Shots:Neurogen Biomarking partnered with Linus Health to form a unified platform by incorporating the latter’s digital cognitive assessments with the Neurogen Biomarking ecosystem, commercially available in Q1’25
The new platform will integrate early detection & care for patients with MCI or dementia related to AD with Linus Health’s scientifically validated assessments to identify…
Shots:The P-III (C-POST) trial assessed Libtayo adj. (n=205; 350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.) vs PBO (n=204) to treat high-risk CSCC patients (N=415) for ~48wks.
Study met its first prespecified interim analysis, showing 68% reduced disease occurrence & death risk at 24mos. median follow-up, with additional…
Shots:AbbVie & Simcere Zaiming (subsidiary Simcere Pharma) have signed an option to license agreement for developing SIM0500, being assessed in P-I for r/r multiple myeloma (MM) in the US & China
As per the terms, Simcere will get an upfront, up to $1.055B option fees & milestones plus net-sales-based tiered royalties outside Greater China…
Shots:FDA has accepted & granted priority review to the BLA of datopotamab deruxtecan (Dato-DXd) for treatment-experienced patients with LA/M EGFR-mutated NSCLC (PDUFA: Q3’25) which also received BTD from US FDA
BLA & designation were based on P-II (TROPION-Lung05) & P-III (TROPION-Lung01) trials along with supporting data from P-I (TROPION-PanTumor01) study. The combined findings…
As we age, ensuring safety and quick access to help during emergencies becomes a top priority. Medical alert systems are valuable tools that provide peace of mind to seniors and their loved ones. With a range of options available, the choice often comes down to two main types: wearable and home-based systems. But which is…
Shots: In this second installment of Dealmaker 2024, PharmaShots presents an insightful guide to the top M&A deals ranked by deal valueThis report highlights Novo Nordisk’s remarkable achievements, including 24 collaborations spanning acquisitions, company formations, contract services, development and commercialization agreements, facility purchases, licensing options, and platform/product purchases. Collectively, these deals amount to a…
Shots:Eli Lilly to acquire Scorpion, plus its leading asset STX-478, for ~2.5B in cash, incl. upfront, regulatory & sales milestones through a definitive agreement
As per the terms, Scorpion will form an independent company owned by its current shareholders with Lilly’s minority stake to hold its employees & non-PI3Kα pipeline assets
STX-478 (oral,…
Shots:The US FDA has granted 510(k) Clearance for Aptiva’s APS IgG & APS IgM reagents, expanding its portfolio from Celiac Diseases & CTD essential reagents to 18 FDA-cleared analytes
The APS reagents semi-quantitatively detect anti-cardiolipin (aCL), plus anti-β2 glycoprotein 1 (aβ2GP1) IgG & IgM in serum levels, aiding in diagnoses of 1° & 2° APS…
Shots:Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio
The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a…
Shots:The US FDA has granted FTD to BBO-8520 for the treatment of metastatic NSCLC with KRAS^G12C mutations in adults
BBO-8520 showed significant tumor inhibition in preclinical models, post resistance to sotorasib. In addition, BBO-8520 is being assessed in a P-I (ONKORAS-101) trial in KRAS^G12C NSCLC patients either receiving KRAS^G12C inhibitors or no targeted…
