Bleeding

Orphan designation: Adeno-associated viral vector serotype 8 encoding B-domain deleted liver specific codon optimized bioengineered chimeric human porcine factor VIII, under a synthetic hepatic combinatorial bundle promoter Treatment of haemophilia [...]

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Tuesday, April 9, 2024
Community, Civil service commission, Diagnosis, Prevalence, Disease, Patient, Committee, Haemophilia, EMA, IRIS, Human, Agency, European, COMP, Bleeding, Factor VIII, Telephone numbers in Hungary, European Commission, MDC, Marketing, Blood, Liver, Medicine, Pharmaceutical industry

Orphan designation: Adeno-associated viral vector serotype 8 encoding B-domain deleted liver specific codon optimized bioengineered chimeric human porcine factor VIII, under a synthetic hepatic combinatorial bundle promoter Treatment of haemophilia A, 13/04/2022 Positive

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Orphan designation: Adeno-associated viral vector serotype 8 encoding B-domain deleted liver specific codon optimized bioengineered chimeric human porcine factor VIII, under a synthetic hepatic combinatorial bundle promoter Treatment of haemophilia A, 13/04/2022 Positive

Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding glucosylceramidase beta Treatment of Gaucher disease, 21/08/2020 Positive

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Tuesday, April 9, 2024
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Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding glucosylceramidase beta Treatment of Gaucher disease, 21/08/2020 Positive

Key Points: 


Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding glucosylceramidase beta Treatment of Gaucher disease, 21/08/2020 Positive

Orphan designation: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII Treatment of haemophilia A, 25/05/2018 Withdrawn

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Tuesday, April 9, 2024
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Orphan designation: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII Treatment of haemophilia A, 25/05/2018 Withdrawn

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Orphan designation: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII Treatment of haemophilia A, 25/05/2018 Withdrawn

Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn

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Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Brain, Disease, Coagulation, Patient, Committee, Knowledge, Internal, Regulation, Haemophilia, EMA, IRIS, Joint, Human, Wound healing, European, COMP, Bleeding, Spinal cord, Antibody, Sponsor, European Commission, Immune system, Safety, Factor IX, Blood, Marketing, Haemophilia B, Medicine, Pharmaceutical industry

Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn

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Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn

CMR Surgical announces over 20,000 surgical cases completed using Versius

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Thursday, March 21, 2024
ICG, Colorectal surgery, CMR, Elective surgery, Nissen fundoplication, CE, Communication, Patient, Contraindication, Hospital, North Hertfordshire, Bleeding, Sale, Cancer, CMR Surgical, General surgery, MD, Thought, Surgeon, Rib cage, Bypass surgery, Pain, GMT, Cholecystectomy, Fatigue, MAS, Dentistry

CMR Surgical (CMR) – the global surgical robotics business – has today announced that over 20,000 Versius surgical cases have now been completed as the Company works with hospitals and surgeons around the world to bring minimal access surgery to everyone who needs it.

Key Points: 
  • CMR Surgical (CMR) – the global surgical robotics business – has today announced that over 20,000 Versius surgical cases have now been completed as the Company works with hospitals and surgeons around the world to bring minimal access surgery to everyone who needs it.
  • The Versius Surgical Robotic System is a small, modular and versatile surgical robot used for soft tissue surgery.
  • Over 75% of hospitals who have adopted Versius are using the system across two or more surgical specialties, leading to some hospitals around the world purchasing more than one system.
  • Through the Versius Connect app, Versius Trainer and CMR clinical registry, Versius unleashes a wealth of insights to ultimately improve surgical care.

CMR Surgical announces over 20,000 surgical cases completed using Versius

Retrieved on: 
Thursday, March 21, 2024
ICG, Colorectal surgery, CMR, Elective surgery, Nissen fundoplication, CE, Communication, Patient, Contraindication, Hospital, North Hertfordshire, Bleeding, Sale, Cancer, CMR Surgical, General surgery, MD, Thought, Surgeon, Rib cage, Bypass surgery, Pain, GMT, Cholecystectomy, Fatigue, MAS, Dentistry

CMR Surgical (CMR) – the global surgical robotics business – has today announced that over 20,000 Versius surgical cases have now been completed as the Company works with hospitals and surgeons around the world to bring minimal access surgery to everyone who needs it.

