Shots:
AstraZeneca has purchased FibroGen’s China subsidiary for ~$160M ($85M enterprise value + ~$75M net cash) with closing expected in mid-2025, obtaining full rights to roxadustat in China
The sale allows FibroGen to repay its Morgan Stanley Tactical Value loan & extend its cash runway to 2027 for advancing FG-3246 in P-II trial for…
NEWS
Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)
Shots:
Following the MHRA approval (Jan 2025), the EC has granted conditional MAA to Seladelpar +/- ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or intolerants to UDCA, respectively; ongoing regulatory review in Canada and Australia
MAA was based on a worldwide P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs…
Shots:
Akeso enrolled the first patient in the P-III (HARMONi-BC1/AK112-308) study of Ivonescimab + CT for the treatment of unresectable locally advanced or metastatic TNBC (already approved for EGFR-TKI-resistant, non-squamous NSCLC in China)
The preliminary efficacy data presented at ESMO’24 showed significant therapeutic efficacy of ivonescimab + CT and a favorable safety profile for…
Shots:
Cosette Pharmaceuticals to acquire Mayne Pharma Group for ~$430M, with shareholders receiving $4.71/share. Closing expected in Q2’25
Acquisition will strengthen Cosette’s dermatology & women’s health business, adding 12 patent-protected products incl. Vyleesi, Intrarosa, Nextstellis, Annovera, Bijuva, Imvexxy, & Rhofade along with multiple pipeline candidates in its product line upon closing
The combined…
Shots:
Elanco has introduced Pet Protect, a veterinarian-formulated supplement line with scientifically-backed ingredients & NASC quality seal for dogs & cats designed to target their various health needs
Pet Protect line incl. supplements like Synovi G3 formula (hip & joint support), DVM Daily Soft Chews (multivitamins) & Lactoquil (digestive health) to maintain GI health…
Shots:
Incyte has partnered with Genesis to advance research, discovery, & development of novel small molecules using GEMS (Genesis Exploration of Molecular Space) AI platform, initially focusing on targets selected by Incyte
As per the agreement, Incyte will gain exclusive rights to develop & commercialize products arising from this deal in exchange for $30M…
Shots:
China’s NMPA has accepted the NDA for Nucala as an add-on treatment for COPD with eosinophilic phenotype based on P-III (MATINEE) study; global regulatory filings is ongoing
The MATINEE study assessing Nucala (100mg, Q4W, SC) vs PBO in addition to inhaled triple therapy in COPD pts (n=804) with type 2 inflammation achieved its 1EP, showing…
Shots:
Harbour BioMed has entered into a strategic collaboration with Insilico Medicine to accelerate therapeutic antibody development, combining their expertise in antibody discovery and artificial intelligence
The companies will also collaborate on early-stage drug discovery targeting novel antibodies, leveraging Insilico's AI expertise and Harbour BioMed's wet lab capabilities for immunology, oncology, and neuroscience, aiming…
Shots:
The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25
AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…
Shots:
The US FDA has accepted & granted priority review to the NDA of zongertinib (BI 1810631) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy (PDUFA: Q3’25)
Submission was based on P-Ib (Beamion LUNG-1) trial assessing zongertinib as Monotx. in 2 arms…

