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NEWS

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…
2 days ago
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…
2 days ago
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)…
3 days ago
Abbvie
AbbVie’s Maviret Receives EC Approval for Acute Hepatitis C Virus Infection
Shots: The EC has approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in pts (≥3yrs.) with compensated liver disease (with or without cirrhosis) Approval was based on the P-III (M20-350) trial assessing Maviret (QD, PO) in pts (≥12yrs.) with acute HCV infection, enrolling 286 treatment-naïve adults across 70 locations globally Trial…
3 days ago
Combotope Therapeutics and Boehringer Ingelheim Collaborate on Next-Generation Cancer Antibody Therapies
Shots: BI has entered into a strategic research collaboration with Combotope to leverage its SMART-Phage platform to produce highly tumor-selective antibodies for next-generation cancer therapies Combotope will discover tumor-selective, high-affinity antibodies against multiple BI oncology targets, while BI will hold global development & commercialization rights, and lead further R&D, manufacturing, & commercialization activities As per…
3 days ago
Spotlight Medical Gains CE Mark for myStage Dx as an AI-Based Prognostic Test for ER+/HER2- Early Breast Cancer
Shots: Spotlight Medical has received CE marking under the EU IVDR for myStage Dx, an AI-enabled prognostic test designed to support risk stratification in patients with ER+/HER2- early breast cancer Test analyzes digitized H&E-stained FFPE pathology slides alongside routine clinicopathological variables to generate a binary prognostic classification of Low Risk or Not Low Risk In…
3 days ago
Abbisko Therapeutics Inks ~$1.9B Multi-Target R&D Deal with Eli Lilly
Shots: Abbisko Therapeutics has entered into a strategic research collaboration & license agreement with Eli Lilly to discover & develop novel therapeutics across multiple targets Abbisko will leverage its early-stage drug discovery platform, R&D ecosystem, & development expertise to conduct discovery & early-stage development of novel therapeutics against disease targets selected by Lilly As per…
3 days ago
Henlius & Organon
Organon and Henlius Launch Bildyos and Tuzemty (Biosimilars, Prolia and Xgeva) in Canada
Shots: Organon & Henlius Biotech have reported availability of Bildyos (60mg/1mL) & Tuzemty (120mg/1.7mL), biosimilar versions of Prolia & Xgeva (denosumab), respectively, in Canada for all indications of reference products Under a 2022 agreement, Henlius granted Organon exclusive global commercialization rights, excl. China, for multiple biosimilars, incl. Bildyos & Tuzemty Denosumab is a mAb that works…
4 days ago
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