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Welcome to PharmaShots Weekly
| | | Jan 19 Edition
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| | PharmaShots Weekly is your Monday signal check: a fast, story-driven run-through of the deals, data, approvals, and platforms that actually shift the biopharma landscape.
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Boston Scientific’s $14.5B Power Play in Cardiovascular Care
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| | AbbVie Scores Big: $5.6B RC148 Oncology License
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| | Novartis Targets the Brain: SciNeuro Alzheimer’s Collaboration
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| | Madrigal Strengthens MASH Pipeline with Pfizer’s Ervogastat
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Stay Curious.
| | | Stay informed!
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| | Stay ahead with PharmaShots Weekly!
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Top Stories This Week
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| • | Boston Scientific Makes a $14.5B Bet on Cardiology with Penumbra Acquisition
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| • | AbbVie Lands RemeGen’s RC148 in a Potential $5.6B Global Oncology Deal
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| • | Novartis Bets Big on SciNeuro’s BBB-Shuttle Antibodies in Alzheimer’s Deal
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| • | Madrigal Secures Pfizer’s Ervogastat to Expand Its MASH Leadership
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Cover Story
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J.P. Morgan Healthcare Conference 2026
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| • | Where Strategy Replaced Storytelling
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| • | Capital discipline, platform plays, and execution-led growth
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Big Deals & Strategic Moves
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| • | Boston Scientific × Penumbra — $14.5B cardio expansion
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| • | AbbVie × RemeGen — $5.6B RC148 oncology license
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| • | Novartis × SciNeuro — Alzheimer’s BBB-shuttle collaboration
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| • | Madrigal × Pfizer — Ervogastat strengthens MASH pipeline
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| • | Teva × Royalty Pharma — $500M vitiligo funding pact
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| • | Genethon × AskBio — Next-gen gene therapy for Pompe
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| • | Novartis × Zonsen PepLib — Radioligand peptide licensing
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| • | Agenus × Zydus — BOT+BAL advances to Phase III in mCRC
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Clinical Trial Readouts
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| • | BRAF V600E–mutated mCRC — Phase III BREAKWATER (Pfizer)
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| • | Advanced GI Adenocarcinomas — TWINPEAK Phase I/II (Phanes)
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| • | RAS/BRAF WT mCRC — OrigAMI-1 long-term follow-up (J&J)
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| • | Adolescent oHCM — SCOUT-HCM Phase III topline (BMS)
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| • | TROP2+ NSCLC — TROPION-Lung17 Phase III initiated (Daiichi Sankyo)
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| • | r/r Multiple Myeloma — MajesTEC-9 Phase III success (J&J)
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| • | NSCLC Immunotherapy — ANKTIVA + CPI QUILT studies (ImmunityBio)
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| • | Dry AMD (GA) — ArMaDa Phase II gene therapy update (Ocugen)
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Regulatory Watch
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Regulatory Wins: A Wave of Global Approvals and Key Filings
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| • | FDA, EMA, China, and Swissmedic decisions across oncology, rare diseases, CNS, diabetes, and biosimilars
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MedTech Update
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MedTech Milestones: Regulatory Clearances Driving Next-Gen Care
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| • | Medtronic MiniMed Go System
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| • | BD EnCor EnCompass breast biopsy platform
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Week-in-Review
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JPM 2026 Takeaways
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| • | Relentless execution across pharma and MedTech
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Stay Ahead with PharmaShots Weekly
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| • | Why Leaders Choose PharmaShots
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| • | Subscribe • Share • Stay Informed
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JPM 2026: Where Strategy Replaced Storytelling
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The 44th J.P. Morgan Healthcare Conference set a clear tone for 2026: execution over optimism, platforms over single assets, and capital efficiency over scale for scale’s sake.
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Across boardrooms and side meetings, leaders doubled down on late-stage confidence, de-risked pipelines, and adjacent platform expansion—a theme reflected in the surge of high-conviction deals and disciplined licensing structures announced around the conference. Cardiovascular interventions, oncology combinations, radioligands, immunology, and CNS delivery technologies emerged as focal points, with buyers prioritizing clinical validation and commercial fit.
