Estonia

Poxel Provides Corporate Update and Reports Cash and Revenue for the Third Quarter and Nine Months 2023

Retrieved on: 
Mittwoch, November 8, 2023
Biotechnology, Pharmaceutical, Health, Adrenoleukodystrophy, Patient, Serono, ALD, Plasma, AMN, Patent, Biomarker, Sumitomo Pharma, Diabetes, Merck, SGLT2, Jaguar 3.4 Litre, EPO, Pharmacokinetics, Male, DPP4, Disease, Prescription, Marshal of France, Pioglitazone, European Patent Office, EUR, United States patent law, Merck Serono, VLCFA, Safety, European Patent Convention, JPY, Estonia, Kidney, POC, Pharmaceutical industry, Imeglimin

Sumitomo Pharma has worked diligently to increase the production and secure inventory capacity to meet this increasing demand.

Key Points: 
  • Sumitomo Pharma has worked diligently to increase the production and secure inventory capacity to meet this increasing demand.
  • For the Sumitomo Pharma FY 2023, as a conservative assumption in line with Sumitomo Pharma’s forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • On July 5th, Poxel was chosen as the winner of the 2023 edition of the I-nov contest for its program in ALD.
  • Next Financial Press Release: Fourth Quarter 2023 Cash and Revenue update, on February 15, 2024

Pearl’s Second Opinion® Dental AI Platform Cleared in Turkey

Retrieved on: 
Mittwoch, Oktober 18, 2023
Health, Dental, Technology, Health Technology, Artificial Intelligence, Medication, Turkish Medicines and Medical Devices Agency, Estonia, Crown, Medicines and Healthcare products Regulatory Agency, Osteoporosis, Dentist, Impacted wisdom teeth, Machine learning, Radioactive decay, Patient, Calculus, Second, Medical device, Dentistry, Pearl

Pearl , the global leader in dental AI solutions, today announced that its Second Opinion® chairside dental pathology detection aid has received clearance from the Turkish Medicines and Medical Devices Agency (TMMDA) as a Class IIa medical device.

Key Points: 
  • Pearl , the global leader in dental AI solutions, today announced that its Second Opinion® chairside dental pathology detection aid has received clearance from the Turkish Medicines and Medical Devices Agency (TMMDA) as a Class IIa medical device.
  • Pearl’s AI delivers its findings in real-time for patient-facing display in the dental operatory, helping dentists ensure the accuracy of their x-ray evaluations and enabling them to better communicate diagnoses to patients.
  • “At Pearl, it is our mission to equip dental practices around the world with the most clinically advanced AI on the market,” said Ophir Tanz, Founder and CEO of Pearl.
  • “Designed to advance consistent high quality and doctor-patient communication, Second Opinion®’s authorization for use in Turkey will deliver the unrivaled clinical benefits of AI to one of the fastest growing dental markets in the world.”

ViiV Healthcare to present 23 abstracts from innovative HIV treatment and prevention portfolio at EACS 2023

Retrieved on: 
Mittwoch, Oktober 18, 2023
AIDS, Health, Infectious Diseases, General Health, Clinical Trials, Pharmaceutical, Biotechnology, EACS, MPH, III, Biomarker, Rilpivirine, LA, HIV, Safety, Conference, Research, RWE, Shionogi, Titan IIIB, Pfizer, Lamivudine, Medicine, Abstract, HTE, GSK, XVII International AIDS Conference, 2008, ViiV Healthcare, Viral load, SOLAR, Estonia, Pharmaceutical industry, Vaccine, Fostemsavir, European, Dolutegravir/lamivudine

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of key abstracts highlighting the breadth of its approved and investigational medicines at the 19th Annual European AIDS Conference (EACS 2023) being held in Warsaw, Poland from 18-21 October 2023.

Key Points: 
  • ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of key abstracts highlighting the breadth of its approved and investigational medicines at the 19th Annual European AIDS Conference (EACS 2023) being held in Warsaw, Poland from 18-21 October 2023.
  • Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “Living well with HIV looks different for every individual, and we believe our upcoming presentations at EACS 2023 reflect our commitment and leadership to address the evolving needs of the HIV community.
  • Our latest data from our diverse portfolio and innovative pipeline explore real-world evidence that further evaluate the effectiveness, safety, and tolerability of 2-drug and long-acting regimens; new findings for broadly neutralizing antibodies; and long-term follow-up in heavily treatment-experienced individuals.
  • Here is a list of ViiV Healthcare-sponsored or supported studies being presented at EACS 2023:

Desktop Health Announces that Flexcera™ Smile Ultra+ is now Available in Europe, Following Recent Class IIa MDR Certification by the European Union

Retrieved on: 
Mittwoch, Oktober 4, 2023
Biotechnology, Practice Management, Medical Supplies, General Health, Health, Medical Devices, Health Technology, Dental, EU, DM, 3D, Multimedia, EnvisionTEC, Desktop Metal, Certification, MDR, Patient, Estonia, FDA, Environment, NYSE, Medical device, 3D printing, A2, A3

Desktop Health™, the trusted health care brand of Desktop Metal (NYSE:DM), announced that its popular Flexcera™ Smile Ultra+ dental resin, for 3D printing permanent and temporary restorations, is now available for purchase in Europe following its successful certification as a Class IIa medical device under the European Union Medical Device Regulation (MDR).

