GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B
GlaxoSmithKline announced that the European Medicines Agency has accepted the marketing authorization application for bepirovirsen, an antisense oligonucleotide targeting chronic hepatitis B. The acceptance follows positive Phase III data from the B‑Well 1 and B‑Well 2 trials, which enrolled patients across 29 countries and demonstrated improved functional cure rates compared with nucleos(t)ide analogue therapy alone, especially in those with baseline HBsAg ≤3000 IU/ml. GSK plans to present the detailed results at an upcoming scientific conference and submit the findings for publication in 2026. The therapy could become the first‑in‑class oral‑free option for chronic hepatitis B.
Insilico Medicine Expands AI-Driven CNS Collaboration with Tenacia in a ~$94.75M Deal
Insilico Medicine and Tenacia Biotechnology have expanded their AI‑driven partnership to create a second central‑nervous‑system (CNS) candidate, now advancing to the preclinical stage. The original March 2025 collaboration combined Insilico’s Pharma.AI platform with Tenacia’s expertise in blood‑brain‑barrier‑permeable small‑molecule inhibitors. Under...
Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026
Abcuro presented Phase II/III MUSCLE trial data for ulviprubart (ABC008) in inclusion body myositis (IBM) at the GCOM 2026 meeting. The study enrolled 272 patients who received either 0.5 mg/kg, 2 mg/kg, or placebo. Across the entire cohort the drug showed only...
PharmaShots CXO Talks | Women’s History Month Special: A Conversation with Dr. Emanuela Offidani of Tris Pharma
Dr. Emanuela Offidani, Tris Pharma’s Medical Director of Digital Health Strategy, highlighted that ADHD is increasingly recognized as a lifelong condition that often goes undiagnosed in women because symptoms are less overt. She explained that Tris Pharma’s proprietary LiquiXR delivery...
Novocure Reports Topline P-II (PANOVA-4) Trial Data on TTFields Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Novocure disclosed topline Phase‑2 PANOVA‑4 data showing that Tumor‑Treating Fields (TTFields) combined with Tecentriq and gemcitabine/nab‑paclitaxel achieved a 74.4% disease‑control rate in metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial, enrolling 78 patients, outperformed the historical MPACT control arm’s 48% DCR. Secondary...
Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)
Otsuka Pharmaceutical presented Phase III VISIONARY trial data for Voyxact (sibeprenlimab‑szsi) in IgA nephropathy patients at risk of progression. At 48 weeks, 82.5% of patients receiving 400 mg subcutaneous Voyxact achieved negative microscopic hematuria versus 52.6% on placebo, with median time to...
Kallisio’s Stentra Receives CE Mark for Precision Oral Immobilization System in Head & Neck Radiation Therapy
Swiss‑based Kallisio has secured CE certification for its Stentra intraoral positioning system under the EU Medical Device Regulation 2017/745. The device, a patient‑specific 3‑D‑printed oral immobilizer, improves millimeter‑level accuracy in head‑and‑neck radiation therapy without altering existing treatment planning software or...
Biogen and Alteogen Partner for ALT-B4 to Advance Subcutaneous Formulations of Biologics
Biogen has signed an exclusive license with South Korean biotech Alteogen for ALT‑B4, a recombinant hyaluronidase enzyme that facilitates subcutaneous administration of biologics traditionally given intravenously. The agreement provides Alteogen with $20 million upfront, a $10 million payment upon initiation of a...
Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid
Japan’s Ministry of Health, Labour and Welfare approved Dupixent (dupilumab) for adults with moderate-to-severe bullous pemphigoid, marking the first targeted therapy for the disease in the country. The approval is based on the phase II/III ADEPT trial, which enrolled 106...
The United Laboratories and Novo Nordisk Report P-II Trial Data on UBT251 in Chinese Patients with Type 2 Diabetes
Novo Nordisk and United Laboratories reported Phase‑II data for the GLP‑1 agonist UBT251 in 211 Chinese patients with type‑2 diabetes. Over 24 weeks, UBT251 achieved a 2.16 % HbA1c reduction, outperforming semaglutide’s 1.77 % and placebo’s 0.66 % from a baseline of 8.12 %....
Pixee Medical’s Knee+ NexSight Receives the European CE Mark for Knee Arthroplasty
Pixee Medical has secured a European CE mark for its Knee+ NexSight augmented‑reality platform, enabling the first EU total knee arthroplasty procedures using the technology. The system projects a voice‑controlled virtual overlay during surgery, delivering robotic‑level precision without a robot,...
Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease
Ionis Pharmaceuticals received FDA acceptance of its new drug application for zilganersen and a priority‑review designation for treating Alexander disease, with a PDUFA target action date of September 22, 2026. The Phase III trial enrolled 54 patients aged 1.5 to 53...
Quotient Therapeutics & Merck Enter ~$2.2B Partnership to Discover Novel Drug Targets in IBD
Quotient Therapeutics and Merck have signed a multi‑year collaboration to use Quotient’s somatic genomics platform for discovering new drug targets in inflammatory bowel disease. The agreement provides Quotient with $20 million upfront and includes milestone payments that could lift the total...
THE IMPACT OF ARTIFICIAL INTELLIGENCE ON PHARMACEUTICAL AND LIFESCIENCES INDUSTRY
Artificial intelligence is reshaping the pharmaceutical and life‑sciences value chain, from molecule discovery with generative and structure‑prediction models to clinical trial design, manufacturing, regulatory submissions, intellectual property and supply‑chain orchestration. Tools such as AlphaFold and de‑novo design engines accelerate lead...
Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)
Prestige Biopharma announced topline results from its phase‑III SAMSON‑II trial comparing HD204, a biosimilar to Avastin (bevacizumab), with the reference product in 625 patients with advanced non‑squamous non‑small cell lung cancer. The study demonstrated an objective response rate (ORR) of...
9th Annual Corporate Compliance & Transparency in Life Sciences Conference
The 9th Annual Corporate Compliance & Transparency in Life Sciences Conference convenes more than 20 compliance leaders, legal experts, and industry innovators for a single-stage event. Attendees will experience over 15 hands‑on presentations and case studies, targeting actionable strategies for...
Reimagining Migraine Treatment: Alon Ironi of Theranica on Nerivio’s Journey to Nationwide Coverage
Theranica’s Nerivio, a remote electrical neuromodulation (REN) device, has secured nationwide coverage for roughly 130 million lives through Blue Cross Blue Shield plans. The therapy’s dual acute and preventive indications offer a drug‑free alternative that expands access to underserved groups such...
Kali Therapeutics Partners with Sanofi for KT501 in a ~$1.2B Deal
Kali Therapeutics has signed a license agreement with Sanofi granting the French giant exclusive worldwide rights to KT501, a next‑generation tri‑specific T‑cell engager aimed at B‑cell‑mediated autoimmune diseases. The deal provides Kali with $180 million in upfront and near‑term payments and...
Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)
Henlius announced that China’s National Medical Products Administration (NMPA) has granted IND clearance for HLX18, a biosimilar of Opdivo (nivolumab), targeting resected solid tumours. The company also reported first‑patient dosing in Phase I trials for HLX17 (Keytruda biosimilar) and HLX13...
IntraBio Reports the US FDA’s sNDA Submission of Aqneursa for Ataxia-Telangiectasia
IntraBio has filed a supplemental New Drug Application (sNDA) with the U.S. FDA seeking approval of Aqneursa (levacetylleucine) for Ataxia‑Telangiectasia (A‑T). The filing is supported by a Phase III trial that met its primary and key secondary endpoints and demonstrated a...
HUTCHMED Initiates P-III Trial of HMPL-760 + R-GemOx for R/R Diffuse Large B-Cell Lymphoma in China
HUTCHMED has launched a Phase III trial of HMPL‑760 combined with R‑GemOx in relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) patients in China, dosing the first patient on March 20, 2026. The study will enroll approximately 240 patients who have failed first‑line therapy and...
Dizal Reports the P-III (WU-KONG28) Trial Results on Zegfrovy (Sunvozertinib) in EGFRm NSCLC
Dizal announced topline results from its Phase 3 WU‑KONG28 trial, comparing oral once‑daily Zegfrovy (sunvozertinib) to platinum‑based chemotherapy as first‑line treatment for advanced NSCLC with EGFR exon 20 insertion mutations. The study met its primary endpoint, demonstrating a statistically significant improvement in...
LivaNova’s Aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)
LivaNova received FDA Premarket Approval for its aura6000 neurostimulation system, targeting adults with moderate‑to‑severe obstructive sleep apnea (OSA) who cannot use or have failed first‑line therapies. The approval is based on the OSPREY randomized controlled trial, which showed a 65%...
Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss
The U.S. Food and Drug Administration granted Breakthrough Device Designation to Nia Therapeutics’ Smart Neurostimulation System (SNS) for treating episodic memory loss in adults with moderate to severe traumatic brain injury. The fully implantable, closed‑loop system records neural activity from...
AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)
AL‑S Pharma released Phase II (AP‑101‑02) data evaluating intravenous AP‑101 every three weeks in 73 ALS patients, including 52 with sporadic disease and 21 with SOD1 mutations. The trial met its primary safety and tolerability endpoint and demonstrated disease modification,...
