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Insights+: EMA Marketing Authorization of New Drugs in December 2023
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Shots:  The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis   PharmaShots has compiled a list of a…
January 23, 2024

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NEWS

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

Shots: The approval was supported by the P-III (MycarinG) study evaluating the safety, efficacy & tolerability of Rystiggo (7 or 10mg/kg) vs PBO in gMG patients. The 1EP of the study includes a change in MG-ADL score at Day43 & 2EPs include a change in MG-C score, QMG, patient-reported outcomes at Day43 and AEs The…
January 8, 2024

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Insights+: EMA Marketing Authorization of New Drugs in February 2023
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in February 2023

Shots: The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industry In February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndrome PharmaShots has compiled…
March 23, 2023

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Exclusive_Iris Loew-Friedrich_2023
EXCLUSIVE

Iris Loew-Friedrich, CMO and Head of Development Solutions at UCB Shares her Thoughts on the Launch of New Innovators Campaign

Shots: Iris shared the specifics of the launch of the UCB’s Innovators campaign. The campaign spotlights the R&D employees’ perspectives on innovation and aims to highlight why innovation is a key driving force at UCB for bettering the lives of patients She gave her thoughts on how UCB is adopting innovative AI programs that use…
March 6, 2023

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Insights+: EMA Marketing Authorization of New Drugs in December 2022
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2022

Shots: The EMA approved 6 New Chemical Entity (NCE) and 6 Biologic Drugs in December 2022, leading to treatments for patients and advances in the healthcare industry In December 2022, the major highlights drugs were Pluvicto’s approval for progressive PSMA+ metastatic castration resistant prostate cancer, Dupixent for Prurigo Nodularis PharmaShots has compiled a list of…
January 24, 2023

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