Shots:The US FDA has granted 510(k) clearance to Prolift Pivot expandable spacer system, expanding Life Spine’s Micro Invasive tech portfolio
The system provides full articulation for precise spinal fusion, while reducing tissue disruption & nerve retraction, allowing surgeons to restore patient alignment with superior control & efficiency. It also features OSSEO-LOC surface tech that promotes osseointegration & long-term…
Dipanshu Dixit
Shots:The P-III (INAVO120) trial evaluated Itovebi + Ibrance + fulvestrant vs matching PBO in PIK3CA-mutated, HR+/HER2-, endocrine-resistant, 1L LA/M breast cancer pts (n=325); ongoing regulatory review in EU & other regions
Study met its 2EP of significant OS demonstrating 57% reduction in risk of disease worsening or death (mPFS: 15 vs 7.3mos.; HR=0.43).…
Shots:The EMA has accepted MAA of Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors, based on an ongoing QUILT 3.032 study. Application covers 27 EU countries, plus Iceland, Norway & Liechtenstein, with submission also made to the UK's MHRA
As of the data cut-off on Jul…
Shots:The US FDA has granted FTD to DYNE-101 for treating myotonic dystrophy type 1 (DM1). US Accelerated Approval is anticipated to submit in H1’26
DYNE-101 is being tested in the global P-I/II ACHIEVE trial for DM1
DYNE-101 is an antisense oligonucleotide (ASO) linked to an antibody fragment (Fab) that targets the transferrin…
Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics and 4 New Chemical Entities in December 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Galderma’s Nemluvio to treat Prurigo Nodularis and Atopic Dermatitis PharmaShots has compiled a list of 9 drugs that have been granted positive…
Shots: Epilepsy is a chronic, non-communicable brain condition that affects neurons and causes recurring seizuresOur Disease of the Month report covers epidemiology, market size, current management strategies, emerging therapeutic options, and the role of patient advocacy groups. Additionally, we highlight the key industry players advancing treatments for epilepsyFor a detailed analysis and tailored…
Shots:Fermion & Simcere Pharma have entered into an exclusive license and collaboration agreement to develop FZ002-037 for pain management
As per the agreement, Simcere secures exclusive rights to develop & commercialize FZ002-037 across Greater China (Mainland China, Hong Kong, Macau & Taiwan) in exchange for an undisclosed upfront, milestones and sales-based tiered royalties…
Shots:The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Submissions are under review in the EU, China, & other areas
Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D)…
Shots:The EC has approved (under exceptional circumstances) Gohibic to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on SoC (incl. systemic corticosteroids) & IMV (with/without ECMO)
Approval was backed by results of the P-III (PANAMO) study assessing Gohibic vs. PBO among invasively mechanically ventilated COVID-19 patients in the ICU, which showed improvement in survival with…
Shots:The US FDA has granted IDE approval to initiate RESORB clinical evaluation of Nexsphere-F for knee osteoarthritis. It is CE-MDD approved for arthritis embolization & has shown superior efficacy in various musculoskeletal embolization cases across Asia & the EU
RESORB study will evaluate the efficacy of Nexsphere-F to ease pain & improve mobility…
