Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Shots:The EC has approved Rxulti (brexpiprazole) to treat schizophrenia in pts (≥13yrs.) following CHMP’s positive opinion in Jan 2025 Approval was based on P-III trial assessing Rxulti (2 to 4mg/day, PO, QD) vs PBO vs Aripiprazole in adolescents (n=316) for 6wks. that showed greater reduction in symptom severity compared to PBO as measured by…

ByRidhi RastogiMarch 13, 2025

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Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Shots:Marija spoke about the data on Migraine and Brain Health presented at the 75th Annual Meeting of the AAN 2023. The 12 abstracts included the data from post-hoc and real-world analyses of VYEPTIShe also talked about a medical symposium sponsored by the company “Migraine: Your Patient, Your Partner. Proactive care for high-frequency, worsening…

BySenior EditorAugust 14, 2023

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Insights+: The US FDA New Drug Approvals in May 2023

Shots:The US FDA approved 15 NDAs and 3 BLA in May 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 54 novel products in 2023In May 2023, the major highlights drugs were, Ayvakit approval for Indolent Systemic Mastocytosis, Rinvoq for Active Crohn's DiseasePharmaShots has…

BySenior EditorJune 21, 2023

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Insights+: The US FDA New Drug Approvals in April 2023

Shots:The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

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Rami Apelian and Marija Geertsen Share Insights from 9 Poster Presentations on Migraine Prevention & Treatment at AHS 2022

Shots:Rami spoke about study design of the P-III study evaluating its lead candidate in migraineMarija Geertsen talked about different treatment options available for migraine & neurological diseasesThe interview highlights the development plans and global expansion of various therapies for brain diseasesSmriti: Explain the details (MOA, ROA, formulations, etc.) of Vyepti.Rami Apelian: VYEPTI®…

BySenior EditorAugust 29, 2022

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Insights+: The US FDA New Drug Approvals in February 2020

The US FDA has approved multiple NDAs and BLAs in Feb 2020, leading to treatments for patients and advances in health careThe Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 13 novel products so far in 2020, including 10 in Feb and 3 in Jan…

BySenior EditorMarch 27, 2020

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PharmaShots’ Key Highlights of Third Quarter 2019

The third quarter of 2019 has ended with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisition where Biocon Biologics acquires Pfizer's Research Facility for expansion of its R&D footprints with the acceleration of the development of its biosimilars from lab to pilot scale. Previously, Amgen acquired…

BySenior EditorSeptember 7, 2019

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Insights+: The US FDA New Drug Approvals in May 2023

Insights+: The US FDA New Drug Approvals in April 2023

Rami Apelian and Marija Geertsen Share Insights from 9 Poster Presentations on Migraine Prevention & Treatment at AHS 2022

Insights+: The US FDA New Drug Approvals in February 2020

PharmaShots’ Key Highlights of Third Quarter 2019

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