Thrombosis

Agios Announces Exclusive Worldwide License Agreement for Novel siRNA for the Potential Treatment of Polycythemia Vera

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torsdag, augusti 3, 2023
PK, Rat, Hematologic disease, Therapy, Polycythemia vera, Hematocrit, PV, Small RNA, AGIO, Thrombosis, Agios, Phlebotomy, Patient, Standard of care, Iron, Risk, Hematology, RNA interference, Agios Pharmaceuticals, Blood volume, Death, IND, TMPRSS6, Pharmaceutical industry, Alnylam Pharmaceuticals

CAMBRIDGE, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) has entered into an exclusive worldwide license agreement with Alnylam Pharmaceuticals, Inc. under which Agios will acquire the rights to develop and commercialize Alnylam’s novel preclinical siRNA targeting TMPRSS6, as a potential disease-modifying treatment for patients with polycythemia vera (PV). This agreement combines Agios’ deep scientific expertise and capabilities in rare hematologic diseases with Alnylam’s industry-leading siRNA platform and strong track record of success.

Key Points: 
  • CAMBRIDGE, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) has entered into an exclusive worldwide license agreement with Alnylam Pharmaceuticals, Inc. under which Agios will acquire the rights to develop and commercialize Alnylam’s novel preclinical siRNA targeting TMPRSS6, as a potential disease-modifying treatment for patients with polycythemia vera (PV).
  • This agreement combines Agios’ deep scientific expertise and capabilities in rare hematologic diseases with Alnylam’s industry-leading siRNA platform and strong track record of success.
  • Under the terms of the agreement, Agios will make an upfront payment of $17.5 million to Alnylam for an exclusive global license to the TMPRSS6 siRNA program.
  • Alnylam will provide manufacturing support for Phase 1, after which Agios will assume full responsibility for manufacturing.

scPharmaceuticals Announces Positive Type C Meeting Feedback from FDA on Potential Heart Failure Class IV Indication Expansion

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tisdag, augusti 1, 2023
Hypersensitivity, Furosemide, NYHA, Congestion, Embolism, US Foods, Hypoproteinemia, Organic acid, Heart failure, Chronic kidney disease, Urine, Creatinine, Cirrhosis, Dehydration, Glucose, Tinnitus, Deafness, Huber loss, Edema, Hepatic encephalopathy, Oliguria, History, Solubility, Diuresis, Uric acid, New York Heart Association Functional Classification, Kidney, Bruise, Ototoxicity, Erythema, Patent, Patient, Physician, Urinary retention, Azotemia, Ascites, Coma, Blood volume, FDA, Benign prostatic hyperplasia, Thrombosis, IND, Cerebral edema, CO2, BUN, Kidney disease, Anuria, Pharmaceutical industry, Medical device

FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure.

Key Points: 
  • FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure.
  • “We are very pleased with the outcome of our recent Type C meeting with the FDA, and believe this paves the way for potential expansion of the FUROSCIX indication to allow for use in NYHA Class IV patients,” stated John Tucker, Chief Executive Officer of scPharmaceuticals.
  • “We estimate that as many as 10% of all heart failure patients are Class IV, and a meaningful percentage of these – as many as 40% - may benefit from FUROSCIX.
  • FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.

Access Vascular Inc. Announces Publication of Study Showing Significantly Reduced Failure Rates with its HydroPICC® Catheter

Retrieved on: 
tisdag, juli 25, 2023
Biotechnology, Health, Clinical Trials, Medical Devices, Journal of Materials Science: Materials in Medicine, Infection, AVI, PICC, Thrombosis, Phlebitis, Patient, Standard of care, Risk, Access, RN, Materials science, Medical device, Medical imaging, Medicine

The retrospective study demonstrated that HydroPICC significantly reduced clot formation and failures, compared with conventional polyurethane PICCs.

Key Points: 
  • The retrospective study demonstrated that HydroPICC significantly reduced clot formation and failures, compared with conventional polyurethane PICCs.
  • This retrospective study investigated whether the HydroPICC, constructed of a novel hydrophilic biomaterial with MIMIX™ technology, reduced thrombotic catheter occlusions, compared to polyurethane devices, in 121 patients who received a PICC as part of their medical care.
  • The study results demonstrated no occlusions or replacements in the 60 HydroPICC insertions, while 13 catheter occlusions were reported in the 61 polyurethane insertions catheter group and eight outright PICC replacements (13%).
  • Recently published clinical data for the HydroMID midline catheter showed six-fold failure reduction compared with a standard polyurethane device.

Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation

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fredag, juli 21, 2023
Medicine, Neoplasm, European Medicines Agency, Diarrhea, Arthralgia, Doctor of Philosophy, Committee, IRCCS, MD, Patient, Division, Risk, European, Committee for Medicinal Products for Human Use, AST, University of Milano-Bicocca, Fatigue, University, Cholesterol, Constipation, Bone pain, EMA, Vomiting, Back pain, HIV disease progression rates, ALT, Headache, Death, Elacestrant, Civil service commission, Creatinine, Triglyceride, CDK, MBC, Indigestion, SOC, Abdominal pain, PFS, European Institute of Oncology, Menarini, European Commission, CHMP, Thrombosis, Progression-free survival, Anemia, ESR1, Advanced Therapy Medicinal Product, Woman, Periodic breathing, European Institute, Drug development, Nausea, Potassium, ER, Breast cancer, Medical imaging, Pharmaceutical industry, EU

ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.

Key Points: 
  • ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.
  • "Patients living with metastatic breast cancer are in need of efficacious and tolerable treatment options.
  • ORSERDU, if approved, will also provide a convenient daily oral treatment," said Elcin Barker Ergun, CEO of the Menarini Group.
  • The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations.

Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation

Retrieved on: 
fredag, juli 21, 2023
Medicine, Neoplasm, European Medicines Agency, Diarrhea, Arthralgia, Doctor of Philosophy, Committee, IRCCS, MD, Patient, Division, Risk, European, Committee for Medicinal Products for Human Use, AST, University of Milano-Bicocca, Fatigue, University, Cholesterol, Constipation, Bone pain, EMA, Vomiting, Back pain, HIV disease progression rates, ALT, Headache, Death, Elacestrant, Civil service commission, Creatinine, Triglyceride, CDK, MBC, Indigestion, SOC, Abdominal pain, PFS, European Institute of Oncology, Menarini, European Commission, CHMP, Thrombosis, Progression-free survival, Anemia, ESR1, Advanced Therapy Medicinal Product, Woman, Periodic breathing, European Institute, Drug development, Nausea, Potassium, ER, Breast cancer, Medical imaging, Pharmaceutical industry, EU

ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.

Key Points: 
  • ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.
  • "Patients living with metastatic breast cancer are in need of efficacious and tolerable treatment options.
  • ORSERDU, if approved, will also provide a convenient daily oral treatment," said Elcin Barker Ergun, CEO of the Menarini Group.
  • The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations.

Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation

Retrieved on: 
fredag, juli 21, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Thrombosis, University, Civil service commission, Progression-free survival, Creatinine, Anemia, Triglyceride, ESR1, Neoplasm, CDK, Cholesterol, European Medicines Agency, MBC, Indigestion, Committee for Medicinal Products for Human Use, Constipation, Woman, Mutation, Periodic breathing, Multimedia, SOC, Doctor of Philosophy, Arthralgia, PFS, Diarrhea, Abdominal pain, Bone pain, Committee, EMA, Vomiting, European Institute, Back pain, European Institute of Oncology, IRCCS, HIV disease progression rates, MD, Patient, Division, Risk, European, Drug development, Nausea, ALT, Headache, CHMP, AST, Death, Potassium, University of Milano-Bicocca, European Commission, ER, Fatigue, Pharmaceutical industry, EU

ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.

Key Points: 
  • ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.
  • “Patients living with metastatic breast cancer are in need of efficacious and tolerable treatment options.
  • ORSERDU, if approved, will also provide a convenient daily oral treatment,” said Elcin Barker Ergun, CEO of the Menarini Group.
  • The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations.

Akebia’s Vafseo (vadadustat) Poised to Make Waves for GSK’s Jesduvroq and FibroGen/Astellas’ Evrenzo

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torsdag, juli 20, 2023
Anemia, GSK, Chronic kidney disease, Civil service commission, Myocardial infarction, ESA, Vadadustat, Stroke, NDA, Nephrology, Launch, Dialysis, Thrombosis, Coronary thrombosis, Patient, Physician, FDA, EC, CKD, Death, RealTime, European Commission, Daprodustat, Pharmaceutical industry, Medical device, EU, Roxadustat

While several agents within the class have found success globally, the U.S. struggled to get even just one approval across the finish line.

