Ailux Collaborates with Eli Lilly to Accelerate Bispecific Antibody Development

Shots:Ailux (XtalPi’s subsidiary) has entered into a strategic platform-based collaboration with Eli Lilly to accelerate the discovery & development of bispecific antibodies (bsAbs) for various diseasesAs per the deal, Lilly will nominate an undisclosed number of target pairs for bsAb design & may license Ailux’s platform for internal use. In exchange, Ailux will…

ByRidhi RastogiNovember 6, 2025

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Dechra Introduces Solovecin to Treat Skin Infections in Dogs and Cats

Shots:Dechra has launched Solovecin (cefovecin sodium) for the treatment of skin infections in dogs & cats across the USSolovecin treats skin infections in dogs (secondary superficial pyoderma, abscesses, & wounds) caused by S. intermedius & S. canis, & in cats (wounds & abscesses) caused by susceptible strains of P. multocidaSolovecin, a long-acting…

ByRidhi RastogiNovember 4, 2025

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BD Secures the US FDA’s 510(k) Clearance and European CE-IVDR Certification for Enteric Bacterial Panels (EBP) on the BD COR System

Shots:BD has received 510(k) clearance & CE Mark for its EBP & EBP plus panels on the BD COR System to detect gastrointestinal bacterial pathogens from a single stool swab using PCR-based testingEBP detects multiple enteric bacterial pathogens, incl. Salmonella, Campylobacter (jejuni, coli), Shigella/Enteroinvasive E. coli, & Shiga toxin-producing E. coli, while EBP plus…

ByRidhi RastogiNovember 4, 2025

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Kaigene Inks ~$744M Licensing Deal with Celltrion for KG006 and KG002 to Treat Autoimmune Diseases

Shots:Kaigene has granted Celltrion exclusive global rights to develop & commercialize KG006 (excl. Greater China & Japan) & KG002As per the deal, Kaigene will receive $8M upfront, & ~$736M in milestone payments, incl. $11M in near-term milestones through the initiation of P-I trials, along with net sales-based tiered royaltiesKG006 is an FcRn…

ByRidhi RastogiNovember 4, 2025

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UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots:FDA has approved Kygevvi (2g/2g; PO) for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age. Kygevvi is expected to launch in the US by Q1’26, & is under EMA's review, with additional regulatory filings plannedApproval was backed by a P-II trial, 2 retrospective chart review studies, & an…

ByRidhi RastogiNovember 4, 2025

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Manifold Bio Partners with Roche to Develop BBB shuttles for Neurological and Neurodegenerative Diseases

Shots:Manifold has entered into a strategic research collaboration & licensing deal with Roche to develop multiple next-gen blood-brain barrier (BBB) shuttles for neurological & neurodegenerative diseases, leveraging Manifold’s shuttle portfolio & mDesign AI-driven in vivo discovery platformAs per the deal, Manifold will lead research & discovery of BBB shuttles for Roche’s therapeutic payloads,…

ByRidhi RastogiNovember 4, 2025

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TransThera Sciences Inks Up to $881.5M Deal with Neurocrine Biosciences to Advance NLRP3 Inhibitors

Shots: TransThera Sciences has entered into a royalty-bearing patent assignment & research collaboration deal with Neurocrine Biosciences to develop preclinical NLRP3 inhibitors for multiple diseasesAs per the deal, Neurocrine will gain exclusive ex-Greater China rights to develop, manufacture & commercialize NLRP3 inhibitors from TransThera’s NLRP3 portfolio, while TransThera will retain Greater China rights (Mainland,…

ByRidhi RastogiNovember 4, 2025

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Calluna Pharma’s CAL101 Receives the US FDA’s Orphan Drug Designation to Treat Idiopathic Pulmonary Fibrosis (IPF)

Shots:The US FDA has granted ODD to CAL101 for the treatment of idiopathic pulmonary fibrosis (IPF)CAL101 (IV, QM for 7mos.) is being investigated in a P-II (AURORA) trial against PBO in 150 IPF pts, with enrolment open in the sites across US, UK, EU, Turkey, & South Korea, evaluating lung function per forced vital…

ByRidhi RastogiNovember 3, 2025

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UCB Reports Results from BE HEARD Trials on Bimzelx (Bimekizumab-bkzx) to Treat Hidradenitis Suppurativa

Shots:UCB has reported 3yr. BE HEARD trials data where 2 P-III (BE HEARD I & II) trials assessed Bimzelx (320mg; Q2W till Wk. 16, then Q4W) vs PBO in 1,014 adults with mod. to sev. HS; 556 pts completing Wk. 48 entered the OLE (BE HEARD EXT) studyAmong pts with ≥1 draining tunnel…

ByRidhi RastogiNovember 3, 2025

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Genentech Reports P-III (ALLEGORY) Trial Findings on Gazyva (Obinutuzumab) for Systemic Lupus Erythematosus (SLE)

Shots:Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300 adults with SLE on SoC for 52wks. followed by ~104wks. OLE periodTrial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…

ByRidhi RastogiNovember 3, 2025

Ridhi Rastogi

Ailux Collaborates with Eli Lilly to Accelerate Bispecific Antibody Development

Dechra Introduces Solovecin to Treat Skin Infections in Dogs and Cats

BD Secures the US FDA’s 510(k) Clearance and European CE-IVDR Certification for Enteric Bacterial Panels (EBP) on the BD COR System

Kaigene Inks ~$744M Licensing Deal with Celltrion for KG006 and KG002 to Treat Autoimmune Diseases

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Manifold Bio Partners with Roche to Develop BBB shuttles for Neurological and Neurodegenerative Diseases

TransThera Sciences Inks Up to $881.5M Deal with Neurocrine Biosciences to Advance NLRP3 Inhibitors

Calluna Pharma’s CAL101 Receives the US FDA’s Orphan Drug Designation to Treat Idiopathic Pulmonary Fibrosis (IPF)

UCB Reports Results from BE HEARD Trials on Bimzelx (Bimekizumab-bkzx) to Treat Hidradenitis Suppurativa

Genentech Reports P-III (ALLEGORY) Trial Findings on Gazyva (Obinutuzumab) for Systemic Lupus Erythematosus (SLE)

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