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NEWS

Samsung Biologics to Acquire PolyPeptide for ~$1.8B

Shots: Samsung Biologics has launched an all-cash public tender offer to acquire 100% of the fully diluted share capital of PolyPeptide, expanding its capabilities beyond antibodies & ADCs to include peptide therapeutics As per the deal, PolyPeptide will receive CHF 44.31 (~$54.8) in cash per share, representing an implied equity value of ~CHF 1.46B (~$1.8B);…
July 20, 2026

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NEWS

BioMarin Reports the US FDA’s sNDA Acceptance for Full Approval of Voxzogo in Achondroplasia

Shots: The US FDA has accepted an sNDA for Voxzogo (vosoritide) for full approval in children with achondroplasia (PDUFA: Feb. 28, 2027) The sNDA was supported by long-term safety & efficacy data from the ongoing 111-205, 111-208, & 111-302 studies, demonstrating clinically meaningful improvements in growth & key skeletal measures, incl. body proportionality & arm span…
July 14, 2026

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New Drug Designations - August 2024
INSIGHTS+

New Drug Designations – August 2024 

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. August month’s report includes designations allotted to 10 small molecules, 9 biologics, 7 cell & gene therapies, 1 vaccine, 2 radiopharmaceutical, 1 peptide, 1 antineoplastic and 2 devices   In August 2024, Invenra’s INV724 received the…
September 25, 2024

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New Drug Designations - May 2024
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New Drug Designations – May 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 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices  This…
June 25, 2024

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New Drug Designations - February 2024
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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
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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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