news
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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Sep 20, 2022
AstraZeneca’s Danicopan Trial; CHMP Recommends Sanofi/AstraZeneca’s nirsevimab; Akero’s NASH Drug Trial; FDA Grants Orphan Drug Status to SY-5609; BMS’s Opdivo Trial Results; Pfizer to File for FDA Approval for Meningitis Vaccine; EMA Orphan Drug Designation to CAN-2409; FDA Starts Priority Review of Chiesi ‘s velmanase alfa
AstraZeneca’s Danicopan Shows Positive Results in Phase III Trial Danicopan, an oral Factor D inhibitor developed by AstraZeneca, was expected to fail a phase II trial in rare kidney disease in 2020, but a new readout could revive the drug. Danicopan (ALXN2040) has demonstrated efficacy as an adjunct treatment f...
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Sep 15, 2022
Aerin Medical’s RhinAer Stylus; CE Mark for Haemonetics’s VASCADE Vascular Closure Device; J&J Vision Launches ACUVUE OASYS MAX 1-Day; Olympus Launches VISERA ELITE III Surgical Visualization Platform; GlucoRx’s Non-Invasive Glucose Monitoring Platform; Medtronic-BioIntelliSense’s Partnership; Corindus’s CorPath GRX Neurovascular System Trial; GE & Lantheus [18F]flurpiridaz PET Radiotracer Trial; Pulmonx’s AeriSeal System Trial; AtriAN’s Second Study on Cardioneuroablation
Johnson & Johnson Vision Launches New Contact Lens Innovation ACUVUE® OASYS MAX 1-Day for Meeting the Needs of Digitally Intense Lifestyles On September 12, 2022, Johnson & Johnson Vision, a part of Johnson & Johnson and a global leader in the eyecare market, had announced the launch of its newest in...
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Sep 13, 2022
Amgen Announced the Result of its CodeBreak-200 Trial; FDA Clears Bristol-Myers Squibb’s Deucravacitinib; BioNTech’s Amplified CAR-T Therapy; TIL Therapy Improves on Yervoy in Melanoma; GSK’s Daprodustat will have to face FDA Advisory Committee; Breakthrough Therapy Status to Pfizer’s Group B Strep Vaccine; EU Approves Gilead’ Tecartus; Gilead’ Trodelvy Results in TROPiCs-02 Trial
Amgen Reveals the Top-line Result of its CodeBreak-200 trial of Lumakras in Lung Cancer The top-line result of Amgen's CodeBreak-200 trial of Lumakras in lung cancer was presented in abstract form at ESMO two weeks ago, showing a 34% improvement in progression-free survival (PFS) compared to chemotherapy. The fu...
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Sep 08, 2022
eCential Robotics’s Surgical Robotic Platform for Spine Surgery; Baxter Gets 510(k) Clearance for Syringe Pump; Medical Microinstruments’s NanoWrist Instruments; Magnus’ SAINT Neuromodulation System; Henry Schein Acquires Midway Dental Supply
eCential Robotics Receives FDA Clearance for its Surgical Robotic Platform for Spine Surgery The FDA has approved a robotic spinal surgery platform designed to assist human surgeons by automating several steps of spinal procedures. The platform, developed by eCential Robotics, combines intraoperative 2D and 3D i...
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Sep 06, 2022
AstraZeneca’s Imfinzi for Biliary Tract Cancer; FDA Clears Boehringer’s Spesolimab; Novo Nordisk to Acquire Forma Therapeutics; Sanofi’s Xenpozyme Approved for ASMD; Another FDA Approval to Azurity’s Konvomep; Amgen’s Lumakras Trial Results; FDA Grants Priority Review to Sanofi & Sobi’s efanesoctocog alfa; Neurocrine Bio to Takeover UK Biotech Diurnal
FDA Approves AstraZeneca’s Imfinzi for Biliary Tract Cancer Imfinzi, a checkpoint inhibitor developed by AstraZeneca, has been approved by the FDA as the first immunotherapy for biliary tract cancer (BTC), a rare and aggressive form of cancer with few treatment options. Imfinzi (durvalumab) has been approved by ...
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