Oklahoma Office of the Chief Medical Examiner

UCB announces U.S. FDA approval of ZILBRYSQ® (zilucoplan) for the treatment of adults with generalized myasthenia gravis

Retrieved on: 
Tuesday, October 17, 2023

It is the only once-daily gMG target therapy for self-administration by adult patients with anti-AChR antibody-positive gMG.

Key Points: 
  • It is the only once-daily gMG target therapy for self-administration by adult patients with anti-AChR antibody-positive gMG.
  • Patients were randomized in a 1:1 ratio to receive daily subcutaneous injections of 0.3 mg/kg ZILBRYSQ or placebo for 12 weeks.
  • The most common adverse reactions (≥10%) in patients with gMG were injection site reactions, upper respiratory tract infection, and diarrhea.
  • The primary endpoint for the RAISE study was change from baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score.

HealthBook+ Introduces Medical Advisory Board and its Mission to Optimize Personalization and Accuracy of its Digital Care Service

Retrieved on: 
Monday, October 2, 2023

DENVER, Colo., Oct. 2, 2023 /PRNewswire-PRWeb/ -- HealthBook+, the digital-first, AI-powered early identification and guidance platform that allows individuals to own their health, today introduced its Medical Advisory Board comprising specialist clinicians with deep experience of areas including: mental and behavioral health, pediatrics, concierge medicine, direct primary care, genetics, and healthcare-related AI issues. Although its existence and vital contribution has hitherto not been discussed publicly, the advisory board has been active since the creation of the company. It is tasked with providing advice to deliver a personalized digital care service to address the broadest set of health issues, while ensuring its guidance is of the highest accuracy.

Key Points: 
  • Although its existence and vital contribution has hitherto not been discussed publicly, the advisory board has been active since the creation of the company.
  • It is tasked with providing advice to deliver a personalized digital care service to address the broadest set of health issues, while ensuring its guidance is of the highest accuracy.
  • The Medical Advisory Board is led by Dr. Panos Sechopoulos, Co-Founder and Chief Medical Officer at HealthBook+, with the support of advisory board coordinator Dr. Arleen Chung.
  • Further experienced medical experts are being selected so that the advisory board can include multiple members with common specialties, and to increase the overall domain scope of the advisory board.

Parexel’s Amy McKee, M.D. Named to 2023 PharmaVoice 100

Retrieved on: 
Wednesday, September 20, 2023

During her tenure at Parexel she has been instrumental in providing patient-led medical and scientific expertise in support of the company’s therapeutic and regulatory strategies.

Key Points: 
  • During her tenure at Parexel she has been instrumental in providing patient-led medical and scientific expertise in support of the company’s therapeutic and regulatory strategies.
  • Since its inception in 2005, the PharmaVoice 100 highlights outstanding individuals across the industry who serve as sources of inspiration to their teams, companies and communities.
  • Each honoree of the PharmaVoice 100 has been nominated and selected based on substantive personal accounts describing how they have profoundly motivated and inspired their colleagues and peers in their respective fields.
  • To view the full list of PharmaVoice 100 honorees, click here .

Othram and Connecticut OCME Collaborate to Bring Answers to Long-Unsolved Cases through Advanced DNA Testing Technology

Retrieved on: 
Wednesday, August 9, 2023

THE WOODLANDS, Texas, Aug. 9, 2023 /PRNewswire-PRWeb/ -- Othram, the leading forensic sequencing laboratory for law enforcement, is proud to announce a collaboration with the Connecticut Office of the Chief Medical Examiner to leverage advanced DNA testing technology to solve human remains cases that have long remained unresolved.

Key Points: 
  • As part of this collaboration, DNASolves is being utilized to fund 16 unsolved cold cases handpicked by the Connecticut Office of the Chief Medical Examiner.
  • Forensic evidence is being processed at Othram's laboratory, the world's first private laboratory purpose-built for forensic genetic genealogy (FGG) and other advanced DNA testing applications.
  • The efforts of Othram and the Connecticut Office of the Chief Medical Examiner have already yielded significant results, with 4 cases already announced as solved.
  • With 4 cases already solved, each of the 12 remaining cases represents an opportunity to bring answers to families and communities.

Inspire Medical Systems, Inc. Announces the Addition of Charisse Y. Sparks, M.D. as Chief Medical Officer

Retrieved on: 
Monday, July 31, 2023

As Chief Medical Officer, Dr. Sparks will be a member of Inspire’s executive leadership team and will lead the Company’s medical and clinical affairs functions.

Key Points: 
  • As Chief Medical Officer, Dr. Sparks will be a member of Inspire’s executive leadership team and will lead the Company’s medical and clinical affairs functions.
  • Dr. Sparks will report to Tim Herbert, President and Chief Executive Officer of the Company.
  • “We are excited to add Dr. Sparks, a board-certified physician with extensive business and leadership experience, to our executive team,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems.
  • "Inspire has long-partnered with leading ear, nose, and throat surgeons, and sleep physicians, as part of our medical advisory boards.

Curium Receives Marketing Authorization in the EU for PYLCLARI™, an Innovative 18F-PSMA PET Tracer Indicated in Adults With Prostate Cancer

Retrieved on: 
Friday, July 28, 2023

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium, commented, “We are very pleased to receive marketing authorization in the EU for PYLCLARI™.

