Observation

Greenwich LifeSciences Partners with GEICAM in Spain & Conducts First Site Initiation Visits in Europe

Retrieved on: 
Tuesday, March 12, 2024

The Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01.

Key Points: 
  • The Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01.
  • These sites were recently approved by Spanish authorities, which led to site initiation visits and training of the first sites this past week.
  • Founded in 1995, GEICAM is a not-for-profit organization leading academic breast cancer research in Spain.
  • Breast cancer is the leading cause of death in women between the ages 35-45 in Spain with 6,836 deaths in 2022.

TELUS International Announces Fuel iX Beta Program, an Enterprise-Grade AI Engine For Bringing Generative AI to Production

Retrieved on: 
Tuesday, April 2, 2024

TELUS International (NYSE and TSX: TIXT), today announced a beta release of Fuel iX, an enterprise-grade AI engine designed to help companies upgrade their generative AI (GenAI) pilots to production scale, deploy customized solutions faster, and effectively manage the technology responsibly.

Key Points: 
  • TELUS International (NYSE and TSX: TIXT), today announced a beta release of Fuel iX, an enterprise-grade AI engine designed to help companies upgrade their generative AI (GenAI) pilots to production scale, deploy customized solutions faster, and effectively manage the technology responsibly.
  • View the full release here: https://www.businesswire.com/news/home/20240402990218/en/
    “Fuel iX was created to provide enterprises with generative AI flexibility, control, productivity, and trust.
  • “TELUS has generative AI solutions in production supporting more than 30,000 users, several pilots and more than 30 new application requests.
  • To learn more about Fuel iX and the company’s suite of AI offerings, visit telusinternational.com/ .

Guess?, Inc. Announces Issuance of Approximately $12.1 Million of Additional 3.75% Convertible Notes Due 2028 and Retirement of Approximately $14.6 Million of Existing 2.00% Convertible Notes Due 2024

Retrieved on: 
Monday, April 1, 2024

Pursuant to the Exchange and Subscription Agreement, the Company will exchange approximately $14.6 million in aggregate principal amount of the 2024 Notes for approximately $12.1 million in aggregate principal amount of additional 3.75% convertible senior notes due 2028 (the “2028 Notes”) (collectively, the “Transactions”).

Key Points: 
  • Pursuant to the Exchange and Subscription Agreement, the Company will exchange approximately $14.6 million in aggregate principal amount of the 2024 Notes for approximately $12.1 million in aggregate principal amount of additional 3.75% convertible senior notes due 2028 (the “2028 Notes”) (collectively, the “Transactions”).
  • The 2028 Notes will have the same CUSIP number as the Existing 2028 Notes and will be issued as additional notes under the indenture governing the Existing 2028 Notes.
  • The 2028 Notes are expected to trade interchangeably with the Existing 2028 Notes immediately upon settlement and be fungible with the Existing 2028 Notes.
  • The 2028 Notes will mature on April 15, 2028, unless earlier repurchased or converted in accordance with their terms.

HealthStream Survey Discovers Underutilized Opportunity to Recruit Nurses: Student Nurse Rotations

Retrieved on: 
Thursday, March 28, 2024

The “voice of the nursing student” with regard to clinical rotations and recruiting is of much interest to nursing schools and healthcare providers alike.

Key Points: 
  • The “voice of the nursing student” with regard to clinical rotations and recruiting is of much interest to nursing schools and healthcare providers alike.
  • Specifically, the completion of clinical rotations is a critical component in student nurses’ education and preparation for their nursing careers.
  • Students’ voluntary survey responses provided a distinct opportunity to hear their perspectives about clinical rotations, their thoughts about post-graduation job offers, and recruiting—or lack thereof.
  • The results of HealthStream’s survey suggest that there may be ample opportunities for recruitment of student nurses in conjunction with their clinical rotations.

Sol-Millennium Responds to FDA’s Warning Letter and Safety Communication

Retrieved on: 
Thursday, March 21, 2024

Sol-Millennium, manufacturer of medical devices, including syringes for medicine delivery and testing, issued a statement regarding March 19th update to the FDA’s Safety Communication (“Evaluating Plastic Syringes Made in China for Potential Device Failures”) and a Warning Letter to Sol-Millennium.