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Notably, capital strategy took center stage. Creative financing, royalty-backed funding, and regional licensing models highlighted a shift toward risk-sharing and balance-sheet discipline, while large-cap pharma leaned into partnerships that accelerate timelines without overextending internal R&D.
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The message from JPM 2026 was unambiguous: growth in 2026 and beyond will be defined by precision, proof, and speed. Companies that can translate differentiated science into late-stage data—and pair it with smart capital deployment—are poised to set the pace for the next cycle of healthcare innovation.
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| | PharmaShots | J.P. Morgan Healthcare Conference 2026 Highlights
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JPM 2026: Where the Future of Healthcare Took Shape
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From decisive pipeline strategies to boardroom-level dealmaking, the 44th Annual J.P. Morgan Healthcare Conference (January 12–15 | San Francisco) set a clear trajectory for healthcare in 2026 and beyond. The focus shifted from narrative to execution—where late-stage confidence, platform scalability, and capital discipline defined leadership agendas.
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PharmaShots has distilled the conference into a comprehensive, insight-driven report capturing the most consequential signals across the healthcare ecosystem. The analysis spans strategic priorities, pivotal clinical milestones, regulatory outlooks, and deal dynamics that emerged across pharma, biotech, and MedTech.
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Preview Available: Sample JPM 2026 Report
As a snapshot of what the full analysis delivers, PharmaShots is releasing a sample report focused on Metabolic and Endocrine presentations—demonstrating the depth, clarity, and decision-ready intelligence embedded in the complete JPM 2026 coverage.
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What the Full JPM 2026 Report Delivers
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| • | Breakthrough clinical developments shaping near- and mid-term pipelines
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| • | Regulatory submission strategies and approval trajectories
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| • | High-conviction deals, partnerships, and strategic intent beyond the headlines
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This is not a conference recap—it’s a strategic playbook built for leaders navigating investment, R&D, and competitive decisions in 2026.
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Access & Inquiries
To access the full paid JPM 2026 report or request a customized conference analysis, contact [email protected]
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| | Boston Scientific Bolsters Cardio Portfolio: $14.5B Penumbra Acquisition
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Boston Scientific Makes a $14.5B Bet on Cardiology with Penumbra Acquisition
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A Game-Changer in Thrombectomy and Embolization Tech
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Boston Scientific signs a definitive agreement to acquire Penumbra at $374 per share, with stockholders electing either cash or 3.8721 shares of Boston Scientific stock. The deal values Penumbra at an enterprise value of ~$14.5 billion and is expected to close in 2026. It significantly broadens Boston Scientific’s cardiovascular offerings with Penumbra’s mechanical thrombectomy and embolization technologies.
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Why This Acquisition Matters
The transaction supercharges Boston Scientific’s cardio lineup by integrating Penumbra’s cutting-edge assets for clot removal and bleeding control:
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| • | Pipeline boost: Best-in-class Lightning Bolt and Lightning Flash CAVT systems for arterial, venous, and pulmonary thrombectomy.
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| • | Strategic fit: Adds minimally invasive embolization platform for vessel closure and hemorrhage management.
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| • | Deal value: $14.5 billion enterprise value at $374/share (cash or stock election).
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| • | Timeline: Closure anticipated in 2026, subject to approvals.
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A Strategic Step Forward
This acquisition fuses Penumbra’s innovative thrombectomy and embolization platforms with Boston Scientific’s development muscle, positioning the company to lead in high-stakes cardiovascular interventions where unmet needs persist.
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AbbVie Lands RemeGen’s RC148 in a Potential $5.6B Global Oncology Deal
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Bispecific PD-1/VEGF Powerhouse Joins Portfolio
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AbbVie secures exclusive rights from RemeGen to develop, manufacture, and commercialize RC148 outside Greater China in a landmark oncology licensing pact. RemeGen gets $650 million upfront, up to ~$4.95 billion in milestones, and tiered double-digit royalties on net sales. RC148, a next-gen PD-1/VEGF bispecific antibody, targets immune checkpoint and angiogenesis inhibition for advanced solid tumors as monotherapy or combo.
