioligand therapy asset As per the deal, Novartis will obtain exclusive worldwide rights & lead the development & commercialization activities for the undisclosed asset In return, PepLib will receive $50M upfront, with additional development, regulatory, & sales milestone payments,…
January 14, 2026

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NEWS

Summit Therapeutics Reports the US FDA’s BLA Submission for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has received BLA of ivonescimab + CT for ≥2L treatment of pts with EGFR-mutated locally advanced or metastatic non-squamous NSCLC; decision is expected by Q4’26 BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC…
January 13, 2026

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BMS
NEWS

BMS Reports P-III (SCOUT-HCM) Trial Findings on Camzyos for Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: 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.…
January 13, 2026

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NEWS

SciNeuro Forges ~$1.7B Deal with Novartis to Advance Therapeutics for Alzheimer’s Disease

Shots: 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…
January 13, 2026

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NEWS

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

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INSIGHTS+

PharmaShots Q4 2025 Highlights 

Shots:  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…
January 12, 2026

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NEWS

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

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