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

INSIGHTS+

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 on the Dealmaker…

ByPrince GiriJanuary 8, 2025

NEWS

Innovent Biologics Collaborates with Roche to Develop IBI3009 for SCLC

Shots: Innovent & Roche have entered into a collaboration & exclusive license agreement for developing IBI3009 to treat advanced SCLC As per the terms, Roche secures exclusive worldwide rights to develop, manufacture & commercialize IBI3009 plus will lead full development after early-stage studies, conducted jointly. Innovent will get $80M upfront, up to $1B development…

ByRidhi RastogiJanuary 2, 2025

INSIGHTS+

The US FDA New Drug Approvals in September 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of September 2024 The US FDA has approved a total of 7 new drugs including 4 new molecular entities and 3 biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drugs were Roche’s Tecentriq Hybreza & Ocrevus Zunovo for…

ByDipanshu DixitOctober 22, 2024

NEWS

Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation

Shots: The US FDA approved Itovebi + Ibrance & fulvestrant as a 1L treatment in adults with endocrine-resistant, PIK3CA-mutated, HR+ & HER2- locally advanced or metastatic breast cancer, based on the P-III (INAVO120) trial P-III (INAVO120) trial assessed the safety and efficacy of Itovebi + Ibrance & fulvestrant vs PBO + Ibrance & fulvestrant (n=…

ByDipanshu DixitOctober 11, 2024

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2024

Shots: The third 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 Eli Lilly's acquisition of Morphic Holdings for ~$3.2B This quarter also showcased multiple clinical trial results including Roche's P-I Study Data of CT-996 to treat Obesity Our…

BySaurabh ChaubeyOctober 1, 2024

NEWS

Roche Reports the US FDA’s Approval of Ocrevus Zunovo for Treating Relapse and Progressive Multiple Sclerosis

Shots: The US FDA has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq), a twice-a-year, 10-minute SC injection, to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) The approval was supported by the pivotal P-III (OCARINA) study assessing the PK, safety, clinical & radiological efficacy of the Ocrevus SC vs IV in patients (n=236)…

ByDipanshu DixitSeptember 13, 2024

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)

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

Innovent Biologics Collaborates with Roche to Develop IBI3009 for SCLC

The US FDA New Drug Approvals in September 2024

Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation

PharmaShots’ Key Highlights of Third Quarter 2024

Roche Reports the US FDA’s Approval of Ocrevus Zunovo for Treating Relapse and Progressive Multiple Sclerosis

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