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Why This Deal Matters
The agreement supercharges AbbVie’s oncology arsenal with a differentiated bispecific:
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| • | Pipeline boost: RC148 for solid tumors (mono/combo regimens).
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| • | Strategic fit: Bolsters AbbVie’s global immuno-oncology leadership ex-Greater China.
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| • | Deal value: $650 million upfront + $4.95 billion milestones + double-digit royalties.
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| • | Timeline: Advances RemeGen’s asset into AbbVie’s development pipeline.
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A Strategic Step Forward
This high-stakes license fuses RemeGen’s bispecific innovation with AbbVie’s oncology prowess, paving the way for transformative therapies in solid tumors where dual-targeting could redefine standards of care.
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Novartis Bets Big on SciNeuro’s BBB-Shuttle Antibodies in Alzheimer’s Deal
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Global License Targets Enhanced Brain Delivery
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Novartis inks a global licensing and collaboration with SciNeuro for amyloid beta–targeted antibodies in Alzheimer’s, powered by proprietary BBB-shuttle tech for superior CNS penetration. Joint early development yields de novo candidates; Novartis then drives global development and commercialization. SciNeuro nets $165 million upfront, research funding, up to ~$1.5 billion in milestones, and tiered royalties. Deal closes H1 2026.
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Why This Deal Matters
The pact accelerates Novartis’ Alzheimer’s push with brain-optimized antibodies:
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| • | Pipeline boost: BBB-shuttled anti-amyloid betas for improved CNS exposure.
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| • | Strategic fit: Novartis takes late-stage reins post-joint early work.
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| • | Deal value: $165 million upfront + $1.5 billion milestones + royalties.
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| • | Timeline: Closure in H1 2026; advances to clinical stages.
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A Strategic Step Forward
Blending SciNeuro’s shuttle innovation with Novartis’ neuro expertise unlocks potential breakthroughs in Alzheimer’s, where crossing the BBB remains a critical hurdle for transformative therapies.
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Madrigal Secures Pfizer’s Ervogastat to Expand Its MASH Leadership
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Global License Bolsters Combo Therapy Pipeline
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Madrigal enters an exclusive global licensing agreement with Pfizer for ervogastat (PF-06865571; oral), fortifying its MASH dominance. Madrigal gains worldwide rights to develop, make, and sell ervogastat plus two early-stage MASH assets; Pfizer gets $50 million upfront, milestones, and royalties. Phase II data showed 150 mg delivering ≥30% liver fat reduction in 72% of patients and ≥50% in 61%, with gains in enzymes and stiffness.
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Why This Deal Matters
The license arms Madrigal with a validated oral asset for MASH combo strategies:
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| • | Pipeline boost: Ervogastat (Ph2-proven) + two early MASH programs.
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| • | Strategic fit: Enables Rezdiffra combos; DDI study and Ph2 trial design slated for 2026.
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| • | Deal value: $50 million upfront + milestones/royalties to Pfizer.
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| • | Timeline: FDA engagement and combo Ph2 planning in 2026.
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A Strategic Step Forward
Pairing Pfizer’s ervogastat with Madrigal’s Rezdiffra expertise unlocks next-gen MASH regimens, targeting superior outcomes in a field ripe for differentiated liver therapies.
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Teva Secures $500M Boost to Fast-Track Vitiligo Program with Royalty Pharma
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Royalty Funding Powers TEV-’408 Phase IIb Push
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Teva enters a strategic funding agreement with Royalty Pharma, receiving ~$500 million to accelerate TEV-’408 development for vitiligo—including $75 million in R&D co-funding for a Phase IIb study in 2026. Royalty Pharma holds an option for up to $425 million more to co-finance Phase III, contingent on Phase IIb data. In exchange, Teva pays milestones and royalties post-approval.
