Food and Drug Administration

InMode Ltd. Securities Fraud Class Action Lawsuit Pending: Contact The Gross Law Firm Before April 15, 2024 to Discuss Your Rights – INMD

Retrieved on: 
Tuesday, March 12, 2024
NEXT, Food and Drug Administration, FDA, Fraud, Food, Security (finance)

NEW YORK, March 12, 2024 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of InMode Ltd.

Key Points: 
  • NEW YORK, March 12, 2024 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of InMode Ltd.
    Shareholders who purchased shares of INMD during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment.
  • DEADLINE: April 15, 2024 Shareholders should not delay in registering for this class action.
  • The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices.
  • The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship.

DIA 2024 Global Annual Meeting Welcomes Life Sciences Leaders to Confront Emerging Challenges in Healthcare

Retrieved on: 
Tuesday, April 2, 2024
Medical Devices, FDA, Health, Health Technology, General Health, Pharmaceutical, Eli Lilly, Combination, DCT, Microsoft Research, Artificiality, Trust (social science), GSK, Novartis, Patient, Food and Drug Administration, Artificial intelligence, USS Midway, AI, EMA, Merck & Co., Medicine, European Medicines Agency, Johnson & Johnson, Ecosystem, Drug development, Pharmacovigilance, Food, DIA, Student, Diamond, DEI, Medical device

The ethical use of artificial intelligence (AI) in healthcare, the development of advanced therapies, and other emerging regulatory and scientific challenges demand in-depth discussion as DIA , a global organization of life sciences professionals, accepts registrations for the DIA 2024 Global Annual Meeting , to be held June 16-20 in San Diego.

Key Points: 
  • The ethical use of artificial intelligence (AI) in healthcare, the development of advanced therapies, and other emerging regulatory and scientific challenges demand in-depth discussion as DIA , a global organization of life sciences professionals, accepts registrations for the DIA 2024 Global Annual Meeting , to be held June 16-20 in San Diego.
  • Thousands of industry representatives, regulators, government officials, academics, innovators, and patients will convene for the world's preeminent neutral life sciences forum — and the only thing missing is you.
  • "This year marks the 60th anniversary of DIA and the Global Annual Meeting, and we're celebrating by continuing to forge a bold future marked by innovation and impact," said Marwan Fathallah, DIA's President and Global Chief Executive.
  • — An interactive forum featuring U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) representatives discussing today's regulatory, scientific, and communication challenges.

Baxter Announces U.S. FDA Clearance of Novum IQ Large Volume Infusion Pump and Dose IQ Safety Software, Advancing Connected and Intelligent Infusion Therapy

Retrieved on: 
Monday, April 1, 2024
Technology, Medical Devices, Hospitals, FDA, Health Technology, Software, Biotechnology, General Health, Pharmaceutical, Health, SYR, Novum, LVP, EMR, Patient, State, Food and Drug Administration, CQI, Hospital, Pharmacist, Baxter International, Computer security, Safety, Nursing, Baxter, Medicine, Pump, Food, Medical device

Baxter International Inc. (NYSE:BAX), an innovative leader in infusion therapies and technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Novum IQ large volume infusion pump (LVP) with Dose IQ Safety Software.

Key Points: 
  • Baxter International Inc. (NYSE:BAX), an innovative leader in infusion therapies and technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Novum IQ large volume infusion pump (LVP) with Dose IQ Safety Software.
  • Offering the Novum IQ LVP in the U.S. demonstrates Baxter’s commitment to continued innovation in advancing infusion therapy.
  • “The Novum IQ platform represents a meaningful shift in how connected and intelligent infusion therapy can impact the way clinicians provide care.
  • IQ Enterprise Connectivity Suite, a scalable all-in-one server, integration engine and software application platform, designed to simplify infusion system connectivity for the Novum IQ Infusion Platform.

QuidelOrtho Receives FDA 510(k) Clearance for Its QuickVue® COVID-19 Test

Retrieved on: 
Tuesday, April 2, 2024
Medical Supplies, FDA, Health, Infectious Diseases, COVID-19, General Health, VZV, Ageing, Food and Drug Administration, Research, Sale, Virus, SARS-CoV-2, Laboratory, CLIA, Multimedia, Data, Marketing, QuidelOrtho, Food

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test.

