Boehringer Ingelheim USA Corporation

PREC to review Ofev (nintedanib) for pulmonary fibrosis; Boehringer Ingelheim seeks reimbursement after 8 years; ICER threshold elasticity crucial for economic assessment; Ofev remains unreimbursed despite high costs and patient need.

Schizophrenia clinical trial pipeline features 55+ companies and 60+ drugs, with key players like Sumitomo Pharma America, Boehringer Ingelheim, and Reviva Pharmaceuticals advancing novel therapies. Recent milestones include Reviva's Phase III RECOVER trial data, Luye Pharma Group's IND approval for LY03020, and Teva's positive SOLARIS trial results. DelveInsight's report provides comprehensive global coverage and insights into the schizophrenia pipeline.

Milan's IP court shake-up impacts proceedings; Italian Supreme Court's Bolar exemption interpretation affects pharma litigation. Trevisan & Cuonzo and Bird & Bird lead in patent disputes, with firms like Hogan Lovells and Simmons & Simmons also prominent. Italian IP boutiques maintain strong presence, often combining academic work with litigation.

Boehringer Ingelheim announced FDA's Breakthrough Therapy designation for survodutide, a dual glucagon/GLP-1 receptor agonist for treating non-cirrhotic MASH and moderate/advanced fibrosis. Two phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, will assess survodutide's efficacy in MASH and fibrosis stages 2-3 and compensated cirrhosis (stage 4), respectively.

Boehringer Ingelheim's survodutide (BI 456906) receives U.S. FDA Breakthrough Therapy designation for non-cirrhotic MASH and moderate/advanced fibrosis. Two Phase III trials initiated for MASH and fibrosis treatment.

Boehringer Ingelheim's survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH and moderate or advanced fibrosis. Boehringer also initiated two Phase III trials for survodutide in MASH and fibrosis treatment.

FDA grants Breakthrough Therapy Designation to survodutide for treating noncirrhotic MASH with moderate or advanced fibrosis. Boehringer Ingelheim initiates phase 3 trials, LIVERAGE and LIVERAGE-Cirrhosis, to investigate survodutide's efficacy. Phase 2 data showed improvement in MASH without worsening fibrosis, positioning survodutide as a potential treatment option for MASH.

Boehringer Ingelheim's survodutide receives U.S. FDA Breakthrough Therapy designation for MASH treatment, initiating two Phase III trials. LIVERAGE and LIVERAGE-Cirrhosis aim to assess survodutide's efficacy in reducing liver disease outcomes in MASH patients with fibrosis stages 2-3 and compensated cirrhosis, respectively.

The US FDA granted Breakthrough Therapy designation to survodutide for treating noncirrhotic MASH with moderate or advanced fibrosis. Boehringer Ingelheim initiated two global phase 3 trials, LIVERAGE and LIVERAGE-Cirrhosis, to assess survodutide's safety and efficacy in MASH patients. Phase 2 results showed survodutide improved MASH without worsening fibrosis.

The FDA granted breakthrough therapy designation to Boehringer Ingelheim’s survodutide for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate or advanced fibrosis. Two global phase 3 trials, LIVERAGE and LIVERAGE-Cirrhosis, will assess survodutide’s safety and efficacy. The trials aim to determine if survodutide can improve MASH and fibrosis, and reduce the risk of end-stage liver disease.