Key Points: 
  • CMR Surgical (CMR) – the global surgical robotics business – has today announced that over 20,000 Versius surgical cases have now been completed as the Company works with hospitals and surgeons around the world to bring minimal access surgery to everyone who needs it.
  • The Versius Surgical Robotic System is a small, modular and versatile surgical robot used for soft tissue surgery.
  • Over 75% of hospitals who have adopted Versius are using the system across two or more surgical specialties, leading to some hospitals around the world purchasing more than one system.
  • Through the Versius Connect app, Versius Trainer and CMR clinical registry, Versius unleashes a wealth of insights to ultimately improve surgical care.

Revive Therapeutics Provides Corporate Update

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Tuesday, March 12, 2024
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TORONTO, March 12, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today a corporate update on the research, clinical and regulatory initiatives with Bucillamine and its long COVID diagnostic product.

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  • TORONTO, March 12, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today a corporate update on the research, clinical and regulatory initiatives with Bucillamine and its long COVID diagnostic product.
  • Exposure to nerve agents can cause tightness of the chest, excessive salivation, abdominal cramps, diarrhea, blurred vision, tremors, and death.
  • In addition, Revive may evaluate the potential of its proposed long COVID diagnostic product as a companion to Bucillamine.
  • The Company, under its wholly-owned subsidiary Revive Diagnostics Inc., is advancing the product development of a potential blood biomarker diagnostic that characterizes long COVID.

ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors

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Saturday, April 6, 2024
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The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .

Key Points: 
  • The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .
  • In DESTINY-PanTumor02, efficacy was assessed in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive (IHC 3+) solid tumors including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors.
  • In DESTINY-Lung01, efficacy was assessed in a subgroup of patients (n=17) with centrally confirmed HER2 positive (IHC 3+) non-small cell lung cancer (NSCLC).
  • In DESTINY-CRC02, efficacy was assessed in the subgroup of patients (n=64) with centrally confirmed HER2 positive (IHC 3+) colorectal cancer.

AngioDynamics Receives 510(k) Clearance for AlphaVac F1885 System in Treatment of PE

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Thursday, April 4, 2024
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The expanded FDA indication allows for the utilization of the AlphaVac F1885 System for the treatment of PE, which broadens the applicability of the AlphaVac F1885 System in the non-surgical removal of thrombi or emboli from the venous vasculature.

Key Points: 
  • The expanded FDA indication allows for the utilization of the AlphaVac F1885 System for the treatment of PE, which broadens the applicability of the AlphaVac F1885 System in the non-surgical removal of thrombi or emboli from the venous vasculature.
  • The indication expands treatment options for patients with PE, reducing thrombus burden and improving right ventricular function.
  • “The addition of the AlphaVac System in the mechanical thrombectomy world is a critical step forward in the treatment of PE patients,” said Dr. Keeling.
  • “The 510(k) clearance of the AlphaVac System represents an important milestone towards the treatment of PE,” said Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA.

Biolinq Raises $58 Million to Advance Wearable Biosensors Through Pivotal Trial for Metabolic Health Using Precision Microsensor Technology

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Thursday, April 4, 2024
Research, Other Health, Pharmaceutical, Technology, Medical Devices, Clinical Trials, Science, Nanotechnology, Biotechnology, Wearables, Mobile Technology, Health, Diabetes, Other Science, Aphelion, AXA, Taisho Pharmaceutical, Skin, Bleeding, Needle, Multimedia, FDA, Incorporated, Silicon

J.P. Morgan served as placement agent to Biolinq in connection with the financing.

Key Points: 
  • J.P. Morgan served as placement agent to Biolinq in connection with the financing.
  • “Our technology approach enables access to a coveted, metabolically active compartment of the skin for biosensing without the use of introducer needles or bleeding,” said Rich Yang, CEO, Biolinq.
  • “Companies that disrupt entire industries often don’t originate from a single discipline,” said Rick Gerson, Chairman of Alpha Wave Global.
  • “Biolinq has attracted leading experts in biosensor development, consumer electronics design, proprietary materials science, software engineering and semiconductor manufacturing to build a new category of biowearables.