Metabolism

Human medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Date of authorisation: 25/07/2019, Revision: 6, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Copper, Urine, Liver, Medical Subject Headings, Diarrhea, Marketing, Meal, Duodenitis, Roger Hawkins (drummer), DSM-IV codes, INN, Deficit spending, Metabolism, Stomach, ATC, Pain, Capsule, International, Tremor, Dysarthria, Ageing, Nausea, Language, Brain, Inflammation, Duodenum, European Medicines Agency, Wilson's disease, Dystonia, Select, Patient, Liver disease, Safety, Anatomy, IIA, Medical device

Human medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Date of authorisation: 25/07/2019, Revision: 6, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Date of authorisation: 25/07/2019, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Date of authorisation: 30/05/2017, Revision: 7, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Brain damage, Medical Subject Headings, Marketing, Traffic barrier, European Commission, Agency, INN, Risk, Fever, Lower respiratory tract infection, Metabolism, Infection, Movement, Allergy, ATC, International, European, Spinal cord, Disease, Nose, Language, Brain, Pharyngitis, Skull, Hypersensitivity, European Medicines Agency, TPP1, Select, CLN2, Safety, Anatomy, Medicine, Vomiting, IIA, CHMP, Medical device

Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Date of authorisation: 30/05/2017, Revision: 7, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Date of authorisation: 30/05/2017, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Xenpozyme, olipudase alfa, Date of authorisation: 24/06/2022, Revision: 2, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Spleen, Liver, Medical Subject Headings, Marketing, Lysosome, Traffic barrier, C-reactive protein, INN, Fever, Risk, Metabolism, Niemann–Pick disease, Allergy, Caregiver, ATC, Anaphylaxis, Itch, International, Enzyme replacement therapy, Headache, Disease, Nausea, ASMD, Tissue, Brain, Blood, Language, Heart, Inflammation, Hypersensitivity, Carbon monoxide, DSM-IV codes, European Medicines Agency, CNS, Myalgia, Select, Patient, Facial muscles, Safety, Fats, Anatomy, Vomiting, IIA, Rash, Medical device

Human medicines European public assessment report (EPAR): Xenpozyme, olipudase alfa, Date of authorisation: 24/06/2022, Revision: 2, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Xenpozyme, olipudase alfa, Date of authorisation: 24/06/2022, Revision: 2, Status: Authorised

Resistance (exercise) is far from futile: The unheralded benefits of weight training

Retrieved on: 
Tuesday, January 2, 2024
Marketing, Walking, CrossFit, Failure, Aerobics, Science, Perspiration, Swimming, Metabolism, Jogging, Running, Athlete, American Heart Association, Woman, Heart rate, Research, Man, Health, Facial muscles, Heart, Posture, Stereotype, Ageing, American College, Longevity, Medicine, Sports medicine, Lifting, Physical fitness, Exercise

Among its many benefits, exercise improves heart and brain function, aids in controlling weight, slows the effects of aging and helps lower the risks of several chronic diseases.

Key Points: 
  • Among its many benefits, exercise improves heart and brain function, aids in controlling weight, slows the effects of aging and helps lower the risks of several chronic diseases.
  • Aerobic exercise such as running, swimming and cycling is popular because it provides great benefits and with ample scientific evidence to back that up.
  • So, if aerobic exercise and resistance training offer roughly equal benefits, how did we end up with so many runners and cyclists compared to weightlifters?

The rise of aerobics

  • The preference for aerobic exercise dates back to landmark research from the Cooper Centre Longitudinal Study, which played a pivotal role in establishing the effectiveness of aerobics — Dr. Ken Cooper invented or at least popularized the word with his book Aerobics, spurring desk-bound Baby Boomers to take up exercise for its own sake.
  • Meanwhile, resistance training languished, especially among women, due to the misguided notion that weightlifting was only for men who aspired to be hyper-muscular.
  • In 1977, Jim Fixx made running and jogging popular with The Complete Book of Running.
  • It made sense to many that breathing hard and sweating from prolonged, vigorous movement was the best way to benefit from exercising.

