University Clinical Centre in Gdańsk

ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results

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Thursday, November 2, 2023
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, Novartis Institute for Tropical Diseases, Research, NSCLC, Acute myeloid leukemia, IMGN, Food, PIN, Biomedical Research, ImmunoGen, European Medicines Agency, Doctor of Philosophy, Medicine, Capital expenditure, New Drug Application, Takeda Pharmaceutical Company, Marketing, BPDCN, ESGO, US Foods, Azacitidine, European Society of Gynaecological Oncology, EMA, ORR, NDA, Safety, Cancer, György Enyedi (geographer), Patient, National Medical Products Administration, Eli Lilly and Company, MAA, Congress, Mirvetuximab soravtansine, Blastic plasmacytoid dendritic cell neoplasm, ASH, Growth, ADC, Spacecraft, FDA, NMPA, PROC, University Clinical Centre in Gdańsk, Society, Senior, Inc., Huadong Medicine, AML, PARP, Vaccine, Pharmaceutical industry, Dietary supplement, Takeda

ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.

Key Points: 
  • ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.
  • We also continued to monitor the NSCLC cohort with IMGC936 and advanced dose escalation with IMGN151, our second-generation ADC targeting FRα.
  • Selling, general and administrative expenses were $37.7 million for the quarter ended September 30, 2023 compared to $33.6 million for the quarter ended September 30, 2022.
  • Capital expenditures were $1.6 million and $1.1 million for the first nine months of 2023 and 2022, respectively.

Oncoinvent Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for Radspherin® in Ovarian Cancer Patients

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Tuesday, October 31, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, IND, Ovarian cancer, Food, Progression-free survival, ESGO, Colorectal cancer, Congress, PFS, University Clinical Centre in Gdańsk, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Society of Gynaecological Oncology, Clinical trial, U.S. FDA, Safety, Patient, Pharmaceutical industry

This represents the second U.S. FDA IND clearance for Radspherin®, as last week, the company also announced an IND acceptance for Radspherin® in patients with peritoneal carcinomatosis from colorectal cancer.

Key Points: 
  • This represents the second U.S. FDA IND clearance for Radspherin®, as last week, the company also announced an IND acceptance for Radspherin® in patients with peritoneal carcinomatosis from colorectal cancer.
  • “We are thrilled to announce the IND clearance for this phase 2b study of Radspherin®, allowing for inclusion of patients in the first-line treatment setting of ovarian cancer,” said Anders Månsson, Chief Executive Officer of Oncoinvent.
  • “This IND clearance comes in succession to the IND clearance of Radspherin® in colorectal cancer patients, announced recently.
  • It is a randomized controlled phase 2b trial, assessing efficacy and safety of Radspherin® in patients with peritoneal metastasis from ovarian cancer.

Avextra Unveils its Alliance for Evidence and Announces its Support of BELCANTO: A Clinical Trial for Oncology Patients

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Wednesday, October 18, 2023
Real-World Evidence, WHO, Kiel University, Summer, Isabella Tree, Trichopus, Federal Institute for Drugs and Medical Devices, CBD, University Clinical Centre in Gdańsk, Medical device, Cannabis, Research, Palliative care, Safety, Overalls, Patient, Pharmaceutical industry, Nursing

Avextra announces its support of BELCANTO; a Phase 2 double-blind clinical trial initiated by Prof. Dr. med.

Key Points: 
  • Avextra announces its support of BELCANTO; a Phase 2 double-blind clinical trial initiated by Prof. Dr. med.
  • As the first project within this alliance, Avextra is delighted to announce its support of its first Phase 2 study – a randomised, double-blind, placebo-controlled clinical trial, under the name BELCANTO.
  • The trial will be mainly conducted at Kiel University along with three other leading medical centres across Germany, enrolling approximately 170 oncology patients.
  • "BELCANTO is an ideal project to launch Avextra’s Alliance for Evidence-based Cannabis Medicine," said Dr. Bernhard Babel, CEO, at Avextra.

Oncoinvent To Present Initial Safety Data from the Phase 1 Trial of Radspherin® in Ovarian Cancer Patients at the 24th Congress of the European Society of Gynaecological Oncology (ESGO)

Retrieved on: 
Thursday, September 28, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Fibroadenoma, European Society of Gynaecological Oncology, DLT, Congress Center, ESGO, University Clinical Centre in Gdańsk, Congress, Patient, Becquerel, Cytoreductive surgery, Istanbul Congress Center, Ovarian cancer, Safety, Pharmaceutical industry

"Oncoinvent is proud to present safety data from our lead candidate, Radspherin® at a major congress of the global gynecological cancer community.