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Why This Deal Matters
The partnership fuels Teva’s immunology pipeline with first-in-class anti-IL-15 monoclonal antibody TEV-’408 (Phase Ib vitiligo, Phase IIa celiac):
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| • | Pipeline boost: Advances high-unmet-need vitiligo program with 2026 Phase IIb readout.
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| • | Strategic fit: Expands TEV-’408 into celiac and beyond as a differentiated asset.
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| • | Deal value: $500 million upfront (scalable to $925 million) for milestones/royalties.
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| • | Timeline: Phase IIb study launches 2026; data expected same year.
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A Strategic Step Forward
This infusion blends Royalty Pharma’s capital with Teva’s expertise, fast-tracking TEV-’408 to deliver novel therapies in autoimmune diseases where patients await breakthrough options.
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Genethon–AskBio Alliance Advances Next-Generation Gene Therapy for Pompe Disease
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Licensing Deal Unlocks CNS-Penetrant Pompe Therapy
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Genethon enters an exclusive worldwide licensing agreement with AskBio, granting use of a patented transgene from AB-1009 for Pompe disease treatment. The Genethon-developed truncated GAA transgene shows strong preclinical efficacy, correcting glycogen buildup in muscle and CNS while improving cardiac, muscular, and respiratory function. AskBio advances the program to clinic, with first patient dosing eyed for early 2026.
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Why This Deal Matters
The alliance propels a one-time gene therapy for Pompe by combining Genethon’s transgene with AskBio’s platform:
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| • | Pipeline boost: CNS-active truncated GAA corrects multi-tissue pathology in preclinical models.
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| • | Strategic fit: Enables AskBio’s pivot to clinical-stage Pompe program.
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| • | Deal value: Exclusive global license for transformative gene therapy asset.
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| • | Timeline: First-in-human trial enrollment in early 2026.
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A Strategic Step Forward
This partnership merges Genethon’s innovative transgene with AskBio’s AAV expertise, positioning the duo to pioneer a game-changing therapy for Pompe patients facing limited durable options.
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Novartis Expands Radioligand Pipeline with Zonsen PepLib Peptide Licensing Deal
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Global Rights Bolster Targeted Radiopharma Arsenal
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Novartis secures a worldwide license from Zonsen PepLib Biotech for an undisclosed peptide-based radioligand therapy asset, amplifying its radiopharma leadership. Novartis gains exclusive global rights and drives development/commercialization via its proven infrastructure. PepLib receives $50 million upfront, plus development/regulatory/sales milestones and tiered royalties on net sales.
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Why This Deal Matters
The license deepens Novartis’ oncology toolkit with next-gen peptide radioligands:
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| • | Pipeline boost: Undisclosed peptide RLT for targeted cancer therapy.
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| • | Strategic fit: Leverages Novartis’ radioligand expertise for rapid advancement.
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| • | Deal value: $50 million upfront + milestones + tiered royalties.
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| • | Timeline: Feeds into Novartis’ established radiopharma pipeline.
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A Strategic Step Forward
This agreement harnesses PepLib’s peptide innovation within Novartis’ radiopharma engine, fueling precision oncology advances where targeted therapies are reshaping tumor control.
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Agenus–Zydus Alliance Gains Momentum as BOT+BAL Advances to Phase III
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mCRC Immunotherapy Hits Pivotal Trial Milestone
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Agenus solidifies its strategic collaboration with Zydus Lifesciences, unlocking global development for BOT+BAL immunotherapy. Zydus paid $75 million upfront for Agenus’ U.S. biologics facilities, plus up to $50 million production milestones; added a $16 million equity investment (~2.1M shares); and gained exclusive BOT+BAL rights in India/Sri Lanka (Agenus gets 5% royalties). Ph3 BATTMAN trial now enrolling in 3L+ MSS mCRC (no active liver mets).
