NEWS

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

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)

Shots:The US FDA has approved Calquence + bendamustine & rituximab for untreated MCL in patients not for autologous HSCT, also transforming its accelerated approval (Oct 2017) to full approval for previously treated MCL. The combination is under review in Australia, Canada, Switzerland, the EU, Japan & other regions Approval was based on P-III…

January 20, 2025

Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer

Shots:The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Submissions are under review in the EU, China, & other areas Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D)…

January 20, 2025

Amgen Receives the US FDA Approval for Lumakras + Vectibix to Treat Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer (mCRC)

Shots:The FDA has approved Lumakras + Vectibix combination to treat metastatic KRAS G12C-mCRC in adults diagnosed via FDA approved test, receiving fluoropyrimidine-, oxaliplatin- & irinotecan-based CT The approval was based on P-III (CodeBreaK 300) Trial assessing Lumakras (960mg/240mg, QD) + Vectibix vs investigator’s choice of SoC (n=54; trifluridine/tipiracil or regorafenib) in patients …

January 20, 2025

InflaRx’s Gohibic (Vilobelimab) Receives the EC Approval for the Treatment of ARDS

Shots:The EC has approved (under exceptional circumstances) Gohibic to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on SoC (incl. systemic corticosteroids) & IMV (with/without ECMO) Approval was backed by results of the P-III (PANAMO) study assessing Gohibic vs. PBO among invasively mechanically ventilated COVID-19 patients in the ICU, which showed improvement in survival with…

January 17, 2025

Ceva Animal Health Partners with Touchlight to Use its dbDNA Technology in Animal Healthcare

Shots:Ceva & Touchlight entered into an agreement & long-term collaboration for developing & manufacturing future animal health products, integrating the former’s development & marketing expertise with Touchlight’s dbDNA tech to develop DNA vaccines As per the agreement, Touchlight is entitled to upfront payment, development milestones & sales-based royalties, while the complete financial terms…

January 17, 2025

NEWS

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

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)

Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer

Amgen Receives the US FDA Approval for Lumakras + Vectibix to Treat Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer (mCRC)

InflaRx’s Gohibic (Vilobelimab) Receives the EC Approval for the Treatment of ARDS

Ceva Animal Health Partners with Touchlight to Use its dbDNA Technology in Animal Healthcare

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