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AstraZeneca Partners with CSPC Pharmaceuticals to Identify and Develop Small Molecule Across Chronic Indications

Shots: AstraZeneca & CSPC have partnered to discover & develop pre-clinical candidates for multiple targets across chronic diseases, incl. a pre-clinical oral small molecule for immunological diseases As per the deal, CSPC will receive $110M upfront as well as ~$1.62B in development & ~$3.6B in sales milestones with net sales-based single digit royalties, while AstraZeneca…
June 16, 20250Comments

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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…
June 13, 20250Comments

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Merck Animal Health
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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 Q3’25 The 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 signs Nobivac L6…
June 13, 20250Comments

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Celldex
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Celldex Highlights P-II Trial Data of Barzolvolimab for Chronic Spontaneous Urticaria at EAACI Congress 2025

Shots: The P-II trial assessed barzolvolimab (Q4W: 75 or 150mg; Q8W: 300mg) vs PBO for 16wks. in 208 CSU pts unresponsive to antihistamines, followed by 36wks. of active treatment, where 75mg & PBO pts were re-randomized to 150 or 300mg; pts were then followed for 24wks. Enrolment to P-III (EMBARQ-CSU1 & EMBARQ-CSU2) trials is ongoing …
June 13, 20250Comments

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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 & 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…
June 13, 20250Comments

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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 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…
June 13, 20250Comments

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UroGen Pharma
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UroGen Pharma Receives the US FDA’s Approval for Zusduri to Treat LG-IR-NMIBC

Shots: The US FDA has approved Zusduri (mitomycin) for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC); expected to be available in the US by Jul 1, 2025 Approval was based on P-III (ENVISION) trial assessing Zusduri (QW, intravesical) in ~240 LG-IR-NMIBC pts across 56 sites, which showed 78% pts…
June 13, 20250Comments

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Moderna
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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…
June 13, 20250Comments

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Novartis
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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…
June 12, 20250Comments

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