news
Nov 10, 2022
QuantuMDx & Menarini’s Agreement; TruClear System Launched by Medtronic in India; FDA 510(k) Clearance for TriVerse Primary Knee Replacement System; FDA Clearance to ProciseDx’s Reactive Protein (CRP) Assay and ProciseDx Instrument; Evolution Optiks’s Enrollment of LFR-260 Phoropter in US; Kardium First-in-Human Clinical Study of the New Globe Pulsed Field System
QuantuMDx and Menarini Announced an Agreement for the Distribution of the Q-POCTM Platform On November 2, 2022, QuantuMDx Group Limited, a UK-based developer of transformational Point-of-Need molecular diagnostics, and A.Menarini Diagnostics S.r.I. (Menarini), announced an exclusive distribution agreement for Qu...
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Nov 08, 2022
Amgen’s Olpasiran Candidate; GSK’s Novel Antibiotic for Urinary Tract Infections; AstraZeneca and Sanofi’s Beyfortus Approval; FDA Orphan Designation to Anavex’s Anavex2-73; FDA Rare Pediatric Disease Designation to Sensorion’s OTOF-GT; GSK’s Blenrep Fails in Phase III Trial in R/R Multiple Myeloma
Amgen Reports Promising Mid-stage Results for its Olpasiran Candidate Amgen has reported encouraging mid-stage results for its olpasiran candidate for lowering lipoprotein(a) - a risk factor for atherosclerotic cardiovascular disease - and now plans to move forward with a phase III program as soon as possi...
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Nov 01, 2022
Actinium Announces SIERRA Trial Results; Santhera Seeks FDA Review for Vamorolone; Seres Announces BLA Submission for SER-109; BMS Announces Results of COMMANDS Trial; Boehringer’s PDE4B Moves Late-stage Clinical Testing; FDA Rejects Gilead’s Hepcludex; Approval to J&J’s BCMAxCD3 Bispecific Antibody for Multiple Myeloma; Syncona to Acquire AGTC
Actinium Announces Positive Top-line Results from Pivotal Phase III SIERRA Trial of Iomab-B Actinium Pharma is on track to submit its targeted radiotherapy for AML patients requiring a bone marrow transplant in the United States, boosted by top-line data from a pivotal trial. The SIERRA trial of Iomab-B, an anti...
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Oct 25, 2022
Sumitomo to Purchase Myovant; AstraZeneca’s Tremelimumab Plus Imfinzi Approved in the US; AbbVie Acquires DJS Antibodies; Roche and Hookipa Pharma Signs USD 25 Million Deal; FDA Accepts BMS’s New Drug Application for CAMZYOS; Jazz and Zymeworks Sign Exclusive Licencing Agreement
FDA Accepts Bristol Myers Squibb’s Supplemental New Drug Application for CAMZYOS Bristol Myers Squibb declared that the U.S. FDA had accepted its supplemental new drug application for CAMZYOS for an expanded indication to reduce the need for septal reduction therapy. CAMYZOS is currently FDA-approved for treatin...
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Oct 20, 2022
Biosense Webster’s HELIOSTAR Radiofrequency Balloon Ablation Catheter; Philips’s ClarifEye Augmented Reality Surgical Navigation Solution; NeuroLogica’s Elite Mobile Computed Tomography Devices; Medtronic’s Natural Conduction System for Heart; Pfizer & BioNTech’s Omicron BA.4/BA.5-Adapted Bivalent Booster Trial; Castle Biosciences’s TissueCypher® Barrett’s Esophagus Test
HELIOSTAR™ Radiofrequency Balloon Ablation Catheter Launched by Biosense Webster in Europe On October 12, 2022, Biosense Webster, a part of Johnson & Johnson Medical technology, announced the launch of HELIOSTAR™ Balloon Ablation Catheter, the first radiofrequency balloon ablation catheter in E...
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Oct 18, 2022
CHMP Reviews Takeda’s Qdenga; FDA Sets Date for Gilead’ Trodelvy Review; Odyssey’s Announces $ 168 Million Series B Financing; Tavros and Vividion Signs Agreement; Pharming Submits Leniolisib for Approval in the EU; FDA Fast Track Designation to Mereo’s Alvelestat
CHMP Gives Positive Opinion on Takeda’s Qdenga The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given its approval to Takeda GmbH’s Qdenga, a live, attenuated dengue tetravalent vaccine (TAK-003). It is the first time the CHMP has reviewed a medicinal product ...
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Oct 13, 2022
Neuspera Medical’s Nuvella System; Abbott Presented the Data for FreeStyle Libre 2 System; ZEISS Receives FDA 510(k) Clearance for MTLawton; FDA 510(k) Clearance for the GHOST 3D-Printed Titanium Spacer System; Thermo Fisher Scientific Launched CE-IVD Marked TaqPath Enteric Bacterial Select Panel; BIOCORP and Merck Announced New Partnership
Neuspera Medical Announces First Successful Implant of the Nuvella™ System in the Second Phase of Its Sans-Uui Ide Clinical Trial On October 10, 2022, Neuspera Medical, a medical device company involved in the development of implantable devices for patients suffering from chronic illnesses, announced that...
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Oct 11, 2022
Merck’s Sotatercept Trial Result; PARP Rivals Closing in on AstraZeneca and Merck’s Lynparza; FDA Clears GSK’s Boostrix for Pertussis; Fast Track Designation to Nanoscope Therapeutics’s MCO-010; FDA Awards Fast Track Designation to Eftilagimod Alpha Plus Pembrolizumab; Solid Biosciences to Acquire AavantiBio
Merck’s Sotatercept Clears Phase III Trial Merck’s USD 11.5 billion acquisition of Acceleron last year was based on the promise of pulmonary arterial hypertension (PAH) candidate sotatercept, which has recently met the mark in a much-anticipated phase III trial. The STELLAR trial found that adding the activin re...
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Sep 27, 2022
Daiichi Sankyo’s Ezharmia; Pfizer & Sangamo Hemophilia A Gene Therapy Trial; Approval for Fennec’s Pedmark; FDA Approves UBE and Santen’s OMLONTI; EC Approves AstraZeneca’s Tezspire; FDA Approves Selpercatinib; FDA Grants Accelerated Approval to Eli Lilly’s Retevmo; GSK & Spero Announce Exclusive License Agreement
Daiichi Sankyo Receives the First Approval for its Blood Cancer Drug Ezharmia Daiichi Sankyo has received the first global approval for Ezharmia, a first-in-class dual EZH1 and EZH2 inhibitor for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma (ATL). The Japanese Ministry of ...
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Sep 22, 2022
Smith+Nephew’s OR3O Dual Mobility System; Medtronic Launches the Evolut FX Next-Gen TAVR System; FDA Approves Edwards’s Pascal Precision Transcatheter Valve Repair System; FDA Clearance to Zimmer Biomet’s Identity Shoulder System; Otsuka Announces Results of RADIANCE II Trial; Smith+Nephew Announces Data for its REGENETEN™ Bioinductive Implant
OR3O™ Dual Mobility System launched by Smith+Nephew in Japan for use in primary and revision hip arthroplasty On September 20, 2022, Smith+Nephew, a leading global portfolio medical technology business, announced the launch of OR3O Dual Mobility System for use in primary and revision hip arthro...
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