Key Points: 
  • Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium, commented, “We are very pleased to receive marketing authorization in the EU for PYLCLARI™.
  • The successful clinical development and granted marketing authorization of PYLCLARI™ in the EU confirms our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine.
  • When in full production, PYLCLARI™ will be the most widely available 18F-PSMA tracer in Europe.
  • In the U.S., Lantheus received approval for [18F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021.

Arbutus Appoints Two New Executives

Retrieved on: 
Monday, July 10, 2023

WARMINSTER, Pa., July 10, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced the appointment of Dr. Karen Sims as Chief Medical Officer and Mr. Christopher Naftzger as General Counsel and Chief Compliance Officer. Mr. Naftzger succeeds Dr. Elizabeth Howard who will continue in an advisory role with respect to the on-going patent infringement litigations. Both Dr. Sims and Mr. Naftzger will report directly to William Collier, Arbutus President and Chief Executive Officer, effective immediately.

Key Points: 
  • Both Dr. Sims and Mr. Naftzger will report directly to William Collier, Arbutus President and Chief Executive Officer, effective immediately.
  • “Karen has played an integral role in the clinical development of AB-729, our lead RNAi therapeutic, during her six-year tenure at Arbutus, and has continued to advance our pipeline of HBV programs.
  • Prior to joining Arbutus, Dr. Sims held multiple positions during her seven-year tenure at Bristol-Myers Squibb (NYSE: BMY).
  • Christopher Naftzger joins Arbutus with more than 25 years of legal experience, including over a decade of experience serving as senior in-house counsel with life science companies.

SunCloud Health to Open Comprehensive Mental Health Outpatient Center in Gaithersburg

Retrieved on: 
Wednesday, July 5, 2023

GAITHERSBURG, Md., July 5, 2023 /PRNewswire/ -- SunCloud Health, a national leader in comprehensive mental health care for individuals with co-occurring disorders, is set to open an outpatient center in Gaithersburg this summer.

Key Points: 
  • GAITHERSBURG, Md., July 5, 2023 /PRNewswire/ -- SunCloud Health, a national leader in comprehensive mental health care for individuals with co-occurring disorders, is set to open an outpatient center in Gaithersburg this summer.
  • The new center will offer a range of services, including a partial hospitalization program (PHP), an intensive outpatient program (IOP), and outpatient therapy.
  • The center treats adults of all genders with co-occurring mood disorders, eating disorders, addiction, and trauma.
  • The new Gaithersburg center will facilitate PHP with 7 hours of programming, 5 days a week, and IOP with 3.5 hours of programming, 5 days a week.

World-Leading Real World Data Registry, TARGET-NASH, Surpasses 7,000+ Enrolled Patients and 500,000+ Months of Patient Follow-Up

Retrieved on: 
Wednesday, June 21, 2023

DURHAM, N.C., June 21, 2023 /PRNewswire/ -- Real world evidence (RWE) leader, Target RWE, today shared updates from its nonalcoholic steatohepatitis (NASH) longitudinal registry of more than 7,000 enrolled patients, representing more than 500,000 patient months of follow up, making TARGET-NASH the most mature dataset following patients with nonalcoholic fatty liver disease (NAFLD) and NASH in the world. Target RWE will be presenting new data from its TARGET-NASH and TARGET-HCC cohorts at the annual EASL Congress in Vienna, Austria June 21-24th, including disease progression and results from a post-authorization safety study.

Key Points: 
  • Estimating fibrosis progression in patients with NAFLD/NASH is essential for understanding the comprehensive burden of disease, risk of future liver-related morbidity and to inform future clinical trial designs.
  • Progression outcomes included all-cause mortality, progression from non-cirrhosis to cirrhosis and from compensated to decompensated cirrhosis, and liver-related and cardiovascular events.
  • "Identifying patient profiles in the real world who may benefit from these novel treatments will be critical.
  • Real world evidence from the TARGET-NASH cohort has been presented and published in numerous peer-reviewed journals and major academic conferences.

JOANN Announces Retirement of President and CEO Wade Miquelon

Retrieved on: 
Tuesday, May 9, 2023

HUDSON, Ohio, May 09, 2023 (GLOBE NEWSWIRE) -- JOANN Inc. (NASDAQ: JOAN) (“JOANN”), the nation’s category leader in sewing and fabrics with one of the largest arts and crafts offerings, announced the retirement of Wade Miquelon as President and Chief Executive Officer effective May 8, 2023.

Key Points: 
  • HUDSON, Ohio, May 09, 2023 (GLOBE NEWSWIRE) -- JOANN Inc. (NASDAQ: JOAN) (“JOANN”), the nation’s category leader in sewing and fabrics with one of the largest arts and crafts offerings, announced the retirement of Wade Miquelon as President and Chief Executive Officer effective May 8, 2023.
  • Chris DiTullio, Executive Vice President and Chief Customer Officer, and Scott Sekella, Executive Vice President and Chief Financial Officer, have been appointed to lead the interim Office of the Chief Executive Officer, and the Board has commenced a search to identify a permanent replacement.
  • Prior to joining JOANN in 2005, Mr. DiTullio held roles in operations and inventory management with JC Penney, Homeplace, Inc., and Cole Vision.
  • For more information on the JOANN Management team and Board of Directors, visit investors.joann.com