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THOUGHTSPOT
The Rise of Industrial Metaverse: Smarter Pharma Starts at AUTOMA+ 2025 
Digital transformation of the pharmaceutical industry is moving beyond buzzwords to real-world impact. At the Pharmaceutical Automation & Digitalisation Congress AUTOMA+ 2025 (24-25 November, Vösendorf, Austria), pharma leaders, including ZETA GmbH, Takeda and Sapio Sciences, are going to showcase how cutting-edge technologies, from digital twins and predictive analytics to minimal code platforms and AI-driven process…
September 23, 20250Comments
VIEWPOINTS
Navigating Amorphous Calcium Carbonate Therapies: Eden Ben from Amorphical in Conversation with PharmaShots 
Shots:  ACC therapies introduce a novel treatment approach by modulating local pH, promoting bone remodeling, and reducing inflammation, with potential applications in osteoarthritis, calcium deficiencies, late-stage cancers, and bone disorders.  Amorphical’s AMOR-18 showed encouraging results in an interim Phase II clinical trial involving COVID-19 patients.  PharmaShots speaks with Eden Ben, CEO of Amorphical, to discuss…
September 22, 20250Comments
Merck
NEWS
Merck’s Keytruda Qlex Receives the US FDA’s Approval for Subcutaneous Use Across 38 Solid Tumor Indications for Keytruda
Shots: The US FDA has approved Keytruda Qlex (pembrolizumab & berahyaluronidase alfa-pmph) for subcutaneous dosing in adults across 38 approved indications of Keytruda, with US availability expected by late Sep 2025 Approval was based on P-III (3475A-D77) trial assessing Keytruda Qlex (790mg/9600 units, Q6W) + Pt doublet CT vs IV Keytruda (400mg, Q6W) + Pt doublet CT…
September 22, 20250Comments
Merck new
NEWS
The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants
Shots: The CHMP has recommended Enflonsia to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season, with potential approval valid in all 30 EEA states Opinion was based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk…
September 22, 20250Comments
NEWS
Medtronic’s Altaviva Device Receives the US FDA’s Approval to Treat Urge Urinary Incontinence
Shots: The US FDA has approved the Altaviva device, an implantable tibial neuromodulation therapy to treat urge urinary incontinence Altaviva device is placed under the skin above the fascia & near the ankle in a minimally invasive, sedation & imaging-free procedure to restore bladder–brain communication & improve bladder control by delivering electrical impulses to the tibial…
September 22, 20250Comments
Henlius & Organon
NEWS
Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)
Shots: The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022, Henlius…
September 22, 20250Comments