Breakthrough

Breakthrough Properties to Develop New European Headquarters for Neogene Therapeutics

Retrieved on: 
Thursday, September 21, 2023
Carbon, CRISPR, Trinity, European Medicines Agency, CRISPR Therapeutics, Cancer, BREEAM, Research, AstraZeneca, PV, TCR, Science, Becton, Dickinson and Company headquarters, Biodiversity, Development, Isatis tinctoria, Innovation Park, City, Patient, UMC, August Kavel, Growth, Heat, UNStudio, Health, Therapy, Environment, Saint John's, BD, Airline, Pharmaceutical industry, Creative industries, Neogene, Breakthrough

AMSTERDAM, Sept. 21, 2023 /PRNewswire/ -- Breakthrough Properties, a premier global life sciences real estate developer, announced that it has reached an agreement with Neogene Therapeutics to develop its new European headquarters within the campus of the Amsterdam University Medical Center (Amsterdam UMC), one of Europe's leading medical institutions.

Key Points: 
  • Kavel F by Breakthrough (Kavel F) is destined to become one of the most sustainable laboratory environments in the world.
  • "Breakthrough is thrilled to support the Neogene team as it aims to bring the potential benefits of T cell receptor therapies to more patients with cancer," said Breakthrough Properties Chief Executive Officer and Co-Founder Dan Belldegrun.
  • "Kavel F is emblematic of Breakthrough Properties' mission to support cutting edge science by delivering high-quality, sustainable environments."
  • Prof. Dr. Hans van Goudoever, dean and vice chair of the executive board of Amsterdam UMC said, "Amsterdam UMC is thrilled to have Breakthrough Properties and Neogene as next-door partners.

Breakthrough Properties to Develop New European Headquarters for Neogene Therapeutics

Retrieved on: 
Thursday, September 21, 2023
Carbon, CRISPR, Trinity, European Medicines Agency, CRISPR Therapeutics, Cancer, BREEAM, Research, AstraZeneca, PV, TCR, Science, Becton, Dickinson and Company headquarters, Biodiversity, Development, Isatis tinctoria, Innovation Park, City, Patient, UMC, August Kavel, Growth, Heat, UNStudio, Health, Therapy, Environment, Saint John's, BD, Airline, Pharmaceutical industry, Creative industries, Neogene, Breakthrough

AMSTERDAM, Sept. 21, 2023 /PRNewswire/ -- Breakthrough Properties, a premier global life sciences real estate developer, announced that it has reached an agreement with Neogene Therapeutics to develop its new European headquarters within the campus of the Amsterdam University Medical Center (Amsterdam UMC), one of Europe's leading medical institutions.

Key Points: 
  • Kavel F by Breakthrough (Kavel F) is destined to become one of the most sustainable laboratory environments in the world.
  • "Breakthrough is thrilled to support the Neogene team as it aims to bring the potential benefits of T cell receptor therapies to more patients with cancer," said Breakthrough Properties Chief Executive Officer and Co-Founder Dan Belldegrun.
  • "Kavel F is emblematic of Breakthrough Properties' mission to support cutting edge science by delivering high-quality, sustainable environments."
  • Prof. Dr. Hans van Goudoever, dean and vice chair of the executive board of Amsterdam UMC said, "Amsterdam UMC is thrilled to have Breakthrough Properties and Neogene as next-door partners.

Brella™ 3-Minute SweatControl Patch Wins Prestigious Allure 2023 Best of Beauty Breakthrough Award

Retrieved on: 
Thursday, September 21, 2023
ASDS, Beauty, Patient, Breakthrough, Society, Needle, Pain

NASHVILLE, Tenn., Sept. 21, 2023 /PRNewswire/ -- Candesant Biomedical ("Candesant"), a private medical device company focused on developing and commercializing non-invasive treatments for primary axillary hyperhidrosis or excessive underarm sweating, is thrilled to announce that Brella™, the only 3-Minute SweatControl Patch, has been named a 2023 Allure Best of Beauty Breakthrough Award Winner. Brella is the first in-office sweat control innovation to receive a Breakthrough Award, which recognizes the most innovative new products in the aesthetic market.

