Lancet

City of Hope Vice Physician-in-Chief Edward S. Kim, M.D., M.B.A, Recognized as a Top Diversity Leader in U.S. Healthcare

Retrieved on: 
Monday, November 6, 2023
Oncology, Professional Services, DEI (Diversity, Equity and Inclusion), Health, Clinical Trials, Research, Science, Faculty, Policy, Modern Healthcare, Friends, American Society of Clinical Oncology, City of Hope, Cancer Prevention Research, Lung cancer, Physician, Friends of Cancer Research, Head, State, Organization, The Lancet, Journal, Society, Multimedia, Quality of life, City, Lung, Clinical trial, Diversity, Journal of Clinical Oncology, Cancer Discovery (journal), Patient, ASCO, National Integration Party (Costa Rica), Nature Medicine, Pharmaceutical industry, Hospital, Nursing, Medical imaging, Hope, Cancer, Lancet

City of Hope, one of the largest cancer research and treatment organizations in the United States, announced today that Vice Physician-in-Chief Edward S. Kim , M.D., M.B.A., has been named a 2023 Modern Healthcare Top Diversity Leader .

Key Points: 
  • City of Hope, one of the largest cancer research and treatment organizations in the United States, announced today that Vice Physician-in-Chief Edward S. Kim , M.D., M.B.A., has been named a 2023 Modern Healthcare Top Diversity Leader .
  • The prestigious honor recognizes diverse health care executives and organizations influencing policy and care delivery across the country.
  • This is the second time Kim — a renowned lung cancer expert and physician-executive — has earned this recognition.
  • “Ed is deeply committed to ensuring that everyone we serve has equitable access to advanced cancer care,” said Annette Walker, president, City of Hope Orange County.

Soundwave Hearing, LLC Announces 510k FDA Clearance for Sontro® Self-Fitting OTC Hearing Aids and the AI award-winning otoTune® app

Retrieved on: 
Monday, November 6, 2023
FDA, Telemedicine, Virtual Medicine, Consumer Electronics, Technology, Apps, Applications, Women, Medical Devices, Seniors, Men, Artificial Intelligence, People with Disabilities, Family, Biotechnology, Software, Consumer, Health, RIC, Sale, Kool-Aid, Hearing, Aural rehabilitation, Hearing aid, OTC, Dementia, Research, HSA, Huber loss, Android, Environment, Curriculum, Risk, Partnership, IOS, FSA, Study, Soundwave, Lancet, Medical device, Personal protective equipment, Cassette tape, Report

Soundwave Hearing today announced 510k FDA clearance for its Class II Medical Device, Sontro® Self-Fitting OTC Hearing Aids, opening the door for Americans to access affordable hearing aids.

Key Points: 
  • Soundwave Hearing today announced 510k FDA clearance for its Class II Medical Device, Sontro® Self-Fitting OTC Hearing Aids, opening the door for Americans to access affordable hearing aids.
  • By combining the power of mobile phones and unique self-fitting AI technology, Soundwave Hearing has created custom personalization for its Sontro Self-Fitting OTC Hearing Aids, removing common barriers to accessing hearing aids.
  • “The 510k FDA Clearance for the Sontro Self-Fitting OTC Hearing Aids is particularly timely, given the regulations for OTC hearing aids and the growing demand for telemedicine-based services.
  • What Makes the Sontro Self-Fitting OTC Hearing Aids Different than other Self-Fitting OTC Hearing Aids?

Oncternal Therapeutics Adds Matthew Smith, M.D., Ph.D. to its Prostate Cancer Scientific Advisory Board

Retrieved on: 
Wednesday, October 25, 2023
Trial of the century, Harvard Medical School, Brigham and Women's Hospital, Therapy, Clinical Cancer Research, Prostate cancer, MD, Dana–Farber Cancer Institute, Doctor of Philosophy, HIV disease progression rates, Journal, Internal medicine, Estate (law), Duke University School of Medicine, Abiraterone acetate, Metastasis, SAN, Oncology, Biochemistry, Massachusetts Institute of Technology, Journal of Clinical Oncology, AR, Canisius College, Patient, Hospital, SAB, Massachusetts Institute of Technology School of Engineering, Prostate, The New England Journal of Medicine, Pharmaceutical industry, Medicine, Lancet

SAN DIEGO, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the addition of Matthew Smith, M.D., Ph.D. to its Prostate Cancer Scientific Advisory Board (SAB).

