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

News

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

News

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

News

Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

Shots: Zealand Pharma & Roche will develop & market petrelintide & its products incl. petrelintide + CT-388 (Roche’s asset) in the US & EU for weight loss, with Roche obtaining exclusive marketing rights in the rest of the world Zealand will handle ~50% marketing in the US & EU with opt-in/out rights under specific…

ByRidhi RastogiMarch 12, 2025

News

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)

Shots: The US FDA has approved Susvimo (port delivery platform with Lucentis) to treat DME Approval was based on P-III (Pagoda) study assessing Susvimo (100 mg/mL, refilled in Q6M) vs Lucentis (0.5mg, intravitreal, Q1M) in DME pts (n=634), where subjects in Susvimo arm received 4 loading doses of Lucentis till 16wks. prior to implantation Study demonstrated sustained vision…

ByRidhi RastogiFebruary 5, 2025

News

Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer

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).…

ByDipanshu DixitJanuary 30, 2025

News

Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy

Shots: The P-III (EMBARK: N=126) study was carried out in 2 parts, with P1 involving ambulatory DMD boys (n=63; 4-7yrs.) to receive Elevidys (1.33x10^14 vg/kg) vs PBO while P2 involved crossing over of the patients (5-9yrs.); 59 crossed over to Elevidys post 52wks. Parts 1 (post 2yrs.) & 2 (post 1yr.) depicted improved NSAA…

ByRidhi RastogiJanuary 28, 2025

News

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

Shots: The US FDA has granted 510(k) clearance & CLIA waiver for Cobas liat STI multiplex assay panels (CT/NG & CT/NG/MG), commercially available under the CE mark in upcoming months The CT/NG (chlamydia & gonorrhea) & CT/NG/MG (chlamydia, gonorrhea & Mycoplasma genitalium) assays compliment the existing portfolio of singleplex & multiplex tests of Cobas liat…

ByRidhi RastogiJanuary 22, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Fourth Quarter 2024

Shots: The Fourth quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Roche's acquisition of Poseida Therapeutics for ~$1.5B This quarter also showcased multiple clinical trial results including Pfizer's P-III Study Data of Talzenna + Xtandi to treat mCRPC …

ByDipanshu DixitJanuary 13, 2025

News

J.P. Morgan Healthcare Conference Special: Dealmaker of the Year 2024 (Part 01)

Shots: The first dose of the J.P. Morgan Special: Dealmaker of the Year report based on the total number of deals signed in 2024 Last year, Roche inked 38 deals comprising acquisitions, contract services, development & commercialization, facility purchase, R&D, platform/product purchases, and sales/co-promotion Leveraging DealForma’s invaluable insights, PharmaShots brings an on-demand report…

ByPrince GiriJanuary 8, 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)

Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME)

Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer

Roche Reveals Data from P-III (EMBARK) Study of Elevidys in Ambulatory Boys with Duchenne Muscular Dystrophy

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

PharmaShots’ Key Highlights of Fourth Quarter 2024

J.P. Morgan Healthcare Conference Special: Dealmaker of the Year 2024 (Part 01)

Contact US

OUR INFORMATION

FOLLW US

FOLLW US

Sign Up to Our Newsletter