Key Points: 
  • Sol-Millennium, manufacturer of medical devices, including syringes for medicine delivery and testing, issued a statement regarding March 19th update to the FDA’s Safety Communication (“Evaluating Plastic Syringes Made in China for Potential Device Failures”) and a Warning Letter to Sol-Millennium.
  • Since November 2023, Sol-Millennium has been providing reports of actions it has taken to address any findings identified in the Warning Letter.
  • The principal focus of the Warning Letter is on our 510(k) and whether our “combination” products (needle + syringe attached) constitute a significant change or modification in design that could significantly alter the safety and effectiveness of the devices.
  • These are the two manufacturers cited in the FDA’s Safety Communication Letter that the FDA recommends to “Immediately transition away from using plastic syringes manufactured” by these manufactures… “[because of] potential quality and performance issues”.

Collette Health Appoints Christine Gall as Chief Nursing Officer

Retrieved on: 
Tuesday, March 19, 2024

Collette Health , a leading provider of virtual patient observation solutions, is pleased to announce the appointment of healthcare visionary Christine Gall DrPH, MS, BSN, as chief nursing officer.

Key Points: 
  • Collette Health , a leading provider of virtual patient observation solutions, is pleased to announce the appointment of healthcare visionary Christine Gall DrPH, MS, BSN, as chief nursing officer.
  • View the full release here: https://www.businesswire.com/news/home/20240319551571/en/
    Collette Health appoints Christine Gall DrPH, MS, BSN as chief nursing officer.
  • (Photo: Business Wire)
    Gall brings three decades of experience and a wealth of knowledge in Patient Safety and Engagement, Quality, and Public Health Leadership.
  • “I’m thrilled to be joining Collette Health at such a pivotal time as we see the role of clinicians evolve and new technology transform the healthcare industry,” said Gall.

Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer

Retrieved on: 
Monday, March 18, 2024

The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.

Key Points: 
  • The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery.
  • Patients who are Signatera MRD-positive will be randomized to receive ACT (FOLFOX 6m) or pursue observation (no chemotherapy).
  • While the Japanese and U.S. trials evaluate the benefit of MRD-guided treatment in stage III and high-risk stage II CRC patients, the French trial is focused on stage II CRC.
  • “We believe this randomized study could establish a new standard of MRD-guided care in stage II colorectal cancer, potentially improving treatment decisions for thousands of patients.”
    Natera has joined the study in progress.

SONIC Celebrates Upcoming Total Solar Eclipse with New Limited-Edition Blackout Slush Float

Retrieved on: 
Monday, March 18, 2024

Guests will also receive one free pair of solar eclipse viewing glasses* with every purchase of the Blackout Slush Float, while supplies last, to help safely watch the eclipse and create fun memories of this momentous occasion.

Key Points: 
  • Guests will also receive one free pair of solar eclipse viewing glasses* with every purchase of the Blackout Slush Float, while supplies last, to help safely watch the eclipse and create fun memories of this momentous occasion.
  • View the full release here: https://www.businesswire.com/news/home/20240318899054/en/
    SONIC Celebrates Upcoming Total Solar Eclipse with New Limited-Edition Blackout Slush Float (Photo: Business Wire)
    Featuring a sweet, cotton candy and dragon fruit flavored, all-black slush representing the temporary darkness from the solar eclipse and topped with creamy white soft serve and blue and purple galaxy-themed sprinkles, the Blackout Slush Float will transport fans straight to outer space.
  • SONIC is also partnering with former NASA astronaut, International Space Station commander and SONIC superfan, Terry Virts, to share tips on how to best enjoy the total solar eclipse.
  • Guests planning to view the eclipse from SONIC should get their branded eclipse viewing glasses, free with every Blackout Slush Float purchase, in advance since supply is limited.

Coinbase Announces Pricing of Upsized Offering of $1.1 Billion of 0.25% Convertible Senior Notes Due 2030

Retrieved on: 
Thursday, March 14, 2024

The aggregate principal amount of the offering was increased from the previously announced offering size of $1.0 billion.

Key Points: 
  • The aggregate principal amount of the offering was increased from the previously announced offering size of $1.0 billion.
  • Coinbase also granted the initial purchasers of the notes a 30-day option to purchase up to an additional $165.0 million principal amount of notes, solely to cover over-allotments.
  • If the initial purchasers exercise their option to purchase additional notes, Coinbase expects to use a portion of the net proceeds from the sale of such additional notes to enter into additional capped call transactions.
  • No sinking fund is provided for the notes, which means that Coinbase is not required to redeem or retire the notes periodically.

Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9

Retrieved on: 
Wednesday, March 13, 2024

Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.

Key Points: 
  • Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage.
  • These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of GARDASIL 9 versus the currently approved three-dose regimen.