Johnson & Johnson’s Yuvanci (macitentan and tadalafil) Receives the CHMP’s Positive Opinion for Treating Pulmonary Arterial Hypertension (PAH)

Shots: The CHMP has granted positive opinion to Yuvanci [macitentan (10mg) + tadalafil (40mg)] as a substitution therapy of PAH adults, based on P-III (A DUE) study The P-III (A DUE) trial assessed Yuvanci STCT vs macitentan (10mg) & tadalafil (40mg) alone in PAH patients (n=187). Subjects with PVR ≥240 dyn×s/cm5 randomly received M/T STCT…

ByDipanshu DixitJuly 26, 2024

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Insights+: EMA Marketing Authorization of New Drugs in June 2024

Shots: 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…

ByDipanshu DixitJuly 23, 2024

INSIGHTS+

Disease of the Month – Small Cell Lung Cancer

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…

ByDipanshu DixitJuly 18, 2024

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Merck’s Winrevair (Sotatercept) Gains the CHMP’s Positive Opinion to Treat Pulmonary Arterial Hypertension (PAH)

Shots: The CHMP has granted positive opinion to Winrevair combined with other therapies to treat PAH. EC’s decision is anticipated in Q3’24, applicable across EU, Iceland, Liechtenstein & Norway The opinion was based on the P-III (STELLAR) study evaluating the safety & efficacy of Winrevair (target dose 0.7mg/kg; n=163) or PBO (n=160) + stable background…

ByDipanshu DixitJune 28, 2024

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Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

Shots: The approval was based on the results from the P-III (STELLAR) trial evaluating Winrevair (0.7mg/kg) vs PBO + stable background therapy (SC, Q3W) in patients (n=163 vs 160) with PAH. The 1EP was change from baseline at wk.24 in 6MWD The results depicted a 41m median increase in 6MWD with Winrevair vs PBO along…

ByDipanshu DixitMarch 26, 2024

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Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension

Shots: The approval was based on the results from the P-III (A DUE) clinical trial evaluating the safety & efficacy of Opsynvi vs macitentan/tadalafil monotx. in patients with PAH (WHO FC II or III). The 1EP was a change from baseline in Pulmonary Vascular Resistance (PVR) at 16wks. The study depicted a greater reduction…

ByDipanshu DixitMarch 22, 2024

Johnson & Johnson’s Yuvanci (macitentan and tadalafil) Receives the CHMP’s Positive Opinion for Treating Pulmonary Arterial Hypertension (PAH)

Insights+: EMA Marketing Authorization of New Drugs in June 2024

Disease of the Month – Small Cell Lung Cancer

Merck’s Winrevair (Sotatercept) Gains the CHMP’s Positive Opinion to Treat Pulmonary Arterial Hypertension (PAH)

Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension

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Johnson & Johnson’s Yuvanci (macitentan and tadalafil) Receives the CHMP’s Positive Opinion for Treating Pulmonary Arterial Hypertension (PAH)

Insights+: EMA Marketing Authorization of New Drugs in June 2024

Disease of the Month – Small Cell Lung Cancer

Merck’s Winrevair (Sotatercept) Gains the CHMP’s Positive Opinion to Treat Pulmonary Arterial Hypertension (PAH)

Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension

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