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…
Shots:The first patient was dosed with iadademstat (ORY-1001) + venetoclax + azacitidine combination to treat AML naïve patients (n=45) under the P-I trial to evaluate the safety, tolerability, preliminary efficacy & optimal dose. Trial will be managed & funded by NCI under CRADA
In addition, the combination is being evaluated to treat 1L…
Shots:J&J entered into a definitive agreement to acquire Intra-Cellular Therapies, incl. its drugs Caplyta & ITI-1284, for a total equity value of ~14.6B (cash + debt), with shareholders receiving $132/share in cash, making the latter private
In Dec 2024, the latter filed an sNDA to the US FDA for Caplyta as adj. therapy…
Shots:The US FDA’s approval of Crenessity as an adjunctive treatment to glucocorticoid replacement to treat CAH was based on a global P-III (CAHtalyst Pediatric: n=103, age: 4-17yrs. & Adult: n=182, age: 18-58yrs.) trials. It has also received PRV on approval
Pediatric study achieved its 1 & 2EP, depicting ~4x greater reductions in androstenedione…
Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of December 2024 The US FDA has approved a total of 10 new drugs including 4 new molecular entities and 6 biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was BMS’ Opdivo Qvantig…
Shots:GSK to acquire IDRx incl. its lead candidate IDRX-42, for $1B upfront & ~$150M in regulatory milestones (total ~$1.15B). It will also pay success-based milestones & tiered royalties to Merck KGaA for IDRX-42
IDRX-42 (TKI, small molecule) targets key KIT mutations, responsible for proliferation & survival of tumor cells, & is under P-I/Ib…
Shots:The P-III (QUANTI; N=808) trials of gadoquatrane (0.04mmol Gd/kg body wt.) comprised of QUANTI CNS for CNS disorders like brain tumors, brain metastasis & multiple sclerosis; QUANTI OBR for other body regions like head & neck, thorax, abdomen & pelvis as well as QUANTI Pediatric study for children (birth to 18yrs.)
Study assessed…
Shots:Gilead has entered into a strategic collaboration with LEO Pharma to develop the latter’s small molecule oral STAT6 programs targeting various inflammatory disorders
As per the terms, Gilead secures worldwide rights to develop, manufacture & commercialize LEO’s preclinical STAT6 inhibitors & degrading proteins, with LEO having the option to co-commercialize them for dermatology…
