Drug Safety

CorMedix Inc. Announces Leadership Updates and Operational Changes

Retrieved on: 
Thursday, May 12, 2022
Quotient, Senior, Cancer, Medical Affairs Bureau, Company, QIDP, Impax, Private Securities Litigation Reform Act, VP, Nasdaq, Teva Pharmaceuticals, New Drug Application, Patient, Supply chain, Goal, Endpoint security, Drug Safety, CE, New chemical entity, Amneal Pharmaceuticals, Marketing, Trial of the century, Research, FDA, EVP, Mark (given name), NDA, CMO, Fast Track, SEC, CEO, GLOBE, Pharmaceutical industry, Management, Medical device, Coronavirus, Pharmacovigilance, Pfizer, Catheter lock solution

Donna joins CorMedix after most recently serving as VP Global Quality Management at Amneal Pharmaceuticals, and with more than 20 years Quality leadership experience in previous roles at Impax, Allergan, and Pfizer.

Key Points: 
  • Donna joins CorMedix after most recently serving as VP Global Quality Management at Amneal Pharmaceuticals, and with more than 20 years Quality leadership experience in previous roles at Impax, Allergan, and Pfizer.
  • I am excited to begin my tenure this week at CorMedix, said Joe Todisco, CorMedix CEO.
  • CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements.
  • CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

AstaLynx Global Signs Multi-Year Contract with Biopharmaceutical for Drug Safety Technology Adoption and Implementation

Retrieved on: 
Tuesday, May 3, 2022
Industry, Compliance, List of life sciences, Solution, Drug Safety, Technology, CEO, Risk management, Efficiency, Fine chemical

NEW YORK, May 3, 2022 /PRNewswire/ -- AstaLynx Global today announced the agreement with a midsize biopharmaceutical company to centralize their mission critical Pharmacovigilance activities.

Key Points: 
  • NEW YORK, May 3, 2022 /PRNewswire/ -- AstaLynx Global today announced the agreement with a midsize biopharmaceutical company to centralize their mission critical Pharmacovigilance activities.
  • The biopharmaceutical will adopt and implement the full suite of AstaLynx's proprietary Drug Safety system, ADRium, into their core business processes.
  • "The selection of the ADRium suite validates the approach that the AstaLynx team takes towards providing intelligent solutions to our clients.
  • In addition to offering Drug Safety technology via the ADRium suite, AstaLynx provides end to end Pharmacovigilance services including case processing, aggregate reporting, signal detection and risk management, executed by their expert team of medical reviewers, safety scientists, and drug safety professionals.

Kenneth D. Katz, MD, FACMT, FAAEM, FACEP is recognized by Continental Who's Who

Retrieved on: 
Friday, April 22, 2022
Well, American Board of Internal Medicine, American College of Medical Toxicology, American Board of Commissioners for Foreign Missions, GiFT, American Academy of Emergency Medicine, Internal, Medicine, American Board of Emergency Medicine, ABEM, Stony Brook University, Association, Drug Safety, MD, Yale University, Medical degree, Internal medicine, Continental, Patient, Loving Memory, Speech disorder, Student, Attending physician, ABIM, Drug, Journal, American College, Parent, Critical care, 2021 Essex County Council election, Medical specialty, Emergency medicine, American Academy, Physician, Multimedia, Fellow of the American College of Emergency Physicians, FACEP, American Board of Medical Specialties, Clinical Toxicology, Biology

Kenneth D. Katz, MD, FACMT, FAAEM, FACEP, is a Medical Toxicology Specialist with experience in treating medical emergencies, overdoses, and substance use disorders.

Key Points: 
  • Kenneth D. Katz, MD, FACMT, FAAEM, FACEP, is a Medical Toxicology Specialist with experience in treating medical emergencies, overdoses, and substance use disorders.
  • With more than 25 years of medical experience, Dr. Katz practices at Lehigh Valley Physician Group, one of the largest medical groups in the United States.
  • With over 160 clinics nationwide, the group includes more than 1,000 physicians and 600 advanced practice specialists.
  • In his spare time, Dr. Katz enjoys spending time with his wife of 17 years, Mrs. Kristina Katz, and their son, Ethan.

