PMDA

Sermonix Pharmaceuticals Announces Chinese Approval of Investigational New Drug Application for Lasofoxifene

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четверг, июня 6, 2024
National Comprehensive Cancer Network, MBC, Patient, Society, CSCO, Mutation, Breast cancer, NCCN, Cancer, Eli Lilly, PMDA, AIS, Breast, Medicine, Therapy, Neoplasm, Biology, SVP, NMPA, Fulvestrant, ESR1, Pharmaceutical industry

The IND approval allows Henlius to join the ongoing global registrational ELAINE-3 trial with responsibility in China.

Key Points: 
  • The IND approval allows Henlius to join the ongoing global registrational ELAINE-3 trial with responsibility in China.
  • This month, Henlius expanded its license from Sermonix to add additional Asia territories for upfront, milestone and royalty payments.
  • The agreement also allows Henlius to share with Sermonix expedited co-development of oral lasofoxifene in Japan.
  • “With active ELAINE-3 enrollment already underway in the U.S., Canada, EU and Israel, we are pleased to announce that Henlius, our Chinese development partner for oral lasofoxifene, received approval for its investigational new drug application,” said Dr. David Portman, Sermonix founder and chief executive officer.

XEOMIN® (incobotulinumtoxinA) receives a new therapeutic indication for Switzerland

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пятница, июня 14, 2024
Biotechnology, Pharmaceutical, Health, Neurology, Survivor, Merz, Patient, AB toxin, Neurotoxin, Therapy, Medication, PMDA, Spasticity, Stroke, Health care, MHRA, Pharmaceutical industry

Previously, the approval included spasticity of the upper limb and has now been extended, enabling Merz Therapeutics to offer more individualized comprehensive treatment to people living with spasticity in Switzerland.

Key Points: 
  • Previously, the approval included spasticity of the upper limb and has now been extended, enabling Merz Therapeutics to offer more individualized comprehensive treatment to people living with spasticity in Switzerland.
  • “The approval in Switzerland is an important next step for Merz Therapeutics, empowering us to maximize patient outcomes to deliver on our promise of ‘Better Outcomes for More Patients’,” says Stefan König, CEO Merz Therapeutics.
  • “Building on last year’s label extension in the United Kingdom, we can now offer combined upper and lower limb spasticity treatment to patients in two European countries.
  • This represents another important step in the right direction and an excellent foundation which we will further build on,” he explains.

Shape Memory Medical Announces First Patient Treated in the AAA-SHAPE Randomized Controlled Pivotal Trial

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понедельник, июня 3, 2024
Science, Cardiology, Biotechnology, Research, Surgery, Health, Medical Devices, Clinical Trials, MD, Patient, Vascular surgery, Indiana University, Trial of the century, Safety, EVAR, Area studies, CE, Abdominal aortic aneurysm, Randomized controlled trial, Aneurysm, Expansion, Blood, Federal, Mortality, AAA, Neurovascular bundle, PMDA, Medical imaging

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first patient treated as part of the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).

Key Points: 
  • Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first patient treated as part of the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).
  • “We would like to congratulate Dr. Motaganahalli and the clinical study team at Indiana University for being the first to enroll a patient in the AAA-SHAPE Pivotal Trial.
  • IMPEDE-FX RapidFill, the investigational device, incorporates Shape Memory Medical’s novel shape memory polymer, a proprietary, porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood.
  • Prior to the AAA-SHAPE Pivotal Trial, the AAA-SHAPE early feasibility studies enrolled a combined 35 patients in New Zealand and the Netherlands.

QIAGEN and Myriad Genetics develop distributable homologous recombination deficiency test for global research and companion diagnostics applications

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четверг, мая 30, 2024
NGS, Partnership, Patient, DNA, CDX, PMDA, Ovarian cancer, Myriad Genetics, QGEN, Clinical trial, MYGN, BRCA2, FDA, Neoplasm, Senior, Research, PMA, GIS, Cancer, Genetics, IP, Biomarker, BRCA1, QIAGEN, Innovation, AstraZeneca, HRD

Next-generation-sequencing-based homologous recombination deficiency (HRD) assay based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digital Insight solutions, and Myriad’s proprietary, FDA-approved MyChoice CDx® biomarkers

Key Points: 
  • Next-generation-sequencing-based homologous recombination deficiency (HRD) assay based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digital Insight solutions, and Myriad’s proprietary, FDA-approved MyChoice CDx® biomarkers
    VENLO, The Netherlands and SALT LAKE CITY, May 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status.
  • The project builds on the recently announced master collaboration agreement between the two companies.
  • “Our partnership with Myriad Genetics underscores a shared commitment to advancing cancer diagnostics.
  • The combined regulatory expertise of QIAGEN and Myriad enables seamless compliance and integration in clinical and companion diagnostic applications.

QIAGEN and Myriad Genetics develop distributable homologous recombination deficiency test for global research and companion diagnostics applications

Retrieved on: 
четверг, мая 30, 2024
NGS, Partnership, Patient, DNA, CDX, PMDA, Ovarian cancer, Myriad Genetics, QGEN, Clinical trial, MYGN, BRCA2, FDA, Neoplasm, LOH, Senior, Research, PMA, GIS, Cancer, Genetics, IP, BRCA1, QIAGEN, Innovation, AstraZeneca, HRD

Venlo, the Netherlands, and Salt Lake City, Utah, May 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status.

