Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is now on a roll, with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one, Simlandi, as an adalimumab interchangeable.
Sosei Group Corp. is getting €25 million (US$27.3 million) up front in a global collaboration and option-to-license deal with Boehringer Ingelheim GmbH aimed at developing GPR52 agonists, a new target for schizophrenia designed to potentially address positive, negative and cognitive symptoms at the same time.
Sosei Group Corp. is getting €25 million (US$27.3 million) up front in a global collaboration and option-to-license deal with Boehringer Ingelheim GmbH aimed at developing GPR52 agonists, a new target for schizophrenia designed to potentially address positive, negative and cognitive symptoms at the same time.
Abbvie Inc.’s blockbuster drug Humira is getting a 10th challenger that could give all the other adalimumab biosimilars a run for their money – depending on pricing and formulary coverage, of course. After delays caused by the COVID-19 pandemic and manufacturing issues, the U.S. FDA approved Simlandi, previously known as AVT-02, as a Humira biosimilar and interchangeable Feb. 23.
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
Boehringer Ingelheim GmbH’s start to the new year includes two fresh deals across two continents. BI struck one deal with Kunshan, China-based Suzhou Ribo Life Science Co. Ltd. and its Mölndal, Sweden-based subsidiary, Ribocure Pharmaceuticals AB, to develop small interfering RNA (siRNA) treatments for nonalcoholic or metabolic dysfunction-associated steatohepatitis. It struck a second deal with San Francisco-based 3T Biosciences Inc. to develop cancer immunotherapies, which builds on an earlier collaboration formed last year. Combined, the two deals are worth more than $2.5 billion.
Boehringer Ingelheim GmbH partnered with Newcastle University and the University of Edinburgh to fund a £30 million (US$38 million) study into liver cirrhosis in a bid to provide scientists with new insights into liver health. The partners hope that the study will not only enhance the understanding of nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) cirrhosis, but also help identify translational biomarkers using a cutting-edge approach called single-cell RNA sequencing to accelerate the development of future therapies.
Boehringer Ingelheim GmbH’s start to the new year includes two fresh deals across two continents. BI struck one deal with Kunshan, China-based Suzhou Ribo Life Science Co. Ltd. and its Mölndal, Sweden-based subsidiary, Ribocure Pharmaceuticals AB, to develop small interfering RNA (siRNA) treatments for nonalcoholic or metabolic dysfunction-associated steatohepatitis. It struck a second deal with San Francisco-based 3T Biosciences Inc. to develop cancer immunotherapies, which builds on an earlier collaboration formed last year. Combined, the two deals are worth more than $2.5 billion.
The U.S. FDA granted breakthrough device designation for CT-155, a prescription digital therapeutic co-developed by Boehringer Ingelheim GmbH and Click Therapeutics Inc. to treat the negative symptoms of schizophrenia. Designed as an adjunctive to pharmaceutical therapy for schizophrenia, among the most challenging mental health conditions to treat, the PDT is one of several products in the collaboration’s pipeline.
Biosimilars grabbed a lot of headlines in 2023, thanks to the biggest U.S. biosimilar launch to date targeting Abbvie Inc.’s mega-blockbuster Humira (adalimumab). Eight biosimilars referencing the immunology drug entered the U.S. market under licensing agreements with Abbvie. Amgen Inc.’s Amjevita led the pack with a five-month headstart in January. The others – including the first adalimumab interchangeable, Boehringer Ingelheim GmbH’s Cyltezo – launched in July.