Tags : Lundbeck

Lundbeck Halts P-II Study of Lu AF11167 in Patients with

Shots: The company discontinues P-II proof POC study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms (NCT03793712). The P-II study evaluated two doses of Lu AF11167 vs PBO as monothx. in patients with schizophrenia and persistent prominent negative symptoms The discontinuation is based on the results of a futility interim […]Read More

Insights+: Novel Approvals of 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 […]Read More

PharmaShots Weekly Snapshot (February 24-28, 2020)

1. Companion Medical’s InPen Diabetes Management System Receives the US FDA’s Approval for Fixed Dosing and Meal Estimation Published: Feb 28, 2020 | Tags: Companion Medical, InPen Diabetes Management System, Receives, US, FDA, Approval, Fixed Dosing, Meal Estimation 2.  Takeda’s Vedolizumab SC Receives CHMP’s Positive Opinion as a Maintenance Therapy for Moderately to Severely Active […]Read More

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 […]Read More

Top 20 Biopharma Acquisitions of 2018 Based on the Total

Biopharma acquisition activity in 2018 shows a significant increase over the previous year. Takeda proved to be on top with the acquisition of Shire among the top 20 acquisitions with a total deal value of $57.17B strengthening its capabilities in gastroenterology, neuroscience, oncology, rare diseases, and plasma-derived therapies. This article is based on the 2018 […]Read More

PharmaShots Weekly Snapshot (September 16– 20, 2019)

1.Boehringer Ingelheim Enters into an Agreement with Inflammasome Therapeutics to Co-Develop Therapies for Retinal Diseases Published: Sept 20, 2019 | Tags: Boehringer Ingelheim, Agreement, Inflammasome Therapeutics, Co-Develop, Therapies, Retinal Disease 2. Astellas and FibroGen’s Evrenzo (roxadustat) Receives MHLW’s Approval for Anemia Associated with Chronic Kidney Disease in Dialysis Patients Published: Sept 20, 2019 | Tags: Astellas, FibroGen, […]Read More

Takeda and Lundbeck’s Trintellix (vortioxetine) Receives MHLW’s Approval for Major

Shots: The MHLW’s approval follows P-III study (NCT02389816) assessing Trintellix (10mg/20mg) vs PBO in 493 patients with recurrent depression in Japan which demonstrated improvement in overall symptoms of depression in adults The NDA submission also follows other three pivotal studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147), submitted on Sept’2018. In 2007, the companies […]Read More

Lundbeck to Acquire Alder BioPharmaceuticals for $1.95B

Shots: Lundbeck acquires Alder BioPharmaceuticals in the all-cash transaction making a total deal value $1.95B. Alder to receive $18/share as upfront, non-tradeable CVR of $2/share on EMA’s approval of Eptinezumab with 79% premium to Alder’s shareholders based on the closing price on Sept 13, 2019. The transaction is expected to be close in Q4’19 The […]Read More

Lundbeck to Acquire Abide Therapeutics for $400M

Shots: Lundbeck acquires Abide, in all-stock transaction for $400M. Abide to receive $250M upfront and $150M development & commercialization milestones with its expected closure in Q2’19 The focus of the acquisition is to strengthen Lundbeck’s CNS portfolio with the addition of Abide’s candidate (ABX-1431) and a chemo-proteomic platform for developing serine hydrolase inhibitors (SHs) to […]Read More