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Why This Deal Matters
The partnership fuels BOT+BAL’s pivot to Ph3 after stellar Ph2 data (42% 2-yr OS, 21-mo median OS):
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| • | Pipeline boost: BOT+BAL combo for hard-to-treat MSS mCRC.
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| • | Strategic fit: Zydus funds facilities/India rights; Agenus leads global Ph3 with CCTG.
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| • | Deal value: $75M upfront + $50M milestones + $16M equity + royalties.
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| • | Timeline: BATTMAN Ph3 enrollment open now.
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A Strategic Step Forward
Merging Zydus’ resources with Agenus’ immuno-oncology momentum propels BOT+BAL toward registration, offering hope for MSS mCRC patients underserved by current standards.
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| | Clinical Trial Readouts That Signal the Next Shift in Medicine
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P-III BREAKWATER Cohort 3 by Pfizer
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BRAF V600E-Mutated mCRC
Insights from P-III BREAKWATER Cohort 3 by Pfizer
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Pfizer has reported data from Cohort 3 of the Phase III BREAKWATER trial, assessing Braftovi (300 mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in patients with previously untreated BRAF V600E-mutated metastatic colorectal cancer (mCRC).
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Key Findings
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| • | Improved ORR: 64.4% vs 39.2%, with 57.4% vs 34.5% achieving responses ≥6 months.
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| • | mDoR and OS: mDoR not estimable for both arms; OS descriptive (median follow-up ~10 months for both).
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| • | Presentation and status: Results presented at ASCO GI’26; trial ongoing with completion expected in 2027.
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These results position Braftovi combinations as a promising frontline option in BRAF V600E-mutated mCRC, addressing a high-unmet-need population where better response durability could shift standards of care.
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Advanced Adenocarcinomas
P-I/II TWINPEAK Data on Spevatamig by Phanes Therapeutics
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Phanes Therapeutics highlighted Phase I/II TWINPEAK trial data assessing spevatamig alone and in combinations for advanced gastric, gastroesophageal junction (GEJ), pancreatic ductal (PDAC), or biliary tract adenocarcinomas in the US. As of Dec 12, 2025, 107 patients received spevatamig alone or in combination; 42 with 1L metastatic PDAC (mPDAC) were treated with spevatamig + gemcitabine/nab-paclitaxel (GnP), with 2 mg/kg QW data presented at ASCO GI’26 (3 mg/kg QW data maturing).
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Key Findings (1L mPDAC, spevatamig 2 mg/kg QW + GnP; n=15)
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| • | DCR and ORR: 93% DCR; 40% ORR (6 PRs, 1 pending confirmation).
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| • | PFS and OS: 6-month PFS rate 59% (mPFS 7.3 months); 6-month OS rate 93% (mOS 13.2 months, maturing).
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| • | Biomarker note: Responses seen in CLDN18.2 ≥10% patients (85% of cohort met threshold).
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These encouraging signals in 1L mPDAC underscore spevatamig’s potential as a CLDN18.2-targeted therapy in high-need GI cancers, paving the way for dose maturation and expanded trials.
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RAS/BRAF Wild-Type mCRC
Longer Follow-Up from P-Ib/II OrigAMI-1 Cohorts D & E by J&J
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J&J has reported longer follow-up results (median 16 months) from Cohorts D & E of the Phase Ib/II OrigAMI-1 trial, assessing Rybrevant (amivantamab-vmjw; IV) ± FOLFOX/FOLFIRI in patients with RAS/BRAF wild-type metastatic colorectal cancer (mCRC).
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Key Findings
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| • | Overall (Rybrevant + FOLFOX n=20 / FOLFIRI n=23): cORR 51%; median time to response 8.3 weeks; mDoR 9.3 months; mPFS 9.2 months; mOS not estimable.
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| • | Liver metastases (n=30): ORR 57%; mPFS 11.3 months.
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| • | 1L (n=11): ORR 73%; mDOR not reached; 4/11 proceeded to curative-intent surgery.
