NEWS

Lantheus Holdings to Acquire Evergreen Theragnostics for ~$1B

Shots: Lantheus will acquire Evergreen Theragnostics for $250M upfront plus ~$752.5M development & sales milestones related to Octevy & other assets in an all-cash transaction, with closing anticipated in H2’25 pending regulatory approvals The acquisition will add Evergreen’s Octevy (registrational-stage PET imaging agent for somatostatin receptor +ve NETs in adults & pediatrics) complementing Lantheus'…

January 29, 2025

Zimmer Biomet to Acquire Paragon 28 for ~$1.2B

Shots: Zimmer Biomet has agreed to acquire Paragon 28 for $13.00/share in cash with an equity value of ~$1.1B & enterprise value of ~$1.2B. Closing is expected in H1’25 As per the terms, shareholders will also get a non-tradeable CVR of $1/share on achieving revenue milestones, which is payable from $0 to $1 (calculated linearly)…

January 29, 2025

Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency

Shots: The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume…

January 29, 2025

ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 to Treat Grade 1 or Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Shots: The P-III (COMPETE) trial assessed ITM-11 (7.5 GBq + nephroprotective amino acid, Q3M × max. 4 cycles) vs everolimus (10mg for ~30mos. or until disease progression) in patients (n=309) with inoperable, progressive, SSTR+ gr 1/2 GEP-NETs. The US FDA’s NDA submission is expected in 2025 The study met its 1EP of improved PFS,…

January 29, 2025

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Shots: The EMA accepted depemokimab’s MAA as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

January 28, 2025

Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy

Shots: The P-III (EMBARK: N=126) study was carried out in 2 parts, with P1 involving ambulatory DMD boys (n=63; 4-7yrs.) to receive Elevidys (1.33x10^14 vg/kg) vs PBO while P2 involved crossing over of the patients (5-9yrs.); 59 crossed over to Elevidys post 52wks. Parts 1 (post 2yrs.) & 2 (post 1yr.) depicted improved NSAA…

January 28, 2025

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Shots: The US FDA has granted 510(k) clearance to ClearPoint Navigation Software 3.0 that will introduce intraoperative CT workflow, expanding its use from MRI. The company is planning to initiate limited market release in Q1’25 & full release in H2’25 Navigation Software 3.0 is compatible with intraoperative CT & Conebeam CT imaging, enabling precision neurosurgery in facilities…

January 28, 2025

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Shots: The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…

January 28, 2025

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Shots: The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25 Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…

January 28, 2025

Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan

Shots: Neurocrine & Takeda have revised their 2020 collaboration to develop & commercialize osavampator (NBI-1065845/TAK-653), which originally granted Neurocrine exclusive license to osavampator, NBI-1070770, & the GPR139 antagonist program As per the amendment, Neurocrine will get exclusive rights to develop & market osavampator to treat major depressive disorder (MDD) globally, while Takeda will reacquire…

January 28, 2025

NEWS

Lantheus Holdings to Acquire Evergreen Theragnostics for ~$1B

Zimmer Biomet to Acquire Paragon 28 for ~$1.2B

Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency

ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 to Treat Grade 1 or Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy

ClearPoint Neuro Receives US FDA’s 510(k) clearance for ClearPoint Navigation Software Version 3.0

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan

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