Drug Safety

American College of Medical Toxicology Presents 2022 Virtual Annual Scientific Meeting & Symposium

Retrieved on: 
Tuesday, January 25, 2022
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ACMT's 2022 Annual Scientific Meeting will feature 40 presentations of original research: 8 platforms, 7 lightning orals, 25 moderated posters, in addition to 130+ posters in our interactive e-Gallery.

Key Points: 
  • ACMT's 2022 Annual Scientific Meeting will feature 40 presentations of original research: 8 platforms, 7 lightning orals, 25 moderated posters, in addition to 130+ posters in our interactive e-Gallery.
  • This 3-day event provides an opportunity for specialists in the field of medical toxicology, addiction medicine, emergency medicine, and more to connect, network, and learn from the cutting-edge research of their peers.
  • Because this event is virtual, registrants may enjoy the flexibility of participating live or accessing presentations later on-demand at their convenience.
  • About ACMT The American College of Medical Toxicology (ACMT) is a professional, nonprofit association of physicians with recognized expertise and board certification in medical toxicology.

Arriello Welcomes High-Profile Pharmacovigilance leader Kieran O'Donnell as VP of Global Drug Safety

Retrieved on: 
Wednesday, January 5, 2022
Drug Safety, Growth, Cros, Grade (consulting), Consultant, Regulatory affairs, MENA, PV, Navitas, Qualified person (European Union), Compliance, Senior Consultant, Legislation, QA, Technology, RQA, Solution, Postgraduate diploma, Risk management, VP, GVP, CIS, Medical device, Renewable energy, Fine chemical, Audit, Pharmacovigilance, EU, LATAM

DUBLIN, Jan. 5, 2022 /PRNewswire-PRWeb/ -- Arriello , Consultancy and provider of Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has appointed leading Pharmacovigilance expert Kieran O'Donnell as VP of Global Drug Safety.

Key Points: 
  • DUBLIN, Jan. 5, 2022 /PRNewswire-PRWeb/ -- Arriello , Consultancy and provider of Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has appointed leading Pharmacovigilance expert Kieran O'Donnell as VP of Global Drug Safety.
  • The strategic appointment comes as Arriello continues to experience soaring international demand for support with intensifying international Pharmacovigilance (PV) and Safety workloads.
  • Kieran has also held PV roles at Shire and i3 Drug Safety, during which time he honed his interest in Pharmacovigilance systems and quality.
  • On taking this new role at Arriello, Kieran said: "Arriello has huge global potential and that's what really excites me.

FDAnews Announces Pharmaceutical Naming Regulation: Understanding the Latest Developments Webinar Jan. 11, 2022

Retrieved on: 
Friday, December 31, 2021
Name, Approximation error, Confusion, Drug Safety, Doctor of Pharmacy, Create, FDA, Medical device

The FDA's recently released naming guidance has several key additions and changes one must understand when developing names.

Key Points: 
  • The FDA's recently released naming guidance has several key additions and changes one must understand when developing names.
  • Failure to follow the guidelines could create confusion and lead to medication errors.
  • Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding, is an international leader in preventing medication errors due to brand name confusion.
  • During this webinar she'll share:
    Create new drug names that won't cause confusion.

Overland Pharmaceuticals Partners with ArisGlobal to Accelerate Safety Capabilities

Retrieved on: 
Tuesday, December 7, 2021
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"With LifeSphere Multivigilance, Overland will realize efficiency gains and obtain real-time insights into risk-benefit profiles across the product life cycle."

Key Points: 
  • "With LifeSphere Multivigilance, Overland will realize efficiency gains and obtain real-time insights into risk-benefit profiles across the product life cycle."
  • "Our goals are to build innovation for patients, achieve flexibility with business partners, and develop program efficiency by centralizing key operations.
  • Another key area that sparked alignment across ArisGlobal and Overland includesshared values of global collaboration, agility, and integrity.
  • Through formative partnerships, Overland will move forward the development and commercialization of the most promising advances in medicine.

Avenue Therapeutics Announces FDA Advisory Committee Meeting to Review IV Tramadol NDA Tentatively Scheduled for February 15, 2022

Retrieved on: 
Monday, November 29, 2021
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NEW YORK, Nov. 29, 2021 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue or the Company), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that the FDA has informed the Company that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee is tentatively scheduled for February 15, 2022.

Key Points: 
  • NEW YORK, Nov. 29, 2021 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue or the Company), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that the FDA has informed the Company that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee is tentatively scheduled for February 15, 2022.
  • The committees will discuss the IV tramadol New Drug Application.
  • 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 and that the OND will respond to Avenues appeal 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 Receives Interim Response to its Formal Dispute Resolution Request from U.S. Food and Drug Administration Office of New Drugs

Retrieved on: 
Monday, October 25, 2021
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The letter indicated that the OND needs additional input from an Advisory Committee in order to reach a decision on the Formal Dispute Resolution Request (FDRR), the details of which have previously been disclosed.