Key Points: 
  • SAN DIEGO, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the addition of Matthew Smith, M.D., Ph.D. to its Prostate Cancer Scientific Advisory Board (SAB).
  • “We wholeheartedly welcome Dr. Smith to Oncternal’s Prostate Cancer Scientific Advisory Board,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.
  • He has published extensively on the treatment and prevention of bone metastases, prostate cancer survivorship, and novel androgen receptor pathway inhibitors.
  • He completed a fellowship in Medical Oncology at Dana Farber Cancer Institute and a postdoctoral fellowship at Massachusetts Institute of Technology.

Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment

Retrieved on: 
Wednesday, October 25, 2023
FDA, Chikungunya, Biologics license application, VLA, PDUFA, Food, CHMP, Priority, Prescription Drug User Fee Act, European Directive on Traditional Herbal Medicinal Products, MD, Health Canada, European Medicines Agency, Regulation of tobacco by the U.S. Food and Drug Administration, Valneva SE, Euronext Paris, Saint-Herblain, CHIKV, Risk, EMA, Public, Fast track (FDA), BLA, Lancet, Pharmaceutical industry

Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553.

Key Points: 
  • Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553.
  • Valneva was also granted accelerated assessment1 for the application by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”.
  • VLA1553 is currently the first and only chikungunya vaccine candidate worldwide for which regulatory review processes are underway.
  • Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s accelerated assessment and will work closely with them to bring this vaccine to market.

The Lancet Publishes 24-Month Results from Phase 3 Studies of SYFOVRE® (pegcetacoplan injection) for Geographic Atrophy (GA)

Retrieved on: 
Friday, October 20, 2023
OAKS, AMD, Geographic atrophy, Research, Conditional sentence, Paratriathlon, Patient, Retina, Lancet, APLS, Pharmaceutical industry

SYFOVRE is the only treatment approved for use beyond 12 months in GA, a chronic disease and leading cause of vision loss.

Key Points: 
  • SYFOVRE is the only treatment approved for use beyond 12 months in GA, a chronic disease and leading cause of vision loss.
  • In the publication, both every-other-month and monthly SYFOVRE showed a clinically meaningful reduction of GA lesion growth with increasing effects over time and a well-demonstrated safety profile in a broad population of more than 1,200 patients.
  • “The vision loss caused by GA takes a tremendous toll on patients and their families, impacting independence and well-being.
  • “With SYFOVRE’s approval in the United States and five additional applications under review globally, we are working urgently to bring this important treatment to patients in need worldwide.”
    Publication co-first authors are Jeffrey Heier, M.D.

Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil

Retrieved on: 
Tuesday, October 24, 2023
FDA, Food, Paroxysmal supraventricular tachycardia, Heart, Heart rate, Regulation of tobacco by the U.S. Food and Drug Administration, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., RAPID, Arrhythmia, NDA, Patient, PVST, Pharmaceutical industry, PSVT, Lancet

The primary analysis and supportive assessments from the pivotal RAPID Phase 3 clinical trial were recently published in The Lancet.

Key Points: 
  • The primary analysis and supportive assessments from the pivotal RAPID Phase 3 clinical trial were recently published in The Lancet.
  • The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review.
  • If accepted, Milestone Pharmaceuticals expects a standard review of 10 months of the company's NDA.
  • Milestone continues to advance commercial preparations to support the anticipated launch of etripamil with the proposed trade name, CARDAMYST™.

Prostate Cancer Diagnosis Just Got Easier with CE Mark Certification of Lucida Medical's New AI Software

Retrieved on: 
Monday, October 23, 2023
Sale, Trial of the century, MRI, Radiology, Active surveillance of prostate cancer, CE, Certification, Entrepreneurship, Prostate cancer, Software, NHS, Life expectancy, Hospital, Biopsy, IRCCS, European Society of Radiology, Cancer, CE marking, Patient, Diagnosis, Prostate, Lancet, Medical imaging, EU

CAMBRIDGE, United Kingdom, Oct. 23, 2023 /PRNewswire/ -- Lucida Medical Ltd, a Cambridge-based start-up company dedicated to improving cancer diagnosis, has announced Class IIb CE certification for its AI-based prostate cancer detection software, Prostate Intelligence™ (Pi™).

