Breakthrough

BioCardia Announces US Patent on Imaging System for Targeting Cardiac Therapies

Retrieved on: 
Wednesday, June 15, 2022
Heart, Security (finance), FDA, Patent, Therapy, NK1R, Heart failure, Company, U.S. Securities and Exchange Commission, Forward-looking statement, CMS, Physician, GLOBE, CT, BCDA, Nasdaq, MRI, United States Patent Office fire, Breakthrough, Pharmaceutical industry, Medical imaging

He continued, The imaging system product enhancement offering we are working towards is expected to benefit both our autologous and allogeneic cardiac cell therapies as well as the biologic therapies in development by respected partners using BioCardia catheter biotherapeutic delivery solutions.

Key Points: 
  • He continued, The imaging system product enhancement offering we are working towards is expected to benefit both our autologous and allogeneic cardiac cell therapies as well as the biologic therapies in development by respected partners using BioCardia catheter biotherapeutic delivery solutions.
  • This new patent is anticipated to strengthen the protection of BioCardia efforts with respect to its cardiovascular therapeutic approaches already afforded by issued patents.
  • BioCardia, Inc. , headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease.
  • BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Zai Lab Announces Breakthrough Therapy Designations Granted for Repotrectinib in China

Retrieved on: 
Friday, June 10, 2022
National Medical Products Administration, Immunotherapy, Turning Point, Coronavirus, Large-cell lung carcinoma, CDE, Research, Neoplasm, Food, Forward-looking statement, Partnership, Policy, TRK, Center, Gene, Breakthrough therapy, U.S. Securities and Exchange Commission, NMPA, Therapy, GLOBE, Patient, Lung cancer, Private Securities Litigation Reform Act, Risk, Infection, Health, CARE, COVID-19, Incidence, Quality of life, NASDAQ, SEC, Diagnosis, Lists of diseases, SAN, ROS1, Degenerative disease, Medicine, Center for Drug Evaluation and Research, Drug development, NSCLC, TKI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Orphan drug, Breakthrough, Pharmaceutical industry

SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., June 10, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted two Breakthrough Therapy Designations for investigational repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and one prior line of platinum-based chemotherapy (EXP-2) and for those with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and no chemotherapy or immunotherapy (EXP-4). The Breakthrough Therapy Designations for repotrectinib were supported by the data from both global and Chinese TKI-pretreated ROS1-positive NSCLC patients enrolled in the Phase 1/2 TRIDENT-1 study.

Key Points: 
  • The Breakthrough Therapy Designations for repotrectinib were supported by the data from both global and Chinese TKI-pretreated ROS1-positive NSCLC patients enrolled in the Phase 1/2 TRIDENT-1 study.
  • Since repotrectinib received Breakthrough Therapy Designation by the CDE earlier this year for ROS1-positive TKI-nave patients, todays recognition further supports repotrectinib as a potential best-in-class treatment for ROS1-positive NSCLC in both TKI-nave and pretreated patients in China, said Alan Sandler, M.D., President and Head of Global Development, Oncology at Zai Lab.
  • Drugs granted Breakthrough Therapy Designations receive priority communications and guidance from the CDE to promote and expedite the drug development process.
  • Zai Lab has an exclusive license agreement with Turning Point Therapeutics to develop and commercialize repotrectinib in Greater China.

Vertex Announces Inaxaplin (VX-147) Granted Breakthrough Therapy Designation by U.S. FDA and Priority Medicines (PRIME) Designation by the EMA

Retrieved on: 
Wednesday, June 8, 2022
Research, FDA, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, EMA, Food, Ageing, Vertex Pharmaceuticals, PRIME, VRTX, FDA, Patient, Review, UPCR, Sickle cell disease, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nephrology, Breakthrough, Safety, FSGS, Pharmaceutical industry, Vertex

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has granted inaxaplin (VX-147) Breakthrough Therapy Designation for APOL1-mediated focal segmental glomerulosclerosis (FSGS) and the European Medicines Agency (EMA) has granted inaxaplin Priority Medicines (PRIME) designation for APOL1-mediated chronic kidney disease (AMKD).

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has granted inaxaplin (VX-147) Breakthrough Therapy Designation for APOL1-mediated focal segmental glomerulosclerosis (FSGS) and the European Medicines Agency (EMA) has granted inaxaplin Priority Medicines (PRIME) designation for APOL1-mediated chronic kidney disease (AMKD).
  • The Breakthrough Therapy Designation was granted based on the Phase 2 clinical study of inaxaplin in patients with APOL1-mediated FSGS, a form of AMKD.
  • PRIME designation was granted based on clinical proof-of-concept data from Vertexs Phase 2 study of inaxaplin in APOL1-mediated FSGS.
  • In the US, this is the ninth breakthrough therapy designation granted to Vertex across its portfolio programs.

