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Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan

Shots: Neurocrine & Takeda have revised their 2020 collaboration to develop & commercialize osavampator (NBI-1065845/TAK-653), which originally granted Neurocrine exclusive license to osavampator, NBI-1070770, & the GPR139 antagonist program As per the amendment, Neurocrine will get exclusive rights to develop & market osavampator to treat major depressive disorder (MDD) globally, while Takeda will reacquire…
January 28, 2025

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Neurocrine’s Crenessity (Crinecerfont) Secures the US FDA’s Approval to Treat Adults and Pediatrics with Congenital Adrenal Hyperplasia (CAH)

Shots: The US FDA’s approval of Crenessity as an adjunctive treatment to glucocorticoid replacement to treat CAH was based on a global P-III (CAHtalyst Pediatric: n=103, age: 4-17yrs. & Adult: n=182, age: 18-58yrs.) trials. It has also received PRV on approval Pediatric study achieved its 1 & 2EP, depicting ~4x greater reductions in androstenedione…
January 14, 2025

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Neurocrine Biosciences
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Neurocrine’s Crenessity (Crinecerfont) Secures the US FDA’s Approval to Treat Adults and Pediatrics with Congenital Adrenal Hyperplasia (CAH) 

Shots:    The US FDA’s approval of Crenessity as an adjunctive treatment to glucocorticoid replacement to treat CAH was based on a global P-III (CAHtalyst Pediatric: n=103, age: 4-17yrs. & Adult: n=182, age: 18-58yrs.) trials. It has also received PRV on approval  Pediatric study achieved its 1 & 2EP, depicting ~4x greater reductions in androstenedione at…
December 13, 2024

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New Drug Designations - February 2024
INSIGHTS+

New Drug Designations – February 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, and EC. This month’s report includes designations allotted to 13 small molecules, 20 biologics, and 2 devices  SN Bioscience’s SNB-101 received ODD from the US FDA for the treatment of pancreatic cancer based on preclinical results. It…
March 28, 2024

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New Drug Designations - January 2024
INSIGHTS+

New Drug Designations – January 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 13 small molecules, 7 devices, 3 biologics ADC, 3 gene therapy, 1 antineoplastics, 1 protein, 1 peptide, 1 recombinant enzyme & 1 vaccine   NRx Pharmaceuticals’ NRX-101 small molecule, focused…
February 20, 2024

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New Drug Designations - December 2023
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New Drug Designations – December 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 6 biological drugs, 10 small molecules, 5 cell and gene therapies, 1 recombinant fusion protein, 1 peptide and 2 devices   Neurocrine Biosciences’ Crinecerfont, focused on the treatment of Congenital Adrenal Hyperplasia…
January 25, 2024

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PharmaShots' Key Highlights of Second Quarter 2022
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PharmaShots’ Key Highlights of Second Quarter 2022

The second quarter of 2022 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, AstraZeneca’s Farxiga (dapagliflozin) meet its primary endpoints for heart failure with a preserved ejection fraction Starting with the latest acquisitions, Pfizer acquire Biohaven for ~$11.6B, GSK acquire Affinivax for ~$3.3B. The second quarter of the year…
June 30, 2022

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