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UreVac

BioNTech to Acquire CureVac for ~$1.25B

Shots: BioNTech has entered into a definitive purchase agreement to acquire CureVac in an all-stock transaction, strengthening its mRNA tech & capabilities As per the deal, each CureVac share will be exchanged for ~$5.46 in BioNTech ADSs, implying a total equity value of ~$1.25B, with a collar-adjusted exchange ratio (0.04318 if BioNTech’s 10-day VWAP >$126.55; 0.06476…

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Elanco

The CVMP Adopts Positive Opinion on Elanco’s Zenrelia for Allergic and Atopic Dermatitis in Dogs

Shots: The CVMP has recommended Zenrelia (ilunocitinib) for the treatment of pruritus linked to allergic dermatitis & clinical symptoms of atopic dermatitis in dogs Opinion was based on clinical data demonstrating quality, safety, efficacy, & a favorable benefit-risk profile incl. a non-inferiority study conducted as a part of the EU approval process Elanco plans to…

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Moderna

Moderna’s mRESVIA Receives the US FDA’s Approval for Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved mRESVIA (mRNA-1345) to prevent lower respiratory tract disease caused by RSV in individuals (18-59yrs.) at risk; expected to be available in US for the 2025–2026 respiratory virus season Approval was based on P-III trial assessing safety & immunogenicity of mRESVIA in adults (18-59yrs.) at increased risk for RSV-associated lower…

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Novartis

Novartis to Highlight P-IIIb Trial Data of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria (PNH) at EHA 2025

Shots: Novartis has reported P-IIIb (APPULSE-PNH) trial data assessing Fabhalta (iptacopan; 200mg, BID, PO) for 24wks. in 52 PNH adults with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab) Trial showed a 2.01 g/dL mean Hb increase, with 92.7% pts achieving ≥12g/dL & no transfusions over 24wks. It also depicted improved fatigue…

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NeurentMedical

Neurent Medical Receives the US FDA’s 510(k) Clearance of NEUROMARK System for Chronic Rhinitis

Shots: The US FDA has granted 510(k) clearance to the next generation NEUROMARK system for pts with chronic rhinitis The new system optimizes posterior nasal nerve treatment by providing real-time feedback for accurate electrode placement & confirming treatment delivery, with a flexible shaft & atraumatic leaflets that conform to pts anatomy for maximizing treatment coverage…

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Abbvie

AbbVie’s Mavyret Receives the US FDA’s Approval for Acute Hepatitis C Virus

Shots: The US FDA has approved label expansion of Mavyret (glecaprevir/pibrentasvir) to treat pts (≥3yrs.) with acute or chronic HCV infection, without cirrhosis or with compensated cirrhosis Label expansion was supported by P-III (M20-350) trial assessing Mavyret (QD, PO) in 286 treatment-naïve adults with acute HCV infection for 8wks. & then followed for 12wks. Trial…

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Deep Apple Therapeutics Enters a Research Collaboration and Licensing Deal with Novo Nordisk to Advance Oral Small Molecules

Shots: Deep Apple & Novo have partnered to discover, develop, & commercialize oral small molecules targeting novel non-incretin GPCRs for cardiometabolic diseases, incl. obesity, using Deep Apple’s drug discovery tech Novo will gain exclusive global rights to develop, manufacture, & commercialize assets discovered & optimized by Deep Apple for ~$812M in upfront, research costs, &…

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