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| • | 2L (n=32): ORR 44%; mDOR 7.4 months; >33% on therapy >1 year (3 >2 years).
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These durable responses, especially in liver mets and 1L settings, reinforce Rybrevant’s role in expanding options for RAS/BRAF wild-type mCRC, with potential to enable surgery in select patients.
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Obstructive HCM in Adolescents
Topline P-III SCOUT-HCM Results by BMS
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BMS reported topline Phase III SCOUT-HCM trial data evaluating Camzyos (mavacamten) in 44 adolescents (12 to <18 years) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The trial includes a 28-week placebo-controlled phase, ongoing 28-week active-treatment phase, and 144-week open-label long-term extension (LTE).
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Key Findings
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| • | Primary endpoint (1EP) met: Reduced Valsalva LVOT gradient at Week 28.
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| • | Secondary endpoints (2EPs): Achieved statistical significance across multiple, including clinically meaningful disease aspects.
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| • | Next steps: Full data to be presented soon; discussions underway with global regulators.
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Camzyos, a selective reversible allosteric cardiac myosin inhibitor, targets HCM pathophysiology by reducing dynamic LVOT obstruction and improving cardiac filling pressures potentially transforming care for young oHCM patients with limited options.
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TROP2-Positive NSCLC
First Patient Dosed in P-III TROPION-Lung17 by Daiichi Sankyo
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Daiichi Sankyo has dosed the first patient in the Phase III TROPION-Lung17 trial evaluating Datroway for TROP2-NMR–positive locally advanced/metastatic nonsquamous NSCLC without actionable genomic alterations, previously treated with immunotherapy (IT) and platinum-based chemotherapy (Pt-CT).
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Key Details
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| • | Design: Datroway (6 mg/kg) vs docetaxel in ~400 patients across Asia, EU, and North America.
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| • | Endpoints: Dual primary endpoints of PFS and OS; key secondaries include ORR, DoR, and safety.
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TROPION-Lung17 advances Datroway’s robust NSCLC development, targeting a post-IT/Pt-CT population with high unmet need in TROP2-expressing disease.
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Relapsed/Refractory Multiple Myeloma
Positive P-III MajesTEC-9 Topline Results by J&J
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J&J has reported positive topline Phase III (MajesTEC-9) results showing Tecvayli (teclistamab) monotherapy significantly outperformed standard of care (PVd or Kd) in relapsed/refractory multiple myeloma patients with 1–3 prior therapies (all prior anti-CD38 and lenalidomide; 85% refractory to anti-CD38, 79% to lenalidomide, >90% to last therapy).
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Key Findings
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| • | PFS benefit: 71% reduction in risk of progression or death vs SoC.
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| • | OS benefit: 40% reduction in risk of death, with superior PFS and OS as early as 2L.
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| • | Safety: Clinically manageable profile consistent with prior data; no new concerns.
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Results, published in The NEJM position Tecvayli as a potential new standard in r/r MM, offering transformative early-line benefits via bispecific T-cell engagement.
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Non-Small Cell Lung Cancer
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Positive ANKTIVA + CPI Data from QUILT Studies by ImmunityBio
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ImmunityBio announced positive results from two clinical studies evaluating ANKTIVA (nogapendekin alfa inbakicept) + checkpoint inhibitors (CPI) in NSCLC across 151 patients, demonstrating statistically significant immune restoration.
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Key Findings
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| • | 1L NSCLC (QUILT-2.023, randomized): Significant sustained ALC increase with ANKTIVA + CPI vs CPI alone (p=0.0065), confirming role as lymphocyte-stimulating agent.
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| • | 2L+ NSCLC (QUILT-3.055, single-arm): ALC restoration/maintenance (≥1.0 ×10³ cells/µL) in 77%; responders had longer OS vs non-responders (mOS 16.2 vs 11.8 months; HR=0.52; p=0.0369).
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| • | Immune competence benefit: Patients with ALC ≥1.2 ×10³ cells/µL achieved mOS of 21.1 months; Phase III ResQ201A confirmatory study ongoing.
