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Novartis Reports the P-III (Lp(a)HORIZON) Trial Data on Pelacarsen in Patients with Elevated Lp(a) and Established CV Disease

Shots: Novartis has reported the topline P-III (Lp(a)HORIZON) trial data assessing pelacarsen vs PBO on the incidence of 4-point major adverse CV events (MACE) in 8,323 pts with elevated Lp(a) & established CVD Pelacarsen did not meet its 1EP of reducing major CV events, despite lowering Lp(a) levels in pts receiving guideline-directed lipid-lowering & antihypertensive…
5 days ago

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Evinova Partners with Lothar Medical to Advance Respiratory Clinical Trials Globally

Shots: Evinova has partnered with Lothar Medical to integrate Lothar’s respiratory device with Evinova’s Unified Trial Solution, supporting connected, data-rich respiratory clinical trials globally Lothar’s 3-in-1 device combines FeNO, spirometry & oscillometry, while Evinova’s GxP-validated platform helps streamline traditional, hybrid & DCTs across 4,000+ sites in 54 countries The partnership aims to accelerate patient recruitment…
5 days ago

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Acepodia Reports the US FDA IND Clearance to Initiate P-I Trial of ACE723 in HCC

Shots: The US FDA has granted IND clearance to ACE723 for the initiation of P-I trial to treat patients with unresectable or metastatic hepatocellular carcinoma (HCC) The P-I study will assess ACE723’s safety, tolerability, dose-limiting toxicities, PK & preliminary antitumor activity in above-mentioned pts, with dose-escalation portion of establishing recommended dose for further development &…
5 days ago

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Astrazeneca
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AstraZeneca Receives the US FDA Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Shots: FDA granted accelerated approval to Etcamah + a CDK4/6 inhibitor for HR+/HER2− LA/M breast cancer with an ESR1 mutation emerging during AI + CDK4/6 inhibitor therapy, alongside approval of a ctDNA-based CDx for detecting ESR1 resistance mutations Approval was based on the P-III (SERENA-6) trial assessing Etcamah + CDK4/6 inhibitor vs AI (anastrozole/letrozole) +…
5 days ago

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Samsung Bioepis
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Samsung Bioepis Reports MHLW Approval of its Ustekinumab Biosimilar

Shots: The MHLW has granted marketing approval to Ustekinumab BS IV infusion 130mg 「NIPRO」, a biosimilar version of Stelara (ustekinumab), for induction therapy in mod. to sev. active Crohn’s disease when other treatments are ineffective Additionally, the MHLW approved Ustekinumab BS SC Injection 45mg Syringes 「NIPRO」in Dec 2025, which was then launched in May 2026  The biosimilar…
September 4, 2026

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Globus Medical Receives the CE Mark for Excelsius3D

Shots: Globus Medical has reported the CE Mark approval for Excelsius3D intelligent 3-in-1 imaging system, expanding the company’s Excelsius Ecosystem & enhancing the capabilities of its ExcelsiusGPS robotic navigation system Excelsius3D combines 3D cone-beam CT, 2D fluoroscopy & digital radiography in one mobile intraoperative platform, integrating with ExcelsiusGPS for seamless imaging & robotic navigation to…
September 4, 2026

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Cipla Partners with Qilu Pharmaceutical to Commercialize QL2107 (Biosimilar, Keytruda) in the US

Shots: Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, has entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing & supply of QL2107, a biosimilar version of Keytruda (pembrolizumab), for the US As per the deal, Qilu will handle product development, regulatory registration & supply, while Cipla USA will commercialize the asset across the…
September 4, 2026

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