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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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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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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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Research & Development (R&D) plays an instrumental role in paving the foundation for innovative therapeutic options in the healthcare sector
The global Top 20 pharmaceutical industry spent $148B in 2022 and grew to $180B in 2023, with Merck & Co., had the highest R&D expenditure of $30.53B, followed by Roche ($15.73) and Johnson &…
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Immunology remains one of the most explored therapy areas. Companies focusing on immunology are steadfastly working to advance treatment options by developing drugs, vaccines, and antibodies
In 2023, the global immunology market size was valued at $98.22B and expected to register $263.22B by 2033, with a CAGR of 10.36% from 2024 to 2033. AbbVie…
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The EMA granted Positive Opinion to 4 Biologics and 3 New Chemical Entities in June 2024, leading to treatments for patients and advances in the healthcare industry
The major highlighted drugs were Merck’s Winrevair to treat Pulmonary Arterial Hypertension (PAH) and Roche’s PiaSky for Paroxysmal Nocturnal Haemoglobinuria (PNH)
PharmaShots has compiled a list of 5 drugs that…
Shots:
Small cell lung cancer (SCLC) aka Oat cell carcinoma is a rare & fast-growing lung cancer and ~15% of bronchogenic carcinomas are SCLC
In this reprise of our Disease of the Month report, we bring an illuminating account of SCLC with a dive analysis of epidemiology, market size, disease management, available therapies, patient advocacy…
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The CHMP’s positive opinion of PiaSky for PNH adults & adolescents (≥12yrs., 40kg) was based on 3 P-III trials incl. COMMODORE 2 study of PiaSky (SC, Q4W) vs eculizumab (IV, Q2W) in patients not treated with C5 inhibitor; COMMODORE 1 study in subjects switched from C5 inhibitor & COMMODORE 3 study in Chinese…
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PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices
This…
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Propelled by unceasing innovations and inch-perfect precision, the diagnostic industry is advancing at an astonishing pace
In 2023, the global diagnostic test market size was valued at $210.58B and is envisioned to reach $284.38B by 2033, registering a CAGR of 3.05 percent from 2024 to 2033. Roche reclaims its first position with a revenue…

