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Metsera Announces an Amended Merger Agreement with Pfizer for ~$10B
Shots: Metsera announced entering into an amended merger agreement with Pfizer to acquire Metsera for up to $86.25 per share, including $65.60 in cash and a contingent value right of up to $20.65 Metsera’s Board of Directors noted that the U.S. Federal Trade Commission had raised potential antitrust concerns regarding Novo Nordisk’s proposed structure  After…
November 8, 2025
Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty
Shots: Nitinotes has received CE Mark approval for its EndoZip System for endoscopic sleeve gastroplasty (ESG) EndoZip automates suturing, transforming ESG into a single-physician, scalable, fast outpatient procedure with improved efficiency & reproducibility compared to manual systems requiring dual operators & longer procedure times The company has planned to launch EndoZip in select EU centers &…
November 7, 2025
Alvotech & Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the MHRA’s Approval to Treat Several Chronic Inflammatory Diseases
Shots: The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while…
November 7, 2025
UroViu Receives European CE Certification for its Cystoscope and Hysteroscope Portfolio
Shots: UroViu has received European CE Mark approval for its cystoscope & hysteroscope portfolio, incl. the reusable UV5000w Wi-Fi Handle & disposable Hystero-V, Uro-V, & Uro-GHD endoscopes UroViu’s portfolio has shown strong clinical value & efficiency in cystoscopy procedures, incl. diagnosis, cancer surveillance & minor therapeutic interventions, as highlighted in data presented at EAU &…
November 7, 2025
Argenx
argenx Receives Health Canada’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy
Shots: Health Canada has approved Vyvgart (efgartigimod alfa; QW, SC, PFS) as a monotx. for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) Approval was based on the ADHERE trial, showing 69% (221/322) of Vyvgart SC-treated pts had clinical improvement, regardless of prior treatment. The study met its 1EP with a 61% reduction in relapse risk vs…
November 6, 2025
Aqua Medical Receives the US FDA IDE Approval to Initiate Trial for Ablation Procedure to Treat Uncontrolled Type 2 Diabetes
Shots: Aqua Medical has received the US FDA IDE approval to initiate the RESTORE-1 study evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure using its radiofrequency vapor ablation (RFVA) system in adults with uncontrolled type 2 diabetes The IDE approval was backed by international data showing safety & metabolic benefits of PIMA, allowing Aqua Medical…
November 6, 2025
AmacaThera Inks a ~$230M Exclusive Global Licensing Deal with Pacira BioSciences to Advance AMT-143
Shots: AmacaThera has entered into an exclusive global license agreement with Pacira to develop & commercialize AMT-143, a long-acting non-opioid anesthetic, leveraging AmacaThera’s tunable hydrogel platform to treat post-operative pain As per the deal, AmacaThera & Pacira will jointly advance AMT-143, with AmacaThera leading select clinical studies & Pacira funding development through commercialization. In exchange, AmacaThera…
November 6, 2025
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