Recognizing the value of resistance

  • Weight training is now coming up alongside and preparing to overtake its speedy rival, as athletes and everyday people alike recognize the value that was always there.
  • It’s important to recognize that resistance training does not invariably lead to bulking up, nor does it demand lifting heavy weights.

Strength and aging

  • The merits of resistance training extend beyond improving muscle strength.
  • As people age, activities of daily living such as standing up, sitting down and climbing stairs demand strength and power more than cardiovascular endurance.

Redefining the fitness narrative

  • The main idea is not to pit resistance training against aerobic exercise but to recognize that they complement each other.
  • Engaging in both forms of exercise is better than relying on one alone.
  • It’s time to redefine the narrative around fitness to make more room for resistance training.


Stuart Phillips receives funding from CIHR, NSERC, U.S. NIH, and several industry funders. He is affiliated with Exerkine Corporation.

Make Your New Year's Resolutions Last with Insights from Dr. Steven Gundry, Featuring Gundry MD Bio Complete 3 Supplement

Retrieved on: 
Friday, December 29, 2023
Fasting, Defecation, Metabolism, Habit, Nutritional science, Weight loss, Capsule, Probiotic, Steven Gundry, Health, Eating, Mitochondrion, Digestion, Energy, Gundry

LOS ANGELES, Dec. 29, 2023 /PRNewswire/ -- As the countdown to the new year begins, so does the tradition of setting resolutions. However, statistics show that by mid-February, many individuals find themselves falling off the wagon. Renowned health expert Dr. Steven Gundry suggests his approach to ensure your resolutions stick: make tiny changes to your routine that can easily evolve into lasting habits.

Key Points: 
  • Supercharge with Supplements: Dr. Gundry recommends incorporating supplements into your daily routine, with a particular emphasis on Gundry MD Bio Complete 3 .
  • Gundry MD Bio Complete 3 is a triple-pronged gut health powerhouse that contains a blend of probiotics, prebiotics, and postbiotics.
  • Dr. Gundry, the founder of Gundry MD, advises users to maintain a consistent intake of Gundry MD Bio Complete 3 for at least three months to fully appreciate its potential and achieve optimal outcomes.
  • Gundry MD Bio Complete 3 can be purchased on the Gundry MD site for the price of $69.95 for a 30-day supply with a 90-day purchase price guarantee.

Ocugen Announces OCU400 Receives Regenerative Medicine Advanced Therapy (RMAT) Designation for Treatment of Retinitis Pigmentosa Associated with RHO Mutations

Retrieved on: 
Tuesday, December 19, 2023
Marketing, Metabolism, Homeostasis, FDA, Vaccine, Retinitis pigmentosa, Regenerative medicine, Trial of the century, RP, Doctor of Philosophy, Mutation, RHO, LCA, Reproduction, Patient, Safety, Paratriathlon, Leber congenital amaurosis, Pharmaceutical industry

“FDA’s decision also reinforces the sense of urgency to bring a therapeutic option to these patients.”

Key Points: 
  • “FDA’s decision also reinforces the sense of urgency to bring a therapeutic option to these patients.”
    RMAT designation is part of the 21st Century Cures Act.
  • The program was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure a serious condition.
  • Receiving RMAT designation offers sponsor companies all the benefits of the fast track and breakthrough therapy designation programs, including early interactions with the FDA.
  • RHO mutations affect more than 10,000 of the 110,000 people in the United States diagnosed with RP.

Processa Pharmaceuticals Provides Interim Analysis from Ongoing Phase 1b Trial of Next Generation Capecitabine Showing Improved Safety Over Capecitabine

Retrieved on: 
Tuesday, December 19, 2023
NGC, Fireside, Metabolism, Fireside chats, FDA, Pharming, PCSA, Acral lentiginous melanoma, Cancer, Capecitabine, Patient, Safety, Pharmaceutical industry

HANOVER, MD, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the safety and efficacy for more cancer patients, provides an interim analysis from its Phase 1b study of its Next Generation Capecitabine (NGC-Cap).

