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VIEWPOINTS
Pain Management & Beyond: Paul Howe from Protega Pharmaceuticals in a Stimulating Conversation with PharmaShots 
Shots:  Abuse-deterrent products are prescription medications, primarily opioids and certain stimulants, designed to resist common methods of misuse, such as crushing, snorting, or injecting  Protega Pharmaceuticals’ RoxyBond is the first and only FDA-approved, immediate-release abuse-deterrent opioid indicated for managing severe pain when alternative treatments are inadequate  PharmaShots is pleased to feature Paul Howe, Chief Operations…
September 17, 20250Comments
Amber implants
NEWS
Amber Implants Reports the US FDA’s 510(k) Clearance of VCFix Spinal System for Treating Vertebral Compression Fractures
Shots: The US FDA has granted 510(k) clearance to VCFix Spinal System for thetreatment of vertebral compression fractures The company plans to launch a US pilot program in early 2026, expand physician access later that year, extend the EXPAND trial into the US, & pursue EU label expansion for stand-alone use & one-level fixation integration…
September 17, 20250Comments
NEWS
Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the EC’s Approval for Retinal Diseases
Shots: The EC has approved Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation Approval was based on P-III trials conducted across the EU, South Korea, & Japan,…
September 17, 20250Comments
NEWS
Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the EU
Shots: J&J has launched Shockwave Javelin peripheral IVL catheter in the EU to modify calcium & cross extremely narrowed vessels in pts with peripheral artery disease (PAD) Shockwave Javelin was studied in FORWARD PAD IDE trial that demonstrated similar safety & effectiveness compared to balloon-based Shockwave IVL catheters, regardless of the nature of calcified lesions…
September 17, 20250Comments
NEWS
Areteia Therapeutics Reports P-III (EXHALE-4) Trial Data of Dexpramipexole to Treat Eosinophilic Asthma
Shots: Areteia Therapeutics has reported P-III (EXHALE-4) trial data assessing dexpramipexole (75 or 150mg, PO, BID) vs PBO as an add-on therapy to treat pts (n=600; ≥12yrs.) with inadequately controlled moderate-to-severe asthma & blood AEC ≥300 cells/μL Trial showed that 150mg improved lung function over Wks. 20 & 24 (1EP), as measured by pre-BD FEV1…
September 17, 20250Comments
NEWS
Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients
Shots: The US FDA has approved the PMA application for Idylla CDx MSI Test, a cartridge-based, fully automated “sample-to-result” companion diagnostic, with US launch anticipated soon & availability in other non-US markets to follow The Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…
September 17, 20250Comments
THOUGHTSPOT
Collagen Supplements: Why Choosing the Right Collagen Manufacturer Matters for Your Brand
The rise of collagen supplements in wellness and beauty sectors underscores the importance of selecting the right collagen manufacturer. As consumers demand effective and trustworthy products, the choice of a manufacturer becomes a pivotal factor in brand success and consumer trust. This article delves into why choosing the right collagen manufacturer is essential for building…
September 16, 20250Comments
Novo-Nordisk
NEWS
Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data of Cagrilintide for Weight Loss in Obese/Overweight 
Shots: Novo Nordisk has reported a sub-analysis of P-III (REDEFINE 1) trial assessing cagrilintide monotx. (2.4mg) with lifestyle intervention vs PBO in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without type 2 diabetes Trial showed 11.8% superior weight loss vs 2.3% after 68wks., while 31.6% lost ≥15% of body weight vs 4.7%. However, weight…
September 16, 20250Comments