Sanofi’s Venglustat Secures the US FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease
Sanofi’s oral glucosylceramide synthase inhibitor venglustat has earned U.S. FDA breakthrough therapy designation for treating the neurological aspects of type 3 Gaucher disease. The designation follows the Phase III LEAP2MONO trial, which showed significant improvements in motor and cognitive scores compared with...
Myriad Genetics Receives the US FDA Approval for MyChoice CDx Test as a Companion Diagnostic for GSK’s Zejula
Myriad Genetics announced FDA approval of its MyChoice CDx test as a companion diagnostic for GSK’s Zejula (niraparib) in advanced ovarian cancer. The clearance follows the PRIMA trial, which showed that patients identified as HRD‑positive derived significant benefit from Zejula...
Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates
Samsung Bioepis and Sandoz have signed a global license, development and commercialization agreement covering up to five biosimilar candidates, including the preclinical SB36 biosimilar to Entyvio (vedolizumab). Samsung Bioepis will manage development, manufacturing and regulatory submissions, while Sandoz will handle...
Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)
Cogent Biosciences announced that the U.S. FDA has accepted its new‑drug application for bezuclastinib in non‑advanced systemic mastocytosis (NonAdvSM), with a PDUFA target date of December 30 2026 and no advisory committee required. The filing is supported by the SUMMIT trial, which...
Ascendis Pharma Reports Topline P-II (New InsiGHTS) Trial Data on TransCon hGH in Turner Syndrome
Ascendis Pharma released topline results from its Phase‑II New InsiGHTS trial evaluating TransCon hGH (lonapegsomatropin) administered once‑weekly versus daily somatropin in 49 prepubertal children with Turner syndrome. At week 52, the weekly formulation achieved an LS mean annualized height velocity...
Voro Therapeutics Collaborates with Daiichi Sankyo to Develop Tumor-Activated ADCs
Voro Therapeutics has signed a research collaboration with Daiichi Sankyo’s San Diego research institute to create tumor‑activated antibody‑drug conjugates (ADCs) using Voro’s PrimeBody platform. The partnership will focus on masked ADCs that employ proprietary masking domains and protease‑cleavable linkers to achieve...
EMA Marketing Authorization of New Drugs in February 2026
In February 2026 the European Commission and the CHMP granted marketing authorisations and positive opinions for a slate of innovative therapies spanning COVID‑19, oncology, cardiology, immunology and rare diseases. Notable approvals include Moderna’s mNEXSPIKE COVID‑19 vaccine, Hansoh’s Aumseqa for EGFR‑mutated...
Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer
Pfizer disclosed topline Phase II (FOURLIGHT‑1) data showing that atirmociclib combined with fulvestrant outperformed fulvestrant alone or everolimus + exemestane in 264 HR+, HER2‑negative metastatic breast cancer patients previously treated with CDK 4/6 inhibitors. The trial met its primary endpoint, delivering a statistically significant...
AstraZeneca Secures the EC Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers
The European Commission has granted approval for AstraZeneca’s Imfinzi (durvalumab) combined with FLOT chemotherapy as a perioperative treatment for resectable, early‑stage and locally advanced gastric and gastro‑esophageal junction (G/GEJ) cancers. The decision is based on the Phase III MATTERHORN trial, which...
Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease
Bayer disclosed results from the pivotal Phase III FIND‑CKD trial evaluating Kerendia (finerenone) in more than 1,500 adults with non‑diabetic chronic kidney disease. Patients received 10 mg or 20 mg of Kerendia alongside standard of care and were compared with placebo. The study...
Roche Receives CE Mark for Its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing
Roche has secured CE Mark approval for its Elecsys ApoE4 in‑vitro diagnostic immunoassay, a blood‑based test that detects the ApoE4 gene variant linked to Alzheimer’s disease. In a validation study of 607 patients with cognitive complaints, the assay achieved 100%...
Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria
Otsuka Pharmaceutical disclosed early open‑label extension (OLE) data for repinatrabit (JNT‑517) in adolescents with phenylketonuria (PKU). A 75 mg twice‑daily regimen achieved a 67% mean reduction in blood phenylalanine by day 56, with responses observed across prior sapropterin responders, non‑responders, and a...
Why Revenue Performance Often Starts with Accurate Clinical Notes
Hospitals that prioritize accurate clinical notes see measurable revenue gains because documentation directly drives coding and reimbursement. Vague or incomplete entries cause denied claims, audit flags, and lost tariffs, even when billing tools are sophisticated. Solutions such as Scribe X and...