Key Points: 
  • "Oncoinvent is proud to present safety data from our lead candidate, Radspherin® at a major congress of the global gynecological cancer community.
  • We believe this is an important first step as we advance the development of Radspherin® as a new treatment for patients with advanced ovarian cancer,” says CEO Anders Månsson.
  • The safety interim analysis after completion of the dose-limiting toxicity (DLT) period demonstrated that Radspherin® was well tolerated.
  • The highest dose of 7 MBq was recommended following the completion of dose escalation of 1-2-4-7 MBq, as no DLT was observed.

ELAHERE® Shows Overall and Progression-Free Survival Benefit Regardless of Prior PARPi Exposure or Prior Lines of Therapy in FRα-Positive Platinum-Resistant Ovarian Cancer

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Thursday, September 28, 2023
Oncology, Health, General Health, Research, Science, Pharmaceutical, Biotechnology, Topotecan, European Society of Gynaecological Oncology, Pros, Bevacizumab, University, Progression-free survival, Neoplasm, Catholic University of Leuven (1834–1968), OS, IC, Cancer, Paclitaxel, PLD, ESGO, PFS, University Clinical Centre in Gdańsk, Mirvetuximab soravtansine, IMGN, PROC, ASCO, Congress, Ventana, American Society of Clinical Oncology, Patient, Physician, TYPE, Annual general meeting, CRS, Spacecraft, GOG, PARP, Society, ORR, Safety, Pharmaceutical industry, Medical imaging

Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 40% had two prior lines of therapy, and 46% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%).

Key Points: 
  • Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 40% had two prior lines of therapy, and 46% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%).
  • 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitor.
  • Key secondary endpoints include objective response rate (ORR), overall survival (OS), and patient-reported outcomes (PROs).
  • ELAHERE demonstrated clinically meaningful improvements in PFS and ORR by investigator assessment and in OS compared to IC chemotherapy, regardless of prior lines of therapy (PLOT).

ImmunoGen Reports Recent Progress and Second Quarter 2023 Financial Results

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Monday, July 31, 2023
Health, General Health, Capital expenditure, ASH, Marketing, MOH, European Medicines Agency, Survival, American Society of Clinical Oncology, György Enyedi (geographer), ESGO, Congress, Huadong Medicine, Patient, National Medical Products Administration, Spacecraft, European Hematology Association, Research, University Clinical Centre in Gdańsk, Mirvetuximab soravtansine, EMA, ADC, FDA, NMPA, Cancer, NSCLC, Acute myeloid leukemia, PROC, Ministry, PIN, ImmunoGen, MAA, Ovarian cancer, ORR, European Society of Gynaecological Oncology, Clinical trial, ASCO, AML, Azacitidine, Annual general meeting, EHA, BPDCN, Society, Food, Medicine, Vaccine, Pharmaceutical industry, Mobile phone

(Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2023.

Key Points: 
  • (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2023.
  • Research and development expenses were $50.1 million for the quarter ended June 30, 2023 compared to $51.4 million for the quarter ended June 30, 2022.
  • Selling, general and administrative expenses were $36.4 million for the quarter ended June 30, 2023 compared to $23.8 million for the quarter ended June 30, 2022.
  • Net loss for the second quarter of 2023 was $4.2 million, or $0.02 per share, compared to a net loss of $62.0 million, or $0.24 per share, for the second quarter of 2022.

First Gene Therapy for Adults with Severe Hemophilia A, BioMarin's ROCTAVIAN™ (valoctocogene roxaparvovec), Approved by European Commission (EC)

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Wednesday, August 24, 2022
People, European Medicines Agency, Experimental Hematology, EMA, Haemophilia, Public health, Fatigue, Safety, Delayed onset muscle soreness, Call, University Clinical Centre in Gdańsk, Malignancy, Biologics license application, Nausea, NASDAQ, Time, Table, Achievement, Factor VIII, AST, Information management, ABR, CMA, United Kingdom Haemophilia Centre Doctors' Organisation, RAFAEL, ALT, Royal commission, Perseverance, Headache, Medication, AE, Consumer Product Information Database, Transfusion medicine, Antibody, Medicine, Company, BLA, EC, BMRN, Adult, Bleeding, Mutation, Risk, Injury, BioMarin Pharmaceutical, Institute, Content, European Commission, Review, Coagulopathy, Patient, Vaccine, Medical device, Pharmaceutical industry, Webcast, EU, Conference

SAN RAFAEL, Calif., Aug. 24, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the European Commission (EC) has granted conditional marketing authorization (CMA) to ROCTAVIAN™ (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5). The EC also endorsed EMA's recommendation for Roctavian to maintain orphan drug designation, thereby granting a 10-period of market exclusivity.  The EMA recommendation noted that, even in light of existing treatments, Roctavian may potentially offer a significant benefit to those affected with severe Hemophilia A.  The one-time infusion is the first approved gene therapy for hemophilia A and works by delivering a functional gene that is designed to enable the body to produce Factor VIII on its own without the need for continued hemophilia prophylaxis, thus relieving patients of their treatment burden relative to currently available therapies. People with hemophilia A have a mutation in the gene responsible for producing Factor VIII, a protein necessary for blood clotting.

