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Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Shots: The EC has approved Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome Approval was based on P-III (Balance) trial assessing Tryngolza (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute pancreatitis events over 12mos.; data…

ByRidhi Rastogi1 day ago0Comments

NEWS

Alvotech Receives the CHMP’s Positive Opinion for AVT03 (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders STADA & Dr. Reddy’s have semi-exclusive commercial rights to AVT03 in the EU, incl. Switzerland & the UK, leading to STADA marketing it as Kefdensis (Prolia; 60mg/mL PFS) & Zvogra (Xgeva; 70mg/mL single-use…

ByRidhi Rastogi2 days ago0Comments

NEWS

Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms

Shots: The CHMP has recommended elinzanetant for treating mod. to sev. vasomotor symptoms linked with menopause or caused by AET related to breast cancer based on P-III (OASIS-1, 2, 3 & 4) trials OASIS-1 & 2 showed reduced mod. to sev. menopausal VMS vs. PBO at wks. 4 & 12, with >80% pts (incl. those…

ByRidhi Rastogi2 days ago0Comments

NEWS

Pfizer Expands into Obesity Treatments with ~$7.3B Metsera Acquisition

Shots: 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.,…

ByRidhi Rastogi2 days ago0Comments

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…

BySaurabh Chaubey2 days ago0Comments

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…

BySaurabh Chaubey2 days ago0Comments

VIDEO

LIFE SCIENCES | DAILY NEWS | SEP 22, 2025 | PHARMASHOTS

ByDipanshu Dixit2 days ago0Comments

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…

ByRidhi Rastogi2 days ago0Comments

NEWS

Roche Reports P-III (evERA Breast Cancer) Trial Data on Giredestrant + Everolimus for ER-Positive Breast Cancer

Shots: The P-III (evERA Breast Cancer) trial evaluated giredestrant + everolimus vs SoC ET + everolimus in ER+, HER2-, LA/M breast cancer pts previously treated with CDK4/6 inhibitors & endocrine therapy (ET) in adj. or LA/M settings Trial met its co-1EPs of improved PFS in both the ITT & ESR1-mutated populations, while OS showed a…

ByRidhi Rastogi2 days ago0Comments

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…

ByRidhi Rastogi2 days ago0Comments

Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Alvotech Receives the CHMP’s Positive Opinion for AVT03 (Biosimilar, Prolia & Xgeva)

Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms

Pfizer Expands into Obesity Treatments with ~$7.3B Metsera Acquisition

The Rise of Industrial Metaverse: Smarter Pharma Starts at AUTOMA+ 2025

Navigating Amorphous Calcium Carbonate Therapies: Eden Ben from Amorphical in Conversation with PharmaShots

LIFE SCIENCES | DAILY NEWS | SEP 22, 2025 | PHARMASHOTS

Merck’s Keytruda Qlex Receives the US FDA’s Approval for Subcutaneous Use Across 38 Solid Tumor Indications for Keytruda

Roche Reports P-III (evERA Breast Cancer) Trial Data on Giredestrant + Everolimus for ER-Positive Breast Cancer

The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants

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