Myalgia

GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen’s Iqirvo® for Primary Biliary Cholangitis

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星期一, 六月 10, 2024
Steroid, Myalgia, Acute kidney injury, Birth, Pregnancy, Patient, Alkaline phosphatase, Drug discovery, Tablet, CPK, ACLF, Milk, Hypersensitivity, Rhabdomyolysis, U.S. FDA, PBC, Allergy, Rash, Hepatic encephalopathy, Fracture, Effectiveness, UDCA, Myopathy, Reproductive system, Clinical trial, Interrupt, Bile, Bilirubin, Survival, Sale, Food, Partnership, Eosinophilia, Primary biliary cholangitis, IPN, Fetus, ADR, Rifampicin, Cirrhosis, Bleeding, ALP, TB, HMG-CoA, Ursodeoxycholic acid, Infant, Hepatology, Enzyme, Ascites, Risk, Lactation, CYP3A4, Miscarriage, FDA, Jaundice, ALT, Pharmaceutical industry

This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP).

Key Points: 
  • This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP).
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Iqirvo is not recommended for people who have or who develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
  • Pascal Prigent, CEO of GENFIT, commented: “This approval is a source of pride for all GENFIT employees.

Replimune Announces Positive Topline Primary Analysis Data by Independent Central Review from IGNYTE Clinical Trial of RP1 plus Nivolumab in Anti-PD1 Failed Melanoma

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星期四, 六月 6, 2024
Incidence, Vomiting, Webcast, Patient, Myocarditis, Appetite, Influenza-like illness, Nausea, Arthralgia, Chills, Diarrhea, Melanoma, Headache, REPL, Clinical trial, Cytokine release syndrome, RP1, Nivolumab, Congress, BLA, Lipase, FDA, Rash, RECIST, ASCO, Injury, Myalgia, Fatigue, Weakness, Pharmaceutical industry

WOBURN, Mass., June 06, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced the topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma. The results by independent central review show one-third of patients receiving RP1 plus nivolumab responded to treatment, improving upon the investigator-assessed data presented at ASCO 2024, with all responses lasting greater than 6 months from baseline.

Key Points: 
  • ET
    WOBURN, Mass., June 06, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced the topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma.
  • The results by independent central review show one-third of patients receiving RP1 plus nivolumab responded to treatment, improving upon the investigator-assessed data presented at ASCO 2024, with all responses lasting greater than 6 months from baseline.
  • The primary analysis by independent central review was triggered once all patients had been followed for at least 12 months.
  • The Company plans to submit the full primary analysis data from the anti-PD1 failed melanoma cohort including key secondary endpoint data and subgroups for presentation at an upcoming medical congress.

Sword Health Introduces Phoenix, the First AI Care Specialist and Raises $130 Million in a Mix of Primary and Secondary Sale, Increasing Valuation to $3 Billion

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星期二, 六月 4, 2024
Intelligence, Sword, Doctor of Philosophy, Myalgia, Pain, Motivation, Khosla Ventures, Human, Sword Health, AI, Thrive, Sale, Medical device

This brings the total funding to $340 million to date, and the company is now valued at $3 billion—up 50% from its Series D valuation.

Key Points: 
  • This brings the total funding to $340 million to date, and the company is now valued at $3 billion—up 50% from its Series D valuation.
  • Globally, billions of people lack access to high-quality care, including two billion people suffering from musculoskeletal issues, and two billion from either pelvic health or mental health conditions.
  • The company has delivered over three million AI sessions to members to date and is available to over 10,000 employers across three continents.
  • It is the only AI solution that enables an independent and clinical-grade delivery of care to patients—anywhere, anytime.

Results are looking promising for a combined COVID and flu vaccine. Here’s how it could benefit public health

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星期五, 六月 14, 2024
Fatigue, Faculty, Diphtheria, International health, World Health Organization, Public, Population health, Cold medicine, Myalgia, Injection, Health, Influenza vaccine, DTP, Safety, Curtin University, MMR, BioNTech, Pfizer, Rubella, Pandemic fatigue, Vaccine, COVID, Clinical trial, Vaccination, Infection, Mumps, Disease, Pain, Tetanus, Parent, Measles, Synthetic control method, Research, Ageing, Cerebral edema

Earlier this week, Moderna announced positive results for its phase 3 clinical trial of a combined vaccine against COVID and influenza. So what exactly did the trial find? And what sort of impact would a two-in-one COVID and flu vaccine have on public health? Let’s take a look.Combination vaccines are already used for other diseases Combination vaccines have been successfully used for several decades in Australia and around the world.

Key Points: 


Earlier this week, Moderna announced positive results for its phase 3 clinical trial of a combined vaccine against COVID and influenza. So what exactly did the trial find? And what sort of impact would a two-in-one COVID and flu vaccine have on public health? Let’s take a look.

