Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has accepted an NDA of Vyepti for the treatment of pts living with migraine, who are eligible for preventive therapy; regulatory review is also ongoing in China & South Korea The NDA was supported by extensive clinical data, incl. the P-III (SUNRISE) trial of Vyepti (100 or 300mg, IV) vs PBO…

ByRidhi Rastogi3 days ago

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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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Alvotech Provides Update on BLA of AVT05 (Biosimilar, Simponi)

Shots: The US FDA has issued a CRL related to the BLA for AVT05, a biosimilar version of Simponi (golimumab), in PFS & autoinjector formulations The CRL noted certain deficiencies from the FDA’s Jul 2025 pre-license inspection of Alvotech’s Reykjavik facility that must be resolved before AVT05 BLA approval, though no other issues were found,…

ByRidhi RastogiNovember 3, 2025

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Fresenius Kabi’s Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) Receives FDA’s Interchangeable Designation

Shots: The US FDA has granted interchangeable designation to Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for the treatment of bone & skeletal disorders Conexxence treats adults at high fracture risk, incl. pts with osteoporosis, pts on long-term glucocorticoid therapy or certain cancer treatments affecting bone density Bomyntra prevents SREs in adults with bone-involved malignancies…

ByRidhi RastogiOctober 30, 2025

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Incyte Partners with Enable Injections for enFuse On-Body Delivery System

Shots: Incyte has partnered with Enable Injections to develop and commercialize specific assets in Incyte’s portfolio, incl. INCA033989, a mutCALR selective mAb, with Enable’s enFuse On-Body Delivery System As per the deal, Incyte will obtain exclusive global rights to use enFuse tech with INCA033989 for essential thrombocythemia & myelofibrosis, with potential expansion to other assets &…

ByRidhi RastogiOctober 28, 2025

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Polpharma Biologics Launches Ranivisio PFS (Biosimilar, Lucentis) in the EU

Shots: Polpharma Biologics has launched Ranivisio pre-filled syringe (PFS), a biosimilar version of Lucentis (ranibizumab) in France Bioeq AG, a joint venture of Polpharma & Formycon, develops & licenses Ranivisio PFS, with Teva holding exclusive commercialization rights in France. The drug substance is manufactured by Rezon Bio (Polpharma Biologics) in Poland Ranibizumab is a recombinant humanized…

ByRidhi RastogiOctober 22, 2025

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Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

Shots: The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible pts Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…

ByRidhi RastogiOctober 21, 2025

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FDA Approves Celltrion’s Yuflyma (Biosimilar, Humira) and its Unbranded Version for Hidradenitis Suppurativa (HS) and Uveitis in Younger Patients

Shots: The US FDA has approved Yuflyma, a biosimilar version of Humira (adalimumab) & its unbranded version for the treatment of HS in adolescents (≥12yrs.), & uveitis in children (≥2yrs.) Yuflyma, an anti-TNFα mAb, was previously approved by the FDA for rheumatoid & psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, &…

ByRidhi RastogiOctober 17, 2025

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Zoetis’ Lenivia (Izenivetmab) Receives the CVMP’s Recommendation for Osteoarthritis Pain Relief in Dogs

Shots: The CVMP has recommended Lenivia for the reduction of pain associated with osteoarthritis in dogs, with EC’s decision expected in Q4’25. Also, a commercial launch in the EU is planned for 2026 Lenivia showed increased mobility & decreased pain after a single administration in a 9mos. field study, along with favorable safety in dogs…

ByRidhi RastogiOctober 13, 2025

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Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across Canada

Shots: Bio-Thera Solutions has entered into an exclusive commercialization & license agreement with Intas Pharmaceuticals for BAT2506, a biosimilar version of Simponi (golimumab), for Canada The agreement expands their Feb 2025 deal, under which Intas holds US commercialization rights for BAT2506, while Bio-Thera handles its development & manufacturing BAT2506 is an IgG1 monoclonal antibody that targets…

ByRidhi RastogiOctober 10, 2025

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

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

Alvotech Provides Update on BLA of AVT05 (Biosimilar, Simponi)

Fresenius Kabi’s Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) Receives FDA’s Interchangeable Designation

Incyte Partners with Enable Injections for enFuse On-Body Delivery System

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

FDA Approves Celltrion’s Yuflyma (Biosimilar, Humira) and its Unbranded Version for Hidradenitis Suppurativa (HS) and Uveitis in Younger Patients

Zoetis’ Lenivia (Izenivetmab) Receives the CVMP’s Recommendation for Osteoarthritis Pain Relief in Dogs

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across Canada

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