Medicines and Healthcare products Regulatory Agency

Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

Retrieved on: 
Tuesday, August 8, 2023

MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablation System. The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AF), features the POLARx FIT Cryoablation Balloon Catheter, a device with the unique capability of enabling two balloon sizes – 28 and 31mm – in one catheter.

Key Points: 
  • First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems
    MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablation System.
  • "The U.S. approval of the POLARx Cryoablation System, which has been used in more than 25,000 patients worldwide to date, marks an exciting advancement for the treatment of AF and a new era of cryoablation capabilities," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific.
  • The POLARx Cryoablation System received CE Mark in February of 2020 and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval in October of 2021.
  • The POLARx FIT catheter received approval in Europe, Japan, Canada and other Asia Pacific markets in 2023.

Entrada Therapeutics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, August 8, 2023

BOSTON, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today reported financial results for the second quarter ending June 30, 2023, and highlighted recent business updates.

Key Points: 
  • – $377 million in cash, cash equivalents and marketable securities as of June 30, 2023 –
    BOSTON, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today reported financial results for the second quarter ending June 30, 2023, and highlighted recent business updates.
  • Research & Development (R&D) Expenses: R&D expenses were $26.3 million for the second quarter of 2023, compared to $16.2 million for the same period in 2022.
  • General & Administrative (G&A) Expenses: G&A expenses were $8.2 million for the second quarter of 2023, compared to $7.3 million for the same period in 2022.
  • Net Loss: Net loss was $25.9 million for the second quarter of 2023, compared to a net loss of $23.2 million for the same period in 2022.

Cara Therapeutics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 7, 2023

“In the second quarter of 2023, the commercialization of KORSUVA® (difelikefalin) injection in the U.S. and Kapruvia® in countries around the world continued to make meaningful progress.

Key Points: 
  • “In the second quarter of 2023, the commercialization of KORSUVA® (difelikefalin) injection in the U.S. and Kapruvia® in countries around the world continued to make meaningful progress.
  • All three trials are enrolling patients and the internal readout from Part A of our KIND Phase 3 program in AD is expected in the fourth quarter of 2023.
  • Wholesalers shipped 66,852 vials to dialysis centers, the majority of which were Fresenius clinics, during the second quarter of 2023.
  • In the second quarter of 2023, Kapruvia generated $1.2 million in net sales and the Company recorded $123,000 in royalty revenue associated with Kapruvia sales in Europe.

Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset

Retrieved on: 
Friday, August 4, 2023

Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical data visualization software .

Key Points: 
  • Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical data visualization software .
  • The combination of Pinnacle 21 Enterprise and SEND Explorer enables synergy for meeting global regulatory guidelines and delivering efficiency.
  • SEND Explorer is a validated, web-based application that provides advanced viewing, data summarization and visualization capabilities for nonclinical study data.
  • Using SEND Explorer, scientists generate visualizations of single and multiple toxicology studies to inform decisions and quickly address questions from health authorities.

iRhythm Technologies Announces Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023

SAN FRANCISCO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today reported financial results for the three and six months ended June 30, 2023.

Key Points: 
  • SAN FRANCISCO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today reported financial results for the three and six months ended June 30, 2023.
  • Revenue for the second quarter of 2023 was $124.1 million, up 21.6% from $102.1 million during the same period in 2022.
  • Operating expenses for the second quarter of 2023 were $105.1 million, compared to $93.7 million for the same period in 2022.
  • Adjusted operating expenses for the second quarter of 2023 were $99.7 million, compared to $93.5 million during the same period in 2022.

180 Life Sciences Provides Update on Regulatory Approval Process in the UK and US for Dupuytren’s Disease Treatment; Continues Consultations with the UK MHRA and Initiates a Type C Meeting Request With the US FDA

Retrieved on: 
Thursday, August 3, 2023

A meeting with the MHRA is anticipated to take place in late Q3 of 2023 with the written responses anticipated to be received prior to year end.

