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) trial Trial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, improved PFS (1EP) by…

ByRidhi RastogiMay 26, 2025

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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

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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

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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

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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 Abs Approval 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

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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

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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

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Roche’s Chest Pain Triage Algorithm Secures European CE Mark to Detect Acute Coronary Syndrome (ACS)

Shots: Roche has received the CE mark for its new Chest Pain Triage algorithm, developed with Universitätsklinikum Heidelberg as part of the navify algorithm suite to detect ACS in pts with chest pains; available in the EU, Middle East & Asia, with US availability planned for a later date Algorithm identifies non-cardiac chest pain by…

ByRidhi RastogiApril 24, 2025

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Oak Hill Bio Enters an Exclusive Licensing Agreement with Roche for Rugonersen

Shots: Oak Hill Bio has entered into an exclusive license agreement with Roche to obtain global rights of rugonersen (RO7248824) for the treatment of angelman syndrome Oak Hill to initiate a pivotal P-III trial of rugonersen for angelman syndrome in early 2026, pending regulatory review of the final trial protocol TANGELO study led by Roche,…

ByRidhi RastogiApril 16, 2025

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Roche’s Columvi (Glofitamab) Regimen Receives the EC’s Approval to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: The EC has granted full approval to Columvi + GemOx for ASCT-ineligible r/r DLBCL pts based on P-III (STARGLO) trial assessing the regimen vs MabThera/Rituxan + GemOx in previously treated DLBCL pts At 11.3mos. mFU (primary analysis), trial showed improved OS, a 41% reduction in death risk, with a 63% improvement in PFS. At…

ByRidhi RastogiApril 14, 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

Roche’s Chest Pain Triage Algorithm Secures European CE Mark to Detect Acute Coronary Syndrome (ACS)

Oak Hill Bio Enters an Exclusive Licensing Agreement with Roche for Rugonersen

Roche’s Columvi (Glofitamab) Regimen Receives the EC’s Approval to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

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