Fatigue

VOYDEYA™ approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular hemolysis in adults with the rare disease PNH

Retrieved on: 
Monday, April 1, 2024

VOYDEYA has also been granted Orphan Drug Designation in the US, European Union (EU) and Japan for the treatment of PNH.

Key Points: 
  • VOYDEYA has also been granted Orphan Drug Designation in the US, European Union (EU) and Japan for the treatment of PNH.
  • You must complete or update meningococcal vaccine(s) and streptococcus vaccine(s) at least 2 weeks before your first dose of VOYDEYA.
  • If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting VOYDEYA.
  • Carry it with you at all times during treatment and for 1 week after your last VOYDEYA dose.

HYAS Sweeps High Honors With Three GOVIES Government Security Awards Wins

Retrieved on: 
Friday, March 29, 2024

HYAS Infosec, the adversary infrastructure platform provider that offers unparalleled visibility, protection, and security against all kinds of malware and attacks, today announced that it has been awarded three top recognitions from Security Today’s GOVIES Government Security Awards.

Key Points: 
  • HYAS Infosec, the adversary infrastructure platform provider that offers unparalleled visibility, protection, and security against all kinds of malware and attacks, today announced that it has been awarded three top recognitions from Security Today’s GOVIES Government Security Awards.
  • HYAS Insight threat intelligence and investigation platform was awarded top honors in the GOVIES Cyber Defense Solutions and Monitoring Solutions categories.
  • “These Security Today GOVIES Government Security Awards are a clear recognition of the dramatic improvements to security posture that can result when organizations can see and respond to the adversarial infrastructures that are otherwise completely invisible to legacy blue team solutions,” said HYAS CEO David Ratner.
  • “We’re excited to honor these companies as they continue to support and enhance the government security industry.”

Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Retrieved on: 
Tuesday, April 2, 2024

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • “The FDA’s acceptance of the BLA brings us closer to providing patients with previously treated HR positive, HER2 negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

Jordan Foster Construction Selected as 2024 Grand Award Winner for Construction Safety Excellence by Associated General Contractors of America

Retrieved on: 
Wednesday, March 27, 2024

Jordan Foster Construction has been recognized with two prestigious awards for construction safety excellence by the Associated General Contractors of America (AGC).

Key Points: 
  • Jordan Foster Construction has been recognized with two prestigious awards for construction safety excellence by the Associated General Contractors of America (AGC).
  • "At Jordan Foster Construction, our people are our most valuable asset," said John Goodrich, President of the Civil Division at Jordan Foster Construction.
  • "The construction industry is changing and Jordan Foster is leading the way," emphasized Clint Henson, Operations Manager of the Civil Division at Jordan Foster Construction.
  • For more information about Jordan Foster Construction and its commitment to safety excellence, visit jordanfosterconstruction.com .

PhotoPharmics Launches Largest Phototherapy Trial for Parkinson’s Disease

Retrieved on: 
Tuesday, March 26, 2024

The "Celeste Light for PD Trial" (found at lightforpd.com) represents a significant stride in Parkinson’s disease (PD) treatment, leveraging innovative Spectramax™ technology through the passive and non-invasive Celeste® phototherapy device.

Key Points: 
  • The "Celeste Light for PD Trial" (found at lightforpd.com) represents a significant stride in Parkinson’s disease (PD) treatment, leveraging innovative Spectramax™ technology through the passive and non-invasive Celeste® phototherapy device.
  • This pivotal trial will assess the efficacy of Celeste®, the company’s FDA Breakthrough phototherapy device to improve non-motor and motor function and quality of life in Parkinson’s disease (PD).
  • This 300-patient phototherapy trial will be the largest trial of its kind.
  • “A pivotal trial for medical devices is similar to a phase 3 trial drug trial,” said Dan Adams, chief science officer.

