Shots:
The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countries
Opinion was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by a post-treatment follow-up duration…
NEWS
Shots:
Angelini Pharma has entered into an exclusive global option agreement with Sovargen to develop & commercialize SVG105 for the treatment of brain health disorders
As per the deal, Angelini & Sovargen will co-lead preclinical development of SVG105, with Angelini having the option to advance it clinically & commercially outside Korea, China, Hong Kong, Macau,…
Shots:
Starpharma has entered into a collaboration & license agreement with Genentech to develop dendrimer-drug conjugates incorporating Genentech’s drugs for oncology targets, leveraging Starpharma’s DEP drug delivery tech
As per the deal, Genentech will receive an exclusive global license under Starpharma’s IP to develop & commercialize collaboration-derived products, potentially multiple per target, in exchange for…
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…
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…
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…
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.,…
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…
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…
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…