Breakthrough Collaborative Announces Vince Marigna as Chief Executive Officer

Retrieved on: 
Tuesday, June 7, 2022
People, K-12, Leadership, Breakthrough Collaborative, Program, School, Marigna-sur-Valouse, Retirement, Organization, Breakthrough, Trustee, Growth, Student, Teach For America, For America, National, Education, Strategic planning, University, Management, Tutoring, Collaboration

OAKLAND, Calif., June 7, 2022 /PRNewswire-PRWeb/ -- Breakthrough Collaborative announced today that Vince Marigna has been named its CEO effective July 18. Marigna will succeed Elissa Vanaver who announced her retirement last fall and who has served as National CEO since 2017.

Key Points: 
  • OAKLAND, Calif., June 7, 2022 /PRNewswire-PRWeb/ -- Breakthrough Collaborative announced today that Vince Marigna has been named its CEO effective July 18.
  • Marigna will succeed Elissa Vanaver who announced her retirement last fall and who has served as National CEO since 2017.
  • Marigna spent over a decade in leadership at KIPP New Jersey, where he served as the Chief Schools Officer/Chief Academic Officer and later as the Chief People Officer.
  • "We believe Vince is the ideal executive to lead Breakthrough's next chapter of growth and success, following Elissa's successful efforts to strengthen the Collaborative," said Pat Talamantes, Chair, Breakthrough Collaborative National Board of Trustees.

Phase 2 Dose‑Ranging Clinical Trial Results of CTP‑543 in Patients with Alopecia Areata published in the Journal of the American Academy of Dermatology

Retrieved on: 
Tuesday, June 7, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Janus, Breakthrough therapy, Adult, Company, Journal, Hair, Dermatology, Food, American Academy, Hair loss, Medication, Breakthrough, Autoimmunity, Alopecia areata, FDA, JAK, Patient, JAAD, Immune system, Autoimmune disease, NASDAQ, Department, Severity, CNCE, Literature, Regulation of tobacco by the U.S. Food and Drug Administration, SALT, Yale School of Medicine, Safety, Pharmaceutical industry

The publication highlights the establishment of two doses of CTP-543 with statistically significant hair regrowth and a generally well tolerated safety profile in patients with moderate to severe alopecia areata.

Key Points: 
  • The publication highlights the establishment of two doses of CTP-543 with statistically significant hair regrowth and a generally well tolerated safety profile in patients with moderate to severe alopecia areata.
  • The robust clinical results observed in the trial supported the Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and the progression of CTP-543 into the THRIVE-AA pivotal Phase 3 clinical program.
  • The Company recently reported positive topline data from the THRIVE-AA1 trial, and topline data from the THRIVE-AA2 trial is expected in the third quarter of 2022.
  • The Phase 2 trial was a randomized, double-blind, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate to severe alopecia areata.

Global Vagus Nerve Stimulators Market to Surpass US$ 1,251.9 Million by 2030 - Coherent Market Insights

Retrieved on: 
Monday, June 6, 2022
World Health Organization, PTSD, ElectroCore, US, Gesellschaft mit beschränkter Haftung, IDE, Epilepsy, Research, Biotechnology, Anxiety, Science, LLC, Inflection point, Food, Depression, The Scientific World Journal, NVN, Migraine, Analysis, WHO, Breakthrough, FDA, Growth, Neuraxis, LivaNova, Adoption, Lists of diseases, Rheumatoid arthritis, Incidence, Prevalence, Boston Scientific, Application, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Post-traumatic stress disorder, CAGR, World, Pharmaceutical industry, Medical device

These key trends are expected to aid in growth of the global vagus nerve stimulators market.

Key Points: 
  • These key trends are expected to aid in growth of the global vagus nerve stimulators market.
  • Furthermore, key players operating in the global vagus nerve stimulators market are focusing on adoption of inorganic growth strategies such as distributor agreements, acquisitions, collaborations, in order to expand their market presence in the global market.
  • The global vagus nerve stimulators market is expected to exhibit a CAGR of 5.1% over the forecast period, owing to rising research in development of novel vagus nerve stimulators.
  • Global Vagus Nerve Stimulators Market, By Product Type:
    Global Vagus Nerve Stimulators Market, By Application:

Net Health's Tissue Analytics for Wound Care Granted Breakthrough Device Status by FDA

Retrieved on: 
Thursday, June 2, 2022
Digital health, Caregiver, Company, Health, Laika (EHR testing framework), Therapy, LLC, TA, CEO, Organization, Solution, Multimedia, FDA, EHR, MCRA, Patient, Hospital, Technology, Net Health, Compliance, Hapi (Nile god), Agency, Diagnosis, The Carlyle Group, Public health, View, Breakthrough, Medical device, Medical imaging, Software, History

PITTSBURGH, June 2, 2022 /PRNewswire/ -- Net Health, a provider of specialty electronic healthcare record (EHR) and predictive analytics software, announced today that Tissue Analytics, the company's AI-powered wound imaging and analysis software, has been granted Breakthrough Device Status by the U.S. Food & Drug Administration (FDA). Tissue Analytics received the rare designation because of its novel diagnostic algorithms. The Company believes the FDA designation represents the first time an EHR company has been granted such designation.

