news

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...

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...

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...

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...

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 ...

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...

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...

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 ...

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...

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...