Shots:
The EMA has validated the Type II Variation MAA for Enhertu as a monotx. for the treatment of adults with HER2+ (IHC 3+ or ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment
MAA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu (5.4mg/kg) vs trastuzumab emtansine in 1,635…
Shots:
Cencora & Covetrus have entered into a definitive agreement to merge Covetrus with MWI Animal Health, forming a unified company delivering a comprehensive animal health platform
The deal values MWI at a $3.5B enterprise value, with Cencora receiving $1.25B in cash, $800M in preferred equity, & $1.45B in common equity, securing a 34.3% non-controlling…
Shots:
Eli Lilly has reported P-IIIb (TOGETHER-PsO) trial data assessing Taltz (ixekizumab) + Zepbound (tirzepatide) vs Taltz alone in 274 adults with mod. to sev. plaque psoriasis & obesity/overweight with ≥1 additional weight-related comorbid condition
At 36wks., the trial met its 1EP with 27.1% pts reaching PASI 100 & ≥10% weight loss compared to 5.8% pts. Trial…
Shots:
The EC has granted conditional approval to Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors in all 30 EEA states, based on P-II/III (QUILT-3.032) study (n=100)
Trial showed a 71% CR rate, with a median duration of CR of 26.6mos., plus DoR range was as long as…
Shots:
Unnatural Products has entered a research collaboration & licensing agreement with Novartis for an undisclosed cardiovascular program developed using UNP’s AI-enhanced macrocycle platform
Under the deal, Novartis will handle IND-enabling studies & subsequent clinical development, manufacturing, & global commercialization of products emerging from the collaboration
As per the terms, UNP will receive ~$100M in…
Shots:
The EC has approved a higher maintenance dose of Wegovy (7.2mg semaglutide; QW) for chronic weight management in adults with obesity across 27 EU countries
Assessed in STEP UP trial (1,407 adults without diabetes) & STEP UP T2D (512 adults with obesity & T2D) trial, Wegovy 7.2mg achieved 21% mean weight loss vs ~2%…
Shots:
FDA has approved Filkri, a biosimilar to Neupogen (filgrastim), for pts receiving myelosuppressive CT, those with AML receiving induction or consolidation CT, cancer pts undergoing bone marrow transplant, pts with sev. chronic neutropenia, & pts exposed to myelosuppressive radiation
Approval was supported by 2 studies in healthy adults, with PK/PD assessed in one, &…
Shots:
Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines
Trial met its 1EP for the three prevalent subtypes of CIndU, incl. symptomatic dermographism, cold urticaria, & cholinergic urticaria, delivering significantly higher complete response rates at Wk. 12
Additionally, Novartis has submitted…
Shots:
Pfizer has reported data from Cohort 3 of P-III (BREAKWATER) trial, assessing Braftovi (300mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in pts with previously untreated BRAF V600E-mutated mCRC
In Cohort 3, the combination improved PFS as assessed by BICR, with OS showing meaningful prolonged improvement; ORR results were…
Shots:
The US FDA has accepted the NDA of iberdomide + daratumumab & dexamethasone (IberDd) for the treatment of pts with r/r multiple myeloma, with submission to be reviewed under Project Orbis (PDUFA: Aug 17, 2026)
NDA was supported by the planned analysis of MRD negativity rates in the P-III (EXCALIBER-RRMM) trial assessing IberDd vs…

