Merck’s Winrevair (Sotatercept) Receives the EC’s Approval to Treat Pulmonary Arterial Hypertension (PAH)

Shots: The EC has granted approval to Winrevair (45 & 60mg) combined with other PAH therapies to treat PAH, valid across whole EU as well as Iceland, Liechtenstein & Norway Approval was based on the P-III (STELLAR) study evaluating the safety & efficacy of Winrevair (target dose 0.7mg/kg, SC, Q3W;…

ByDipanshu DixitAugust 26, 2024

INSIGHTS+

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

INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2024

Shots: The second quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Vertex’ acquisition of Alpine Immune Sciences for ~$4.9B This quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19…

BySenior EditorJuly 2, 2024

NEWS

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

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2024

Shots: The first quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Gilead's acquisition of CymaBay Therapeutics for an aggregate of ~$4.3B This quarter also showcased multiple clinical trial results including Axsome Therapeutics P-III results for AXS-12 and BMS'…

BySenior EditorApril 1, 2024

NEWS

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

NEWS

Merck’s Keytruda (pembrolizumab) in Combination with Chemotherapy Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer

Shots: The company received the positive opinion based on the results from the P-III (KEYNOTE-671) clinical trial evaluating neoadjuvant Keytruda + platinum-containing CT followed by adjuvant Keytruda monotx. vs neoadjuvant PBO in patients with resectable NSCLC at high risk of recurrence The study met its dual 1EP by demonstrating a statistically significant & clinically meaningful…

ByDipanshu DixitFebruary 26, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in December 2023

Shots: The US FDA approved 11 NDAs & 2 BLAs in December 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 109 novel products in 2023 In December 2023, the major highlight drugs were Jaypirca (pirtobrutinib) approved for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, and Iwilfin…

BySenior EditorJanuary 17, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in November 2023

Shots: The US FDA approved 5 NDAs & 4 BLAs in November 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 109 novel products in 2023 In November 2023, the major highlights drugs were Wezlana (ustekinumab) approved for Multiple Inflammatory Diseases, and Cosentyx (secukinumab) for the Treatment…

BySenior EditorDecember 20, 2023

Merck’s Winrevair (Sotatercept) Receives the EC’s Approval to Treat Pulmonary Arterial Hypertension (PAH)

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

Disease of the Month – Small Cell Lung Cancer

PharmaShots’ Key Highlights of Second Quarter 2024

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

PharmaShots’ Key Highlights of First Quarter 2024

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

Merck’s Keytruda (pembrolizumab) in Combination with Chemotherapy Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer

Insights+: The US FDA New Drug Approvals in December 2023

Insights+: The US FDA New Drug Approvals in November 2023

Contact US

OUR INFORMATION

FOLLOW US