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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…
January 22, 2025

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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…
January 8, 2025

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J.P. Morgan Healthcare Conference Special: Dealmaker of the Year 2024 (Part 01)
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…
January 8, 2025

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The US FDA New Drug Approvals in September 2024
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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…
October 22, 2024

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Roche
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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=…
October 11, 2024

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Roche
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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)…
September 13, 2024

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Roche
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Roche’s Tecentriq Hybreza Receives the US FDA’s Approval for Cancer Treatment 

  Shots:    The US FDA has approved Tecentriq Hybreza (SC) to treat all IV indications, incl. lung, liver, skin & soft tissue cancers. Regulatory reviews across other regions are underway  The approval was supported by P-IB/III (IMscin001) study assessing Tecentriq Hybreza (SC) vs Tecentriq (IV) in locally advanced or metastatic NSCLC patients (n=371) failed on…
September 13, 2024

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