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 2024Evrysdi, 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

NEWS

Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer

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

ByRidhi RastogiMay 26, 2025

NEWS

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

Shots:The US FDA has approved Susvimo (port delivery platform with Lucentis) for the treatment of diabetic retinopathy (DR)Approval was based on 1 yr. P-III (Pavilion) trial data assessing Susvimo (100mg/mL, refilled Q9M) vs monthly clinical observation in 173 pts with non-proliferative DR without center-involved DME, where subjects in Susvimo arm received 2 loading…

ByRidhi RastogiMay 23, 2025

NEWS

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra) Across Canada

Shots: Following the launch of Idacio (adalimumab) Citrate-free, Fresenius Kabi Canada has launched Tyenne (IV/SC), a biosimilar version of Actemra (tocilizumab) from Roche, now available in Canada Tyenne (IL-6 receptor blocker) is approved to treat inflammatory and immune conditions such as rheumatoid arthritis (RA), giant cell arteritis (GCA), Polyarticular juvenile idiopathic arthritis (pJIA), and systemic…

ByDipanshu DixitMay 21, 2025

TOP 20

Top 20 Biopharma Deal Terminations of 2024

Shots: In the Biopharma industry, navigating M&A and licensing deals is challenging due to strict antitrust laws and shifting regulations. When these pressures create significant risks, nullifying or restructuring existing agreements can be the most rational and strategic response In 2024, the termination of the $4.45B deal between Adaptimmune and Genentech became a major talking…

ByPrince GiriMay 14, 2025

NEWS

Sarepta Therapeutics Reports the MHLW’s Conditional & Time-Limited Approval of Elevidys for Duchenne Muscular Dystrophy (DMD)

Shots:Japan's MHLW has granted conditional & time-limited approval to Elevidys for DMD pts (3–8yrs.) with no exon 8/9 deletions in the DMD gene & who are negative for anti-AAVrh74 AbsApproval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was…

ByRidhi RastogiMay 14, 2025

NEWS

Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Shots:Roche has launched its Elecsys PRO-C3 test, developed with Nordic Bioscience to evaluate the severity of liver fibrosis in pts showing signs of metabolic dysfunction–associated steatotic liver disease Elecsys PRO-C3 test requires a single assay & in combination with ADAPT formula (incl. PRO-C3 levels, platelet count, age, & diabetes status) provides clear assessment of…

ByRidhi RastogiMay 6, 2025

TOP 20

Top 20 Biopharma Companies of 2025

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

ByPrince GiriApril 24, 2025

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

Roche’s Itovebi Regimen Secures the CHMP’s Positive Opinion for PIK3CA-mutated Breast Cancer

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra) Across Canada

Top 20 Biopharma Deal Terminations of 2024

Sarepta Therapeutics Reports the MHLW’s Conditional & Time-Limited Approval of Elevidys for Duchenne Muscular Dystrophy (DMD)

Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Top 20 Biopharma Companies of 2025

Contact US

OUR INFORMATION

FOLLOW US