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…
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…
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…
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…
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…
Shots: Driven by mutual growth and expansion, strategic collaborations are embedded deeply in the modus operandi of life sciences deals. In 2023, the volume of life science deals was comparatively high vs. 2022 The collaboration deal between Daiichi Sankyo and Merck & Co. for $22B ranks first in our list followed by the development and…
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…
Shots:The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…
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 fractionStarting with the latest acquisitions, Pfizer acquire Biohaven for ~$11.6B, GSK acquire Affinivax for ~$3.3B. The second quarter of the year…
The second quarter of 2020 has ended with big approvals in pharma and biotech industry. Moving with the latest approval of Roche's Phesgo and Enspryng & Zogenix's Fintepla. Highlights of the quarter is COVID-19 as the development of vaccines and drugs were on peak. Celltrion evaluated Remsima (biosimilar, infliximab) against COVID-19 in the UK. The…
