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

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2023

Shots: Third quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, Biogen acquired Reata Pharmaceuticals for ~$7.3B and Danaher acquired Abcam for ~$5.7B The third quarter of the year also showcases multiple clinical trial results which include Janssen reported P-IIb…

BySenior EditorOctober 2, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in August 2023

Shots: The EMA approved 5 New Chemical Entity (NCE) and 6 Biologic Drugs in August 2023, leading to treatments for patients and advances in the healthcare industry In August 2023, the major highlight drugs were Aquipta (atogepant) approved for the preventive treatment of migraine in adults & Opdivo (nivolumab) as an adjuvant treatment for completely…

BySenior EditorSeptember 28, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in July 2023

Shots: The EMA approved 9 New Chemical Entity (NCE) and 5 Biologic Drugs in July 2023, leading to treatments for patients and advances in the healthcare industry In July 2023, the major highlights drugs were Soliris approval for refractory generalised myasthenia gravis and Trodelvy for pre-treated HR+/HER2- metastatic breast cancer PharmaShots has compiled a list…

BySenior EditorAugust 24, 2023

VIEWPOINTS

Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

Shots: Ahsan spoke about the US FDA acceptance for Priority Review of sBLAs for PADCEV and KEYTRUDA to treat patients with LA/mUC who are not eligible to receive cisplatin-containing CT He also talked about the study design and outcomes from the P-Ib/II (EV-103) clinical trial that supported the sBLA. The results from Dose Escalation/Cohort A…

BySenior EditorAugust 17, 2023

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

PharmaShots’ Key Highlights of Third Quarter 2023

Insights+: EMA Marketing Authorization of New Drugs in August 2023

Insights+: EMA Marketing Authorization of New Drugs in July 2023

Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

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