Shots:
Novartis has entered into an agreement to acquire Tourmaline Bio, incl. its asset pacibekitug, expanding its cardiovascular portfolio
As per the deal, Novartis, through its subsidiary, will acquire Tourmaline for $48/share, representing an aggregate of ~$1.4B, & will merge the subsidiary into Tourmaline upon completion, making it an indirect wholly owned unit of Novartis; closing…
Shots:
Eli Lilly has reported P-III (BRUIN CLL-313) trial data assessing Jaypirca (pirtobrutinib; 200mg, PO, QD) vs chemoimmunotherapy (bendamustine + rituximab) in 282 pts with 1L chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions
Trial met its 1EP of improved PFS per IRC, while OS was immature but showed a favorable trend &…
Shots:
ONWARD Medical has received MDR CE Mark approval for its ARC-EX system to treat people with spinal cord injury (SCI); first EU commercial sales are expected by Q4’25
Approval was backed by extensive clinical data, incl. Up-LIFT trial published in Nature Medicine, showing 90% pts improved strength or function, 87% reported better QoL, &…
Shots:
Servier has entered into a definitive agreement with Kaerus Bioscience to acquire KER-0193, a potential treatment for Fragile X syndrome (FXS)
As per the deal, Kaerus will receive a total of ~$450M incl. an upfront payment as well as development & commercial milestones
KER-0193 is a BK channel modulator, which showed improvement across syndrome-relevant…
Shots:
AstraZeneca has reported P-III (FLAURA2) trial findings on Tagrisso + Pt-based CT as a 1L treatment of pts with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC
The P-III (FLAURA2) trial assessed Tagrisso (80mg, QD, PO) + pemetrexed + cisplatin/carboplatin (Q3W for 4 cycles) followed by Tagrisso + pemetrexed maintenance (Q3W) vs…
Shots:
Hengrui Pharma & Braveheart Bio have entered into an exclusive license agreement for Hengrui’s HRS-1893 to treat cardiovascular diseases
As per the deal, Braveheart will obtain exclusive global rights (ex-China, Hong Kong, Macao & Taiwan) to develop, manufacture & commercialize HRS-1893 in exchange for $65M upfront (50% in cash + 50% in shares), ~$10M…
Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease
Shots:
FDA has approved a label extension for Vonvendi to incl. routine prophylaxis for reducing bleeding in adults with Type 1 & 2 von Willebrand disease (VWD), & for on-demand & perioperative bleeding management in pediatric pts
Approval was backed by extensive data, incl. a P-III trial in adults, a P-III trial in children, a P-IIIb continuation…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, Animal Health and Biosimilars. Check out our full report below:
Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)
Read More: Merck
AstraZeneca Reports P-III (BaxHTN) Trial Data on Baxdrostat…
Shots:
SignalPET has launched SignalPET 360°, an integrated AI-powered radiology solution for veterinary medicine
SignalPET 360 provides an integrated diagnostic platform with built-in PACS, allowing clinics to store & view all imaging modalities, generate AI-powered reports for every case, & seamlessly escalate to advanced AI or radiologist review when required
SignalPET 360° suite provides immediate…
Shots:
Genentech has reported new data from the open-label AVONELLE-X & P-IIIb/IV (SALWEEN) studies of Vabysmo (faricimab-svoa) at Euretina’25
The 2yr. AVONELLE-X study was an extension of P-III (TENAYA & LUCERNE) trials, showing maintained vision & anatomy in wet AMD, with ~80% pts extending dosing to Q3M/Q4M after ~4yrs. of therapy
SALWEEN study in Asia…

