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FDA has approved Padcev (enfortumab vedotin-ejfv) + Keytruda or Keytruda Qlex for neoadj. & adj. treatment for cisplatin-ineligible pts with MIBC, before the PDUFA action date (Apr 07, 2026)
Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B…
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In 2025, the global Prescription Drugs market is projected to generate an impressive $1.13T, with steady annual growth of 3.94% expected through 2030, ultimately reaching $1.37T. Leading the pack is Keytruda, securing the first position with $29.48B, closely followed by Ozempic at $28.18B, and Eliquis, which recorded $20.69B in global sales. Fourth position is…
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Metsera announced entering into an amended merger agreement with Pfizer to acquire Metsera for up to $86.25 per share, including $65.60 in cash and a contingent value right of up to $20.65
Metsera’s Board of Directors noted that the U.S. Federal Trade Commission had raised potential antitrust concerns regarding Novo Nordisk’s proposed structure
After…
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Metsera has declared Novo Nordisk’s unsolicited ~$9B acquisition proposal, valuing shares up to $77.75, as a “Superior Company Proposal” than its existing Pfizer Merger Agreement
The 2-step proposal incl. an initial $56.5/share cash payment & issuance of non-voting preferred stock for 50% of Metsera’s share capital, followed by a CVR of ~$21.25/share in cash…
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Pfizer has reported P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC following induction therapy in the 1L setting
Trial met its 1EP with a significant improvement in the investigator-assessed PFS & showed favorable safety; data to…
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Pfizer has entered into a definitive agreement to acquire Metsera, expanding to obesity & cardiometabolic market
As per the deal, Metsera will receive $47.5/share, representing an enterprise value of ~$4.9B, plus a non-transferable CVR of ~$22.50/share tied to milestones: $5 on P-III start of MET-097i + MET-233i, $7 on FDA approval for MET-097i monotx.,…
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ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care
In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…
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FDA has approved sBLA of Comirnaty (LP.8.1-adapted monovalent COVID-19 vaccine) for active immunization in adults (≥65yrs) & individuals (5–64yrs) with ≥1 high-risk condition for severe COVID-19 outcomes; FDA recommends LP.8.1 for fall 2025, with vaccine shipping immediately for US availability soon
Approval was backed by extensive data, incl. trial in children (5–11yrs.), & preclinical data…
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Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being
The global Top 20 pharmaceutical leaders spent ~$180B in 2024, with Merck & Co. contributing the most with a whopping $17.93B, followed by Johnson & Johnson ($17.23B) and Roche…
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The P-III (KEYNOTE-905/EV-303) trial randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B (surgery alone), or Arm C (3 cycles of Keytruda + Padcev before surgery, followed 6 cycles of the combination, then 8 cycles of Keytruda alone)
Arms C & B showed improved…

