Food and Drug Administration

Elevation Oncology Appoints Experienced Clinical Development Leaders Julie Cherrington, Ph.D. and Alan Sandler, M.D. to Board of Directors

Retrieved on: 
Monday, March 4, 2024

"We are thrilled to welcome Julie and Alan as Elevation Oncology's newest directors," said Steve Elms, Chairman of Elevation Oncology.

Key Points: 
  • "We are thrilled to welcome Julie and Alan as Elevation Oncology's newest directors," said Steve Elms, Chairman of Elevation Oncology.
  • On behalf of the Board, I look forward to Julie and Alan's many insights into both clinical and regulatory strategy as Elevation Oncology continues to advance its pipeline of differentiated, potentially best-in-class antibody-drug conjugate (ADC) therapies."
  • Earlier, Dr. Cherrington served as CEO of QUE Oncology, and as President and CEO of Arch Oncology, Revitope Oncology, Inc., Zenith Epigenetics, and Pathway Therapeutics.
  • Dr. Sandler is an accomplished leader in oncology and drug development, with experience leading clinical development and operations, regulatory affairs, drug safety and asset development strategy across industry and academia.

Boston Scientific Receives FDA Approval for the AGENT™ Drug-Coated Balloon

Retrieved on: 
Friday, March 1, 2024

MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue.

Key Points: 
  • First coronary drug-coated balloon in U.S. provides safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence
    MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.
  • ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue.
  • Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9029352-boston-scientific-fda-ap...
    "With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the U.S," said Lance Bates, president, Interventional Cardiology Therapies, Boston Scientific.
  • Boston Scientific plans to launch the technology in the U.S. in the coming months.

Reese Pharmaceutical Launches New At-Home Colon Cancer Screening Test

Retrieved on: 
Tuesday, February 27, 2024

CLEVELAND, Feb. 27, 2024 /PRNewswire/ -- Reese Pharmaceutical is expanding its over-the-counter (OTC) diagnostic portfolio with the launch of ColoTest®, an at-home Fecal Immunochemical Test (FIT) that identifies the presence of hidden blood in the stool in support of the early detection of colon cancer or gastrointestinal disorders such as colitis, diverticulitis, and polyps.

Key Points: 
  • A recent report by the American Cancer Society revealed a troubling spike in new colon and rectal cancer diagnoses across the US.
  • "90% of colon cancer-related deaths are thought to be preventable if caught early, and yet more than 29 million Americans are not screening for it.
  • With colon cancer rates on the rise, it is more important than ever for people to be proactive.
  • This test is performed in the comfort of your own home with results at home as soon as 1 minute," said Jeffrey Reese, President, of Reese Pharmaceutical.

Westat Awarded Contract to Continue Supporting the PATH Study

Retrieved on: 
Wednesday, February 21, 2024

ROCKVILLE, Md., Feb. 21, 2024 /PRNewswire/ -- The National Institutes of Health's (NIH's) National Institute on Drug Abuse (NIDA) and the U.S. Food and Drug Administration's (FDA's) Center for Tobacco Products (CTP) have announced the award of a third contract to Westat to continue to support the Population Assessment of Tobacco and Health (PATH) Study. Westat has supported the study since its inception in 2011.

Key Points: 
  • Westat is committed to continuing the trusted partnership with NIH/NIDA and FDA/CTP on the Population Assessment of Tobacco and Health (PATH) Study to understand tobacco use patterns and impacts on public health.
  • Westat has supported the study since its inception in 2011.
  • The PATH Study is a uniquely large, long-term study of tobacco use and health in the United States.
  • "Our work will build on the knowledge we have gained during the past 12 years of supporting the PATH Study and a foundation of over 35 years of tobacco research," notes Charles Carusi, PhD , a Westat Vice President and the project director for the PATH Study.

Calliditas Year-end report, January - December 2023

Retrieved on: 
Wednesday, February 21, 2024

Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.

Key Points: 
  • Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.
  • Loss per share before and after dilution amounted to SEK 0.34 and SEK 0.07 for the three months ended December 31, 2023, and 2022, respectively.
  • Cash amounted to SEK 973.7 million and SEK 1,249.1 million as of December 31, 2023, and 2022, respectively.
  • Net sales amounted to SEK 1,206.9 million, of which TARPEYO net sales amounted to SEK 1,075.8 million, for the year ended December 31, 2023.

Calliditas Year-end report, January - December 2023

Retrieved on: 
Wednesday, February 21, 2024

Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.

Key Points: 
  • Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively.
  • Loss per share before and after dilution amounted to SEK 0.34 and SEK 0.07 for the three months ended December 31, 2023, and 2022, respectively.
  • Cash amounted to SEK 973.7 million and SEK 1,249.1 million as of December 31, 2023, and 2022, respectively.
  • Net sales amounted to SEK 1,206.9 million, of which TARPEYO net sales amounted to SEK 1,075.8 million, for the year ended December 31, 2023.

ROSEN, TOP RANKED INVESTOR COUNSEL, Encourages InMode Ltd. Investors to Secure Counsel Before Important Deadline in Securities Class Action – INMD

Retrieved on: 
Friday, February 16, 2024

WHAT TO DO NEXT: To join the InMode class action, go to https://rosenlegal.com/submit-form/?case_id=22575 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the InMode class action, go to https://rosenlegal.com/submit-form/?case_id=22575 or call Phillip Kim, Esq.
  • toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

Investor Notice: Robbins LLP Informs Investors of Class Action Filed Against InMode Ltd. (INMD)  

Retrieved on: 
Friday, February 16, 2024

SAN DIEGO, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Robbins LLP informs investors that a shareholder filed a class action on behalf of purchasers of InMode Ltd. (NASDAQ: INMD) common stock between June 4, 2021 and October 12, 2023.

Key Points: 
  • SAN DIEGO, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Robbins LLP informs investors that a shareholder filed a class action on behalf of purchasers of InMode Ltd. (NASDAQ: INMD) common stock between June 4, 2021 and October 12, 2023.
  • InMode produces medical equipment, including devices purporting to offer body sculpting and other rejuvenation technologies.
  • For more information, submit a form , email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • The customers also stated that InMode offered to replace defective products on the condition of signing confidentiality agreements with non-disparagement clauses.

Gainey McKenna & Egleston Announces A Class Action Lawsuit Has Been Filed Against InMode (INMD)

Retrieved on: 
Thursday, February 15, 2024

Investors who purchased or otherwise acquired shares of InMode should contact the Firm prior to the April 15, 2024 lead plaintiff motion deadline.

Key Points: 
  • Investors who purchased or otherwise acquired shares of InMode should contact the Firm prior to the April 15, 2024 lead plaintiff motion deadline.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
  • If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq.
  • of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at [email protected] or [email protected] .

INMODE LTD. SHAREHOLDER ALERT: Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against InMode Ltd. (NASDAQ: INMD)

Retrieved on: 
Thursday, February 15, 2024

Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the common stock of InMode Ltd. (“InMode or the “Company”) (NASDAQ: INMD) between June 4, 2021 and October 12, 2023, inclusive (the “Class Period”).

Key Points: 
  • Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the common stock of InMode Ltd. (“InMode or the “Company”) (NASDAQ: INMD) between June 4, 2021 and October 12, 2023, inclusive (the “Class Period”).
  • If you purchased or acquired InMode common stock, and/or would like to discuss your legal rights and options please visit InMode Ltd.
  • Shareholder Class Action Lawsuit or contact Investor Relations Manager Peter Allocco at (212) 951-2030 or [email protected] .
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.