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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)

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…

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The US FDA New Drug Approvals in September 2024

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…

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Roche

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=…

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Roche

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)…

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Roche

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…

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Oncology Top 20 2024

Top 20 Oncology Companies of 2024

Shots: With more than 50 percent of ongoing clinical trials, Oncology remains one of the most explored therapy areas in healthcare In 2023, the global oncology market was valued at $222.36B and is envisioned to grow to $521.6B by 2033, registering a CAGR of 8.9% from 2024 to 2033. With $27.6B registered oncology revenue, Merck…

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Roche

Roche’s PiaSky Receives the EC’s Approval to Treat Paroxysmal Nocturnal Haemoglobinuria (PNH) 

Shots:    The EC has granted approval to PiaSky (crovalimab) for treating PNH in adults & adolescents (≥12yrs., weight: ≥40kg) who are either treatment-experienced or treatment-naïve  Approval was based on P-III (COMMODORE 2) trial assessing PiaSky vs eculizumab in PNH patients not treated with C5 inhibitors plus results from another P-III trials, COMMODORE 1 (PNH patients…

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