PRISM BioLab and Receptor.AI Partner to Develop a Drug Discovery Platform
PRISM BioLab has teamed with Receptor.AI to build an AI‑driven, physics‑guided platform for discovering orally available small molecules that target intracellular protein‑protein interactions, membrane proteins, and complex receptor systems. The collaboration fuses PRISM’s PepMetics technology—3‑dimensional scaffolds that mimic α‑helix and...
Ultragenyx Reports the P-III (Enh3ance) Trial for DTX301 AAV8 Gene Therapy in OTC Deficiency
Ultragenyx announced Phase 3 Enh3ance data for its DTX301 AAV8 gene therapy targeting ornithine transcarbamylase (OTC) deficiency. At week 36, the therapy lowered 24‑hour plasma ammonia by 18% versus placebo and kept levels in the normal range, even as scavenger drug use...
Natera Launches Zenith Genomics in the US to Diagnose Rare Diseases
Natera announced the commercial launch of Zenith Genomics, a next‑generation whole‑genome sequencing (WGS) assay aimed at diagnosing rare and ultra‑rare diseases in the United States. The platform pairs standard WGS with long‑read sequencing confirmation to capture complex genomic features such...
PharmaShots Magazine-March-2026 Edition
AI is reshaping clinical trial oversight by moving from periodic checks to continuous, real‑time intelligence. Advanced analytics and machine learning now power predictive, risk‑based monitoring that aggregates data from decentralized sites, wearables, ePROs and multiple clinical systems. This integration enables...
Aplagon Doses First Patient in P-IIa (HEALING) Trial of APAC for Peripheral Arterial Occlusive Disease/Chronic Limb Threatening Ischemia
Aplagon Therapeutics has administered the first dose of its intravenous APAC candidate to a patient in a Phase 2a (HEALING) trial for peripheral arterial occlusive disease leading to chronic limb‑threatening ischemia in Finland. The study will enroll approximately 42 CLTI...
Insulet Reports EVOLUTION 2 Study Results for FCL Automated Insulin Delivery System in Type 2 Diabetes
Insulet presented data from its EVOLUTION 2C feasibility study of a fully closed‑loop (FCL) automated insulin delivery system for adults with type 2 diabetes at ATTD'26. In the 24‑patient trial, the final algorithm raised time‑in‑range (TIR) to an average 68%,...
George Medicines Partners with Ahngook Pharmaceutical to Commercialize GMRx2 in Korea
George Medicines has signed an exclusive licensing and supply agreement with South Korea’s Ahngook Pharmaceutical to bring its triple‑combination antihypertensive pill, GMRx2, to the Korean market. The single‑pill formulation blends telmisartan, amlodipine and indapamide in three dose strengths, aiming for...
C2N Diagnostics Partners with BeauBrain Healthcare to Offer PrecivityAD2 Blood Test for Alzheimer’s Disease in South Korea
C2N Diagnostics has signed a partnership with BeauBrain Healthcare to introduce its PrecivityAD2 blood test for Alzheimer’s disease in South Korea, targeting patients aged 50 and older with mild cognitive impairment or dementia. Clinical studies published in JAMA and npj...
Cairn Surgical Reports the FDA De Novo 510(k) Submission for BCL System to Improve Accuracy of Lumpectomy
Cairn Surgical has filed a De Novo 510(k) application with the U.S. FDA for its Breast Cancer Locator (BCL) System, a device designed to improve the accuracy of breast‑conserving surgery. The company completed a pivotal U.S. trial that demonstrated a...
UCB Reports P-III (BE BOLD) Trial Results on Bimzelx (Bimekizumab) in Active Psoriatic Arthritis
UCB announced results from its Phase III BE BOLD trial comparing Bimzelx (bimekizumab) to risankizumab in 553 adults with active psoriatic arthritis. The study met its primary endpoint, showing Bimzelx superior in achieving ACR50 responses at week 16. Bimzelx is...
ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1
ARTHEx Biotech announced that its RNA‑based drug ATX‑01 has received U.S. FDA Fast Track designation for treating Myotonic Dystrophy Type 1 (DM1). The therapy works by inhibiting miR‑23b, thereby increasing free MBNL protein, correcting splicing errors and reducing toxic DMPK mRNA...
Rapport Therapeutics Partners with Tenacia Biotechnology to Advance RAP-219 in Greater China
Rapport Therapeutics has granted Tenacia Biotechnology exclusive rights to develop and commercialize its TARPγ8‑specific AMPA receptor negative allosteric modulator RAP‑219 in Greater China, covering indications such as focal onset seizures and bipolar mania. The agreement provides Rapport with a $20 million...
