GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD

Shots:China’s NMPA has accepted the NDA for Nucala as an add-on treatment for COPD with eosinophilic phenotype based on P-III (MATINEE) study; global regulatory filings is ongoing The MATINEE study assessing Nucala (100mg, Q4W, SC) vs PBO in addition to inhaled triple therapy in COPD pts (n=804) with type 2 inflammation achieved its 1EP, showing…

ByRidhi RastogiFebruary 20, 2025

NEWS

GSK Reports the US FDA Approval of Penmenvy (MenABCWY Vaccine) for Protection Against Invasive Meningococcal Disease (IMD)

Shots:The US FDA has approved Penmenvy for individuals (10-25yrs) to protect against 5 serogroups of N. meningitidis (A, B, C, W, & Y) responsible for IMD. Meanwhile, the CDC's ACIP will vote on Feb 26, 2025, to recommend the use of Penmenvy in adolescents & young adults Approval was supported by 2 P-III…

ByRidhi RastogiFebruary 17, 2025

NEWS

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Shots:The EMA accepted depemokimab’s MAA as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

BySenior EditorJanuary 28, 2025

NEWS

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

Shots:The EC has approved Jemperli + CT (carboplatin & paclitaxel) as a 1L treatment of primary advanced or recurrent endometrial cancer in adults eligible for systemic therapy Approval was based on part 1 of P-III (RUBY) study assessing Jemperli + CT followed by Jemperli vs CT + PBO followed by PBO and part…

BySenior EditorJanuary 20, 2025

NEWS

GSK to Acquire IDRx for ~1.15B, Boosting its GI Cancer Portfolio

Shots:GSK to acquire IDRx incl. its lead candidate IDRX-42, for $1B upfront & ~$150M in regulatory milestones (total ~$1.15B). It will also pay success-based milestones & tiered royalties to Merck KGaA for IDRX-42 IDRX-42 (TKI, small molecule) targets key KIT mutations, responsible for proliferation & survival of tumor cells, & is under P-I/Ib…

BySenior EditorJanuary 13, 2025

NEWS

GSK’s GSK’227 Secures the US FDA’s Breakthrough Therapy Designation for Treating Late-Line R/R Osteosarcoma

Shots:The US FDA has granted BTD to GSK5764227 (GSK’227) for treating r/r osteosarcoma in patients with disease progression on at least 2 prior lines of therapy Designation was supported by P-II (ARTEMIS-002) trial (carried out by Hansoh Pharma) assessing the safety & efficacy of GSK’227 to treat patients (n=60; 42 had osteosarcoma) with…

ByRidhi RastogiJanuary 7, 2025

NEWS

GSK’s Nucala (Mepolizumab) Secures the NMPA’s Approval for Treating Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots:The NMPA has approved Nucala as an add-on therapy with intranasal corticosteroids in CRSwNP adults with inadequately controlled disease. It is approved for patients (≥12yrs.) as an add-on treatment of severe eosinophilic asthma & for adults having eosinophilic granulomatosis with polyangiitis Approval was based on 2 P-III studies: MERIT assessing Nucala vs PBO…

ByRidhi RastogiJanuary 3, 2025

TOP 20

Top 20 Immunology Companies of 2024

Shots: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 antibodiesIn 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…

ByPrince GiriJuly 25, 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 ~$4.9BThis 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

INSIGHTS+

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

Shots: Witness the journey of the biopharma companies over 20 years with this informative and engaging report. The report highlights the development of the biopharma industry and the key factors influencing them In 2023, JNJ reclaims the topmost position in the list from Pfizer with a revenue of $85.16B, showcasing a sharp 10.30 percent vs…

BySaurabh ChaubeyMay 1, 2024

GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD

GSK Reports the US FDA Approval of Penmenvy (MenABCWY Vaccine) for Protection Against Invasive Meningococcal Disease (IMD)

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

GSK to Acquire IDRx for ~1.15B, Boosting its GI Cancer Portfolio

GSK’s GSK’227 Secures the US FDA’s Breakthrough Therapy Designation for Treating Late-Line R/R Osteosarcoma

GSK’s Nucala (Mepolizumab) Secures the NMPA’s Approval for Treating Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Top 20 Immunology Companies of 2024

PharmaShots’ Key Highlights of Second Quarter 2024

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

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