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These data highlight ANKTIVA’s potential to enhance CPI efficacy in NSCLC via immune restoration, addressing a critical need in both early- and later-line settings.
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Geographic Atrophy in Dry AMD
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Preliminary 12-Month P-II ArMaDa Data by Ocugen
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Ocugen has reported preliminary 12-month data from its Phase II (ArMaDa) trial (n=51) of OCU410 (AAV5-RORA) in geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), with ~50% of patients evaluated to date.
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Key Findings
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| • | GA lesion growth reduction: 46% overall vs control (medium + high dose); 54% with medium dose.
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| • | Response rates: 50% of patients achieved >50% lesion size reduction; subgroup (n=14, ≥7.5 mm² baseline) showed 57% greater reduction.
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| • | Phase I confirmation (n=9): 60% slower ellipsoid zone (EZ) loss in treated vs untreated eyes; reduced EZ-RPE loss.
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Next steps: Full Phase II data by late Q1’26; Phase III initiation in 2026; BLA filing planned for 2028. These results position OCU410 as a promising one-time gene therapy for dry AMD GA.
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| | Regulatory Wins: A Wave of Global Approvals and Key Filings
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Regulatory Milestones That Are Reshaping Global Healthcare
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From first-in-class therapies to biosimilars and lifecycle expansions, regulators across the U.S., Europe, China, and Switzerland delivered a strong set of approvals and acceptances, underscoring sustained momentum across diabetes, oncology, rare diseases, and CNS disorders.
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| • | Sanofi’s Teplizumab (Teizeld) received European Commission approval to delay the progression of Type 1 diabetes, reinforcing its role as a disease-modifying therapy in early-stage patients.
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| • | Merck KGaA announced the U.S. FDA’s acceptance of its NDA for pimicotinib in tenosynovial giant cell tumor (TGCT), advancing a targeted option for this rare condition.
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| • | Summit Therapeutics reported the U.S. FDA’s BLA submission for ivonescimab to treat EGFR-mutant non-squamous NSCLC, marking a key regulatory milestone for its oncology pipeline.
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| • | Ipsen secured U.S. FDA Breakthrough Therapy Designation for IPN60340 in unfit acute myeloid leukemia (AML), highlighting its potential to address a high unmet need.
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| • | Sandoz received European Commission approval for Ondibta, a biosimilar to Lantus and SoloStar, strengthening access to insulin therapies across Europe.
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| • | Emergent BioSolutions gained U.S. FDA approval of an sNDA for NARCAN Nasal Spray, introducing a new carrying case to improve accessibility in opioid overdose emergencies.
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| • | Sanofi secured China approvals for Myqorzo and Redemplo in obstructive hypertrophic cardiomyopathy (oHCM) and familial chylomicronemia syndrome (FCS), expanding its footprint in rare cardiometabolic diseases.
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| • | Sobi reported European Commission approval of Aspaveli for C3 glomerulopathy and primary IC-MPGN, broadening treatment options in rare renal diseases.
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| • | Santhera Pharmaceuticals announced Swissmedic approval of Agamree (vamorolone) for Duchenne muscular dystrophy, a milestone for patients seeking alternatives to traditional steroids.
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| • | PharmaEssentia reported the U.S. FDA’s acceptance of an sBLA for ropeginterferon alfa-2b-njft in essential thrombocythemia, supporting its expansion beyond existing indications.
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| • | Sentynl Therapeutics received U.S. FDA approval for Zycubo to treat pediatric Menkes disease, delivering a critical option for this ultra-rare, life-threatening condition.
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| | MedTech Milestones: Regulatory Clearances Driving Next-Gen Care
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MedTech Breakthroughs: Regulatory Greenlights Powering the Next Generation of Care
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This week brought notable U.S. FDA clearances in diabetes management and interventional diagnostics, highlighting continued innovation across connected care and precision MedTech solutions.