Key Points: 
  • QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test.
  • This clearance allows the test to be used with accuracy and convenience in home and medical facility settings with CLIA certificates of waiver.
  • For healthcare providers, comprehensive instructions for use accompany the QuickVue COVID-19 test, facilitating seamless integration into existing diagnostic protocols.
  • QuidelOrtho secured FDA 510(k) clearance in December 2023 for its Savanna PCR platform and Savanna HSV 1+2/VZV PCR assay.

AscellaHealth Releases Q1 2024 Specialty & Rare Pipeline Digest™: Captures Data and Progress of Groundbreaking Therapies in 2024

Retrieved on: 
Thursday, March 28, 2024
Other Health, Research, Pharmaceutical, Oncology, Hospitals, Genetics, Clinical Trials, Science, Biotechnology, FDA, Other Science, Health, Food and Drug Administration, Specialty, Patient, Multimedia, Food, Core Services, Doctor of Pharmacy, CGT, Fine chemical

AscellaHealth , a global healthcare and specialty pharmacy solutions organization, today released its latest Specialty & Rare Pipeline Digest™, the industry’s most comprehensive quarterly resource of new, pending and upcoming Specialty and Rare Disease drug launches, cell and gene therapies (CGT), biosimilars and generics.

Key Points: 
  • AscellaHealth , a global healthcare and specialty pharmacy solutions organization, today released its latest Specialty & Rare Pipeline Digest™, the industry’s most comprehensive quarterly resource of new, pending and upcoming Specialty and Rare Disease drug launches, cell and gene therapies (CGT), biosimilars and generics.
  • Continuing its tradition of providing a quarterly, complimentary, digital source of industry information to support the specialty drug market needs of all stakeholders and decision-makers, AscellaHealth captures essential information and updates on products that may impact treatment for millions of individuals worldwide who are affected by complex, chronic conditions or rare diseases.
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240328442451/en/
    “This comprehensive, timely report provides valuable insights and current data, reflecting the multitude of specialty products poised for introduction during the first quarter of 2024,” says Andy Szczotka, PharmD, chief pharmacy officer, AscellaHealth.

TruLite Health® Truity™ Platform Earns HITRUST® Certification

Retrieved on: 
Wednesday, March 27, 2024
Technology, Security, Health Technology, Professional Services, Software, Practice Management, DEI (Diversity, Equity and Inclusion), Managed Care, General Health, Health, Certification, Food and Drug Administration, Risk management, Joint Commission, Health equity, HITRUST, Patient, Health information management, Electronic health record, Workflow, Medicaid, Joint, Medicare, Privacy, Food, Medical device

TruLite Health , developer of the only health equity solution to remediate clinical bias, announced its Truity™ platform earned certified status by HITRUST for foundational cybersecurity.

Key Points: 
  • TruLite Health , developer of the only health equity solution to remediate clinical bias, announced its Truity™ platform earned certified status by HITRUST for foundational cybersecurity.
  • It addresses this challenge by driving patient-specific clinical, social and behavioral interventions, leading to improved healthcare outcomes and costs as part of an organization’s health equity strategy.
  • As the market’s first health equity platform, this certification is great validation of our commitment to securing sensitive health information with everything we do,” said Shaung Liu, TruLite Health chief technology officer and co-founder.
  • “We applaud TruLite Health for their commitment to cybersecurity and successful completion of their HITRUST e1 Certification.”

USA Patient Registry Software Market Outlook to 2028, Featuring IQVIA, Optum (UnitedHealth Group), Phytel, Dacima Software, FIGmd, Syapse and Pharos Innovations - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 19, 2024
Oncology, Research, Software, University, Infectious Diseases, Education, Hospitals, Health Technology, Genetics, Health Insurance, Data Management, Science, Technology, Clinical Trials, Biotechnology, FDA, Insurance, Health, Professional Services, IOT (Internet of Things), Data Analytics, White House, Federal Government, Practice Management, Managed Care, Other Health, Public Policy, Government, Pharmaceutical, Other Science, Pancreatic disease, Consolidated, Patient, Conditional sentence, Optum, Health information management, Food and Drug Administration, Geography, NPF, RWE, Internet of things, Openclinica, DNA, Policy, Electronic health record, NIH, City, Privacy, CMS, Food, Organization, Prevalence, Federation, Internet, Cancer, Drug development, IQVIA, Evidence-based medicine, RDCRN, Type, Data science, Caregiver, Public health surveillance, Government agency, Registry, EHR, CDC, National Institutes of Health, Bangladesh Technical Education Board, Medicare, Collection, Medical device

The patient registry market in the US involves the collection, management & analysis of data related to patients with specific medical conditions & diseases.

