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Roche
The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer
Shots: The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or…
22 hours ago
Candel Therapeutics and RTW Enter Royalty Funding Agreement to Support the Launch Aglatimagene Besadenovec in Localized Prostate Cancer
Shots: Candel Therapeutics has entered into a $100M royalty funding agreement with RTW Investments, contingent on FDA approval of Aglatimagene Besadenovec (CAN-2409) for intermediate- to high-risk localized prostate cancer As per the deal, RTW will receive a capped, tiered single-digit percentage of US annual net sales of aglatimagene. Candel Plans to submit a BLA for…
23 hours ago
NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 into P-II/III Study for Vernal Keratoconjunctivitis
Shots: The US FDA has cleared NexEos Bio’s IND application to initiate a P-II/III clinical study of NTX-1024 ophthalmic solution for the treatment of vernal keratoconjunctivitis (VKC) The P-II/III study will evaluate the safety and efficacy of NTX-1024 in VKC, following positive results from an open-label investigator-initiated study showing improvements in symptoms and ocular inflammation…
24 hours ago
Hims & Hers to Acquire Eucalyptus for ~$1.15B
Shots: Hims & Hers has entered into a definitive agreement to acquire Eucalyptus, to expand into Australia and Japan, and deepen its presence in the UK, Germany, and Canada As per the deal, Hims & Hers will acquire Eucalyptus for up to ~$1.15B, including upfront ~$240M in cash The acquisition is expected to close mid-2026,…
1 day ago
Covetrus to Merge with Cencora’s MWI Animal Health in a $3.5B Deal
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…
2 days ago
Eli lilly
Eli Lilly Reports the P-IIIb (TOGETHER-PsO) Trial Data on Taltz + Zepbound for Adults with Psoriasis and Obesity or Overweight
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…
2 days ago
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