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

News

Roche’s PiaSky Receives the CHMP’s Positive Opinion for Treating Paroxysmal Nocturnal Haemoglobinuria (PNH)

Shots: 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…

ByDipanshu DixitJune 28, 2024

News

AstraZeneca’s Voydeya Receives CHMP’s Recommendation for Treating Paroxysmal Nocturnal Haemoglobinuria (PNH) with Residual Haemolytic Anaemia

Shots: The CHMP has recommended Voydeya as an add-on therapy to SoC for treating PNH adult patients with residual haemolytic anaemia The recommendation was based on the P-III (ALPHA) study investigating the safety & efficacy of Voydeya as an add-on therapy to Ultomiris or Soliris (SoC) for treating PNH patients with extravascular haemolysis (EVH) The…

ByDipanshu DixitFebruary 26, 2024

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

Disease of the Month – Small Cell Lung Cancer

Roche’s PiaSky Receives the CHMP’s Positive Opinion for Treating Paroxysmal Nocturnal Haemoglobinuria (PNH)

AstraZeneca’s Voydeya Receives CHMP’s Recommendation for Treating Paroxysmal Nocturnal Haemoglobinuria (PNH) with Residual Haemolytic Anaemia

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