Drug Safety

Arriello appoints experienced Pharmacovigilance expert, Sam Tomlinson as VP of Global Drug Safety

Retrieved on: 
Wednesday, March 15, 2023
EMA, ANSM, Health Canada, HPRA, EU, MHRA, FDA, Eli Lilly, QA, Drug Safety, Audit, PV, Regulatory affairs, Health authority, Pharmaceutical industry, Pharmacovigilance

DUBLIN, March 15, 2023 /PRNewswire-PRWeb/ -- Arriello, a leading provider of integrated Regulatory Affairs, Pharmacovigilance (PV) and Auditing & QA solutions and services, has appointed distinguished Pharmacovigilance professional Sam Tomlinson to the position of VP of Drug Safety, where she will develop and direct clinical and non-clinical PV services and solutions, and lead the company's expanding multi-national PV team.

Key Points: 
  • Sam has over 20 years strategic and operational experience in global PV in both large pharma and small to medium-sized pharma organizations.
  • Commenting on her appointment, Sam said: "Arriello leads the field in providing innovative drug safety services to clients worldwide, so this is a great opportunity for me to contribute to the future of drug safety practices.
  • Arriello CEO and co-founder Alan White added, "Everyone at Arriello is delighted to welcome Sam on board as VP of Global Drug Safety.
  • Her extensive experience in PV will help us provide more comprehensive safety services across the entire product lifecycle.

Newly Published Retrospective Analysis Showed Lower All-Cause Mortality Risk Among Parkinson’s Disease Psychosis Patients Treated with NUPLAZID® (pimavanserin) Compared to Those Treated with Other Atypical Antipsychotics

Retrieved on: 
Tuesday, January 3, 2023
Mental Health, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., ACAD, Psychosis, Acadia Pharmaceuticals, Risperidone, Clozapine, CI, Delusion, Death, PDP, Patient, Mortality, Medical Affairs Bureau, PS, Particle-size distribution, Physician, FDA, Hallucination, LTC, Observational study, Long-term care, Aripiprazole, Drug Safety, Senior, HR, SNF, Medicare, Pharmaceutical industry

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that the journal Drug Safety published results from a retrospective analysis finding a lower mortality risk in patients with Parkinson’s disease psychosis (PDP) treated with NUPLAZID® (pimavanserin) compared to other atypical antipsychotics over 12 months and across various subgroups.

Key Points: 
  • Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that the journal Drug Safety published results from a retrospective analysis finding a lower mortality risk in patients with Parkinson’s disease psychosis (PDP) treated with NUPLAZID® (pimavanserin) compared to other atypical antipsychotics over 12 months and across various subgroups.
  • NUPLAZID is the only medication approved by the U.S. FDA for the treatment of hallucinations and delusions associated with PDP.
  • “We were encouraged by this large, real-world study showing a lower mortality risk in patients with PDP after initiation of NUPLAZID, compared to other atypical antipsychotics.
  • After matching the two cohorts using propensity scores (PS), there were 2,891 patients in each of the NUPLAZID and comparator cohorts.

Shatterproof Applauds the Passage of the MATE Act to Expand Addiction Education

Retrieved on: 
Friday, December 23, 2022
Public Policy, Government, White House, Federal Government, Public Policy, General Health, Health, Mental Health, Healthcare Reform, Congressional News, Views, Well, Education, Doctor of Nursing Practice, Addiction, Mental health, Legislation, School, Pain, SUD, Substance-related disorder, American College, Health, Voices, Omnibus Appropriations Act, 2009, SMART Recovery, House, Drug Safety, Organization, Buprenorphine, National Council, Drug Enforcement Administration, Federation, National Safety Council, American Society of Addiction Medicine, Drug, Opioid use disorder, Research, MAT, Patient, Representative, Curriculum, Society, Oxford, OUD, Maintenance, Student, American College of Medical Toxicology, MATE, Congress, Suds, Louisiana House of Representatives, University, Addiction medicine, DEA, Speech disorder, Pharmaceutical industry, Medicine, The 39 Clues

Shatterproof applauds the passage of the Medication Access and Training Expansion (MATE) Act (H.R.

Key Points: 
  • Shatterproof applauds the passage of the Medication Access and Training Expansion (MATE) Act (H.R.
  • Passage of the MAT Act along with the MATE Act will enable better access to life-saving treatment.
  • The MATE Act mainstreams addiction medical education on SUDs across the nation’s medical educational programs.
  • Shatterproof worked closely with the American Society of Addiction Medicine on the passing of the MATE Act.

