Disease of the Month – Amyotrophic Lateral Sclerosis (ALS)

Shots: Amyotrophic lateral sclerosis (ALS) is a fatal motor neuron disease that leads to the progressive degeneration of nerve cells in the spinal cord and brain Our Disease of the Month report covers epidemiology, market size, current management strategies, emerging therapeutic options, and the role of patient advocacy groups. Additionally, we highlight the key industry…

ByDipanshu DixitFebruary 25, 2025

NEWS

BMS’ Reblozyl Gains CHMP’s Positive Opinion to Treat Transfusion-Dependent Anemia Due to Myelodysplastic Syndrome (MDS)

Shots: The positive opinion was supported by the P-III (COMMANDS) study assessing the safety & efficacy of Reblozyl (1.0mg/kg, titration ~1.75mg/kg, Q3W) vs epoetin alfa (450 IU/kg, titration ~1050IU/kg, QW) for ≥24 wks. to treat transfusion-dependent anemia due to very low-, low- or intermediate-risk (IPSS-R) MDS in patients naïve to erythropoiesis-stimulating agent The data, as…

ByDipanshu DixitFebruary 23, 2025

NEWS

Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Shots:Following the MHRA approval (Jan 2025), the EC has granted conditional MAA to Seladelpar +/- ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or intolerants to UDCA, respectively; ongoing regulatory review in Canada and Australia MAA was based on a worldwide P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs…

ByDipanshu DixitFebruary 21, 2025

NEWS

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Shots:The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblastomas, or pNET unsuitable for localized procedures and advanced ccRCC post-PD-1/PD-L1 inhibitors or VEGF therapies progression across EU member states, as well as Iceland, Liechtenstein & Norway Approval for VHL-related tumors was based on P-II (LITESPARK-004) study (n=61), showing ORR of 49% (all…

ByDipanshu DixitFebruary 19, 2025

NEWS

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

Shots:The UK’s MHRA & Swissmedic have approved Nemluvio (SC) for mod. to sev. PN & AD, where it is approved in adults for PN & in combination with TCS ± TCI in pts (≥12yrs.; ≥30kg) for AD who are candidates for systemic therapy. Awaits approval in Singapore & Australia Approval is based on P-III…

ByDipanshu DixitFebruary 18, 2025

NEWS

CSL and Arcturus Therapeutics Report the EC’s Approval of Kostaive Against COVID-19

Shots:The EC has approved Kostaive (ARCT-154) for active immunization to prevent COVID-19 in subjects of age ≥18yrs in the EU & EEA states following CHMP positive opinion in Dec 2024 Approval was based on Kostaive's clinical data incl. P-I/II/III showing its efficacy & tolerability, plus P-III COVID-19 booster trial depicting superior immunogenicity vs…

ByDipanshu DixitFebruary 18, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in January 2025

Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics in January 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Capvaxive to treat Pneumococcal Disease PharmaShots has compiled a list of 4 drugs that have been granted positive opinions and approvals by the EMA’s…

ByDipanshu DixitFebruary 18, 2025

INSIGHTS+

The US FDA New Drug Approvals in January 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of January 2025 The US FDA has approved a total of 3 new drug including 2 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Daiichi Sankyo &…

ByDipanshu DixitFebruary 11, 2025

INSIGHTS+

A Complete Account of FDA Approvals in 2024

Shots:In 2024, around 50 new drugs were approved by the US FDA across several indicationsPharmaShots, in an enlightening report, brings a summarized analysis of the approved drugs. The most explored section remains Oncology, Hematology, Dermatology, and CardiologyFor the complete report with analysis, reach out to us at connect@pharmashots.com While you embraced the new…

ByDipanshu DixitFebruary 5, 2025

NEWS

Vanda Pharmaceuticals Enters into an Exclusive Global License Agreement with AnaptysBio to Develop and Commercialize Imsidolimab

Shots:Vanda received exclusive rights to develop, manufacture & commercialize imsidolimab which has completed 2 P-III (GEMINI-1 & GEMINI-2) trials for generalized pustular psoriasis As per the terms, Anaptys will get $10M upfront, $5M for existing drug supply, & ~$35M in regulatory & sales milestones, plus 10% royalty on net sales, whereas Vanda will…

ByDipanshu DixitFebruary 4, 2025

Dipanshu Dixit

Disease of the Month – Amyotrophic Lateral Sclerosis (ALS)

BMS’ Reblozyl Gains CHMP’s Positive Opinion to Treat Transfusion-Dependent Anemia Due to Myelodysplastic Syndrome (MDS)

Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

CSL and Arcturus Therapeutics Report the EC’s Approval of Kostaive Against COVID-19

EMA Marketing Authorization of New Drugs in January 2025

The US FDA New Drug Approvals in January 2025

A Complete Account of FDA Approvals in 2024

Vanda Pharmaceuticals Enters into an Exclusive Global License Agreement with AnaptysBio to Develop and Commercialize Imsidolimab

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