NEWS

Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Shots: The US FDA has accepted the Class 2 BLA resubmission of narsoplimab for the treatment of HSCT-associated thrombotic microangiopathy (TA-TMA), with PDUFA goal date assigned in late Sept 2025; EMA’s MAA filing expected by late Q2’25 The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival…

May 7, 2025

PBI-Gordon Companies Acquires TriviumVet, Expanding its Animal Healthcare Product Portfolio

Shots: PBI-Gordon Companies has acquired TriviumVet, incl. its product Felycin-CA1 (Sirolimus Delayed-Release Tablets), adding it to the PRN Pharmacal portfolio (PBI-Gordon’s Brand) to expand its animal healthcare product portfolio Felycin-CA1 will be available for veterinary orders by Aug 2025, with PRN Pharmacal expanding its team by hiring over 50 additional employees Felycin-CA1 has been conditionally…

May 7, 2025

Elanco Inks a $295M Deal with Blackstone for Xdemvy’s Royalties and Milestones, Accelerating Debt Repayment

Shots: Elanco has sold certain future royalties & milestones linked to Xdemvy (0.25% lotilaner ophthalmic solution) for human use, to Blackstone Life Sciences & Blackstone Credit & Insurance to reduce its debt & strengthen its financial position As per the deal, Elanco will receive $295M in cash to repay portions of its loans on a…

May 7, 2025

Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Shots: Roche has launched its Elecsys PRO-C3 test, developed with Nordic Bioscience to evaluate the severity of liver fibrosis in pts showing signs of metabolic dysfunction–associated steatotic liver disease Elecsys PRO-C3 test requires a single assay & in combination with ADAPT formula (incl. PRO-C3 levels, platelet count, age, & diabetes status) provides clear assessment of…

May 6, 2025

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya for Ulcerative Colitis (UC)

Shots: J&J has reported P-III (ASTRO) trial data assessing Tremfya SC induction (400mg at Wks. 0, 4 & 8) followed by either Tremfya 100mg SC Q8W or 200mg SC Q4W vs PBO in adults with mod. to sev. active UC; sBLA under the US FDA’s review At Wk. 24, trial showed improved clinical remission rates…

May 6, 2025

Eli Lilly Enters a ~$415M Licensing Agreement with Alchemab Therapeutics for ATLX-1282 to Treat Amyotrophic Lateral Sclerosis (ALS)

Shots: Eli Lilly has entered into a licensing agreement with Alchemab for ATLX-1282 to treat ALS & other neurodegenerative conditions As per the deal, Alchemab will receive ~$415M, incl. an upfront payment, potential discovery, development, & commercial payments, as well as royalties, plus will handle early P-I trial activities, with Lilly leading further development &…

May 6, 2025

Immutep Reports P-IIb (KEYNOTE-C34/ TACTI-003) Trial Data of Eftilagimod Alfa + Keytruda for Head and Neck Squamous Cell Carcinoma (HNSCC)

Shots: Immutep has reported Cohort B data from P-IIb (KEYNOTE-C34/ TACTI-003) trial, with Cohort B assessing eftilagimod alfa + Keytruda as a 1L treatment of recurrent/metastatic HNSCC pts with PD-L1 expression (CPS <1) As of Mar 31, 2025, trial showed improved mOS of 17.6mos. in evaluable pts (n=31) compared to historical mOS of cetuximab +…

May 6, 2025

Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Shots: The US FDA has accepted NDA of Bysanti, an active metabolite of iloperidone to treat acute bipolar I disorder & schizophrenia (PDUFA: Feb 21, 2026). If approved, Bysanti may receive 5yrs. of data exclusivity, with pending patents extending into the 2040s NDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1…

May 6, 2025

Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeable designation to Selarsdi, a biosimilar version of Stelara (ustekinumab) for all indications incl. treatment of adult & pediatric PsA & plaque PsO as well as Crohn’s disease, & ulcerative colitis, effective as of Apr 30, 2025 Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved presentations: 45mg/0.5mL & 90mg/mL…

May 6, 2025

VERAXA Biotech Collaborates with OmniAb to Develop Novel Bispecific Antibody Drug Conjugate for Solid Tumors

Shots: VERAXA Biotech has entered into a co-discovery alliance with OmniAb to develop novel bispecific antibody drug conjugate (bsADC) targeting solid tumors using the former’s ADC linker tech & conjugation expertise & OmniAb’s suite of transgenic antibody discovery solutions As per the deal, VERAXA will initiate novel bsADC program targeting 2 cancer-related molecules, using OmniAb’s…

May 5, 2025

NEWS

Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

PBI-Gordon Companies Acquires TriviumVet, Expanding its Animal Healthcare Product Portfolio

Elanco Inks a $295M Deal with Blackstone for Xdemvy’s Royalties and Milestones, Accelerating Debt Repayment

Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya for Ulcerative Colitis (UC)

Eli Lilly Enters a ~$415M Licensing Agreement with Alchemab Therapeutics for ATLX-1282 to Treat Amyotrophic Lateral Sclerosis (ALS)

Immutep Reports P-IIb (KEYNOTE-C34/ TACTI-003) Trial Data of Eftilagimod Alfa + Keytruda for Head and Neck Squamous Cell Carcinoma (HNSCC)

Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

VERAXA Biotech Collaborates with OmniAb to Develop Novel Bispecific Antibody Drug Conjugate for Solid Tumors

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