Symposium to Address Suicidality, Bridging Toxicology and Mental Health

Retrieved on: 
Friday, December 9, 2022
GiFT, Intersection, Symposium, Mental health, Physician, MPH, Psychology, American College of Medical Toxicology, Emergency medicine, Toxicology, San Diego Marriott Marquis & Marina, Death, American College, Poisoning, Forensic toxicology, Addiction medicine, Central nervous system, Ethics, Military medicine, Drug Safety, Symptoms of COVID-19, Risk, Public health, Patient, Medicine, Residential care, Pharmaceutical industry, Suicide, Psychiatry, MD

Phoenix, AZ, Dec. 09, 2022 (GLOBE NEWSWIRE) -- After a 2-year hiatus from in-person activities, The American College of Medical Toxicology (ACMT ) is pleased to present a full-day symposium exploring the intersection of medical toxicology and mental health.

Key Points: 
  • Phoenix, AZ, Dec. 09, 2022 (GLOBE NEWSWIRE) -- After a 2-year hiatus from in-person activities, The American College of Medical Toxicology (ACMT ) is pleased to present a full-day symposium exploring the intersection of medical toxicology and mental health.
  • The event, titled “ Self-Harm, Suicidality, and the Poisoned Patient: The Intersection of Toxicology and Mental Health ,” will take place on Thursday, March 30, 2023 at the San Diego Marriott La Jolla.
  • This program brings together distinguished experts in Medical Toxicology, Psychiatry, Emergency Medicine, Medical Ethics, Military Medicine, Addiction Medicine, Public Health and related fields.
  • The American College of Medical Toxicology (ACMT) is a professional, nonprofit association of physicians with recognized expertise and board certification in medical toxicology.

Arriello appoints distinguished regulatory expert, Pete Embley, as Chief Regulatory Officer

Retrieved on: 
Tuesday, November 29, 2022
MENA, GlaxoSmithKline, PV, Ranbaxy Laboratories, CIS, Knowledge, Grade (consulting), Regulatory affairs, Audit, Norton Healthcare, PPD, QA, Regulation, Drug Safety, ATMP, Advanced Therapy Medicinal Product, Risk management, Clinical trial, Commercialization, Safety, Medical device, Renewable energy, Pharmaceutical industry, LATAM, Pharmacovigilance, Central Europe, EU

DUBLIN, Nov.  29, 2022 /PRNewswire-PRWeb/ -- Arriello, a leading provider of integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has appointed respected regulatory expert Pete Embley as Chief Regulatory Officer, signalling the company's commitment to growing its pre-approval service line.

Key Points: 
  • DUBLIN, Nov. 29, 2022 /PRNewswire-PRWeb/ -- Arriello , a leading provider of integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has appointed respected regulatory expert Pete Embley as Chief Regulatory Officer, signalling the company's commitment to growing its pre-approval service line.
  • Pete, who joined Arriello in September and is based in Oxford in the UK, is the company's first Chief Regulatory Officer.
  • Accelerated pathways trigger an earlier and more intensive engagement with Regulatory agencies.
  • Pete has known Arriello since the company's inception, having previously worked with the co-founders Alan White and Anna Lukyanova.

Clinigen adds pharmacovigilance capabilities with acquisition of Drug Safety Navigator

Retrieved on: 
Tuesday, November 29, 2022
Drug Safety, PV, Acquisition, Pharmacovigilance, DSN, Safety, Risk management

Clinigen Limited (Clinigen or the Company), the global pharmaceutical services company, has agreed to acquire Drug Safety Navigator Inc. (DSN), a specialist pharmacovigilance service provider based in the US.

Key Points: 
  • Clinigen Limited (Clinigen or the Company), the global pharmaceutical services company, has agreed to acquire Drug Safety Navigator Inc. (DSN), a specialist pharmacovigilance service provider based in the US.
  • This acquisition enables Clinigen to add vital pharmacovigilance capabilities to its leading pharma services offering for pharmaceutical and biotech clients.
  • Drug Safety Navigator has built a formidable reputation providing pharmacovigilance services to its client base with whom it enjoys extremely strong relationships, and this acquisition provides an important entry into pharmacovigilance services which Clinigen hopes to build out further.
  • We are excited about having Drug Safety Navigator as part of the Clinigen family.

Healthy Blue and EVERFI Bring Critical Health and Wellness Education to Students Across Kansas Communities

Retrieved on: 
Thursday, October 13, 2022
News, LinkedIn, Fortune (magazine), Blue, SEC, Prevalence, Education, LLC, Drug Safety, NASDAQ, Health minister, School, Blue Cross, Instagram, Twitter, Mental health, APHC, Student, Blue Shield, Drinking, Curriculum, GSV, World, Health, BLKB, Awareness, Legal drinking age, Empathy, Risk, Medicine, Medicaid, Facebook, Blackbaud

WASHINGTON, Oct. 13, 2022 /PRNewswire/ -- Healthy Blue, a collaboration of Blue Cross and Blue Shield of Kansas, Blue Cross and Blue Shield of Kansas City (Blue KC) and Anthem Partnership Holding Company, along with EVERFI, a leading social impact education innovator, today announced the launch of an interactive, health and wellness initiative across select communities in Kansas.