Key Points: 
  • PITTSBURGH, June 2, 2022 /PRNewswire/ -- Net Health, a provider of specialty electronic healthcare record (EHR) and predictive analytics software, announced today that Tissue Analytics , the company's AI-powered wound imaging and analysis software,has been granted Breakthrough Device Status by the U.S. Food & Drug Administration (FDA).
  • Breakthrough Status is not granted solely on the severity of the device's applicable condition.
  • In granting the Breakthrough Device Status, the FDA recognized that the software could help wound care providers improve care by standardizing the diagnosis and care process of triaging patients with chronic, non-healing wounds with poor healing trajectories.
  • "The FDA's breakthrough designation acknowledges that Tissue Analytics is a first-of-its-kind device in Wound Care.

PolyPid Announces Completion of Enrollment in Phase 3 SHIELD I Trial of D-PLEX₁₀₀ for Prevention of Surgical Site Infections in Abdominal Surgery

Retrieved on: 
Tuesday, May 31, 2022
SHIELD, QIDP, Company, Hospital, Private Securities Litigation Reform Act, SOC, Polypide, Infection, Maxima and minima, PLEX, Patient, DSMB, Review, Nature, Mortality, European Union vs. Google, Trial of the century, SSIS, FDA, Partnership, Forward-looking statement, Data monitoring committee, Safety, Technology, Glioblastoma, Standard of care, Breakthrough, NDA, LinkedIn, End, Breakthrough therapy, Twitter, Colorectal surgery, GLOBE, United, Arm, Surgery, MAA, Active ingredient, Pharmaceutical industry, Risk management

We look forward to the availability of top-line results from SHIELD I by the end of the third quarter of 2022.

Key Points: 
  • We look forward to the availability of top-line results from SHIELD I by the end of the third quarter of 2022.
  • D-PLEX100, PolyPids lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
  • D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery.
  • PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of soft tissue abdominal and sternal bone surgical site infections.

Now on Store Shelves: Breakthrough Journal Releases 2022 Spring Issue “Climate Geopolitics”

Retrieved on: 
Tuesday, May 24, 2022
Carbon, Climate change, Breakthrough Institute, VP, Survival, Â, Mass, Berggruen Institute, Climate, Multilateralism, Policy, Government, Global catastrophic risk, Barnes & Noble, Energy, Wind, Poverty, World Bank, Time, Pressure, University, Democracy, Human Rights Watch, Barnes, GLOBE, Gun, CA, World, Journalism, Renewable energy, News, Breakthrough

The new issue, Climate Geopolitics, focuses on how global climate action efforts often divorce geopolitical problems from their historical contexts in order to make them fit within the framework of climate change.

Key Points: 
  • The new issue, Climate Geopolitics, focuses on how global climate action efforts often divorce geopolitical problems from their historical contexts in order to make them fit within the framework of climate change.
  • The Breakthrough Journal is the Breakthrough Institute 's quarterly magazine delivering pragmatic opinion and analysis, grounded in the belief that even our most wicked environmental problems have technological solutions.
  • The issue includes 7 essays, 3 responses, and one board game review.
  • Before I came on as editor of the Breakthrough Journal, I spent years in foreign policy journalism.

BioCardia Reports First Quarter 2022 Business Highlights and Financial Results

Retrieved on: 
Wednesday, May 11, 2022
Investigational New Drug, NK1R, Food, Research, U.S. Securities and Exchange Commission, China Biologic Products, Review, Cell, Intelligent Medical Objects, Heart failure, Breakthrough, Health Canada, Safety, AVANCE, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmacology, Pharmaceuticals and Medical Devices Agency, DSMB, Clinical trial, Medicare, Data monitoring committee, Growth, Achievement, GLOBE, Company, CMS, Letter, Insurance, Burn, Bone marrow, Adult, FDA, PMDA, Therapy, Security (finance), Nasdaq, Patient, Helix, Â, IND, BCDA, Forward-looking statement, Union, Centers for Medicare & Medicaid Services, Cell therapy, Diagnosis, Pharmaceutical industry, Medical device, Video game, COVID-19

First Quarter 2022 Financial Results:

Key Points: 
  • First Quarter 2022 Financial Results:
    The Company ended the quarter with cash and cash equivalents totaling $9.9 million, which together with the $1.5 million in net proceeds from our ATM in April 2022 at an average of $2.64 per share, provide runway into the first quarter of 2023.
  • Revenues increased to $60,000 in the first quarter of 2022, compared to $46,000 in the first quarter of 2021, due primarily to collaboration with corporate partners.
  • Selling, general and administrative expenses of $1.2 million in the first quarter of 2022 remained consistent with the $1.2 million in the first quarter of 2021.
  • Our net loss was $3.3 million in the first quarter of 2022, compared to $3.0 million in the first quarter of 2021.