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Sanofi
Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)
Shots: Sanofi has reported the P-III (Baby-COMET) trial results assessing Nexviazyme (avalglucosidase alfa; 40mg/kg, Q2W, IV) in 17 treatment-naïve pediatric pts (≤12mos.) with IOPD Trial met its 1EP, with more treatment-naïve pts (≤6mos.) alive & free of invasive ventilation at 52wks., and achieved all 2EPs, including higher survival without invasive ventilation in pts at 12…
June 30, 2026
Zambon’s Hopledo Receives the CHMP Positive Opinion for Parkinson’s Disease and Moderate to Severe Motor Fluctuations
Shots: The CHMP has recommended Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Opinion was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…
June 30, 2026
Astrazeneca and Daiichi-Sankyo New
The EC Approves Daiichi Sankyo and AstraZeneca’s Enhertu for Previously Treated HER2+ Metastatic Solid Tumors
Shots: Enhertu approval for previously treated adults with unresectable or metastatic HER2+ (IHC 3+) solid tumors & no satisfactory treatment option, was based on subgroup data from P-II trials, incl. DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. In DESTINY-PanTumor02, Enhertu achieved a cORR of 52.3% & mDOR of 21.1mos. in previously treated HER2+ solid tumors (n=111), while DESTINY-Lung01 reported a cORR of…
June 29, 2026
Zymeworks to Acquire Theravance for ~$929M
Shots: Zymeworks has entered into a definitive agreement to acquire Theravance Biopharma, adding Yupelri, the only once-daily nebulized LAMA for COPD, to its partnered portfolio to strengthen long-term commercial cash flows As per the deal, Zymeworks will acquire Theravance for ~$929M, with Theravance’s shareholders receiving $17 per share in cash; closing is expected in H2’26…
June 29, 2026
Samsung Bioepis
Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)
Shots: Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026 The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT,…
June 29, 2026
Ipsen to Acquire Kartos Therapeutics for ~$1.75B
Shots: Ipsen has entered into a definitive merger agreement to acquire Kartos Therapeutics, incl. its asset, navtemadlin, expanding its hemato-oncology late-stage pipeline As per the deal, Ipsen will acquire Kartos Therapeutics through a fully-owned subsidiary for $450M upfront & ~$1.3B in milestones, incl. a significant regulatory approval milestone & sales-based milestones; closing is expected by…
June 29, 2026
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