Hypoglycemia

Glytec Announces Major Expansion of Executive Team to Drive Innovation and Growth

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화요일, 1월 30, 2024
AHRQ, Growth, CFO, Agency, History, Patient, MSN, Glucommander, Hyperglycemia, SVP, Business operations, Health, Software as a service, Humana, Doctor of Philosophy, RN, Hypoglycemia, Hospital, Pharmaceutical industry

WALTHAM, Mass., Jan. 30, 2024 /PRNewswire/ -- Glytec, the only provider of cloud-based insulin management software as a service (SaaS) solutions across the continuum of care, proudly announces the addition of key healthcare leaders to its executive team to continue to scale the company, grow its client base, and meet the needs of the growing healthcare industry and diabetes technology market. 

Key Points: 
  • I feel privileged to collaborate with this team of experts with an extensive track record of healthcare innovation, positive patient impact at scale, and a history of remarkable success," said Patrick Cua, CEO of Glytec.
  • [2]
    The market demand for Glucommander is surging, and these seasoned executives will bring invaluable experience and skills to drive and support continued growth.
  • McPherson's strategic financial leadership will play a crucial role in sustaining Glytec's growth trajectory and fortifying the foundation for continued innovation.
  • These healthcare leaders will join a broader, dynamic team that is set to drive groundbreaking advancements in diabetes technology, healthcare applications, and market impact.

Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism

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화요일, 1월 23, 2024
Congenital hyperinsulinism, Patient, MHRA, Healthcare Improvement Scotland, Medication, Innovation, Health care, SMC, Hypoglycemia, Pharmaceutical industry

Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of hypoglycemia due to congenital hyperinsulinism (HI).

Key Points: 
  • Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of hypoglycemia due to congenital hyperinsulinism (HI).
  • The Innovation Passport designation in the U.K. is the entry point to the Innovative Licensing and Access Pathway (ILAP).
  • “Congenital hyperinsulinism is the most frequent cause of severe, persistent hypoglycemia in newborn babies, infants and children,” said Susan Stewart, J.D., Chief Regulatory Officer at Rezolute.
  • “The Innovation Passport opens the door for Rezolute to discuss access considerations for potential future indications for RZ358.

A Powerful Alliance: Dexcom G7 Now Connects to Tandem t:slim X2

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월요일, 1월 15, 2024
Wearables, Mobile Technology, Technology, Medical Devices, Diabetes, Clinical Trials, Health Technology, Software, Biotechnology, Health, Data Management, CGM, FIN Atlantic Film Festival, Dexcom, EASD, Associate professor, Partnership, Hypoglycemia, University, Risk, DXCM, Diabetic retinopathy, Insulin, G7, Tandem Diabetes Care, AID, Tandem, University of Nottingham, Medical device

DexCom, Inc. (Nasdaq: DXCM), a global leader in real-time continuous glucose monitoring for people with diabetes, announced today the Dexcom G7 Continuous Glucose Monitoring (CGM) System now connects with the t:slim X2™ insulin pump by Tandem Diabetes Care in countries across Europe and in South Africa.

Key Points: 
  • DexCom, Inc. (Nasdaq: DXCM), a global leader in real-time continuous glucose monitoring for people with diabetes, announced today the Dexcom G7 Continuous Glucose Monitoring (CGM) System now connects with the t:slim X2™ insulin pump by Tandem Diabetes Care in countries across Europe and in South Africa.
  • The announcement comes just a month after the system launched in the United States and combines the power and accuracy of Dexcom G7 with the discretion of the Tandem t:slim X2.
  • Additionally, the COMISAIR seven-year follow up demonstrated further substantial reduction in HbA1c when Dexcom CGM is connected to the t:slim X2 insulin pump with Control-IQ technology5.
  • To learn more and to get started with Dexcom G7 and the Tandem t:slim X2 insulin pump, visit Dexcom.co.uk/tandem.

