AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)

Shots: The EC has approved Calquence + bendamustine & rituximab for the treatment of ASCT-ineligible pts with previously untreated MCL; regulatory review is ongoing in Japan & other regions Approval was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed improved PFS of 27%,…

ByRidhi RastogiMay 8, 2025

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ViVerita Therapeutics Collaborates with Boehringer Ingelheim to Accelerate Discovery of Novel Therapeutic Targets in Oncology

Shots: ViVerita Therapeutics & BI have entered into a strategic research collaboration to accelerate discovery & validation of novel cancer targets. Although financial terms of the deal were not disclosed As per the deal, ViVerita will utilize its in vivo CRISPR discovery platform to study selected potential targets from BI, evaluating their functions in physiologically relevant…

ByRidhi RastogiMay 8, 2025

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Johnson & Johnson Reports the EC’s Approval of Subcutaneous & Intravenous Tremfya for Active Crohn’s Disease

Shots: Approval was based on P-III trials, incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara; MAA of SC Tremfya for mod. to sev. UC under EMA’s review based…

ByRidhi RastogiMay 7, 2025

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Gilead Reports Final P-III (MYR301) Trial Data of Bulevirtide for Patients Living with Chronic Hepatitis Delta Virus

Shots: Gilead has reported final P-III (MYR301) trial data assessing bulevirtide (QD) for 144wks. in 150 pts living with HDV, who were randomized to either bulevirtide (2mg, n=49 or 10mg, n=50) or no antiviral therapy arm (n=51); pts in no therapy arm were switched to 10mg after 48wks. In the trial, 36% adults (23/64) with…

ByRidhi RastogiMay 7, 2025

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Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca has reported topline P-III (DESTINY-Breast11) trial data assessing neoadj. Enhertu (5.4mg/kg) monotx. or Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) vs SoC + THP in high-risk, locally advanced HER2+ early-stage breast cancer pts (n=927) Trial showed that Enhertu regimen achieved significant improvement in pCR rate (1EP), while EFS (2EP) data was…

ByRidhi RastogiMay 7, 2025

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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…

ByRidhi RastogiMay 7, 2025

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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…

ByRidhi RastogiMay 7, 2025

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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…

ByRidhi RastogiMay 7, 2025

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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…

ByRidhi RastogiMay 6, 2025

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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…

ByRidhi RastogiMay 6, 2025

Ridhi Rastogi

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)

ViVerita Therapeutics Collaborates with Boehringer Ingelheim to Accelerate Discovery of Novel Therapeutic Targets in Oncology

Johnson & Johnson Reports the EC’s Approval of Subcutaneous & Intravenous Tremfya for Active Crohn’s Disease

Gilead Reports Final P-III (MYR301) Trial Data of Bulevirtide for Patients Living with Chronic Hepatitis Delta Virus

Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

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)

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