Alexion (AstraZeneca) and Neurimmune Expand Alliance to Develop NI009 for AL Amyloidosis

Shots: Neurimmune has entered into an exclusive global collaboration & licensing deal with Alexion to develop NI009, a preclinical human mAb for the treatment of AL amyloidosis Alexion will obtain an exclusive global license to Neurimmune’s AL amyloidosis–targeting Abs, incl. NI009, with Neurimmune handling preclinical activities, early manufacturing & the FIH study, while Alexion will…

ByRidhi Rastogi2 days ago

NEWS

Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

Shots: Formycon has entered into an exclusive licensing & supply agreement with MS Pharma for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the MENA region As per the deal, Formycon will receive an upfront payment, potential development & regulatory milestones, & a significant share of regional gross profits, though…

ByRidhi Rastogi3 days ago

NEWS

The US FDA Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: The US FDA has approved Omlyclo, an interchangeable biosimilar version of Xolair (omalizumab), in PFS presentation (300mg/2ml, SC) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), & IgE-mediated food allergy Omlyclo previously received the US FDA approval in Mar 2025 for PFS injections at…

ByRidhi Rastogi4 days ago

NEWS

Zoetis’ Lenivia (Izenivetmab) Receives the EC Approval for Osteoarthritis Pain Relief in Dogs

Shots: The EC has approved Lenivia (Q3W) for the reduction of pain associated with osteoarthritis in dogs Lenivia showed increased mobility & decreased pain after a single administration in a 9mos. field study, along with favorable safety in dogs Lenivia, a monoclonal antibody targeting NGF, is designed to provide longer-lasting pain relief in osteoarthritis by…

ByRidhi RastogiNovember 27, 2025

NEWS

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary IgAN at risk for disease progression Approval was based on the interim data from the ongoing P-III (VISIONARY) trial, assessing Voyxact (400mg, SC, Q4W) vs PBO in 510 IgAN adults, who were on SoC therapy Trial…

ByRidhi RastogiNovember 26, 2025

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Teva Receives EC Approval for Ponlimsi and Degevma (Biosimilar, Prolia and Xgeva) to Treat Bone and Skeletal Disorders

Shots: The EC has approved Ponlimsi & Degevma, biosimilar versions of Prolia & Xgeva (denosumab), respectively, following the CHMP positive opinion for bone health treatments Approval was based on comprehensive analytical, preclinical, & clinical data, demonstrating comparable quality, safety, & efficacy of Ponlimsi & Degevma to the reference product Ponlimsi & Degevma are anti-RANKL monoclonal…

ByRidhi RastogiNovember 26, 2025

NEWS

The EC Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: The EC has approved Omlyclo, a biosimilar version of Xolair (omalizumab), in PFS presentation (300 mg/2ml) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU) & chronic rhinosinusitis with nasal polyps (CRSwNP) Omlyclo previously received the EC approval in May 2024 for PFS injections at 75mg/0.5mL & 150mg/1mL Omalizumab is a…

ByRidhi RastogiNovember 18, 2025

NEWS

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

Shots: The CHMP has recommended Teizeild to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regions Opinion was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32) for 14 days in 76…

ByRidhi RastogiNovember 17, 2025

NEWS

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 RastogiNovember 14, 2025

NEWS

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

Alexion (AstraZeneca) and Neurimmune Expand Alliance to Develop NI009 for AL Amyloidosis

Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

The US FDA Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Zoetis’ Lenivia (Izenivetmab) Receives the EC Approval for Osteoarthritis Pain Relief in Dogs

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Teva Receives EC Approval for Ponlimsi and Degevma (Biosimilar, Prolia and Xgeva) to Treat Bone and Skeletal Disorders

The EC Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

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)

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