The U.S. FDA has become the first global regulator to approve Boehringer Ingelheim GmbH’s spesolimab, the first treatment specifically approved for generalized pustular psoriasis flares in adults, a rare and potentially fatal disease. Branded as Spevigo, it works by inhibiting interleukin-36 and is delivered via intravenous injection. Ingelheim, Germany-based Boehringer Ingelheim is not giving away details about pricing but Carinne Brouillon, a member of the company’s board responsible for human pharma, said Spevigo is “priced similarly to the other biologic therapies used to treat rare dermatologic diseases.”
Biomérieux SA is stepping up investments in the antimicrobial resistance (AMR) space through a new new €40 million ($40.75 million) joint venture with Evotec SE and Boehringer Ingelheim GmbH. The companies are teaming up to launch a new company, Aurobac Therapeutics SAS which will develop AMR diagnostic tests and antimicrobial therapies.
Singapore’s Agency for Science, Technology and Research (A*STAR) has inked a deal with Boehringer Ingelheim GmbH to develop and commercialize targeted cancer therapies.
Singapore’s Agency for Science, Technology and Research (A*STAR) has inked a deal with Boehringer Ingelheim GmbH to develop and commercialize targeted cancer therapies.
CDR-Life Inc. has closed a $76 million series A round to advance development of a new generation of cancer immunotherapies designed to treat solid tumors by targeting intracellular antigens that occur only in tumors, with the aim of increasing effectiveness while reducing off-target effects.
Four biopharma companies are pooling some of their chemical data and making it public for the first time as part of the pioneering stage of a European effort to reduce the need for animal testing in drug development.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
With licensed Humira (adalimumab) biosimilar competition a little more than a year away in the U.S., Abbvie Inc. is trying to fend off competitors that have not signed an agreement with the North Chicago-based company.
NHS England has struck new pricing agreements that expands access in the U.K. to blood thinning direct oral anticoagulants (DOACs) to tackle strokes in patients with atrial fibrillation. Though still available to NHS clinicians, Boehringer Ingelheim GmbH’s blockbuster DOAC Pradaxa (dabigatran) is notably not involved.
With the U.S. biosimilar pathway clearly developed, industry and the FDA are turning their attention to interchangeables in the third iteration of the biosimilar user fee agreement (BsUFA).
