Biopharma scored a victory of sorts in the ongoing 340B war that’s pitting drug companies against the combined forces of hospital groups, contract pharmacies and the U.S. Department of Health and Human Services.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.
Boehringer Ingelheim GmbH has begun a three-year collaboration with researchers at Australia’s WEHI, looking into a potentially powerful approach to targeted protein degradation also being studied by its German rival Merck KGaA.
DUBLIN – Apeiron Biologics AG reported March 12 that APN-01, recombinant angiotensin converting enzyme 2 (ACE2; alunacedase alfa) failed to attain the primary endpoint of lowering all-cause death or the need for invasive mechanical ventilation in hospitalized patients with severe COVID-19.
The U.S. Court of Appeals for the Seventh Circuit grappled with whether so-called patent thickets and certain global patent settlements constitute antitrust behavior as it heard arguments Feb. 25 in UFCW Local 1500 Welfare Fund v. Abbvie Inc.
LONDON – Enara Bio Ltd. has landed the first major deal around its dark antigen technology platform, signing up Boehringer Ingelheim GmbH in an agreement worth a potential €876 million (US$1.06 billion). Reaching that figure would require a product to make it to market. More immediately, Enara is getting an up-front payment, research and preclinical milestones for each of up to three tumor types explored in the partnership.
The latest global regulatory news, changes and updates affecting biopharma, including: Health care bills become U.S. law; MHRA releases safety review of epilepsy drugs.
DUBLIN – Boehringer Ingelheim GmbH is paying up to €1.18 billion (US$1.4 billion) to acquire antibody-drug conjugate (ADC) developer NBE-Therapeutics AG. The deal includes an undisclosed up-front payment, plus development and regulatory milestones linked to the progress of NBE’s pipeline of clinical and preclinical ADC programs.
The latest global regulatory news, changes and updates affecting biopharma, including CDER, CBER promise EUA transparency; FDA plasma guidance updated, again; WHO targets cervical cancer; Draft guidance to help FDA respond to 2012 citizen petition; More time to comment on instituting PTAB trials.
Click Therapeutics Inc. and Boehringer Ingelheim GmbH inked a deal valued at more than $500 million to collaborate on the development and commercialization of a prescription-based digital therapeutic for schizophrenia. The mobile application, currently called CT-155, uses cognitive and neurobehavioral techniques to reduce the symptoms of schizophrenia, such as cognitive deficits and impaired social functioning.
