EMA Marketing Authorization of New Drugs in July 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 3 Biologics and 10 new chemical entities in July 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Roche’s Itovebi Secures the EC’s Approval for PIK3CA-mutated Breast Cancer PharmaShots has compiled a list of 13 drugs…

ByDipanshu DixitAugust 19, 2025

NEWS

Pilatus Biosciences Collaborates with Roche to Evaluate PLT012 & Tecentriq Combination for Hepatocellular Carcinoma (HCC)

Shots: Pilatus Biosciences & Roche have entered into a clinical trial collaboration to evaluate PLT012 + atezolizumab for HCC pts Under the collaboration, Roche will supply atezolizumab (Tecentriq) for Pilatus' P-I study of PLT012 in combination therapy for HCC, with plans to expand to other cancers PLT012 is a humanized mAb that blocks CD36-driven lipid uptake, targeting…

ByDipanshu DixitAugust 14, 2025

NEWS

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Shots: The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy The cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as…

ByDipanshu DixitAugust 7, 2025

NEWS

Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD)

Shots: Roche has reported data from the ongoing OLE P-III (Portal) study of Susvimo (port delivery platform with Lucentis) for the treatment of nAMD The P-III (Archway) trial assessed Susvimo (Q6W refill, n=248) vs Lucentis (QM, IVT, n=168) in 415 nAMD pts responsive to prior anti-VEGF therapy; 352 entered the Portal OLE study, where 132…

ByRidhi RastogiAugust 4, 2025

TOP 20

Top 20 Immunology Companies of 2025

Shots: Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…

ByPrince GiriJuly 24, 2025

NEWS

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Shots: Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology Approval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of…

ByRidhi RastogiJuly 23, 2025

NEWS

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

Shots: The EC has approved Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, ER+/HER2- locally advanced or metastatic breast cancer recurring on or within 12mos. of adj. endocrine therapy, based on the P-III (INAVO120) trial Trial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, which showed improved PFS…

ByRidhi RastogiJuly 23, 2025

NEWS

The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy

Shots: The EC has approved label extension of Evrysdi (5mg oral tablet) for pts with spinal muscular atrophy (SMA) Approval was based on P-I study assessing Evrysdi 5mg tablet vs oral solution, showing bioequivalence with comparable efficacy & safety; data was presented at SMA Europe 2024 Evrysdi, an SMN2 splicing modifier, treats SMA caused by…

ByRidhi RastogiJune 5, 2025

NEWS

Roche Reports P-III (IMforte) Trial Findings on Tecentriq Regimen as a 1L Maintenance Therapy for ES-SCLC

Shots: Roche has reported P-III (IMforte) trial data of Tecentriq + lurbinectedin as 1L maintenance therapy for ES-SCLC pts (≥18yrs) Trial assessed the regimen vs Tecentriq monotx. in ES-SCLC pts, where 660 pts received induction therapy with Tecentriq + CT (4 x 21-day cycles) & 483 pts without progression were then randomized to maintenance with…

ByRidhi RastogiJune 3, 2025

TOP 20

Top 20 Diagnostics Companies of 2025

Top 20 Diagnostics Companies of 2025 Shots: Driven by continuous innovation and enhanced precision, the diagnostic industry is advancing rapidly, transforming the way healthcare is delivered In 2025, the global diagnostic testing market is valued at approximately $207.96B in 2025 and is projected to grow to around $272.9B by 2034, reflecting a CAGR of 3%.…

ByPrince GiriMay 29, 2025

EMA Marketing Authorization of New Drugs in July 2025

Pilatus Biosciences Collaborates with Roche to Evaluate PLT012 & Tecentriq Combination for Hepatocellular Carcinoma (HCC)

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Top 20 Immunology Companies of 2025

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Roche’s Itovebi Regimen Secures the EC’s Approval for PIK3CA-mutated Breast Cancer

The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy

Roche Reports P-III (IMforte) Trial Findings on Tecentriq Regimen as a 1L Maintenance Therapy for ES-SCLC

Top 20 Diagnostics Companies of 2025

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