Biomea Fusion Announces Dosing of First Type 1 Diabetes Patient in Phase II Study (COVALENT-112) with BMF-219

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월요일, 1월 8, 2024
Phase, Disease, Health, Diabetes, Insulin, Trial of the century, MD, Clinical trial, DSM-IV codes, Person, Cancer, Patient, Diagnosis, Safety, Hypoglycemia, Pharmaceutical industry

The clinical study, COVALENT-112, has initiated enrollment of adults living with type 1 diabetes in the US and Canada.

Key Points: 
  • The clinical study, COVALENT-112, has initiated enrollment of adults living with type 1 diabetes in the US and Canada.
  • Eligible patients include those who have been diagnosed with type 1 diabetes for up to 15 years.
  • Beta cell loss is thought to be a root cause of type 1 and type 2 diabetes.
  • Preclinical studies have shown the potential of BMF-219 to specifically proliferate insulin-producing beta cells in animal models of type 1 and type 2 diabetes.

Lexicon Pharmaceuticals Provides Business and Pipeline Update at 42nd Annual J.P. Morgan Healthcare Conference

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월요일, 1월 8, 2024
Lithium, UGT, Risk, Digoxin, Shanda, Hypotension, FDA, SGLT1, Type 2 diabetes, Acute kidney injury, Congress, Pyelonephritis, Conference, Fever, Ketoacidosis, Pregabalin, Pregnancy, Pain, Assessment, Gabapentin, Tenderness, New Drug Application, Amber Grid, HCM, Common, SGLT2, PROGRESS, Hypertrophic cardiomyopathy, Diabetes, Kidney, Heart failure, Dialysis, History, Patient, Prescription, Type, Neuropathic pain, Webcast, Insulin, T2DM, EGFR, Erythema, T1DM, Hypoglycemia, Partnership, Contraindication, Diarrhea, NDA, Incidence, Swelling, Urinary tract infection, Hospital, Chronic kidney disease, Internationalized domain name, Metabolic acidosis, Creatinine, Growth, Lactation, Pharmaceutical industry

THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.

Key Points: 
  • THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.
  • “Lexicon achieved major advancements in 2023 in its business and pipeline of pharmaceutical innovations,” said Lonnel Coats, chief executive officer and director of Lexicon.
  • The company will also focus on ensuring a strong ongoing awareness of INPEFA in the medical community through medical publications and congress presence.
  • Company to Present at J.P. Morgan Healthcare Conference Thursday, January 11, 2024 at 10:30am PST (1:30pm ET)
    Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation.

Vertex Provides Pipeline and Business Updates in Advance of Upcoming Investor Meetings

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일요일, 1월 7, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, SCD, Kingdom, Blue Shield, Conference, T1D, Sickle cell disease, Gene editing, Blue Cross, Pain, Messenger, EMA, FDA, PDUFA, Cystic fibrosis, Insulin, Vertex Pharmaceuticals, Abdominoplasty, European Medicines Agency, Sciatica, SAD, PNP, Glycated hemoglobin, Patient, TDT, Safety, Diabetes, Acceleration, Hypoglycemia, CFTR, VRTX, CHMP, Pharmaceutical industry

Epidemiology update: Vertex revised its estimates for the number of patients living with cystic fibrosis from ~88,000 to ~92,000 in the U.S., Europe, Australia, and Canada.

Key Points: 
  • Epidemiology update: Vertex revised its estimates for the number of patients living with cystic fibrosis from ~88,000 to ~92,000 in the U.S., Europe, Australia, and Canada.
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 30, 2024, for CASGEVY in TDT.
  • VX-993: Vertex also anticipates initiating a Phase 2 study with an oral formulation of VX-993 for the treatment of PNP in 2024.
  • A live webcast of management's remarks will be available through the Vertex website, www.vrtx.com , in the "Investors" section under the "News and Events" page.

