Shots:
BI has reported P-III (SYNCHRONIZE-1) trial assessing survodutide (BI 456906; 3.6 or 6mg, QW) vs PBO in 725 adults living with obesity or overweight, without type 2 diabetes
Trial met co-1EP, with ~85.1% achieving ≥5% weight loss vs 38.8%, & 16.6% sustained mean loss vs 3.2% after 76wks. (efficacy estimand), mainly driven by fat…
Shots:
Biopharma dealmaking in 2025 continued to face significant headwinds, with collaborations frequently collapsing due to strategic reprioritization, fierce competitive pressures, unfavorable clinical readouts, and failure to meet key closing conditions highlighting the inherent uncertainty and capital risk embedded in innovation-driven partnerships
The year underscored a clear dominance of R&D-focused collaborations and licensing agreements,…
Shots:
The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …
Shots:
The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the 1L treatment of pts with advanced NSCLC harboring HER2 (ERBB2) tyrosine kinase domain activating mutations
Approval was based on the data from a treatment-naïve cohort (N=72) of the P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 76% (11%…
Shots:
The US FDA has granted Emergency Use Authorization (EUA) for NexGard (afoxolaner) chewables for treating infestations caused by New World screwworm (NWS) in dogs and puppies, and NexGard COMBO topical solution for treating infestations caused by NWS in cats and kittens
NexGard (afoxolaner) is approved for dogs only and is safe for puppies 8…
Shots:
The US FDA has granted Emergency Use Authorization for the use of Ivomec (ivermectin) 1% Injection for the prevention of infestations caused by New World screwworm (NWS) in cattle
Under the EUA, Ivomec is authorized for NWS prevention when administered within 24hrs. of birth, at castration, or upon wound appearance, with specific exclusions for…
Shots:
Boehringer Ingelheim and Simcere have entered a license and collaboration agreement to develop SIM0709, a preclinical TL1A/IL-23p19 bispecific antibody, for the treatment of inflammatory bowel disease (IBD)
As per the deal, Boehringer Ingelheim gains global rights to the asset excluding Greater China, while Simcere is eligible for an upfront payment, milestones up to €1.058B…
Shots:
Rectify has entered into a strategic research & licensing agreement with BI to accelerate the development of small molecule therapies for CKD & other conditions
Collaboration will leverage Rectify’s positive functional modulators (PFM) platform to develop oral small molecules that restore or enhance ABCC6 function, targeting pathologic calcification to slow disease progression in CKD, Pseudoxanthoma elasticum,…
Shots:
The US FDA has approved Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF)
Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, where Jascayd significantly reduced lung function decline at Wk. 52, with FVC decreases of 86mL (18mg) & 69mL (9mg) vs 152mL with PBO, showing clinically meaningful…
Shots:
The Chinese NMPA has approved Boehringer Ingelheim's Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF)
Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, which met its 1EP of reduced FVC at Wk. 52 & showed a significant reduction in death risk
Additionally, Jascayd'ssNDA for PPF is under…