Key Points: 
  • WASHINGTON, Oct. 13, 2022 /PRNewswire/ -- Healthy Blue, a collaboration of Blue Cross and Blue Shield of Kansas, Blue Cross and Blue Shield of Kansas City (Blue KC) and Anthem Partnership Holding Company, along with EVERFI, a leading social impact education innovator, today announced the launch of an interactive, health and wellness initiative across select communities in Kansas.
  • The curriculum, directed at middle and high school students, is made available at no cost to schools through Healthy Blue's relationship with EVERFI.
  • Since launching in May, Healthy Blue has already impacted over 1,600 students and nine schools.
  • Healthy Blue is a collaboration of Blue Cross and Blue Shield of Kansas, Blue Cross and Blue Shield of Kansas City (Blue KC) and Anthem Partnership Holding Company, LLC which was formed specifically to serve Medicaid enrollees.

Mythic Therapeutics Announces Appointment of Gilles Gallant, BPharm PhD FOPQ as Chief Development Officer

Retrieved on: 
Tuesday, August 23, 2022
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Mythic Therapeutics, a biotechnology company focused on the development of antibody-drug conjugate-based therapies for the treatment of a wide range of cancers, announced today the appointment of Gilles Gallant, BPharm, PhD, FOPQ, to the new position of Chief Development Officer.

Key Points: 
  • Mythic Therapeutics, a biotechnology company focused on the development of antibody-drug conjugate-based therapies for the treatment of a wide range of cancers, announced today the appointment of Gilles Gallant, BPharm, PhD, FOPQ, to the new position of Chief Development Officer.
  • The company also announced that Mythic co-founder and CEO Alex Nichols, PhD, has transitioned in order to pursue new opportunities.
  • View the full release here: https://www.businesswire.com/news/home/20220822005749/en/
    We are delighted to have Dr. Gallant join our team at Mythic, said Brian Fiske, PhD, Co-founder and Chief Scientific Officer.
  • As Chief Development Officer, Dr. Gallant is responsible for the strategy, direction, and execution of the companys clinical development program.

Brand Institute Executive, a Former FDA Team Leader, Celebrates 15 Years with Company's Subsidiary, Drug Safety Institute

Retrieved on: 
Thursday, June 23, 2022
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MIAMI, June 23, 2022 /PRNewswire/ -- Brand Institute , the global leader in pharmaceutical and healthcare-related name development, recently celebrated the 15-year anniversary of former FDA Team Leader, Dr. Nora Roselle, with Brand Institute/Drug Safety Institute.

Key Points: 
  • MIAMI, June 23, 2022 /PRNewswire/ -- Brand Institute , the global leader in pharmaceutical and healthcare-related name development, recently celebrated the 15-year anniversary of former FDA Team Leader, Dr. Nora Roselle, with Brand Institute/Drug Safety Institute.
  • Dr. Roselle joined Drug Safety Institute (DSI) as Managing Director of U.S. Regulatory Affairs in May 2007, and later as Vice President, Global Regulatory Affairs in 2012.
  • Dr. Roselle oversees all U.S. brand nomenclature safety assessments and FDA name submissions.
  • Drug Safety Institute (DSI) is a wholly owned subsidiary of Brand Institute that provides Brand Institute's healthcare clients with industry-leading guidance pertaining to drug name safety, packaging, and labeling.

Tremeau Receives May Proceed Notification From FDA For Phase III Program in Acute Migraine For TRM-201 (Rofecoxib)

Retrieved on: 
Tuesday, June 14, 2022
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Tremeau Pharmaceuticals today announced it has successfully opened an investigational new drug (IND) application and received a May Proceed Notification from FDA to expand the development program for TRM-201 (rofecoxib), an investigational non-opioid treatment, to include a Phase III program for acute migraine.

Key Points: 
  • Tremeau Pharmaceuticals today announced it has successfully opened an investigational new drug (IND) application and received a May Proceed Notification from FDA to expand the development program for TRM-201 (rofecoxib), an investigational non-opioid treatment, to include a Phase III program for acute migraine.
  • Previously marketed as VIOXX, rofecoxib is a cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile in multiple indications, including acute migraine.
  • Tremeau expects that the development program for TRM-201 will include one Phase III acute efficacy and safety study in migraine.
  • Tremeau is a Massachusetts-based pharmaceutical company focused on providing non-opioid pain treatments for well-defined patient populations with significant unmet needs.