Combination vaccines are already used for other diseases

  • Combination vaccines have been successfully used for several decades in Australia and around the world.
  • For example, the DTP vaccine, a shot that combines protection against diphtheria, tetanus and pertussis (whooping cough), was first administered in 1948.

So what did the trial find?

  • In both age groups, participants were randomised to either receive the combined vaccine (called mRNA-1083) or a control.
  • The control group in the 50-to-64 age category were given the Fluarix flu vaccine, as well as Moderna’s mRNA COVID vaccine, Spikevax.
  • While the trial results are promising, they are yet to be published in a peer-reviewed journal, which means independent experts haven’t yet verified them.
  • And further research may be required to test how the combined vaccine works in younger age groups.

What are the advantages of combined vaccines?

  • Each year they prevent up to 5 million deaths around the world from a range of life-threatening infections.
  • At the same time, we can always do more to boost vaccination uptake, especially in areas with fewer resources and among vulnerable populations.
  • For example, the need for fewer injections reduces costs for health systems, decreases storage requirements and reduces the burden on parents.

Two important diseases

U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors

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星期四, 六月 13, 2024
Oncology, Health, FDA, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Drug development, MD, Myalgia, Bristol Myers Squibb, Fusion, Patient, Lead, Cancer, NSCLC, Safety, Hope, Hepatotoxicity, BMY, ILD, Disease, Corr, Central nervous system, Marker beacon, NTRK, Food, TKI, CNS, Ageing, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.1 The approval is based on results from the Phase 1/2 TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK-positive solid tumors.1 This indication is approved under accelerated approval based on overall response rate and duration of response.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.1 The approval is based on results from the Phase 1/2 TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK-positive solid tumors.1 This indication is approved under accelerated approval based on overall response rate and duration of response.
  • The median duration of response (mDOR) was not yet reached.
  • “Today’s FDA approval of Augtyro for patients with NTRK-positive tumors adds to its indication in ROS1-positive NSCLC, showing its clinical value for more people across multiple genetic markers,” said Nick Botwood, senior vice president of Medical Oncology at Bristol Myers Squibb.1 “Previously, there was not an FDA approved treatment option for NTRK-positive cancers that was studied in both TKI-naïve and TKI-pretreated patients across solid tumors.
  • This milestone helps address this area of unmet need and builds on Bristol Myers Squibb’s longstanding legacy of bringing innovations to individuals who are facing cancer and urgently seeking new treatment options.”
    “Cancer can be frightening regardless of the type, but having a rare gene fusion driving it can be especially stressful and isolating,” said Susan Spinosa, president and patient co-founder of NTRKers, a patient advocacy group.

BioCryst Presents New Real-world Evidence Showing Reductions in Attack Rates in HAE Patients with Normal C1-Inhibitor after Beginning ORLADEYO® (berotralstat) Treatment

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星期日, 六月 2, 2024
Perception, Myalgia, LTP, Patient, Berotralstat, Internal medicine, Acne, Cohort (statistics), Cancer, Dermatology, Hereditary angioedema, BioCryst Pharmaceuticals, Human, Liver, Translational medicine, Menstruation, Liver cancer, Virilization, Risk, HAE, Diagnosis, Androgen, Fraunhofer Society, Physician, Congress, EAACI, Tranexamic acid, Pharmaceutical industry

The data were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress in Valencia, Spain.

Key Points: 
  • The data were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress in Valencia, Spain.
  • “The diagnosis of HAE patients with normal C1-inhibitor is complicated and often delayed by the lack of an easily measurable biochemical marker.
  • One patient experienced gastrointestinal symptoms upon initiation, which became milder after the first two weeks and did not lead to treatment discontinuation.
  • Additional new results presented at EAACI demonstrate the adverse health outcomes associated with attenuated androgen use as a prophylactic treatment for HAE.

Hinge Health Integrates Movement-Based Menopause Support into its Digital Musculoskeletal Clinic

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星期二, 五月 14, 2024
Biotechnology, Technology, Other Health, Health, General Health, Women, Pharmaceutical, Software, Hospitals, Consumer, Clinical Trials, Therapy, Bone density, Hot, Hormone replacement therapy, Education, Workforce, Exercise, Pelvic floor, MD, MSK, Movement, Woman, Menopause, Myalgia, Facial muscles

Hinge Health announced today the launch of movement-based menopause support tailored to individuals with musculoskeletal (MSK) and pelvic health conditions.

Key Points: 
  • Hinge Health announced today the launch of movement-based menopause support tailored to individuals with musculoskeletal (MSK) and pelvic health conditions.
  • For women who experience musculoskeletal and pelvic health issues, the decline in estrogen during menopause can not only worsen existing symptoms but also trigger new joint, muscle, and pelvic health issues.
  • "Regular physical activity can significantly reduce the frequency and severity of disruptive symptoms that occur with menopause,” said Tamara Grisales, MD, Urogynecologist, Hinge Health.
  • “By incorporating care for menopause, companies can retain employees, boost productivity, and achieve significant cost savings,” said Inessa Lurye, Head of Women’s Health, Hinge Health.