Key Points: 
  • The patient registry market in the US involves the collection, management & analysis of data related to patients with specific medical conditions & diseases.
  • Patient registry software could facilitate data sharing and analysis among these entities, leading to increased adoption
    The patient registry software market in the USA is a part of the broader healthcare information technology sector.
  • Key players in the USA patient registry software market includes IQVIA, Dacima Software, OpenClinica, FIGmd, Dendrite Clinical Systems and various universities conducting medical clinical studies.
  • As technology & data science continue to evolve, the patient registry software market is likely to incorporate more advanced analytics techniques.

Positive RUBY phase III data show potential for Jemperli (dostarlimab-gxly) combinations in more patients with primary advanced or recurrent endometrial cancer

Retrieved on: 
Saturday, March 16, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, OS, Food and Drug Administration, Endometrial cancer, Progression-free survival, Risk, GSK, Patient, Aes, Death, MD, Nature, Clinical trial, Copenhagen University Hospital, Gynecologic Oncology (journal), Division, PFS, Food, Pharmaceutical industry

2 Exploratory analyses of OS in dMMR/MSI-H and OS in MMRp/MSS populations were pre-specified with no planned hypothesis testing.

Key Points: 
  • 2 Exploratory analyses of OS in dMMR/MSI-H and OS in MMRp/MSS populations were pre-specified with no planned hypothesis testing.
  • RUBY Part 2: addition of niraparib to dostarlimab-gxly in maintenance setting significantly improved PFS in first-line primary advanced or recurrent endometrial cancer compared to chemotherapy alone, meeting the primary endpoint of the trial.
  • Discontinuation of dostarlimab-gxly or placebo due to a TEAE occurred in 24.1% of patients in the treatment arm and 5.2% of patients in the control arm.
  • Discontinuation of niraparib or placebo due to a treatment-emergent AE occurred in 15.7% of patients in the treatment arm and 4.2% of patients in the control arm.

Nuvation Bio Doses First Patient in Phase 1/2 Study of NUV-1511 for the Treatment of Advanced Solid Tumors

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, NUVB, Safety, Therapy, Patient, Food and Drug Administration, FDA, PROC, DDC, Food, Pharmaceutical industry

Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic.

Key Points: 
  • Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic.
  • “Dosing the first patient with NUV-1511 marks a significant milestone for our proprietary DDC platform, from which we are developing potent oncology-focused chimeric small molecules designed to selectively deliver anti-cancer therapeutics to cancer cells, while mitigating effects on healthy non-target tissues,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.
  • “DDCs are the core technology upon which the Company was founded and we are excited to bring our first DDC clinical candidate to patients.”
    The dose escalation portion of the study employs a flexible design that allows for the potential to explore two dosing schedules for NUV-1511 with the goal of establishing the recommended Phase 2 dose.
  • The study will initially evaluate safety and tolerability, pharmacokinetic profile, and assess for signs of clinical activity in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. Food and Drug Administration (FDA) labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), advanced pancreatic cancer, and platinum-resistant ovarian cancer (PROC).

Altria to Significantly Enhance Cash Returns to Shareholders Through Expanded Share Repurchase Program in Connection with Pricing of Offering of Anheuser-Busch InBev Stock; Raises 2024 Full-Year Earnings Guidance

Retrieved on: 
Thursday, March 14, 2024
Tobacco, Retail, Wine & Spirits, Health, Uncertainty, Climate change, European Economic Area, Growth, Gross metropolitan product, Exercise, MSA, EPS, Risk, Accounting, Law enforcement, Food and Drug Administration, Climate, ASR, History, Sale, Acquisition, ANB, Private sector, ADS, AB InBev, Euronext, Artificial intelligence, Investment, Annual report, Heated tobacco product, NPM, GAAP, Vision, Income tax, Information, Pandemic, Privacy, Food, Share repurchase, Security (finance)

In connection with the pricing of the offering, we announce a $2.4 billion increase to our existing $1 billion share repurchase program.

Key Points: 
  • In connection with the pricing of the offering, we announce a $2.4 billion increase to our existing $1 billion share repurchase program.
  • Our Board of Directors (Board) has authorized the expanded program, which we expect to complete by December 31, 2024.
  • Share repurchases depend on marketplace conditions and other factors, and the program remains subject to the discretion of our Board.
  • As part of the expanded share repurchase program, we expect to enter into an estimated $2.4 billion accelerated share repurchase (ASR) program.