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Boehringer Ingelheim

Boehringer Ingelheim Reports Topline Data from P-III (FIBRONEER-ILD) Study of Nerandomilast for Progressive Pulmonary Fibrosis (PPF)

Shots: BI reported topline data from P-III (FIBRONEER-ILD) study assessing nerandomilast (BI 1015550; 9/18mg, BID) vs PBO in PPF pts (n=1178) for ~52wks. with regulatory filings in the US & other regions underway Study met its 1EP of absolute change from baseline in forced vital capacity (FVC; mL) with favorable safety consistent with P-II; full…

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Boehringer Ingelheim Partners with Quallent Pharmaceuticals to Expand the Access of Cyltezo (Biosimilar, Humira) 

Shots:  Boehringer Ingelheim has signed an agreement with Quallent Pharmaceuticals to expand the access of citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), across the US  As per the agreement, BI will handle the manufacturing activity of adalimumab-adbm for Quallent and will continue the commercialization of Cyltezo (adalimumab-adbm) injection and Adalimumab-adbm  Quallent will provide high-concentration (40mg/0.4mL)…

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Boehringer Ingelheim

The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira) 

Shots:  Boehringer Ingelheim has received the US FDA’s approval for the high-concentration (100mg/mL), citrate-free formulation of Cyltezo (biosimilar to Humira) to treat various chronic inflammatory diseases. Its low concentration of 50mg/mL has been available since Jul 2023  The approval was supported partly by the data from P-I (VOLTAIRE-HCLF) evaluating the bioavailability of high-concentration vs low-concentration…

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

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…

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Exclusive_Noelle Bush_2024

Noelle Bush in an Enlightening Interview with PharmaShots Shares Insights from the It Takes 2 Awareness Program

Shots:  Exemplifying awareness campaign at its best with a hint of contemporary music, “It takes 2” by Boehringer Ingelheim and Eli Lilly is a noble initiative aimed at integrating UACR testing with eGFR for better screening of CKD  Noelle Bush, in an engaging conversation with PharmaShots, cites the growing incidences of CKD in the US.…

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