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| • | Medtronic reported U.S. FDA 510(k) clearance for the MiniMed Go System, expanding its diabetes management portfolio with a streamlined, connected solution designed to support day-to-day glucose control.
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| • | BD (Becton, Dickinson and Company) secured U.S. FDA 510(k) clearance for the EnCor EnCompass System, a next-generation breast biopsy platform aimed at improving procedural accuracy and workflow efficiency in breast cancer diagnosis.
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| | ViVE 2026: Where Healthcare Leadership Meets Technology
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ViVE 2026 is returning to Los Angeles, bringing together over 9,000 executives from across the healthcare ecosystem to explore the future of digital health and innovation. Co-created by HLTH Inc. and CHIME, the event is the premier forum where health system and payer leaders connect with innovators, investors, and solution providers driving measurable transformation in healthcare delivery.
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This is where CIOs, CTOs, CMIOs, and digital health executives come to accelerate strategy, evaluate what truly works, and build collaborations beyond the noise. In just a few days, ViVE delivers insights and connections that would otherwise take months to achieve.
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Attendees can expect thought-provoking sessions, hands-on demonstrations, and peer-to-peer networking with leaders shaping the next era of healthcare technology. From breakthrough solutions in telehealth, AI, and patient engagement to strategic discussions on digital transformation and operational efficiency, ViVE 2026 provides an immersive environment for actionable insights.
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Whether you’re looking to discover new technologies, foster partnerships, or gain executive-level insights, ViVE is the destination for those shaping what’s next in healthcare.
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Exclusive for the PharmaShots community:
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| • | Get $250 off ViVE General Attendee passes
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| • | Use discount code: V26PHARMASHOTS
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Los Angeles | 2026 – don’t miss your chance to be part of the future of digital health.
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| | That’s a Wrap for This Week
We will see you next week
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JPM 2026 Takeaways: High-Conviction Deals, Data-Driven Bets, and Relentless Execution
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This week’s edition reflects the core themes emerging from J.P. Morgan Healthcare Conference 2026: disciplined capital deployment, platform-driven dealmaking, and late-stage execution.
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Deal activity led the narrative, highlighted by Boston Scientific’s $14.5B acquisition of Penumbra, alongside high-impact licensing and funding agreements from Teva–Royalty Pharma, AbbVie–RemeGen, Madrigal–Pfizer, Novartis–SciNeuro, Novartis–PepLib, and Agenus–Zydus—signaling strong appetite for differentiated assets across cardiology, immunology, oncology, MASH, neurology, and radioligands.
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Clinical momentum accelerated with pivotal and late-stage readouts from Pfizer, J&J, BMS, Daiichi Sankyo, ImmunityBio, and Ocugen, reinforcing trends toward biomarker-driven strategies and earlier-line expansion.
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Regulatory wins and MedTech clearances across the US, EU, China, and Switzerland rounded out the week, underscoring sustained execution across pharma and devices.
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Bottom line: 2026 is shaping up to be a year of focused innovation, high-conviction deals, and data-led progress—and PharmaShots Weekly keeps it distilled, decisive, and ahead of the curve.
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Stay Ahead with PharmaShots Weekly
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The pharma industry doesn’t slow down—and neither should your intelligence. PharmaShots Weekly keeps you ahead of the curve with sharp, decision-ready insights on pipelines, regulatory moves, competitive dynamics, and strategic deal signals—all distilled into minutes, not hours.
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Join us every Monday at 8:00 AM EST for a clear view of what’s shaping the industry. If this issue sparked new thinking, make it a routine. Subscribe to PharmaShots Weekly and get insights delivered with precision—concise, credible, and built for leaders who can’t afford fragmented noise.
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Know someone in R&D, Competitive Intelligence, Strategy, or Business Development who values signal over clutter? Forward this edition. And if a takeaway resonated, share it on LinkedIn and tag us—we’re always happy to amplify informed perspectives.
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The industry moves fast.
Your intelligence should move faster.
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| | Questions?
Reach out to us [email protected] for any collaboration comments, questions, and media inquiry.
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