NEWS

ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

Shots: The US FDA has granted FTDto ATX-01 for the treatment of Myotonic Dystrophy Type 1 (DM1) ATX-01 showed increased free MBNL, improved splicing abnormalities, & restored function in animal models, & is being evaluated in the P-I/IIa (ArthemiR) study ATX-01 is an RNA-based therapeutic designed to inhibit miR-23b, which results in increased MBNL protein…

March 11, 2026

Curatis Grants Neupharma Japan Rights to Corticorelin for Brain Edema

Shots: Curatis & Neupharma have entered into an exclusive license & development agreement for Corticorelin (C‑PTBE‑01) in Japan to treat Peritumoral Brain Edema As per the deal, Neupharma will develop & commercialize corticorelin in Japan & fund a pivotal trial to support PMDA approval, in exchange of upfront & regulatory & commercial milestones totaling up…

March 11, 2026

Celltrion Introduces Remsima IV Liquid Formulation (Biosimilar, Remicade) in the EU

Shots: Following the EU approval of Remsima IV in Nov’25, Celltrion launched Remsima IV, a biosimilar version of Remicade (Infliximab), across Europe Celltrion has filed and secured patents for the Remsima liquid formulation across most EU countries, including key markets such as the UK, Germany, and France The Remsima liquid formulation adds to existing IV (100 mg lyophilized) and SC options, aligning with clinical demand in Europe…

March 11, 2026

QIAGEN Wins the US FDA Clearance for QIAstat-Dx GI Panels on QIAstat-Dx Rise Syndromic Testing System

Shots: The US FDA has cleared all QIAstat-Dx GI Panels for use on the QIAstat-Dx Rise automated syndromic testing system The clearance enables laboratories to run both GI and respiratory panels on the high-throughput platform, which can process up to 160 tests/day, run 16 samples per batch, and deliver results in ~1hr. using real-time PCR…

March 11, 2026

LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Shots: The EMA has received MAA of Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults MAA was supported by the 3 P-III (CLARITY) trials evaluating Vizz (QD) across the US, in which Vizz met all 1 & 2EPs, showing rapid near vision improvement within 30min., lasting up to 10hrs. Additionally, LENZ…

March 11, 2026

Medtronic to Acquire Scientia Vascular for $550M

Shots: Medtronic has entered into a definitive agreement to acquire Scientia Vascular, expanding its neurovascular device portfolio As per the deal, Medtronic will acquire Scientia Vascular for $550M, with potential undisclosed earn-out & milestone payments post-acquisition Acquisition will integrate Scientia’s access platform with Medtronic’s neurovascular therapies to support the full procedural workflow for hemorrhagic &…

March 11, 2026

Pulse Biosciences Reports Clinical Data on nPulse Vybrance System for Benign Thyroid Nodule Ablation

Shots: Pulse Biosciences has reported clinical data from the ablation study (n=21), an extension of the initial feasibility study, to assess the outcome durability of the nPulse Vybrance Percutaneous Electrode System for benign thyroid nodules Long-term follow-up showed durable efficacy with ~74% average volume reduction in treated benign thyroid nodules at 15-22mos., continued reduction was…

March 10, 2026

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations Approval was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…

March 10, 2026

Pfizer Reports Topline P-II Trial Data on Tilrekimig in Moderate to Severe Atopic Dermatitis

Shots: The P-II trial consists of 4 overlapping stages: Stage 1 (vs PBO) for tilrekimig & ompekimig; Stage 2 (dose-ranging) & Stage 3 (ongoing) evaluated tilrekimig, with Stage 3 involving biologic-experienced adults; Stage 4 is an ongoing ompekimig dose-ranging study Trial met its 1EP with more pts achieving EASI-75 at Wk. 16; PBO-adjusted rates were…

March 10, 2026

Agilent Technologies to Acquire Biocare Medical for $950M

Shots: Agilent Technologies has entered into a definitive agreement to acquire Biocare Medical from investor groups led by Excellere Partners & GHO Capital Partners As per the deal, Agilent will acquire Biocare in an all-cash transaction valued at $950M, with closing anticipated by Q4’26, after which Biocare will become a part of the Agilent Life…

March 10, 2026

NEWS

ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

Curatis Grants Neupharma Japan Rights to Corticorelin for Brain Edema

Celltrion Introduces Remsima IV Liquid Formulation (Biosimilar, Remicade) in the EU

QIAGEN Wins the US FDA Clearance for QIAstat-Dx GI Panels on QIAstat-Dx Rise Syndromic Testing System

LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Medtronic to Acquire Scientia Vascular for $550M

Pulse Biosciences Reports Clinical Data on nPulse Vybrance System for Benign Thyroid Nodule Ablation

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Pfizer Reports Topline P-II Trial Data on Tilrekimig in Moderate to Severe Atopic Dermatitis

Agilent Technologies to Acquire Biocare Medical for $950M

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