Glytec Announces Patrick F. Cua as Chief Executive Officer

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목요일, 1월 4, 2024
Brain damage, EHR, Agency, Risk, CUA, Acquisition, Software as a service, AHRQ, Glucommander, Hospital, Hyperglycemia, Medicare, Infection, Growth, Patient, Organization, Seizure, Hypoglycemia, CMS

WALTHAM, Mass., Jan. 4, 2024 /PRNewswire/ -- Glytec, the only provider of cloud-based insulin management software as a service (SaaS) solutions across the continuum of care, today announced the appointment of Patrick F. Cua as Chief Executive Officer. In his new role, Cua will prepare the company for rapid growth to meet increasing demand for Glucommander amid a surging industry focus on healthcare outcomes, cost savings, diabetes technology, and glycemic management.

Key Points: 
  • WALTHAM, Mass., Jan. 4, 2024 /PRNewswire/ -- Glytec , the only provider of cloud-based insulin management software as a service (SaaS) solutions across the continuum of care, today announced the appointment of Patrick F. Cua as Chief Executive Officer.
  • "Glytec is an early innovator for inpatient glycemic management SaaS and has built and maintained a reputation as the trusted partner for healthcare providers," said Cua.
  • I'm excited to grow the organization and scale its technology through this transformative time, not just for Glytec, but also for healthcare and the diabetes technology industry."
  • To learn more about Glytec and its insulin management software, visit https://glytecsystems.com/ .

Human medicines European public assessment report (EPAR): Trajenta, linagliptin, Date of authorisation: 23/08/2011, Revision: 21, Status: Authorised

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화요일, 1월 2, 2024
Liver, Medical Subject Headings, Marketing, Kidney, European Commission, Diabetes, INN, Risk, Allergy, ATC, Hypoglycemia, Hormone, International, Diet, Pancreas, European, Insulin, Metformin, Disease, Blood, Language, Glycated hemoglobin, DPP-4, Glucose, Type, Tablet, Select, Committee, Patient, Safety, Pioglitazone, Anatomy, Medicine, IIA, CHMP, Exercise, Medical device

Human medicines European public assessment report (EPAR): Trajenta, linagliptin, Date of authorisation: 23/08/2011, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Trajenta, linagliptin, Date of authorisation: 23/08/2011, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Date of authorisation: 24/05/2018, Revision: 8, Status: Authorised

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화요일, 1월 2, 2024
Liver, Medical Subject Headings, Diarrhea, Marketing, Diabetes, INN, Diabetic ketoacidosis, Allergy, ATC, International, Pancreas, Insulin, Disease, Language, Blood, Porphyrin, Mellitus, Glycated hemoglobin, Mouth, Blood sugar level, Infant, Abdominal pain, Porphyria, KATP, European Medicines Agency, ATP, Tablet, Chronic pain, Select, Cell, Patient, Time, Anatomy, Medicine, IIA, Neonatal diabetes, Hypoglycemia, Life, Medical device

Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Date of authorisation: 24/05/2018, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Date of authorisation: 24/05/2018, Revision: 8, Status: Authorised

U.S. Food and Drug Administration issues Complete Response Letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility

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토요일, 12월 23, 2023
Food, Priority review, CGM, Symantec Endpoint Protection, FDA, NDA, New Drug Application, Congenital hyperinsulinism, Part, CRL, Patient, Safety, Hypoglycemia, Pharmaceutical industry

The CRL is related to deficiencies identified at a third-party manufacturing facility following an inspection but are not specific to dasiglucagon.

Key Points: 
  • The CRL is related to deficiencies identified at a third-party manufacturing facility following an inspection but are not specific to dasiglucagon.
  • The CRL is related to deficiencies identified following an inspection at a third-party contract manufacturing facility.
  • The FDA granted dasiglucagon Priority Review on August 30, 2023 for up to three weeks of dosing.
  • Part 1 relates to dosing of up to 3 weeks and Part 2 relates to the use beyond 3 weeks.