X Waiver Mini-Course Expands Emergency Clinician Recognition and Treatment of Opioid Withdrawal, Study Finds

Retrieved on: 
Wednesday, April 13, 2022
Confusion, American College of Medical Toxicology, Pharmacology, IBC, Families Empowered and Supporting Treatment of Eating Disorders (F.E.A.S.T.), MTF, Perelman School of Medicine at the University of Pennsylvania, Research, Drug Safety, Opioid use disorder, Center, OUD, JMT, GLOBE, Education, Policy, Patient, Addiction medicine, Emergency medicine, Physiology, Principal, Independence Blue Cross Foundation, Journal of Medical Toxicology, Journal, American College, University, EM, Independence Blue Cross, Physician, Certification, STOP, Association, Knowledge, Medicine, Pharmaceutical industry, Buprenorphine

Buprenorphine is one of three evidence-based treatments for opioid use disorder and can be initiated by any clinician for the treatment of opioid withdrawal.

Key Points: 
  • Buprenorphine is one of three evidence-based treatments for opioid use disorder and can be initiated by any clinician for the treatment of opioid withdrawal.
  • Despite the evidence in support of the use of buprenorphine in the treatment of Opioid Use Disorder (OUD), emergency department (ED)-initiated buprenorphine is still uncommon.
  • Many emergency medicine (EM) clinicians lack training on how to manage acute opioid withdrawal or initiate treatment with buprenorphine.
  • This change potentially allows every emergency clinician to be capable of initiating treatment for patients experiencing withdrawal.

Dragonfly Therapeutics Expands Clinical Leadership Team, Appointing Dr. Hesham Aboshady as Head of Safety & Pharmacovigilance and Rajesh Israni as Head of Regulatory Affairs

Retrieved on: 
Wednesday, March 30, 2022
Drug development, Therapy, Internal medicine, Genomics, Leadership, Risk management, Information system, Public, Multimedia, Stevens Institute of Technology, Head, MPH, Associate, Dragonfly, Medical school, AbbVie, CEO, Public health, Assistant, Regeneron Pharmaceuticals, MD, View, Boehringer Ingelheim, Technology, University, University of Massachusetts Medical School, Twitter, Drug Safety, Nivolumab, Bristol Myers Squibb, Rutgers University, Patient, Degree, Merck, Ipilimumab, Cairo University, Pharmaceutical industry, Medicine, Biotechnology, Sanofi

WALTHAM, Mass., March 30, 2022 /PRNewswire/ -- Dragonfly Therapeutics, Inc. ("Dragonfly" or the "Company"), today announced it has expanded its Clinical Leadership Team with the addition of Dr. Hesham Aboshady, an experienced clinician as Head of Drug Safety, and Rajesh Israni as Head of Regulatory.

Key Points: 
  • Hesham Aboshady MD, MPH brings 10+ years of drug safety experience to and Rajesh Israni brings 20+ years of regulatory experience, to Dragonfly Therapeutics.
  • WALTHAM, Mass., March 30, 2022 /PRNewswire/ --Dragonfly Therapeutics, Inc. ("Dragonfly" or the "Company"), today announced it has expanded its Clinical Leadership Team with the addition of Dr. Hesham Aboshady, an experienced clinician as Head of Drug Safety, and Rajesh Israni as Head of Regulatory.
  • "We are delighted that Hesham and Rajesh have joined Dragonfly," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics.
  • Hesham Aboshady, M.D., MPH is a pharmacovigilance leader with broad expertise in clinical development of immuno-oncology, oncology and immunology therapeutic agents.

OPTX Looks to Bright Future with Steve Bright

Retrieved on: 
Tuesday, March 29, 2022
University, Video game industry, Pointer, Machine learning, Chicago (franchise), Multimedia, Data, View, Artificial intelligence, Technology, Drug Safety, Georgia Institute of Technology School of Computational Science & Engineering, Data science, Algorithm, Casino, Medical device, Physics, Pharmacovigilance

Bright will lead OPTX's Data Science team, which designs, develops, tests, and monitors new AI features.

Key Points: 
  • Bright will lead OPTX's Data Science team, which designs, develops, tests, and monitors new AI features.
  • Bright will lead OPTX's Data Science team, which designs, develops, tests, and monitors new Artificial Intelligence (AI) features for OPTX's data modules.
  • Prior to joining OPTX, Steve Bright worked as a Data Scientist in many different industries, and has over 30 published papers in fields running from Experimental High Energy Physics to Pharmacovigilance (Drug Safety).
  • Bright's published works may be found at: https://orcid.org/0000-0001-9250-3729
    For more information about OPTX or to schedule a demo, go to www.OPTX.com .

