NEWS

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…

January 22, 2025

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…

January 21, 2025

Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat β -Thalassemia

Shots: Yoltech reported the initiation of a dose-escalation study for YOLT-204 (QD) to evaluate its safety & efficacy as an off-the-shelf treatment of transfusion-dependent beta-thalassemia (TDT) without CT & HSCT In preclinical studies, YOLT-204 showed consistent expression of fetal hemoglobin, associated with reduced polymerization of sickle hemoglobin, fewer complications, & lower mortality. These findings…

January 21, 2025

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

Shots: Junshi with its subsidiary, TopAlliance, has partnered with LEO to market toripalimab in 32 EU countries incl. EEA, Switzerland & the UK. TopAlliance will remain the authorization holder overseeing development, manufacturing, registration & other activities in the EU LEO Pharma will handle the drug distribution, promotion & sales plus will pay an upfront…

January 21, 2025

InnoCare and KeyMed Together Partner with Prolium Bioscience to Develop ICP-B02

Shots: InnoCare & KeyMed together have signed an exclusive license agreement with Prolium to develop & commercialize ICP-B02 (CM355) Prolium gains exclusive rights to develop, manufacture & commercialize ICP-B02 globally (non-oncology) and in ex-Asia regions (oncology) while InnoCare & KeyMed will get a total of ~$520M (upfront & near-term payments), minority equity stake in…

January 21, 2025

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 +…

January 21, 2025

Formycon Reports the EC’s Approval of FYB203 (Biosimilar, Eylea) Under the Brand Names Ahzantive and Baiama

Shots: Formycon & Klinge Biopharma have reported the EC’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand names: Ahzantive & Baiama valid across the EU plus Iceland, Liechtenstein & Norway after receiving the CHMP’s recommendation in Nov 2024 The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other…

January 21, 2025

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

Shots: The EC has approved Jemperli + CT (carboplatin & paclitaxel) as a 1L treatment of primary advanced or recurrent endometrial cancer in adults eligible for systemic therapy Approval was based on part 1 of P-III (RUBY) study assessing Jemperli + CT followed by Jemperli vs CT + PBO followed by PBO and part…

January 20, 2025

Fermion Technology and Simcere Pharma Join Hands to Develop FZ002-037 for Pain Management

Shots: Fermion & Simcere Pharma have entered into an exclusive license and collaboration agreement to develop FZ002-037 for pain management As per the agreement, Simcere secures exclusive rights to develop & commercialize FZ002-037 across Greater China (Mainland China, Hong Kong, Macau & Taiwan) in exchange for an undisclosed upfront, milestones and sales-based tiered royalties…

January 20, 2025

Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes

Shots: The P-IIIb (STEP UP) study assessed semaglutide (7.2mg) vs semaglutide (2.4mg) & PBO as an adjunct to lifestyle intervention in obese adults (n=1,407; BMI ≥30kg/m^2) without diabetes for 72wks. STEP program also includes STEP UP T2D study of semaglutide (7.2mg) in obese adults (n=512) with T2D for 72wks. Study met its 1EP, depicting…

January 20, 2025

NEWS

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

Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat β -Thalassemia

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

InnoCare and KeyMed Together Partner with Prolium Bioscience to Develop ICP-B02

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

Formycon Reports the EC’s Approval of FYB203 (Biosimilar, Eylea) Under the Brand Names Ahzantive and Baiama

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

Fermion Technology and Simcere Pharma Join Hands to Develop FZ002-037 for Pain Management

Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes

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