Key Points: 
  • Three to Four Months Without Needles, Pain, or Downtime1
    NASHVILLE, Tenn., Sept. 21, 2023 /PRNewswire/ -- Candesant Biomedical ("Candesant"), a private medical device company focused on developing and commercializing non-invasive treatments for primary axillary hyperhidrosis or excessive underarm sweating, is thrilled to announce that Brella™, the only 3-Minute SweatControl Patch, has been named a 2023 Allure Best of Beauty Breakthrough Award Winner .
  • Brella is the first in-office sweat control innovation to receive a Breakthrough Award, which recognizes the most innovative new products in the aesthetic market.
  • "We're honored to receive this prestigious award and to have Brella's sweat control technology recognized as a Breakthrough by Allure's world-renowned beauty experts," said Niquette Hunt, Founder and CEO of Candesant.
  • I am excited to offer Brella as a true breakthrough technology in sweat control."

Mount Nittany Medical Center Increases Accuracy and Efficiency of Vancomycin Dosing Using InsightRX Model-Informed Precision Dosing Platform

Retrieved on: 
Tuesday, September 19, 2023
Infection, Vancomycin, Partnership, Doctor of Pharmacy, AUC, Workflow, Mount Nittany Medical Center, Research, Doctor of Philosophy, AKI, State College, Pennsylvania, Acute kidney injury, Data analysis, Hospital, Patient, SAN, Breakthrough, Conference, Pharmaceutical industry, Nursing, List of things named after Thomas Bayes

SAN FRANCISCO, Sept. 19, 2023 /PRNewswire/ -- InsightRX – which provides cloud-based precision medicine software to optimize treatment decisions – today announced results of a data analysis by Mount Nittany Medical Center showing how deploying InsightRX's Bayesian software integrated with PINC AI™ Clinical Surveillance powered by TheraDoc® for monitoring vancomycin dosing helped increase efficiency and optimized pharmacist workflow compared to industry benchmarks.

Key Points: 
  • Based in State College, Pa., Mount Nittany Health operates Mount Nittany Medical Center, a 260-bed acute care facility with a 24-bed intensive care unit and a 61-bed emergency department (ED).
  • Mount Nittany Medical Center has roughly 55,000 ED visits each year.
  • While there are several ways to calculate AUC, Mount Nittany Medical Center chose to implement Bayesian modeling using InsightRX's model-informed precision dosing (MIPD) software platform.
  • "We are excited by the results of Mount Nittany Medical Center's comparative analysis and look forward to continuing our partnership."

INOVIO Announces U.S. FDA Breakthrough Therapy Designation Granted for INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis

Retrieved on: 
Thursday, September 7, 2023
DNA, TRIO, Contract research organization, Civil service commission, Face, RRP, Food, ABEA, Cancer, Infection, Breakthrough therapy, Orphan drug, Patient, ALA, Annual general meeting, Breakthrough, HPV, Recurrence, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Commission, Pharmaceutical industry, Laryngoscopy

PLYMOUTH MEETING, Pa., Sept. 7, 2023 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for INO-3107 as a potential treatment for patients with Recurrent Respiratory Papillomatosis (RRP). The FDA's Breakthrough Therapy designation is a process designed to expedite the development and review of drug candidates that are intended to treat a serious or life-threatening condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

Key Points: 
  • "As we recently announced, we have been interacting with the FDA with the goal to launch a pivotal trial for INO-3107 in the near term.
  • The President of the Recurrent Respiratory Papillomatosis Foundation, Kim McClellan, said: "RRP patients will tell you that even one reduction in the number of disruptive, invasive surgeries they face would be life-changing.
  • This Breakthrough Therapy designation for INO-3107 follows receipt of Orphan Drug designation from the European Commission in May 2023 and from the FDA in 2020.
  • INOVIO plans to initiate a pivotal trial of INO-3107 in the first quarter of 2024, subject to FDA clearance.

6sense to Host the Fifth Annual Breakthrough 2023, Bringing Together a Robust Community of Sales and Marketing Leaders

Retrieved on: 
Wednesday, September 6, 2023
Software, Digital Marketing, Marketing, Content Marketing, Artificial Intelligence, Data Management, Communications, Technology, Omni, Burnout, The Challenger Sale, Business development, SDR, Conga, Organization, Community, NVIDIA, Author, Breakthrough, ThoughtSpot, CFO, Growth, AI, Sales, Management, Industrial design, Intelligence, Twilio

The fifth annual Breakthrough event will feature:

Key Points: 
  • The fifth annual Breakthrough event will feature:
    Expanded programming that brings the entire revenue team together.
  • This year includes full content tracks for Sales and Business Development Representative (SDR/BDR) leaders to ensure alignment.
  • 6sense Solutions Lounge, where attendees have time and space to meet with product leaders and subject-matter experts.
  • Community building, memorable experiences, and fun with 1,200 marketing and sales professionals over the course of three days.

Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib for Treatment of Patients with NTRK-positive TKI-pretreated advanced solid tumors in China

Retrieved on: 
Wednesday, August 30, 2023
TKI, Policy, New Drug Application, NDA, Quality of life, Medicine, NSCLC, HKEX, Patient, NTRK, National Medical Products Administration, Breakthrough, CDE, Center for Drug Evaluation and Research, NMPA, TRK, Pharmaceutical industry

The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.

Key Points: 
  • The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.
  • “We are excited to receive our fourth Breakthrough Therapy Designation for repotrectinib in China.
  • Today’s recognition further supports repotrectinib as a potential first-in-class treatment for patients with NTRK-positive, TKI-pretreated solid tumors in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • Drugs granted Breakthrough Therapy Designations receive priority communications and guidance from the CDE to promote and expedite the drug development process.

BioXcel Therapeutics Reports Second Quarter 2023 Financial Results and Announces Strategic Reprioritization

Retrieved on: 
Monday, August 14, 2023
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ET today

Key Points: 
  • ET today
    NEW HAVEN, Conn., Aug. 14, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the second quarter ended June 30, 2023, and a strategic reprioritization to strengthen its focus and significantly reduce operating expenses.
  • Continuing to actively evaluate strategic options for OnkosXcel Therapeutics, including potential financing or strategic partnership, M&A, or sale.
  • Net Loss: BioXcel Therapeutics had a net loss of $53.5 million for the second quarter of 2023, compared to a net loss of $37.7 million for the same period in 2022.
  • ET to discuss its second quarter 2023 financial results and provide an update on recent operational highlights.

AngioDynamics Receives FDA Breakthrough Device Designation for the AngioVac System for the Non-Surgical Removal of Right Heart Vegetation

Retrieved on: 
Tuesday, August 15, 2023
Cardiology, Surgery, Oncology, Health, FDA, Medical Devices, Health Technology, Other Health, IVC, Communication, Cancer, Superior vena cava, Quality of life, Patient, Thrombus, Blood, Diagnosis, SVC, Embolism, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Food, Pharmaceutical industry, Medical device

The FDA Breakthrough Device designation is designed to help patients gain timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved or cleared alternatives exist.

Key Points: 
  • The FDA Breakthrough Device designation is designed to help patients gain timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved or cleared alternatives exist.
  • The system allows for the removal of thrombus and embolic material while minimizing blood loss via a recirculation of blood through the AngioVac extracorporeal (venovenous) bypass circuit.
  • Target vessels for the thrombus/embolus extraction include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Heart.
  • Under the Breakthrough Device designation, AngioDynamics will engage with the FDA to achieve this new expanded indication for the non-surgical removal of vegetation from the right heart.

TLGY Acquisition Corporation Announces Filing of Registration Statement on Form S-4 in Connection With Its Proposed Business Combination With Verde Bioresins

Retrieved on: 
Tuesday, August 15, 2023
Chemicals, Plastics, Manufacturing, SPAC, LLP, Plastic, Partnership, PIPE, Economics, TPG, Wilmer Cutler Pickering Hale and Dorr, Braskem, Register, Prospectus, Acquisition, Investment, Earnout, Form, Corona Labs Inc., Environment, Breakthrough, IRR, Registration statement, Security (finance), Oil

While the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Verde, TLGY, and the proposed business combination.

Key Points: 
  • While the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Verde, TLGY, and the proposed business combination.
  • The proposed business combination sets Verde's implied pre-money enterprise value at closing at $365 million ($433 million pro forma EV), excluding earnouts.
  • Cleary Gottlieb Steen & Hamilton LLP is serving as legal advisor and Marcum Bernstein & Pinchuk LLP is serving as auditor to TLGY Acquisition Corporation.
  • IR Labs Inc. is serving as investor relations and public relations for the proposed business combination.