Takeda Reports US FDA Approval of GAMMAGARD LIQUID ERC for Primary Immunodeficiency

The US FDA has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] for treating primary immunodeficiency (PI) pts (age≥2); commercialization will be anticipated in 2026 and in the EU in 2027, where it’s approved as DEQSIGA by the EMA GAMMAGARD LIQUID ERC is a 10% ready-to-use IG therapy with ≤2 µg/mL IgA, for IV or…

ByDipanshu DixitJuly 1, 2025

News

Philochem and RayzeBio Enter Into a Development and Commercialization Deal of ~$1.35B

Shots: Philochem and RayzeBio (BMS) entered into a development and commercialization agreement under which Philochem granted RayzeBio exclusive worldwide rights to develop, manufacture, and commercialize its radiopharmaceutical agent OncoACP3 for prostate cancer Under the agreement, Philochem will receive $350M up front and is eligible for up to $1B in development, regulatory, and commercial milestones, plus…

ByPrince GiriJune 11, 2025

INSIGHTS+

Key Biosimilars Events of April 2025

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   Henlius Collaborates with Sandoz for the Commercialization of HLX13. Our team at PharmaShots…

ByDipanshu DixitMay 6, 2025

INSIGHTS+

Key Biosimilars Events of March 2025

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 & BAT2506…

ByDipanshu DixitApril 8, 2025

News

Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B

Shots: The US FDA has approved Qfitlia to treat routine prophylaxis and prevent or reduce the frequency of bleeding episodes in pts. (age≥ 12yrs.) with hemophilia A or B, with or without factor VIII or IX inhibitors. Regulatory submissions have been completed in China & Brazil Qfitlia published clinical data in the NEJM in 2017, showing…

ByRidhi RastogiApril 1, 2025

News

Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 (Biosimilar, Stelara) & BAT2506 (Biosimilar, Simponi) Across the Southeast Asia

Shots: Bio-Thera and Dr. Reddy’s have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) & BAT2206, a biosimilar version of Stelara (ustekinumab) As per the agreement, Bio-Thera will handle the development, manufacturing, and supply of BAT2206 & BAT2506, while Dr. Reddy’s will manage regulatory approvals &…

ByDipanshu DixitMarch 28, 2025

News

Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

Shots: Biocon Biologics has entered into strategic collaboration agreement with Civica to extend access & affordability of Insulin Aspart in the US As per the deal, Biocon will supply Insulin Aspart drug substance to Civica, which will manufacture prefilled pens & vials of insulin at its Petersburg, Virginia facility. Civica will commercialize it in the US…

ByRidhi RastogiMarch 7, 2025

INSIGHTS+

Key Biosimilars Events of February 2025

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   A major highlight was the Samsung Bioepis & Teva Partners to Commercialize…

ByDipanshu DixitMarch 4, 2025

INSIGHTS+

Key Biosimilars Events of January 2025

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   A major highlight was the Samsung Bioepis & Teva Partners to Commercialize Epysqli in…

ByDipanshu DixitFebruary 4, 2025

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Intelligent Automation and Beyond: Dale Curtis Jr from Astrix in an Enlightening Conversation with PharmaShots

Shots: The biopharma industry faces several challenges, including digital transformation, regulatory compliance, and managing large volumes of data Intelligent automation plays a vital role in drug discovery, clinical trials, manufacturing, and commercialization, helping optimize operations and better meet customer needs Astrix CEO Dale Curtis Jr. discusses the role of AI and machine learning in global…

BySaurabh ChaubeyJanuary 31, 2025

Takeda Reports US FDA Approval of GAMMAGARD LIQUID ERC for Primary Immunodeficiency

Philochem and RayzeBio Enter Into a Development and Commercialization Deal of ~$1.35B

Key Biosimilars Events of April 2025

Key Biosimilars Events of March 2025

Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B

Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 (Biosimilar, Stelara) & BAT2506 (Biosimilar, Simponi) Across the Southeast Asia

Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

Key Biosimilars Events of February 2025

Key Biosimilars Events of January 2025

Intelligent Automation and Beyond: Dale Curtis Jr from Astrix in an Enlightening Conversation with PharmaShots

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