Methemoglobinemia

Hagens Berman: Lawsuit Accuses Oregon Port, Commercial Farms and Animal Feeding Operation of Contaminating Groundwater, Putting Tens of Thousands of Oregonians at Risk

Retrieved on: 
Wednesday, February 28, 2024
Legal, Class Action Lawsuit, Concentrated animal feeding operation, Soil, Filtration, Natural Resources, Nitrate, Pregnancy, Methemoglobinemia, District court, Cooking, Learning, Groundwater, Behavior, Drinking, City, Drinking water, Environmental quality, EPA, Agriculture, DEQ, GMA, Farm, Nitrogen, Manure, Thyroid, Miscarriage, Water, Cancer, Sewage treatment

Between Nov. 1, 2023, and Jan. 11, 2024, alone, the Port violated its permit at least 395 times, the lawsuit states.

Key Points: 
  • Between Nov. 1, 2023, and Jan. 11, 2024, alone, the Port violated its permit at least 395 times, the lawsuit states.
  • Attorneys say the Port of Morrow, commercial farms, and CAFOs have allegedly contributed to “soaring” levels of nitrates in local groundwater.
  • “The Port and these commercial farms have placed us and hundreds of other families in an impossible position.
  • The lawsuit states that in 1990, the Oregon DEQ declared the Lower Umatilla Basin a groundwater management area (GMA).

FDA Issues Reminder of Non-Substitution of PEDMARK® (sodium thiosulfate injection) for Pediatric Patients Receiving Cisplatin

Retrieved on: 
Thursday, February 1, 2024
Hypothermia, Sodium nitrite, Fatigue, Ototoxicity, Cisplatin, Patient, FENC, STS, FDA, Restless, Kidney, TSX, Argyreia nervosa, Communication, Food, Methemoglobinemia, Risk, Dermatitis, Headache, Potassium chloride, Pharmaceutical industry

PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Key Points: 
  • PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.
  • The FDA reminded health care providers that as stated in PEDMARK’s prescribing information , PEDMARK is not substitutable with other sodium thiosulfate products.
  • Sodium nitrite is co-packaged with sodium thiosulfate as a separate vial in some products; it is not present in PEDMARK.
  • The FDA encourages those with any questions to contact [email protected].

USPTO Grants New Patent to Evoke Pharma Covering the Usage of GIMOTI® To Treat Moderate to Severe Gastroparesis

Retrieved on: 
Wednesday, December 7, 2022
NMS, Depression, Metoclopramide, Absorption, Suicidal ideation, EPS, Fatigue, Physiology, Evoke, Tardive dyskinesia, Gastroparesis, MBA, Neuroleptic malignant syndrome, Creatinine, COVID-19, Parkinsonism, Dysgeusia, Food, FDA, Patent, Risk, Internal bleeding, Perforation, Methemoglobinemia, Hypersensitivity, Extrapyramidal symptoms, Water, Moderate, Hypertension, Neoplasm, Orange Book, Bronchospasm, Epilepsy, Liver, Seizure, Patient, Kidney, United, Catecholamine, TD, Headache, Pheochromocytoma, Suicide, Stomach, Hyperprolactinaemia, History, CYP2D6, Pharmaceutical industry, Aroma compound, Residential care, Generic drug, EU
Key Points: 

    Evoke Pharma Strengthens its Intellectual Property Portfolio with a Notice of Allowance from the USPTO for a Patent Application Related to GIMOTI®

    Retrieved on: 
    Wednesday, November 30, 2022
    United, Liver, Kidney, United States Patent and Trademark Office, Risk, Bronchospasm, Creatinine, Tardive dyskinesia, Hyperprolactinaemia, Hypertension, NMS, Metoclopramide, Hypersensitivity, Dysgeusia, Patient, Suicidal ideation, Fatigue, Neoplasm, EPS, Catecholamine, TD, Seizure, Gastroparesis, FDA, Internal bleeding, COVID-19, Epilepsy, Suicide, Evoke, History, Parkinsonism, CYP2D6, Methemoglobinemia, Extrapyramidal symptoms, Vomiting, Patent, Depression, Physiology, Water, Stomach, Perforation, Headache, Neuroleptic malignant syndrome, Absorption, Pheochromocytoma, Pharmaceutical industry, Aroma compound, Residential care, Generic drug

    This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.

    Key Points: 
    • This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.
    • We are thrilled and highly encouraged by the strides we have made with the USPTO and its continued acknowledgement of the novel and inventive nature of GIMOTI, said Matt DOnofrio, Chief Business Officer of Evoke Pharma.
    • Most common adverse reactions (5%) for GIMOTI are: dysgeusia, headache, and fatigue.These are not all of the possible side effects of GIMOTI.
    • Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects.