Key Points: 
  • Desktop Health™, the trusted health care brand of Desktop Metal (NYSE:DM), announced that its popular Flexcera™ Smile Ultra+ dental resin, for 3D printing permanent and temporary restorations, is now available for purchase in Europe following its successful certification as a Class IIa medical device under the European Union Medical Device Regulation (MDR).
  • View the full release here: https://www.businesswire.com/news/home/20231004075864/en/
    Desktop Health's Flexcera™ Smile Ultra+ dental resin for 3D printing permanent and temporary restorations is now available for purchase in Europe following its successful certification as a Class IIa medical device under the European Union Medical Device Regulation (MDR).
  • (Photo: Business Wire)
    Flexcera Smile Ultra+ delivers exceptional strength, life-like aesthetics, and the long-term performance expected from a permanent restoration material.
  • Already an FDA 510(k) Class II cleared material, Flexcera Smile Ultra+ has been commercially available in the United States since February 2022.

Poxel Reports Financial Results for First Half 2023 and Provides a Corporate Update

Retrieved on: 
Dienstag, September 26, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Diabetes, ULF, Adrenoleukodystrophy, Prescription, Plasma, JPY, Patent, Patient, Serono, Merck, R, Estonia, POC, Pioglitazone, Sumitomo Group, Disease, Male, NASH, Pharmacokinetics, Sumitomo Pharma, EPO, Fatty liver disease, Leukodystrophy, Marshal of France, Rare, Kidney, Conference, Safety, Abstract, DPP4, ALD, JDS, Merck Serono, European Patent Office, Biomarker, DSM-IV codes, AMN, IRIS, Scientific communication, United States patent law, SGLT2, VLCFA, EUR, European Patent Convention, Pharmacology, TZD, Pharmaceutical industry, Medical device, Imeglimin, Euronext

POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2023 and provided a corporate update.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2023 and provided a corporate update.
  • For the Sumitomo Pharma FY 2023, as a conservative assumption in line with Sumitomo Pharma’s forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • On July 5th, Poxel was chosen as the winner of the 2023 edition of the I-nov contest for its program in ALD.
  • This recently issued patent provides additional protection through 2041, with the potential for an additional 5 years through patent term extension.

Poxel Reports Cash and Revenue for the Second Quarter and First Half 2023 and Provides Corporate Update

Retrieved on: 
Mittwoch, August 30, 2023
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, ULF, Senior, Adrenoleukodystrophy, Prescription, Plasma, JPY, Patent, Patient, Serono, Merck, R, Estonia, POC, Pioglitazone, Sumitomo Group, Disease, Male, NASH, Pharmacokinetics, USD, EPO, Fatty liver disease, Leukodystrophy, Marshal of France, Rare, Kidney, Conference, Safety, Abstract, DPP4, ALD, JDS, Merck Serono, European Patent Office, Biomarker, DSM-IV codes, Communication, AMN, IRIS, Scientific communication, Sumitomo Pharma, United States patent law, SGLT2, VLCFA, European Patent Convention, Pharmacology, TZD, Pharmaceutical industry, Medical device, Cryptocurrency, Imeglimin, EUR, Euronext

These factors have resulted in a much higher increase in demand for TWYMEEG than expected by Sumitomo, and thus inventories are temporarily tight.

Key Points: 
  • These factors have resulted in a much higher increase in demand for TWYMEEG than expected by Sumitomo, and thus inventories are temporarily tight.
  • For the Sumitomo FY 2023, as a conservative assumption in line with Sumitomo’s forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • On July 5th, Poxel was chosen as the winner of the 2023 edition of the I-nov contest for its program in ALD.
  • As of June 30, 2023, cash and cash equivalents were EUR 7.6 million (USD 8.2 million), as compared to EUR 13.1 million (USD 14.0 million) as of December 31, 2022.