Key Points: 
  • The EMA recommendation noted that, even in light of existing treatments, Roctavian may potentially offer a significant benefit to those affected with severe Hemophilia A.
  • People with hemophilia A have a mutation in the gene responsible for producing Factor VIII, a protein necessary for blood clotting.
  • It is estimated that more than 20,000 adults are affected by severe hemophilia A across more than 70 countries in Europe, the Middle East, and Africa.
  • Of the 8,000 adults with severe hemophilia A in the 24 countries within BioMarin's footprint covered by today's EMA approval, there are an estimated 3,200 patients who will be indicated for Roctavian.

German skin cancer patients join the EPIC-Skin study

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Thursday, July 28, 2022
Time, Skin, Rhenium, Trial of the century, CEO, Social media, University Clinical Centre in Gdańsk, Nuclear medicine, Destroy All Humans! 2, Risk, Squamous cell carcinoma, Health, Scar, Efficacy, Safety, Cancer, Quality of life, Regeneration, Patient, Skin cancer, Pharmaceutical industry, Medical imaging, Medical device, NMSC

The first German patients were treated on 21st July, and are now part of 210 adults participating in the international study that will follow their progress over the next 24 months.

Key Points: 
  • The first German patients were treated on 21st July, and are now part of 210 adults participating in the international study that will follow their progress over the next 24 months.
  • The EPIC-Skin study is being conducted through study centres located in Australia, Austria, United Kingdom and Germany.
  • In addition to this EPIC-Skin Study, The University Clinic of Rostock has also been involved in a local clinical study using Rhenium-SCT, with results due to be presented later this year.
  • To provide a simple and streamlined way to record their experiences, patients in the study will utilise OncoBeta's Clinical Study app.

BioMarin Receives Positive CHMP Opinion in Europe for Valoctocogene Roxaparvovec Gene Therapy to Treat Adults with Severe Hemophilia A

Retrieved on: 
Friday, June 24, 2022
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SAN RAFAEL, Calif., June 24, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization (CMA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. A final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission in Q3 2022.

Key Points: 
  • ET
    SAN RAFAEL, Calif., June 24, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization (CMA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A.
  • Roctavian is the first gene therapy to be recommended for approval in Europe for hemophilia A.
  • BioMarin has multiple clinical studies underway in its comprehensive gene therapy program for the treatment of hemophilia A.
  • Individuals with the most severe form of hemophilia A make up approximately 50 percent of the hemophilia A population.

ReCor Medical Launches the Paradise™ Ultrasound Renal Denervation for the Treatment of Hypertension in Europe

Retrieved on: 
Wednesday, October 6, 2021
Biotechnology, Medical Devices, Health, Radiology, Cardiology, DGK, Mortality, Blood pressure, ReCore, University Clinical Centre in Gdańsk, Homburg (Saar) Hauptbahnhof, Culture, PMA, Saarland University, Sale, Tokyo Stock Exchange, FDA, Renal artery, Patient, Physician, Caregiver, Hospital, Disease, Hypertension, TRIO, CEO, Death, European Society of Cardiology, Artery, PD, SOLO, Incidence, Quality of life, Pharmaceutical industry, ReCor Medical, Inc., Otsuka Medical Devices Co., Ltd., RECOR MEDICAL, INC., OTSUKA MEDICAL DEVICES CO., LTD.

ReCor Medical, Inc. (ReCor), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., announced today that the companys Paradise Ultrasound Renal Denervation System (the Paradise System) is now available for the treatment of uncontrolled hypertension in Germany.

Key Points: 
  • ReCor Medical, Inc. (ReCor), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., announced today that the companys Paradise Ultrasound Renal Denervation System (the Paradise System) is now available for the treatment of uncontrolled hypertension in Germany.
  • We are pleased to be one of the first hospitals in Europe to offer renal denervation with ultrasound.
  • Paradise ultrasound renal denervation is a device-based, minimally invasive procedure for the treatment of high blood pressure.
  • With its Paradise System ReCor has pioneered the minimally invasive use of ultrasound in renal denervation to treat patients with hypertension.