Key Points: 
  • We are encouraged to be near completion of the Phase 1b trial as we make preparations for a subsequent Phase 2 trial with NGC-Cap,” said David Young, Pharm.D., Ph.D., President of Research and Development at Processa.
  • “We are very encouraged with the interim results from the Phase 1b trial.” added Dr. Young.
  • It is believed that NGC-Cap’s ability to inhibit the production of catabolites like FBAL is key to the success of NGC-Cap.
  • Content from the Fireside Chat will be archived through June 20, 2024.

Structure Therapeutics Provides Comprehensive GSBR-1290 Program Update Including Clinically Meaningful Proof-of-Concept Data From Phase 2a Clinical Study

Retrieved on: 
Monday, December 18, 2023
Metabolism, Șaeș, Division, Aes, Weight loss, Bilirubin, Nausea, Glycated hemoglobin, Duke University, GPCR, Obesity, Fatty liver disease, Patient, Safety, Therapy, Vomiting, Dietary supplement

ET

Key Points: 
  • ET
    SAN FRANCISCO, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and cardiopulmonary diseases, today provided a comprehensive development program update for its highly selective oral GLP-1 receptor agonist, GSBR-1290.
  • “The unmet medical need for both T2DM and chronic weight management continues to be very large, and the GLP-1 receptor is a target with considerable potential.
  • The T2DM cohort enrolled 54 participants, randomized to GSBR-1290 45 mg (n=10) or 90 mg (n=26), or placebo (n=18), dosed once daily.
  • The primary endpoint of the Phase 2a study is safety and tolerability of GSBR-1290.

Mithra Receives Positive DSMB Opinion on DONESTA® European Phase 3 Trial

Retrieved on: 
Monday, December 18, 2023
DSMB, Quality of life, Food, Metabolism, Estetrol, Risk, Woman, VMS, FDA, EMA, E4, Menopause, Brussels Stock Exchange, Trial of the century, NDA, C301, European Medicines Agency, MITRA, Safety, Data monitoring committee, Pharmaceutical industry

Positive efficacy top line results have been previously reported from the menopause phase 3 program, including the European trial.

Key Points: 
  • Positive efficacy top line results have been previously reported from the menopause phase 3 program, including the European trial.
  • Graham Dixon, Chief Scientific Officer of Mithra, commented, “This DSMB recommendation allows us to continue the extension of the DONESTA® phase 3 trial in Europe, which will generate important data for our marketing authorization applications.
  • Promising top-line safety results from the phase 3 trial in North America (C302) were announced in 2023, and primary safety data from the European trial are expected in H1 2024.
  • This additional safety data is foreseen to be included in the European Medicines Agency (EMA) and FDA submissions, planned within the same time frame.

Processa Pharmaceuticals Announces Successful Phase 2 Meeting with FDA for Next Generation Capecitabine

Retrieved on: 
Wednesday, December 13, 2023
Doctor of Pharmacy, Food, Metabolism, FDA, PCSA, Cancer, Patient, Safety, Pharmaceutical industry

HANOVER, MD, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces the outcomes from a successful meeting with the U.S. Food and Drug Administration (“FDA”) regarding the Company’s next Phase 2 study supporting the advancement of Next Generation Capecitabine (“NGC-Cap”) for cancer patients.

Key Points: 
  • HANOVER, MD, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces the outcomes from a successful meeting with the U.S. Food and Drug Administration (“FDA”) regarding the Company’s next Phase 2 study supporting the advancement of Next Generation Capecitabine (“NGC-Cap”) for cancer patients.
  • “The FDA provided helpful guidance on the overall design of our NGC-Cap Phase 2 study for which we anticipate beginning enrollment in mid-2024.
  • The meeting with the FDA was supported by the interim results from the ongoing Phase 1b study that should complete enrollment in the first quarter of 2024.
  • These interim results are expected to be available for public release by the end of the year.