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Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar & Animal Health. Check out our full report below:  Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN Read More: Apellis Pharmaceuticals and Sobi Daiichi Sankyo Reports First Patient…
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Merck Animal Health
News

Merck Animal Health Reports the CVMP Positive Opinion for Nobivac L6 and Nobivac LoVo L6 Vaccines for Canine Leptospirosis

Shots:The CVMP has recommended Nobivac L6 & Nobivac LoVo L6 for the active immunization of dogs against leptospirosis; EC’s decision expected by Q3’25The vaccine protects against 6 Leptospira serovars: Canicola, Copenhageni, Bratislava, Bananal/Lianguang, Icterohaemorrhagiae, & Grippotyphosa, preventing mortality, renal carriage, renal lesions, & urinary excretion while reducing infection & clinical signsNobivac L6…
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UreVac
News

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 & capabilitiesAs 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
News

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 dogsOpinion 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 processElanco plans to…
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Moderna
News

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 seasonApproval 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
News

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…
3 days ago0Comments

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NeurentMedical
News

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 rhinitisThe 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…
3 days ago0Comments

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