Juvisé Pharmaceuticals Acquires Multiple Sclerosis Drug PONVORY® (ex-US/Canada) and Opens Its Capital to Bpifrance and Pemberton

Retrieved on: 
Tuesday, March 26, 2024

To fund this acquisition, the French sovereign fund Bpifrance and Pemberton Asset Management (‘Pemberton’), a leading European private credit manager, have acquired a minority stake in Juvisé Pharmaceuticals.

Key Points: 
  • To fund this acquisition, the French sovereign fund Bpifrance and Pemberton Asset Management (‘Pemberton’), a leading European private credit manager, have acquired a minority stake in Juvisé Pharmaceuticals.
  • “We are very excited about Ponvory® and its potential to have a very positive impact on the lives of patients with multiple sclerosis” announces Frédéric Mascha, founder and President of Juvisé Pharmaceuticals.
  • Juvisé Pharmaceuticals will work closely with Johnson & Johnson to ensure a seamless transition and continuous availability of Ponvory® for patients.
  • Finally, Juvisé Pharmaceuticals will assume the worldwide manufacturing duties for Ponvory® from sites based in France and Switzerland.

U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • View the full release here: https://www.businesswire.com/news/home/20240322544788/en/
    U.S. FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Columbus McKinnon and Milwaukee Tool Announce Development of First-of-Its Kind Battery-Powered Chain Hoist Combining Industry-Leading Hoist and Battery Technology

Retrieved on: 
Wednesday, March 20, 2024

Combining Columbus McKinnon’s industry-leading hoist design with Milwaukee Tool’s expertise in lithium-ion battery and brushless motor technology, the innovative BatteryStar™ hoist provides the lifting strength and speed of an electric chain hoist and the portability of a manual hoist without the need for time-consuming manual operation or access to a power source.

Key Points: 
  • Combining Columbus McKinnon’s industry-leading hoist design with Milwaukee Tool’s expertise in lithium-ion battery and brushless motor technology, the innovative BatteryStar™ hoist provides the lifting strength and speed of an electric chain hoist and the portability of a manual hoist without the need for time-consuming manual operation or access to a power source.
  • Designed to reduce downtime, the BatteryStar allows an operator to replace the battery quickly and easily for minimal operation interruption.
  • with the standard 20 feet of chain, this hoist can be transported and installed anywhere it is needed.
  • The hoist will be available for sale from Columbus McKinnon beginning in the Summer of 2024.

HD Nursing and WellnessMats Announce Strategic Partnership, Improving Comfort and Safety of Healthcare Professionals with Medical Grade Premium Standing Solutions

Retrieved on: 
Friday, March 15, 2024

“As the leader in Premium Standing Solutions and recognized for exemplary performance throughout various industries, we are thrilled to now join forces with HD Nursing and P4 to leverage our extensive experience to enhance the occupational comfort of medical and healthcare professionals,” says Daniel Bouzide, founder and president, WellnessMats. “This is a timely opportunity for healthcare leaders in virtually every healthcare setting to rethink and prioritize the well-being of their workforces and advance initiatives for employee retention -- one step at a time.”

Key Points: 
  • HD Nursing , the leading patient safety solution that combines predictive analytics with individualized fall and pressure injury prevention and WellnessMats , the leader in Premium Standing Solutions, proudly announce a strategic partnership.
  • This collaboration inaugurates a new era of improved comfort, safety, fatigue and stress relief for healthcare professionals and personnel throughout hospital and health system enterprises.
  • “This initiative underscores our joint dedication to advancing patient safety and supporting healthcare professionals throughout the healthcare ecosystem,” says Dr. Amy Hester, PhD, RN, BC, FAAN, chairwoman and CEO, HD Nursing.
  • Their professional-grade construction ensures a lasting investment that contributes to a positive work environment, improving employee retention and overall well-being.

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Retrieved on: 
Thursday, March 14, 2024

TEVIMBRA will be available in the U.S. in the second half of 2024.

Key Points: 
  • TEVIMBRA will be available in the U.S. in the second half of 2024.
  • The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.
  • More than 900,000 patients have been prescribed TEVIMBRA globally to date.