    Evoke Pharma to Participate in the 2022 American College of Gastroenterology Annual Scientific Meeting

    Retrieved on: 
    Thursday, October 20, 2022
    LinkedIn, Suicide, NMS, Internal bleeding, U.S. Securities and Exchange Commission, Metoclopramide, Hypertension, Risk, Fatigue, Liver, Kidney, Hyperprolactinaemia, Neoplasm, Parkinsonism, Neuroleptic malignant syndrome, Patient, Depression, Seizure, TD, Gastroparesis, Facebook, History, CYP2D6, Private Securities Litigation Reform Act, EPS, Creatinine, Physiology, Epilepsy, Headache, Suicidal ideation, Pheochromocytoma, Absorption, Patent, Lists of diseases, United, Tardive dyskinesia, Perforation, Stomach, Bronchospasm, Hypersensitivity, Water, Methemoglobinemia, Catecholamine, FDA, COVID-19, Extrapyramidal symptoms, Dysgeusia, Pharmaceutical industry, Aroma compound, Residential care, Generic drug, Evoke

    SOLANA BEACH, Calif., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases, today announced that the Company will participate in the 2022 American College of Gastroenterology Annual Scientific Meeting taking place from October 21 – 26, 2022 in Charlotte, North Carolina. Also, as a nominee for the Healio Industry Breakthrough Product Award, Evoke will attend the Healio Disruptive Innovators Awards Program on Sunday, October 23rd, in Charlotte during the ACG meeting.

    Key Points: 
    • FollowEvoke Pharmaon Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724
      FollowEvoke Pharmaon LinkedIn: https://www.linkedin.com/company/evoke-pharma/
      GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
    • Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements.
    • The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved.
    • This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    Mallinckrodt Announces Submission of 510(k) to the U.S. FDA for Inhaled Nitric Oxide Delivery System

    Retrieved on: 
    Wednesday, September 28, 2022
    Autoimmunity, Rheumatology, Risk, NICU, Safety, Blood gas tension, Investor relations, NO2, FDA, Nitric oxide, Food, Sale, Blood, Ophthalmology, Nephrology, Biological functions of nitric oxide, Company, Analgesic, Immunotherapy, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, Inhalation, Extracorporeal membrane oxygenation, Pulmonary edema, U.S. Securities and Exchange Commission, Automation, Annual report, Neurology, Nitrogen dioxide, Ajman Specialty General Hospital, SEC, INO, Pulmonary hypertension, Methemoglobin, Pharmaceutical industry, Mallinckrodt, Methemoglobinemia

    DUBLIN, Sept. 28, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced the submission of a 510(k) premarket notification application to the U.S. Food and Drug Administration (FDA) for an investigational inhaled nitric oxide delivery system for INOmax® (nitric oxide) gas, for inhalation.

    Key Points: 
    • DUBLIN, Sept. 28, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced the submission of a 510(k) premarket notification application to the U.S. Food and Drug Administration (FDA) for an investigational inhaled nitric oxide delivery system for INOmax (nitric oxide) gas, for inhalation.
    • The safety and efficacy of the investigational inhaled nitric oxide delivery system has not been evaluated by the FDA.
    • The investigational inhaled nitric oxide delivery system is not available for sale, distribution or use.
    • This release includes forward-looking statements concerning Mallinckrodt's s 510(k) premarket notification application and the Company's inhaled nitric oxide delivery system.

    Innocoll and DURECT Announce U.S. launch of POSIMIR®

    Retrieved on: 
    Monday, September 26, 2022
    Central nervous system, Injection, Safety, Bradycardia, Achievement, Patient, U.S. Securities and Exchange Commission, Bupivacaine, Technology, C-reactive protein, Pain management, Annual report, Headache, AH, Risk, Fatty liver disease, COVID-19, Respiratory arrest, Methemoglobinemia, Sale, Food, Diarrhea, Vomiting, Anesthetic, Bruise, Surgeon, DNA, Nausea, SEC, Patent, Dizziness, Allergy, Coma, FDA, NASH, Association, Shoulder joint, Tinnitus, Paresthesia, Form 10-K, Chondrolysis, United States patent law, Somnolence, SABER, Constipation, Marketing, Itch, Blood, Incidence, Hypersensitivity, Elective surgery, Private Securities Litigation Reform Act, Regulation of tobacco by the U.S. Food and Drug Administration, Chronic liver disease, CNS, Anemia, Dentistry, Pharmaceutical industry, Vaccine, Fever, Dysuria, Dysgeusia, Hypoesthesia

    "We are excited to bring a potential cornerstone of multi-modal post-operative pain management to surgeons with the launch of POSIMIR," said Louis Pascarella, Chief Executive Officer of Innocoll.

    Key Points: 
    • "We are excited to bring a potential cornerstone of multi-modal post-operative pain management to surgeons with the launch of POSIMIR," said Louis Pascarella, Chief Executive Officer of Innocoll.
    • Per the terms of the collaboration between Innocoll and DURECT, Innocoll will make a $2 million payment to DURECT triggered by the first commercial sale of POSIMIR.
    • Previously, in August 2022, DURECT was issued a new patent by the US Patent Office, extending US patent coverage of POSIMIR to at least 2041, resulting in an $8 million milestone payment by Innocoll to DURECT.
    • NOTE: POSIMIR is a trademark of Innocoll Pharmaceuticals Limited in the U.S. and a trademark of DURECT Corporation outside of the U.S. SABER is a trademark of DURECT Corporation.