Project Lyme Harnesses the Power of Public Service Announcements to Inform Parents Their Child's Complex Illness Could Be Lyme

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星期三, 五月 8, 2024
Myalgia, Risk, CDC, Health, Arthralgia, DSM-IV codes, Parent, Depression, Conditional sentence, Tic disorder, Pressure, Patient, Lyme disease, Headache, Fatigue, Irritability, Lymph, Multimedia, Diagnosis, Infection, Fever, Anxiety, Approximation error, PSAS, Tick-borne disease, Deficit spending, Heart failure, Pharmaceutical industry

NEW YORK, May 8, 2024 /PRNewswire/ -- The CDC now estimates nearly half a million people will contract Lyme disease in the United States each year. However, most people do not realize how Lyme disease can cause diverse, devastating symptoms in some patients. The range of symptoms is expansive and often overwhelming, from flu-like symptoms such as fatigue, fever, enlarged lymph nodes, headaches, muscle aches, and joint pain in the early stages to more serious issues such as cognitive impairment, sleep problems, mood changes, shortness of breath or heart failure when a diagnosis is missed or delayed. Lyme has been reported in all 50 states, with case counts increasing throughout the country. As the risk of contracting a tick-borne infection increases nationally, it is imperative to educate a broader audience, especially parents of young children.

Key Points: 
  • However, most people do not realize how Lyme disease can cause diverse, devastating symptoms in some patients.
  • Children are at the greatest risk of contracting Lyme disease and delayed diagnosis can prevent them from living a normal life.
  • In their new PSAs , Project Lyme tells the stories of Rylyn and Pippa , two young children who are recovering from Lyme disease.
  • Project Lyme's PSAs provide advice that if you are unsure of the source of your child's illness, it could be Lyme.

Nika Pharmaceuticals, Inc. (NKPH) Purchased the Technologies for Three Drugs in Tablet Form and One Dietary Supplement

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星期一, 四月 15, 2024
Sale, Brain, Pain, Myalgia, Stroke, Woman, Tissue, Dietary supplement, Infertility, Infection, Testosterone, DSM-IV codes, Pelvic floor dysfunction, Male, Climacteric, Insomnia, System, Dementia, Dysmenorrhea, Erectile dysfunction, Lipid, Anxiety, Toothache, Oxygen, Headache, Acquisition, Memory, Libido, Tribulus terrestris, Tracheobronchitis, Fever, Metamizole

HENDERSON, Nev., April 15, 2024 (GLOBE NEWSWIRE) -- Nika Pharmaceuticals, Inc. (OTCMKTS: NKPH) announces the purchase of four technologies for production of three generic drugs in tablet form and one dietary supplement.

Key Points: 
  • HENDERSON, Nev., April 15, 2024 (GLOBE NEWSWIRE) -- Nika Pharmaceuticals, Inc. (OTCMKTS: NKPH) announces the purchase of four technologies for production of three generic drugs in tablet form and one dietary supplement.
  • The acquisition includes full dossiers for each product, which will allow NKPH to quickly register them for sale once the company has finalized the branding of each.
  • The technologies, which were purchased through NKPH’s subsidiary, Nika Europe Ltd., have a proven market track record, as each of them satisfy an important health need of the population.
  • MENTHYL VALERATE 60mg is an over-the-counter drug with a positive effect on the central nervous and cardiovascular systems.

AIM ImmunoTech Announces Charles Lapp, MD, as a Consulting Medical Officer for its ME/CFS and Long COVID Programs

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星期一, 四月 15, 2024
FDA, Albany Medical College, AIM, MD, Myalgia, International Association, Chronic fatigue syndrome, ME/CFS, CFS, National Fibromyalgia Association, Knowledge, Pharmaceutical industry

As a Consulting Medical Officer and an independent contractor, he will help manage the company’s research programs related to ME/CFS and Long COVID, including the development of protocols and new clinical trials.

Key Points: 
  • As a Consulting Medical Officer and an independent contractor, he will help manage the company’s research programs related to ME/CFS and Long COVID, including the development of protocols and new clinical trials.
  • I am devoted to doing whatever I can to get Ampligen FDA-approved and available for commercial use.”
    Dr. Lapp is a graduate of Albany Medical College.
  • AIM Chief Executive Officer Thomas K. Equels states: “Having worked with Dr. Lapp for many years, I’m continually impressed by his knowledge, confidence and experience.
  • He is one of the foremost experts in his field and we are extremely grateful that he is joining the AIM team.”