Poxel, winner of the 2023 edition of the I-nov contest

Retrieved on: 
Mittwoch, Juli 5, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, AMN, Male, State, Ministry of Culture (Spain), NASH, Adrenoleukodystrophy, Life, Marketing, Sovereignty, ALD, DSM-IV codes, Energy transition, Ministry, Ministry of Ecological Transition (France), Patient, Fatty liver disease, Marshal of France, Estonia, Investment, Ministry of Territorial Cohesion, Education, Ministry of Higher Education, Science, Research and Innovation, SME, Pharmaceutical industry, Renewable energy, Euronext, Culture, Research

This distinction is a recognition of the potential of the Company's drug candidates in development for this indication, PXL770 and PXL065.

Key Points: 
  • This distinction is a recognition of the potential of the Company's drug candidates in development for this indication, PXL770 and PXL065.
  • These studies are ready to be launched in adult male patients with adrenomyeloneuropathy (AMN), the most common form of ALD, subject to additional funding, which the Company is currently working on.
  • It selects, within the framework of a procedure encouraging competition, innovative projects with particularly high potential for the French economy.
  • The i-Nov competition, funded by the French State via France 2030 plan, is operated by Bpifrance in collaboration with ADEME.

Sorrento Announces Positive Phase IIa Study Results of Abivertinib for the Treatment of Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL) and Its Plan for a Pivotal Phase III Study

Retrieved on: 
Mittwoch, Juli 5, 2023
DOR, DCR, IC50, Lung cancer, BTK, PFS, Hypertension, Patient, EGFR, SAN, OTC, National Medical Products Administration, CR, Estonia, Arrhythmia, Therapy, III, NMPA, ORR, Safety, Pharmaceutical industry, Medical device

Sorrento has communicated with the China Health Authority (National Medical Products Administration or NMPA) regarding the design of a pivotal phase III registration study of R/R MZL in China.

Key Points: 
  • Sorrento has communicated with the China Health Authority (National Medical Products Administration or NMPA) regarding the design of a pivotal phase III registration study of R/R MZL in China.
  • SAN DIEGO, July 05, 2023 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (OTC: SRNEQ) today announced positive results from a China phase IIa study of Abivertinib on R/R MZL and its plan for a pivotal study.
  • (3) Sorrento has communicated with the NMPA, and a consensus has been reached for a pivotal phase III registration study for the treatment of R/R MZL.
  • The pivotal study will be a multicenter phase III study to assess the efficacy and safety of Abivertinib for treatment of relapsed/refractory marginal zone lymphoma.

HaemaLogiX Announces Positive Final Results from KappaMab Combination Phase IIb Myeloma Trial

Retrieved on: 
Donnerstag, Juni 29, 2023
Multiple myeloma, Lenalidomide, KMA, Dexamethasone, British Journal of Haematology, Patient, Toxic epidermal necrolysis, Estonia, Death, Safety, Disease, Pharmaceutical industry, Medical device

Excellent safety profile and significant efficacy bolster HaemaLogiX's plan to progress further KappaMab / standard of care combination studies.

Key Points: 
  • Excellent safety profile and significant efficacy bolster HaemaLogiX's plan to progress further KappaMab / standard of care combination studies.
  • SYDNEY, June 29, 2023 /PRNewswire/ -- HaemaLogiX Ltd, a clinical stage Australian biotech company developing novel immunotherapies for multiple myeloma, today announced positive final results from a Phase IIb clinical study of its monoclonal antibody KappaMab in combination with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatment options.
  • This Phase IIb trial followed a Phase IIa open-label multiple dose trial to determine the safety and efficacy of multiple doses of KappaMab monotherapy in 19 relapsed and / or refractory patients who had received multiple prior treatments.
  • Along with positive efficacy results, the trial demonstrated an excellent safety profile with no patients experiencing KappaMab related serious side effects.

Gleamer Raises €27 Million in Series B Funding Round to Expand its AI Solutions Portfolio and Speed up International Expansion

Retrieved on: 
Mittwoch, Juni 28, 2023
Health, Medical Devices, Technology, Software, Radiology, Artificial Intelligence, Biotechnology, DNA, CT, Pulmonary pathology, Catalog, Bone, Radiological Society of North America, Certification, MDR, Publication, Patient, Investment, MSK, Diagnosis, Estonia, RSNA, FDA, Mammography, Medical device

Today, Gleamer, the leading European manufacturer in AI-powered solutions for medical imaging, announced a Series B financing of €27 million.

Key Points: 
  • Today, Gleamer, the leading European manufacturer in AI-powered solutions for medical imaging, announced a Series B financing of €27 million.
  • This new investment will enable Gleamer to expand its portfolio of solutions, strengthen its European and American teams, and accelerate its international development plans.
  • Total funds raised to date amount to €36 million (which includes a Series A funding round of €7.5 million in 2020 and seed funding of €1.5 million in 2018).
  • Tomorrow, by extending its portfolio of solutions to CT scans and mammography, Gleamer will cover 70% of radiologists' daily needs.