Avenue Therapeutics Announces Outcome of FDA Advisory Committee Meeting on IV Tramadol

Retrieved on: 
Wednesday, February 16, 2022
NASDAQ, Patient, Food, Anesthetic, Advisory Committee, OND, Applicant (sketch), Calendar, SEC, Regulation, Forward-looking statement, Drug Quality and Security Act, Private Securities Litigation Reform Act, Tramadol, Risk management, Tobacco Products Scientific Advisory Committee, Securities Exchange Act of 1934, Regulation of tobacco by the U.S. Food and Drug Administration, Securities Act of 1933, Therapy, FDA, Patent, Drug Safety, Pain, Research, COVID-19, GLOBE, Pharmaceutical industry

NEW YORK, Feb. 15, 2022 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced the outcome of the U.S. Food and Drug Administration (FDA) joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol.

Key Points: 
  • NEW YORK, Feb. 15, 2022 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced the outcome of the U.S. Food and Drug Administration (FDA) joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol.
  • FDA Advisory Committees provide the FDA with independent advice and non-binding recommendations.
  • The FDA has previously stated that input from an Advisory Committee is needed for the Office of New Drugs (OND) to reach a decision on Avenues formal dispute resolution request (FDRR) and that the OND will respond to Avenues FDRR within 30 calendar days after the Advisory Committee meeting.
  • Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City.

Avenue Therapeutics Stock Trading Halted Today

Retrieved on: 
Tuesday, February 15, 2022
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NEW YORK, Feb. 15, 2022 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that NASDAQ has halted trading of the Companys common stock.

Key Points: 
  • NEW YORK, Feb. 15, 2022 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that NASDAQ has halted trading of the Companys common stock.
  • The Advisory Committee meeting is scheduled for Tuesday, February 15, 2022, from 9:30 a.m. to 5:00 p.m.
  • Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City.
  • Forward-looking statements are based on managements current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value.

"Substance Use, Pregnancy, and Baby" Symposium Draws on Expertise of Medical, Social Science Professionals

Retrieved on: 
Monday, February 7, 2022
Prenatal development, GLOBE, Drug Safety, Obstetrics, Department, Emergency medicine, Symposium, Family, CPNP, Methamphetamine, University of Texas Southwestern Medical Center, Division, University of Louisville School of Medicine, Doctor of Philosophy, Pediatrics, State, Parkland Health & Hospital System, DO, APRN, American College, MHA, Pregnancy, IBCLC, MD, University, Assistant professor, Medical director, RN, Cannabis, FAAN, Addiction medicine, Physician, Association, Counselor, Child protective services, Hospital, Child, Education, Associate professor, Medicine

Phoenix, AZ, Feb. 07, 2022 (GLOBE NEWSWIRE) -- This one-day symposium draws on the expertise of professionals from multiple medical and social science fields to address drug/medication-related issues and psychosocial issues faced by pregnant women who have substance use disorders.

Key Points: 
  • Phoenix, AZ, Feb. 07, 2022 (GLOBE NEWSWIRE) -- This one-day symposium draws on the expertise of professionals from multiple medical and social science fields to address drug/medication-related issues and psychosocial issues faced by pregnant women who have substance use disorders.
  • The focus of this symposium presents a unique opportunity to bring together medical and social science wordls to offer a timely and pertinent education opportunity for professionals from both spheres.
  • Topics will include drug testing approaches and implications, and the impact of drug testing upon child protective services decision-making.
  • ACMT members work in clinical, academic, governmental, and public health settings, and provide poison control center leadership.

CADTH Establishes New Post-Market Drug Evaluation Program

Retrieved on: 
Friday, February 4, 2022
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OTTAWA, ON, Feb. 4, 2022 /CNW/ -CADTH is pleased to announce it is expanding its expertise in the management of pharmaceuticals in Canada with the creation of a new Post-Market Drug Evaluation (PMDE) Program.

Key Points: 
  • OTTAWA, ON, Feb. 4, 2022 /CNW/ -CADTH is pleased to announce it is expanding its expertise in the management of pharmaceuticals in Canada with the creation of a new Post-Market Drug Evaluation (PMDE) Program.
  • The PMDE Program will be responsible for launching and coordinating a network that leverages Canadian expertise in applied drug research, methodology, and data analysis.
  • "The creation of the Post-Market Drug Evaluation Program means decision-makers can turn to CADTH for advice across the life cycle of a drug, starting before a drug is approved through to its use in the real world," said CADTH President and Chief Executive Officer Suzanne McGurn.
  • On February 8, 2022 CADTH will host an information session to provide researchers and other stakeholders with details about the PMDE Program.