Ascendis Pharma Reports Topline P-II (New InsiGHTS) Trial Data on TransCon hGH in Turner Syndrome

Shots: Ascendis Pharma has reported the P-II (New InsiGHTS) trial data assessing TransCon hGH (lonapegsomatropin, QW) vs somatropin (QD) in 49 prepubertal children (1-10yrs.) with Turner syndrome At Wk. 52, TransCon hGH showed improved annualized height velocity (AHV) with LS mean AHV of 9.05 vs 9.04 cm/year, irrespective of starting dose, with mean dose of…

ByRidhi RastogiMarch 18, 2026

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Voro Therapeutics Collaborates with Daiichi Sankyo to Develop Tumor-Activated ADCs

Shots: Voro Therapeutics has entered into a research collaboration with Daiichi Sankyo via its Daiichi Sankyo Research Institute, San Diego to develop tumor-activated biologics using the PrimeBody platform The collaboration will focus on generating masked ADCs designed for tumor-selective activation, using proprietary masking domains & protease-cleavable linkers to improve therapeutic index Voro will design &…

ByRidhi RastogiMarch 18, 2026

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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…

ByRidhi RastogiMarch 17, 2026

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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…

ByRidhi RastogiMarch 17, 2026

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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…

ByRidhi RastogiMarch 17, 2026

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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…

ByRidhi RastogiMarch 17, 2026

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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…

ByRidhi RastogiMarch 17, 2026

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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…

ByRidhi RastogiMarch 17, 2026

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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,…

ByRidhi RastogiMarch 16, 2026

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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,…

ByRidhi RastogiMarch 16, 2026

Ridhi Rastogi

Ascendis Pharma Reports Topline P-II (New InsiGHTS) Trial Data on TransCon hGH in Turner Syndrome

Voro Therapeutics Collaborates with Daiichi Sankyo to Develop Tumor-Activated ADCs

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)

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