Key Points: 
  • A meeting with the MHRA is anticipated to take place in late Q3 of 2023 with the written responses anticipated to be received prior to year end.
  • The Company’s regulatory consultants have indicated that initiation of an additional clinical trial (Phase 3) may be required to obtain CMA approval, and such a trial has been designed.
  • In support of our FDA Type C meeting request, a leading pharmaceutical biosimilar manufacturer will be participating with 180 Life Sciences in the FDA advice discussion.
  • Promising data from a Phase 2b Dupuytren’s treatment trial was published in the June 2022 issue of The Lancet Rheumatology(1).

Virtuosi® Immersive Training Program Implemented at Samsung Bioepis

Retrieved on: 
Wednesday, August 2, 2023

ALEXANDRIA, Va., Aug. 2, 2023 /PRNewswire-PRWeb/ -- Pharmaceutical manufacturing and training innovations required for the industry's Pharma 4.0 advancement have been accelerating throughout the world, most recently in South Korea, where Samsung Bioepis just adopted Quality Executive Partners Inc.'s Virtuosi immersive learning and training program for manufacturing operators.

Key Points: 
  • Virtuosi was created by the technical experts at Quality Executive Partners, Inc. to meet the needs of industry.
  • ALEXANDRIA, Va., Aug. 2, 2023 /PRNewswire-PRWeb/ -- Pharmaceutical manufacturing and training innovations required for the industry's Pharma 4.0 advancement have been accelerating throughout the world, most recently in South Korea, where Samsung Bioepis just adopted Quality Executive Partners Inc.'s Virtuosi immersive learning and training program for manufacturing operators.
  • Virtuosi's tech-forward one-of-a-kind platform uses video courses to teach employees analytical and critical thinking skills, including the "why" behind the science.
  • QxP's installation of Virtuosi in South Korea marks a significant step in its expansion into the Asia-Pacific region.

Entrada Therapeutics Receives Authorization in the United Kingdom to Initiate Phase 1 Clinical Trial of ENTR-601-44 for the Potential Treatment of Duchenne Muscular Dystrophy

Retrieved on: 
Tuesday, August 1, 2023

BOSTON, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today announced that it has received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its CTIMP (Clinical Trial of an Investigational Medicinal Product) for a Phase 1 clinical trial in healthy volunteers for ENTR-601-44. ENTR-601-44 is Entrada’s lead product candidate within its Duchenne franchise and is being developed for the potential treatment of individuals with Duchenne who are exon 44 skipping amenable.

Key Points: 
  • ENTR-601-44 is Entrada’s lead product candidate within its Duchenne franchise and is being developed for the potential treatment of individuals with Duchenne who are exon 44 skipping amenable.
  • “We are looking forward to this important next step in advancing ENTR-601-44 for the potential treatment of people with exon 44 skipping amenable Duchenne muscular dystrophy, where there exists a profound unmet medical need,” said Dipal Doshi, President and Chief Executive Officer of Entrada Therapeutics.
  • The trial will also evaluate tolerability, pharmacokinetics and target engagement as measured by exon skipping in the skeletal muscle.
  • The first participant is expected to be dosed in September of this year with data anticipated in the second half of 2024.

CDISC Selects Myota to Protect IP Against Ransomware Attacks

Retrieved on: 
Friday, July 21, 2023

CDISC has selected Myota's bucketZero solution to bolster their IP protection capabilities.

Key Points: 
  • CDISC has selected Myota's bucketZero solution to bolster their IP protection capabilities.
  • "With Myota bucketZero, CDISC gains an unparalleled defense against evolving data threats.
  • About CDISC: CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality.
  • About Myota: Myota is a leading provider of advanced data protection platforms, offering comprehensive solutions that ensure data durability, availability, security, and compliance.

C-Path Integrates European Offices to Optimize Global Operations and Collaborative Partnerships

Retrieved on: 
Tuesday, July 18, 2023

This integration will enable C-Path to increase its activity in Europe and broaden its global operations.

Key Points: 
  • This integration will enable C-Path to increase its activity in Europe and broaden its global operations.
  • "We are thrilled to bring the talented European teams together as a unified organisation.
  • Doing so allows us to expand our presence in Europe and strengthen our global operations.
  • With this strengthened global presence, it remains committed to leading collaborations that accelerate drug development, advancing better treatments for people worldwide.