Top 20 Biopharma Deal Terminations of 2025

Shots: Biopharma dealmaking in 2025 continued to face significant headwinds, with collaborations frequently collapsing due to strategic reprioritization, fierce competitive pressures, unfavorable clinical readouts, and failure to meet key closing conditions highlighting the inherent uncertainty and capital risk embedded in innovation-driven partnerships The year underscored a clear dominance of R&D-focused collaborations and licensing agreements,…

ByPrince GiriApril 24, 2026

NEWS

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Shots: Lundbeck has reported P-IIb (PROCEED) trial results evaluating bocunebart (SC/IV; QM for 3mos.) vs PBO in migraine patients with prior failure of 1-4 preventive therapies, with the IV arm randomizing 431 pts across 14 countries Trial met its 1EP in the multiple IV dosing arm, showing a statistically significant reduction in monthly migraine days…

ByRidhi RastogiFebruary 16, 2026

NEWS

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has accepted an NDA of Vyepti for the treatment of pts living with migraine, who are eligible for preventive therapy; regulatory review is also ongoing in China & South Korea The NDA was supported by extensive clinical data, incl. the P-III (SUNRISE) trial of Vyepti (100 or 300mg, IV) vs PBO…

ByRidhi RastogiNovember 14, 2025

NEWS

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

VIEWPOINTS

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 VYEPTI She 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

INSIGHTS+

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 2023 In May 2023, the major highlights drugs were, Ayvakit approval for Indolent Systemic Mastocytosis, Rinvoq for Active Crohn's Disease PharmaShots has…

BySenior EditorJune 21, 2023

INSIGHTS+

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 2023 In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

VIEWPOINTS

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 migraine Marija Geertsen talked about different treatment options available for migraine & neurological diseases The interview highlights the development plans and global expansion of various therapies for brain diseases Smriti: Explain the details (MOA, ROA, formulations, etc.) of Vyepti. Rami Apelian: VYEPTI®…

BySenior EditorAugust 29, 2022

INSIGHTS+

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 care The 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

INSIGHTS+

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

Top 20 Biopharma Deal Terminations of 2025

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

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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