Skip to content Skip to footer

Chiesi Group and Arbor Biotechnologies Secure the EC’s Orphan Drug Designation for ABO-101 to Treat Primary Hyperoxaluria

Shots: The EC has granted ODD to ABO-101 for the treatment of primary hyperoxaluria ABO-101 is being evaluated in an open-label global P-I/II (redePHine) study assessing safety, tolerability, PK/PD, & preliminary efficacy of a single dose of ABO-101 in pts with PH type 1 ABO-101 is a one-time, liver-directed gene-editing therapy that uses an Acuitas-licensed…

Read more

CStone Pharmaceuticals Partners with Arrotex to Commercialize Sugemalimab across Australia and New Zealand

Shots: CStone Pharmaceuticals has entered into an exclusive commercialization agreement with Arrotex for the commercialization of sugemalimab in Australia & New Zealand As per the deal, Arrotex will be responsible for regulatory submissions & obtain exclusive commercialization rights for sugemalimab in Australia & New Zealand across all approved & future indications In return, CStone will…

Read more

Merck KGaA to Acquire Bio-Techne for ~$11.3B

Shots: Merck KGaA has entered into a definitive agreement to acquire Bio-Techne, bringing together two companies with complementary portfolios spanning research tools, diagnostics, bioprocessing, and advanced therapeutics As per the deal, Merck KGaA will acquire Bio-Techne for $73/share in cash, representing a total enterprise value of ~$11.3B; closing is expected by late 2026 or early…

Read more

Otsuka Reports P-IIIb Trial Data on Centanafadine in ADHD and Comorbid Anxiety

Shots: Otsuka has reported topline P-IIIb trial results evaluating centanafadine XR (280mg, QD) vs PBO in 315 adults (18-65yrs.) with attention-deficit/hyperactivity disorder (ADHD) & comorbid generalized anxiety disorder and/or social anxiety disorder The trial met its 1EP, with AISRS total score improvement at Wk. 8 (-18.5 vs -12.6), evident from Wk. 1 & sustained throughout the…

Read more

Pfizer New

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Shots: The US FDA has approved Pfizer's Ibrance (palbociclib) + trastuzumab ± pertuzumab, & endocrine therapy for the maintenance treatment of adults with HR+, HER2+ locally advanced or metastatic breast cancer following induction treatment Approval was based on the AFT-sponsored P-III (PATINA) trial, where pts receiving a median of 6 cycles of induction treatment were…

Read more

Antares Therapeutics Inks ~$1.9B Deal with Novartis for Undruggable Oncology Targets

Shots: Antares Therapeutics has entered into a strategic collaboration with Novartis to discover, develop & commercialize small molecule therapies against undruggable oncology targets Antares will lead research & apply its discovery engine to a select number of historically undruggable targets until option exercise, while continuing to advance its wholly owned & partnered precision medicine pipeline…

Read more

Merck

Merck Receives EC Approval for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The EC has approved Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC across all 30 EEA states Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or Arm C (neoadj. & adj. Keytruda + Padcev)…

Read more