Virbac Launches Zenifel Pheromone Product to Address Stress-Related Behaviors in Cats

Shots: Virbac has launched Zenifel pheromone product in two formats (gel diffuser & Spray) to manage stress-related behaviors in cats & improve their health Zenifel Gel Diffuser provides ~2mos. of calming effects, covering ~750 sq. ft. & reducing stress by ~80%, while the spray format offers 400+ odorless sprays, plus ensures quick relief for…

ByRidhi RastogiJanuary 24, 2025

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Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Shots: The US FDA has granted Orphan Drug Designation to Zai Lab’s ZL-1310 for treating small cell lung cancer (SCLC) The designation is based on promising P-Ia/Ib trial data of ZL-1310 as monotherapy and with atezolizumab in treatment-experienced ES-SCLC patients, presented at the ENA Symposium 2024 ZL-1310 is a novel ADC targeting DLL3…

ByRidhi RastogiJanuary 23, 2025

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Holon Health Reports Development of Holon Vibe App for the People with Substance Use Disorders (SUD)

Shots: Holon Health reported the development of Holon Vibe, a multi-modal therapeutic app to provide health evaluations & care plan management for people with SUD in Indiana & Arizona, with more states to be added in 2025 Primary data for the app showed a 65%+ appointment show rate for users, a 61-day increase in…

ByRidhi RastogiJanuary 23, 2025

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Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots: The P-III (ALLEVIATE-1) study assessed analgesic efficacy of cebranopadol (400µg, QD) vs PBO for treating moderate-to-severe acute pain post abdominoplasty surgery Study depicted significantly reduced pain intensity as evaluated by Pain Numeric Rating Scale (NRS) AUC4-48 (1.34 mean hourly difference) and a well-tolerated safety with nausea being the common AE Tris will…

ByRidhi RastogiJanuary 23, 2025

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The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM patients, following the CHMP’s positive opinion. Regulatory findings are under review in Japan & China Approval was based on a P-III (IMROZ) study assessing Sarclisa + VRd vs VRd, which showed improved PFS of 40% (1EP) with findings reported…

ByRidhi RastogiJanuary 22, 2025

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Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

Shots: The US FDA has granted 510(k) clearance & CLIA waiver for Cobas liat STI multiplex assay panels (CT/NG & CT/NG/MG), commercially available under the CE mark in upcoming months The CT/NG (chlamydia & gonorrhea) & CT/NG/MG (chlamydia, gonorrhea & Mycoplasma genitalium) assays compliment the existing portfolio of singleplex & multiplex tests of Cobas liat…

ByRidhi RastogiJanuary 22, 2025

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ArriVent Biopharma Collaborates with Lepu BioPharma to Develop and Commercialize MRG007 for the Treatment of Gastrointestinal Cancers

Shots: ArriVent & Lepu Biopharma entered into an exclusive license agreement for MRG007, where ArriVent will get rights to develop & market MRG007 (ADC) globally excl. Greater China (mainland China, Hong Kong, Macau & Taiwan) As per the terms, Lepu Biopharma will receive upfront, near-term milestones ($47M cash) & development, regulatory & sales milestones…

ByRidhi RastogiJanuary 22, 2025

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The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

Shots: The US FDA has approved sNDA for Spravato CIII nasal spray to treat MDD patients unresponsive to at least two oral antidepressants, following the FDA Priority Review Approval was based on a multicenter trial that assessed Spravato vs PBO, showing an improved MADRS total score. In a post-hoc analysis, Spravato improved all 10…

ByRidhi RastogiJanuary 22, 2025

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The US FDA Approves Innovate’s MediBeacon Transdermal GFR System to Evaluate Renal Function

Shots: The US FDA has approved MediBeacon TGFR to assess patients with normal or impaired renal function The system met FDA-approved 1EP of 94% P30 value (% of GFR estimates within ±30% of mGFR) in patients with varied GFR & skin tones. The approval aligns with recent data publication in support of Lumitrace in…

ByRidhi RastogiJanuary 21, 2025

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Takeda Receives Health Canada’s Approval for Fruzaqla (fruquintinib) to Treat Metastatic Colorectal Cancer (mCRC)

Shots: Health Canada has approved Fruzaqla to treat mCRC patients receiving prior therapy or are ineligible for SoCs based on 2 P-III (FRESCO & FRESCO-2) trials. In addition, the CDA-AMC & INESSS recommended reimbursement of Fruzaqla FRESCO assessed Fruzaqla + BSC vs PBO + BSC in 3L+ mCRC patients, while FRESCO-2 assessed Fruzaqla +…

ByRidhi RastogiJanuary 21, 2025

Ridhi Rastogi

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Holon Health Reports Development of Holon Vibe App for the People with Substance Use Disorders (SUD)

Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

ArriVent Biopharma Collaborates with Lepu BioPharma to Develop and Commercialize MRG007 for the Treatment of Gastrointestinal Cancers

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

The US FDA Approves Innovate’s MediBeacon Transdermal GFR System to Evaluate Renal Function

Takeda Receives Health Canada’s Approval for Fruzaqla (fruquintinib) to Treat Metastatic Colorectal Cancer (mCRC)

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