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NEWS

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara) 

Shots:  Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023  Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US,…
October 11, 2024

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NEWS

Teva and mAbxience Join Forces on Second Biosimilar Candidate in Oncology 

  Shots:  Teva and mAbxience have entered into a second global licensing agreement to develop an anti PD-1 biosimilar candidate in oncology  As per the agreement, mAbxience will employ its state-of-the-art, cGMP-compliant facilities in Spain and Argentina for the development & production of biosimilar while Teva will handle its regulatory approvals & commercialization  The agreement…
October 3, 2024

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NEWS

Lupin Reports the P-III Study Completion of LUBT010 (Biosimilar, Lucentis) for Neovascular Age-related Macular Degeneration 

Shots:  Lupin has concluded P-III study evaluating the efficacy, safety & immunogenicity of LUBT010 (0.5mg, intravitreal, QM for 1yr.) vs Lucentis in wet AMD adults (n=600) across India, US, EU & Russia  The trial met its 1EP, showing therapeutic equivalence in visual acuity improvement plus similarity in safety & immunogenicity b/w both the drugs. Results will…
August 5, 2024

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Viewpoints_Gunjan Sharma
VIEWPOINTS

Redefining Care: Gunjan Sharma from The US Oncology Network in Conversation with PharmaShots

Shots:  Megestrol, an appetite stimulator is listed as an inappropriate medication based on the American Geriatrics Society (AGS) Beers Criteria and is considered a high-risk medication for elderly people by the Pharmacy Quality Alliance  In a study by the US Oncology Network, the use of megestrol was reviewed and weight gain benefits was evaluated in…
July 31, 2024

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Samsung Bioepis
NEWS

Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

 Shots:    The US FDA has granted approval to the company’s BLA of Epysqli (eculizumab-aagh), a biosimilar version of Soliris (eculizumab)  Approval was supported by data from the P-I trial depicting similar PK/PD, safety, tolerability & immunogenicity profiles among healthy subjects and the P-III trial showing comparable efficacy, safety, PK & immunogenicity in PNH patients b/w Epysqli vs Soliris …
July 22, 2024

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New Drug Designations - April 2024
INSIGHTS+

New Drug Designations – April 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices   Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…
May 30, 2024

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VIEWPOINTS_Jason Hannon_2024
VIEWPOINTS

Funds Raised: Jason Hannon from Mainstay Medical in a Stimulating Conversation with PharmaShots

Shots:  Mainstay Medical recently raised $125M in the company’s largest funding round. The financing is intended to accelerate the commercial growth of the company’s ReActiv8, a restorative Neurostimulation therapy in the US, Europe, and Australia  Today, at PharmaShots, we had Jason Hannon, CEO of Mainstay Medical, who talked in great length about the ReActiv8 Restorative Neuromodulation System developed for…
May 27, 2024

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ThoughtSpot_Saurabh Chaubey6
THOUGHTSPOT

A Peek into the US Healthcare System

Shots:  The US contributes significantly to the healthcare budget but still registers unfavorable healthcare outcomes owing to health inequality and healthcare disparities  The Land of Opportunities registers 46.2M immigrants and nearly half of the undocumented immigrants lack basic healthcare  The article covers the historical journey of US healthcare with takes on a few public healthcare programs adopted by the…
May 7, 2024

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New Drug Designations - March 2024
INSIGHTS+

New Drug Designations – March 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices    Trellis Bioscience's…
April 30, 2024

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