Key Points: 
  • CAMBRIDGE, United Kingdom, Oct. 23, 2023 /PRNewswire/ -- Lucida Medical Ltd, a Cambridge-based start-up company dedicated to improving cancer diagnosis, has announced Class IIb CE certification for its AI-based prostate cancer detection software, Prostate Intelligence™ (Pi™).
  • Built with leading clinicians and UK NHS hospitals, the CE mark means the software can now benefit patients across Europe.
  • Using AI, Pi™ analyses the MRI and is fully integrated into the radiologist's workflow, targeting key issues of variability, radiologist time, and diagnostic accuracy in prostate cancer.
  • As the most common cancer in men, each year, prostate cancer gains 1.4 million diagnoses and claims 375,000 lives.

Elevar Therapeutics and Jiangsu Hengrui Pharma Announce Global Commercialization Licensing Agreement for PD-1 Inhibitor Camrelizumab in Combination with Rivoceranib for uHCC

Retrieved on: 
Tuesday, October 17, 2023
Congress, Jiangsu Hengrui Medicine, Food, Hepatocellular carcinoma, Research, Standard of care, BLA, Death, Survival, R, Liver cancer, FDA, ESMO, Therapy, Oncology, Sorafenib, NDA, Regulation of tobacco by the U.S. Food and Drug Administration, European Society for Medical Oncology, PDUFA, Progression-free survival, HCC, Patient, Pharmaceutical industry, Generic drug, Lancet, EU

Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales.

Key Points: 
  • Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales.
  • In May 2023, a new drug application (NDA) for rivoceranib and a biologics license application (BLA) for camrelizumab were submitted to the U.S. Food and Drug Administration (FDA) for the combination of rivoceranib and camrelizumab as a first-line therapy for uHCC.
  • In January 2023, the combination was approved in China as a first-line treatment for uHCC.
  • Camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and increased overall response rate versus sorafenib, a standard first-line treatment for uHCC.

Jiangsu Hengrui Pharma and Elevar Therapeutics Announce Global Commercialization Licensing Agreement for PD-1 Inhibitor Camrelizumab in Combination with Rivoceranib for uHCC

Retrieved on: 
Tuesday, October 17, 2023
Congress, Food, Hepatocellular carcinoma, Research, BLA, R, FDA, Sorafenib, Therapy, NDA, Regulation of tobacco by the U.S. Food and Drug Administration, Responses to the COVID-19 pandemic in September 2022, PDUFA, Progression-free survival, HCC, Patient, Pharmaceutical industry, Generic drug, Lancet

Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales.

Key Points: 
  • Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales.
  • Rivoceranib, under the name apatinib (brand name: Aitan®), is developed by Hengrui Pharma in China.
  • Elevar and Hengrui Pharma presented CARES-310 study results at the September 2022 ESMO Congress and published them in The Lancet on July 24, 2023.
  • Camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and increased overall response rate versus sorafenib, a standard first-line treatment for uHCC.

United Renewables Highlights: Climate Scholars Express Growing Frustration Over Political Inaction in New Reports

Retrieved on: 
Friday, October 6, 2023
Intergovernmental Panel on Climate Change, IPCC, Climate change, Isle, Climate, Policy, Frustration, Global health, Renewable energy, Lancet

DOUGLAS, Isle of Man, Oct. 06, 2023 (GLOBE NEWSWIRE) -- In a recent episode of the Conversations on Climate Podcast, host Chris Caldwell sat down with Dr. Matt Winning, a senior researcher and leading expert on climate change. During their discussion, Dr. Winning revealed a concerning shift in the tone of major climate reports. He explained that leading institutions, such as the Lancet and the IPCC, have adopted a more political lexicon, driven by the growing frustration among academics over climate indifference and policy stagnation. He stressed that this shift in tone reflects a growing sense of urgency, as the window for meaningful action to address the climate crisis continues to narrow.

Key Points: 
  • During their discussion, Dr. Winning revealed a concerning shift in the tone of major climate reports.
  • He explained that leading institutions, such as the Lancet and the IPCC , have adopted a more political lexicon, driven by the growing frustration among academics over climate indifference and policy stagnation.
  • He stressed that this shift in tone reflects a growing sense of urgency, as the window for meaningful action to address the climate crisis continues to narrow.
  • Conversations on Climate ," a collaborative endeavour between United Renewables and the London Business School Alumni Energy Club, regularly features dialogues with esteemed academics and industry trailblazers on sustainability matters.