Key Points: 
  • The letter indicated that the OND needs additional input from an Advisory Committee in order to reach a decision on the Formal Dispute Resolution Request (FDRR), the details of which have previously been disclosed.
  • Accordingly, the FDA will convene an Advisory Committee meeting and seek advice from the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
  • The letter stated that the OND will respond to the FDRR within 30 calendar days after the Advisory Committee meeting.
  • Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates.

Spero Health Opens Addiction Treatment Clinic in Columbus to Bring Life-Saving Care

Retrieved on: 
Wednesday, October 20, 2021
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Spero Health, a national leader who has helped more than 25,000 patients on their journey to stable recovery from addiction, announced today it will open a new clinic in Columbus, OH.

Key Points: 
  • Spero Health, a national leader who has helped more than 25,000 patients on their journey to stable recovery from addiction, announced today it will open a new clinic in Columbus, OH.
  • Individuals who need addiction treatment services are encouraged to walk-in for help or call: 614-363-4489 for more information or to schedule an immediate appointment.
  • Dr. Hannah Hays, board-certified in Emergency Medicine and Medical Toxicology, board-eligible in Addiction Medicine, and holds academic appointments in various professional organizations, will be the lead physician at the Columbus Spero Health clinic.
  • Spero Health is changing the landscape of addiction treatment by providing high-quality, innovative care close to home for patients suffering from substance use disorders.

Quality deemed more critical than price as companies progress with PV case intake automation, 2021 Arriello UK/US survey finds

Retrieved on: 
Wednesday, October 6, 2021
Adoption, Compliance, Solution, Congress, Pharmacovigilance, October, CIS, PSMF, MENA, Fear, Risk management, COVID-19, Drug Safety, Technology, Automation, Organization, Literature, AE, Medical device, Renewable energy, Agriculture

To delve deeper, this year's survey asked about companies' drivers for investing in PV automation.

Key Points: 
  • To delve deeper, this year's survey asked about companies' drivers for investing in PV automation.
  • Across the research base these emerged as quality (cited by 71 per cent) and speed (mentioned by 67 per cent).
  • The full 2021 survey findings are available to download from the Arriello web site here .
  • These services include market consultancy, global regulatory affairs strategy and implementation, full and local pharmacovigilance solutions, clinical drug safety and quality and compliance auditing systems.

Alector Provides Executive Leadership Update

Retrieved on: 
Tuesday, September 7, 2021

SOUTH SAN FRANCISCO, California, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that Shehnaaz Suliman, M.D., MBA, M.Phil., and Robert Paul, M.D., Ph.D., will be stepping down from their respective roles as President and Chief Operating Officer and Chief Medical Officer. Each will continue to serve for a transition period and plan to remain available as advisors until the end of 2021. Sam Jackson, M.D., MBA, Senior Vice President, Clinical Sciences, will assume the role of interim Chief Medical Officer. Dr. Jackson is an established leader with more than 15 years of experience leading clinical development functions. He joined Alector in 2020 and among his primary responsibilities is the development of AL001, which is currently in Phase 3 clinical testing for the treatment of frontotemporal dementia.  

Key Points: 
  • On behalf of the Alector team and board, we are grateful for their leadership and I am confident that they will excel in their future endeavors, said Arnon Rosenthal, Ph.D., Alectors co-founder and Chief Executive Officer.
  • Dr. Suliman joined Alector in 2019 and provided strategic and operational leadership while overseeing the companys early development, portfolio, business development, finance, investor relations, legal and administrative functions.
  • These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alectors forward-looking statements.
  • Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Illicit Benzodiazepine Overdose Trends Detected by Toxicology Investigators Consortium (ToxIC)

Retrieved on: 
Thursday, September 2, 2021
Anxiety, DO, Disease, Morbidity and Mortality Weekly Report, Icahn School of Medicine at Mount Sinai, South Carolina Opioid Overdose Prevention Bill, District, Naloxone, Death, MMWR, American College of Medical Toxicology, Physician, Association, Seizure, American College, Toxicity, Benzodiazepine, Drug Safety, GLOBE, Drug, Pharmaceutical industry

This publication presents a detailed evaluation of 21 suspected opioid overdoses in which illicit benzodiazepines were detected.

Key Points: 
  • This publication presents a detailed evaluation of 21 suspected opioid overdoses in which illicit benzodiazepines were detected.
  • Concurrent exposure to both illicit benzodiazepines and opioids may increase overdose risk and/or make treatment for opioid overdose increasingly difficult.
  • The 5-year study, entitled"Predicting Medical Consequences of Novel Fentanyl Analog Overdose Using theToxicology Investigators Consortium (ToxIC), includes 9 geographically diverse ToxIC sites around the country.
  • The American College of Medical Toxicology (ACMT) is a professional, nonprofit association of physicians with recognized expertise and board certification in medical toxicology.