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Intas Pharmaceuticals, through its Accord subsidiaries, has completed the acquisition of Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv), a biosimilar of Neulasta
With the acquisition, Accord BioPharma, Intas’ U.S. specialty arm, continues Udenyca commercialization, offering patient-friendly administration options autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS)
Udenyca is a leukocyte growth factor used to reduce infection risk in…
NEWS
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UroGen Pharma has reported P-III (ENVISION) trial data of Zusduri (mitomycin; QW, intravesical) as a chemoablative therapy for adults (n=240) with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
Trial showed a 24mos. DoR of 72.2% (Kaplan-Meier) in pts with CR at 3mos., with a mFU of 23.7mos. after 3mos. CR; the mDoR was…
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Kashiv BioSciences and MS Pharma have signed a license & supply agreement for ADL-018, a Xolair (omalizumab) biosimilar, across the Middle East and North Africa (MENA) region, with anticipated regulatory submissions in Q4’25
Under the agreement, Kashiv BioSciences will develop ADL-018, while MS Pharma will handle licensing, distribution, and commercialization in MENA, with local…
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SERB Pharmaceuticals has entered into a definitive merger agreement to acquire Y-mAbs, incl. its asset Danyelza (naxitamab-gqgk), strengthening its rare oncology portfolio
As per the deal, SERB will acquire Y-mAbs for a total equity value of ~$412M, with its shareholders receiving $8.6/share in cash, delisting Y-mAbs from Nasdaq; closing expected in Q4’25
Additionally, Y-mAbs’ pipeline incl.…
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Ethris has dosed the first pts in a P-IIa trial of ETH47 for asthma symptom reduction after rhinovirus challenge, building on P-I trial data, which showed strong respiratory tract activity, local IFNλ induction, antiviral gene activation, & no systemic exposure
The P-IIa trial will evaluate ETH47 vs PBO in ~50 adults with asthma who…
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Polpharma has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, a biosimilar version of Takeda’s Entyvio (vedolizumab) for the treatment of mod. to sev. ulcerative colitis & Crohn’s disease
As per the deal, Fresenius will obtain global commercialization rights to PB016, excl. Middle East & North Africa, while Polpharma will…
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Alcon has entered into a definitive merger agreement to acquire STAAR Surgical Company incl. its asset EVO family of lenses (EVO ICL)
As per the deal, Alcon will acquire STAAR for a total equity value of ~$1.5B, with its shareholders receiving $28/share in cash; the deal is expected to close within 6-12mos.
EVO ICLs are…
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The US FDA has approved IND application of IBI3032 to initiate P-I trial for cardiometabolic disorders
The P-I trials will be initiated simultaneously in China & the US, with dosing in healthy & overweight or obese participants anticipated to start in H2’25
IBI3032, an oral GLP-1 receptor agonist biased toward the cAMP pathway, showed…
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AliveDx has received the European IVDR-CE mark approval for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture's) disease
VAS assay diagnoses autoimmune vasculitis using just 10μL of sample in a single test, with 3 key autoantibody markers: MPO, PR3, & GBM
VAS assay allows accurate serological evaluation with…
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The US FDA has accepted sBLA & granted priority review to Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy (PDUFA: Dec 5, 2025)
sBLA is supported by the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl.…