Key Points: 
  • While several agents within the class have found success globally, the U.S. struggled to get even just one approval across the finish line.
  • However, Jesduvroq’s approval did come with a black box warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
  • At the same time, their perceptions of ESAs as a treatment for renal anemia in dialysis patients have become increasingly favorable.
  • Assuming approval, Akebia’s launch of vadadustat will also be covered once commercially available and benchmarked against Jesduvroq at a similar time post-launch​.

New Data Shows Advantages of Rapid Medical’s COMANECI™ Embolization Assist Device

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onsdag, juli 19, 2023
Research, Medical Devices, Surgery, Neurology, Other Health, Biotechnology, General Health, Health, Science, Other Science, Medicine, University, Endovascular aneurysm repair, World Neurosurgery, Anatomy, Vasospasm, Buffalo buffalo Buffalo buffalo buffalo buffalo Buffalo buffalo, Buffalo, Stroke, BAC, Meta-analysis, Doctor of Philosophy, Jacobs Institute for Design Innovation, Subarachnoid hemorrhage, Thrombosis, MD, Patient, Neurosurgery, Bleeding, SAC, George Washington University, Medical device

Rapid Medical ™, a leading developer of advanced neurovascular devices, today announced new clinical data showing significant advantages of its novel COMANECI™ embolization assist device over established techniques to treat ruptured wide-neck intracranial aneurysms.

Key Points: 
  • Rapid Medical ™, a leading developer of advanced neurovascular devices, today announced new clinical data showing significant advantages of its novel COMANECI™ embolization assist device over established techniques to treat ruptured wide-neck intracranial aneurysms.
  • “The COMANECI device is a highly useful adjunct tool for patients with subarachnoid hemorrhage.
  • It has been used in over 12,000 procedures worldwide in wide-neck aneurysm treatments–and in Europe only–to open arteries constricted by vasospasm.
  • However, COMANECI-assisted coiling showed significantly lower thromboembolic and aneurysmal complication rates and periprocedural complications–than both SAC and BAC.

Common diabetes drug metformin could protect against long COVID

Retrieved on: 
onsdag, juli 12, 2023
Infection, Pregnancy, Diabetes, Gestational diabetes, Placebo, Clinical trial, Woman, Risk, COVID, Diarrhea, The Lancet, Rash, Thrombosis, Participation, Patient, Metformin, Overweight, Diagnosis, Ageing, Bias, Group, Disease, Pharmaceutical industry, Vaccine, Birth control, Bookkeeping

Of the 564 people who received metformin, 35 developed long COVID (6.3%) compared with 58 out of 562 (10.4%) who took a placebo.

Key Points: 
  • Of the 564 people who received metformin, 35 developed long COVID (6.3%) compared with 58 out of 562 (10.4%) who took a placebo.
  • This equates to a 41% lower risk of long COVID for patients who received metformin.
  • However, because relatively few people developed long COVID, large numbers of people needed to take metformin to prevent a single case of long COVID.
  • While it’s not clear how exactly metformin might work to protect against long COVID, this study offers a promising glimpse of how we might prevent it from developing in future.

Bridge Biotherapeutics Joins PROLIFIC, the Prognostic Lung Fibrosis Consortium

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tisdag, juli 11, 2023
Drug development, Therapy, AUC, Inflammation, Cancer, Biomarker, Science, Pulmonary fibrosis, Thrombosis, Fibrosis, CXCL13, CCL18, Patient, Physician, Medicine, MMP-7, Idiopathic pulmonary fibrosis, Disease, Pharmaceutical industry

SEONGNAM, South Korea and CAMBRIDGE, Mass., July 11, 2023 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for fibrosis, cancer and inflammation, announced that it has joined PROLIFIC, the Prognostic Lung Fibrosis Consortium, an organization devoted to boosting scientific exploration and drug development in pulmonary fibrosis.

Key Points: 
  • SEONGNAM, South Korea and CAMBRIDGE, Mass., July 11, 2023 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for fibrosis, cancer and inflammation, announced that it has joined PROLIFIC , the Prognostic Lung Fibrosis Consortium, an organization devoted to boosting scientific exploration and drug development in pulmonary fibrosis.
  • PROLIFIC is a non-profit consortium of top-tier research institutions, academic medical centers, and pharmaceutical and biotech companies that are committed to developing treatments for pulmonary fibrosis.
  • By joining PROLIFIC, Bridge Biotherapeutics will be able to collaborate with other pioneering companies in the area of pulmonary fibrosis.
  • In addition to industry-wide advances, Bridge Biotherapeutics hopes to speed development of proprietary idiopathic pulmonary fibrosis pipeline and accelerate development of novel treatments for patients.