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Daiichi Sankyo & Astrazeneca
NEWS

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

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InflaRx
NEWS

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

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NEWS

NEXTBIOMEDICAL Secures the US FDA’s IDE Approval of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis

Shots: The US FDA has granted IDE approval to initiate RESORB clinical evaluation of Nexsphere-F for knee osteoarthritis. It is CE-MDD approved for arthritis embolization & has shown superior efficacy in various musculoskeletal embolization cases across Asia & the EU RESORB study will evaluate the efficacy of Nexsphere-F to ease pain & improve mobility…
January 16, 2025

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NEWS

The US FDA grants 510(k) Clearance to Werfen’s Aptiva Antiphospholipid Syndrome (APS) Reagents

Shots: The US FDA has granted 510(k) Clearance for Aptiva’s APS IgG & APS IgM reagents, expanding its portfolio from Celiac Diseases & CTD essential reagents to 18 FDA-cleared analytes The APS reagents semi-quantitatively detect anti-cardiolipin (aCL), plus anti-β2 glycoprotein 1 (aβ2GP1) IgG & IgM in serum levels, aiding in diagnoses of 1° & 2° APS…
January 14, 2025

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NEWS

Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel

Shots: Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a…
January 14, 2025

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NEWS

The US FDA Grants Fast Track Designation to BridgeBio Oncology Therapeutics’ BBO-8520 for KRASG12C-Mutated Metastatic Non-Small Cell Lung Cancer

Shots: The US FDA has granted FTD to BBO-8520 for the treatment of metastatic NSCLC with KRAS^G12C mutations in adults BBO-8520 showed significant tumor inhibition in preclinical models, post resistance to sotorasib.  In addition, BBO-8520 is being assessed in a P-I (ONKORAS-101) trial in KRAS^G12C NSCLC patients either receiving KRAS^G12C inhibitors or no targeted…
January 14, 2025

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NEWS

Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine in P-I Trial to Treat 1L Acute Myeloid Leukemia (AML)

Shots: The first patient was dosed with iadademstat (ORY-1001) + venetoclax + azacitidine combination to treat AML naïve patients (n=45) under the P-I trial to evaluate the safety, tolerability, preliminary efficacy & optimal dose. Trial will be managed & funded by NCI under CRADA In addition, the combination is being evaluated to treat 1L…
January 14, 2025

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NEWS

Neurocrine’s Crenessity (Crinecerfont) Secures the US FDA’s Approval to Treat Adults and Pediatrics with Congenital Adrenal Hyperplasia (CAH)

Shots: The US FDA’s approval of Crenessity as an adjunctive treatment to glucocorticoid replacement to treat CAH was based on a global P-III (CAHtalyst Pediatric: n=103, age: 4-17yrs. & Adult: n=182, age: 18-58yrs.) trials. It has also received PRV on approval Pediatric study achieved its 1 & 2EP, depicting ~4x greater reductions in androstenedione…
January 14, 2025

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