NEWS

Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer

Shots: Pfizer has reported P-II (FOURLIGHT-1) trial data assessing atirmociclib + fulvestrant vs fulvestrant or everolimus plus exemestane in 264 pts with HR+, HER2- advanced or metastatic breast cancer who had received prior CDK 4/6 inhibitor-based treatment Trial met its 1EP, showing improved PFS as assessed by the investigator, with benefit consistent across all subgroups. OS…

15 hours ago

Sun Pharma Reports US FDA’s sBLA Acceptance of Ilumya for Active Psoriatic Arthritis

Shots: The US FDA has accepted sBLA of Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis (PsA), with PDUFA target action date of Oct 29, 2026 sBLA was backed by P-III (INSPIRE-1 & INSPIRE-2) trials assessing Ilumya (100mg) in pts with PsA over 52wks., where INSPIRE-1 enrolled pts with prior anti-TNF exposure…

16 hours ago

AstraZeneca Secures the EC Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Shots: The EC has approved perioperative Imfinzi + FLOT for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, based on P-III (MATTERHORN) trial; regulatory review is ongoing in Japan In the trial, Pts (n=948) received either Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles, then surgery followed by…

17 hours ago

Celltrion Introduces Avtozma SC (Biosimilar, Actemra) in the US

Shots: Celltrion launched Avtozma SC, a biosimilar to Actemra (tocilizumab), in the US, becoming among the first to offer both IV & SC formulations approved by the US FDA & available in the market Avtozma received the FDA & EC approval in Jan & Feb 2025, respectively, based on a global P-III trial showing comparable…

19 hours ago

Prodeon Medical Secures FDA Clearance for Urocross Expander System to Treat Urinary Symptoms Associated with BPH

Shots: The US FDA has granted 510(k) clearance to the Urocross Expander System for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), backed by extensive data incl. the Expander-1 & Expander-2 trials Expander-2 (n=240) showed mean 48.1% IPSS improvement & a 74.5% responder rate (≥30% IPSS reduction) at 12mos. post implantation…

20 hours ago

Eli Lilly Reports P-III (ADorable 1) Trial Data on Ebglyss (Lebrikizumab-lbkz) in Atopic Dermatitis (AD)

Shots: The P-III (ADorable‑1) study data assessed Ebglyss vs PBO in 363 pediatric pts (≥6mos.) with mod. to sev. AD; Topical corticosteroids were required for 2 wks. pre-randomization through Wk. 16, with tapering or discontinuation allowed once pts achieved IGA ≤2 At Wk. 16, the trial met it 1EP & key 2EPs, with 63% vs…

21 hours ago

Sana Biotechnology Reports Clinical Data on UP421 in Type 1 Diabetes

Shots: Sana has reported 14mos. follow-up data from a FIH study of UP421, a hypoimmune-engineered allogeneic islet cell therapy, transplanted into a patient with Type 1 Diabetes without immunosuppression Results showed sustained survival & function of pancreatic β cells. At 14mos., fasting & MMTT C-peptide levels matched the first 6mos. & exceeded in mos. 9-12,…

2 days ago

Amplifon to Acquire GN Store Nord’s Hearing Business for DKK 17B (~$2.59B)

Shots: GN Store Nord has entered into a definitive agreement to sell its Hearing business to Amplifon for DKK 17B (~$2.59B), incl. DKK 12.6B (~$1.9B) in cash & DKK 56M (~$8.5M) Amplifon shares, giving GN ~16% stake in Amplifon The deal will include hearing brands such as ReSound, Beltone & others, along with IP, R&D,…

2 days ago

Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Shots: Bayer has reported the P-III (FIND-CKD) trial data assessing Kerendia (finerenone; 10 or 20mg) vs PBO, both in addition to SoC, in >1,500 adults with non-diabetic chronic kidney disease Trial met its 1EP, showing a statistically significant improvement in eGFR slope, defined as the mean annual change in eGFR from baseline to Month 32; data…

2 days ago

Roche Receives CE Mark for its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing

Shots: Roche has received the CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test, an in-vitro diagnostic immunoassay to identify the presence of the ApoE4 gene variant in the bloodstream The assay was evaluated in a study of 607 subjects with cognitive complaints or objective memory impairment of unknown aetiology, where Elecsys ApoE4 assay showed…

2 days ago

NEWS

Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer

Sun Pharma Reports US FDA’s sBLA Acceptance of Ilumya for Active Psoriatic Arthritis

AstraZeneca Secures the EC Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Celltrion Introduces Avtozma SC (Biosimilar, Actemra) in the US

Prodeon Medical Secures FDA Clearance for Urocross Expander System to Treat Urinary Symptoms Associated with BPH

Eli Lilly Reports P-III (ADorable 1) Trial Data on Ebglyss (Lebrikizumab-lbkz) in Atopic Dermatitis (AD)

Sana Biotechnology Reports Clinical Data on UP421 in Type 1 Diabetes

Amplifon to Acquire GN Store Nord’s Hearing Business for DKK 17B (~$2.59B)

Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Roche Receives CE Mark for its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing

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