    Horizon to Highlight Novel Insights in Gout Care During the American College of Rheumatology Convergence 2022

    Retrieved on: 
    Monday, September 19, 2022
    Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Adult, Rheumatology, Autoimmunity, Courage, RCT, Glucose-6-phosphate dehydrogenase deficiency, Pharmacokinetics, Anaphylaxis, Heart, Kidney, American College, DECT, Lightning, COVID-19, Twitter, Risk, Methemoglobinemia, Immunogenicity, Randomness, Vomiting, LinkedIn, Methotrexate, NSAID, Hypertension, Arthralgia, Hemolysis, History, Instagram, Gout, G6PD, Pain, Nasdaq, EST, Clinical trial, Heart failure, Science, Randomized controlled trial, Boxed warning, Serial, Inflammation, Horizon, Nausea, Fatigue, MIRROR, Colchicine, Pharmaceutical industry, Medical device, Medicine, Facebook, Patient

    Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.

    Key Points: 
    • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
    • Anaphylaxis may occur with any infusion, including a first infusion and generally manifests within 2 hours of the infusion.
    • Patients should be premedicated with antihistamines and corticosteroids and closely monitored for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
    • Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA.

    GIMOTI Receives Nomination for 2022 Healio Industry Breakthrough Award

    Retrieved on: 
    Wednesday, September 14, 2022
    Creatinine, Neuroleptic malignant syndrome, Kidney, Face, Hypertension, Catecholamine, Patient, Gastroenterology, NASDAQ, Metoclopramide, Absorption, Disease, Headache, Parkinsonism, Methemoglobinemia, Lists of diseases, NMS, Vomiting, CME, Treatment, History, Gastroparesis, Tardive dyskinesia, Internal bleeding, Physiology, Evoke, Depression, Stomach, TD, Seizure, Risk, FDA, Dysgeusia, United, News, Neoplasm, Water, Epilepsy, CEO, EPS, Liver, GLOBE, Fatigue, Suicide, Extrapyramidal symptoms, Suicidal ideation, Perforation, Pheochromocytoma, LinkedIn, Hypersensitivity, Facebook, Hyperprolactinaemia, CYP2D6, Bronchospasm, Pharmaceutical industry, Medicine, Aroma compound, Residential care, Generic drug, Industry

    SOLANA BEACH, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced that its flagship product, GIMOTI has been nominated for Healio’s Annual Disruptive Innovators Awards under the Healio Industry Breakthrough Award category. GIMOTI was selected amongst other novel gastroenterology products from major pharmaceutical companies.

    Key Points: 
    • The Disruptive Innovators Awards hosted by Healio is an annual event to celebrate the trailblazers, movers, and industry name-makers that are creating a revolution in gastroenterology.
    • "We are extremely honored to receive the nomination for GIMOTI as a Healio Disruptive Innovator.
    • We look forward to the Healio organization's unveiling of the award winners in each category and encourage all Evoke supporters to access the Healio survey and vote for GIMOTI."
    • Most common adverse reactions (5%) for GIMOTI are: dysgeusia, headache, and fatigue.These are not all of the possible side effects of GIMOTI.

    Evoke Pharma Regains Compliance with Nasdaq Listing Requirements and Provides Financial Update

    Retrieved on: 
    Wednesday, June 8, 2022
    Lists of diseases, Seizure, Company, Extrapyramidal symptoms, Perforation, Dysgeusia, Pheochromocytoma, Suicidal ideation, COVID-19, Gastroparesis, Physiology, History, TD, Bronchospasm, Tardive dyskinesia, Metoclopramide, Headache, MBA, Depression, CYP2D6, Methemoglobinemia, Hypertension, Epilepsy, Suicide, EPS, Stomach, Hypersensitivity, Neuroleptic malignant syndrome, Patient, Kidney, Compliance, Private Securities Litigation Reform Act, Catecholamine, Absorption, Parkinsonism, Water, Facebook, Creatinine, NMS, Neoplasm, Fatigue, LinkedIn, United, Hyperprolactinaemia, FDA, GLOBE, Risk, Evoke, NASDAQ, Internal bleeding, Liver, Pharmaceutical industry, Aroma compound, Residential care, Generic drug, Nasdaq

    As previously disclosed, in early May, the Company utilized its at-the-market program to raise proceeds of approximately $7.1 million, net of commissions and fees.

    Key Points: 
    • As previously disclosed, in early May, the Company utilized its at-the-market program to raise proceeds of approximately $7.1 million, net of commissions and fees.
    • Matt DOnofrio, MBA, Chief Business Officer of Evoke Pharma commented, We are pleased to regain compliance with the Nasdaq listing standards.
    • In conjunction, we are happy to announce that weve substantially bolstered our cash reserves and extended operational runway.
    • We believe the additional capital positions us to sustain and increase GIMOTI sales and to capitalize on future market opportunities.