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.
Companies have invested billions for decades to crack the problem of treating the deep complexities involving stromal cancers, Phenomic AI CEO Girish Aakalu told BioWorld. Now he and his company are on the receiving end as they enter a new collaboration with Boehringer Ingelheim GmbH.
Boehringer Ingelheim GmbH has acquired T3 Pharmaceuticals AG for CHF450 million (US$507.5 million) to gain access to a technology that uses live bacteria to deliver immune-modulating proteins to cancer cells and tumor microenvironments.
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
In a historic first, the European Commission (EC) sanctioned a pharmaceutical cartel focused on controlling an active pharmaceutical ingredient (API) in the European Economic Area.
Day Zero Diagnostics Inc. added more of the right kind of zeros to its coffers as it closed a $16 million financing round supported by existing investors. Venture capital investment in the diagnostics company to date totals $49 million, with more than $18 million in additional non-dilutive funding. The company is developing a diagnostic that provides same-day identification of an infectious pathogen and its antimicrobial susceptibility profile.
If the U.S. FDA has its way, biosimilars and interchangeable biosimilars would no longer be a difference with a distinction – at least when it comes to labeling. Instead of distinguishing between the two, the agency is recommending that the labeling for both follow-ons include a “biosimilarity statement.”