Key Points: 
  • Venlo, the Netherlands, and Salt Lake City, Utah, May 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status.
  • “Our partnership with Myriad Genetics underscores a shared commitment to advancing cancer diagnostics.
  • The IP license grants QIAGEN the capability to collaborate with pharmaceutical partners to create an IVD-validated test, intended for use as a companion diagnostic outside of the United States.
  • The combined regulatory expertise of QIAGEN and Myriad enables seamless compliance and integration in clinical and companion diagnostic applications.

Alpha Tau Medical Announces First Quarter 2024 Financial Results and Provides Corporate Update

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понедельник, мая 20, 2024
Insurance, Patient, Hepatectomy, Liver disease, PMDA, Marketing, McGill University Health Centre, Colorectal cancer, KPC, Clinical trial, Neoplasm, Government, D&O, Head, Safety, Alpha Sigma Tau, Congress, Pancreatic cancer, Brain, Carcinoma, Rambam Health Care Campus, Lung cancer, Alpha, G&A, Liver cancer

JERUSALEM, May 20, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, reported first quarter 2024 financial results and provided a corporate update.

Key Points: 
  • Alpha Tau anticipates remaining adequately capitalized to support all of these programs over the coming years," he concluded.
  • In May, preclinical data demonstrating an abscopal immune effect in pancreatic murine tumor models was presented at ESTRO 2024 Congress in Glasgow.
  • Initial data demonstrates significant reduction in distant pancreatic cancer tumor growth rate starting from three weeks after first tumor is treated with Alpha DaRT alone.
  • Targeting completion of patient recruitment in the ReSTART U.S. multi-center pivotal trial in recurrent cutaneous squamous cell carcinoma in H2 2024.

Verrica Pharmaceuticals Announces Amendment to Company’s Collaboration and License Agreement with Torii Pharmaceutical Co. Ltd. to Fund Global Pivotal Phase 3 Clinical Trial to Study YCANTH® for the Treatment of Common Warts

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среда, мая 15, 2024
Patient, PMDA, Prevalence, Clinical trial, Shanda, FDA, Safety, European, Common, Dermatology, Molluscum contagiosum, Wart, Therapy, Skin, Pharmaceutical industry

WEST CHESTER, Pa., May 15, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has entered into an amendment to its existing licensing agreement with Torii Pharmaceutical Co. Ltd. (Torii), to jointly conduct a global pivotal Phase 3 clinical trial of YCANTH® for the treatment of common warts.

Key Points: 
  • “We are pleased to announce this significant amendment to our license agreement with Torii Pharmaceutical to advance YCANTH into a global pivotal Phase 3 clinical trial for the treatment of common warts,” said Ted White, President and Chief Executive Officer of Verrica Pharmaceuticals.
  • In addition, Torii would make a milestone payment of $8 million to Verrica upon the first patient dosed in Japan in the Phase 3 clinical trial.
  • In the United States, approximately 50% of the patients who seek treatment for common warts are children.
  • Verrica has previously announced positive results from the Phase 2 COVE-1 clinical trial that evaluated YCANTH (VP-102) for the treatment of common warts.

Viracta Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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четверг, мая 9, 2024
FDA, CRR, DLBCL, Investment, Safety, Food, Nausea, Research, PTCL, Peripheral T-cell lymphoma, Thrombocytopenia, Insurance, Weight loss, Appetite, PTLD, Data, Dor, Patient, Fatigue, Diarrhea, SDD, Therapy, PMDA, Valganciclovir, Food and Drug Administration, SAN, Anemia, Pharmaceutical industry

We look forward to sharing additional data from Stage 1, which continue to mature, as well as initial results from Stage 2 in the third quarter of 2024.

Key Points: 
  • We look forward to sharing additional data from Stage 1, which continue to mature, as well as initial results from Stage 2 in the third quarter of 2024.
  • As of the February 7, 2024 data cutoff date, Nana-val demonstrated greater efficacy than nanatinostat alone and was generally well-tolerated.
  • Present Stage 1 + Stage 2 data (n=21) in the R/R EBV+ PTCL cohort in patients treated with Nana-val in the third quarter of 2024.
  • Initiate a dose-optimization cohort to confirm the RP2D as part of the study’s Phase 2 expansion by year-end 2024.

Travere Therapeutics Reports First Quarter 2024 Financial Results

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понедельник, мая 6, 2024
FDA, Total, Risk, Ligand Pharmaceuticals, European Commission, Research, UPCR, Webcast, HCU, IND, EGFR, PDUFA, SIMD, Civil service commission, Diagnosis, PMDA, GAAP, CMA, Congress, Table, PROTECT, Priority review, Food, Abstract, FSGS, Income tax, CSL Vifor, Quarter, Medication, Therapy, SAN, Plasma, Urine, International, Safety, Proteinuria, ANNA, Immunoglobulin A, Homocysteine, Investigational New Drug, Society, Shanda, New Drug Application, Genetic, European, Disease, Patient, Quality of life (healthcare), IPR, Bank statement, Growth, Pharmaceutical industry

Net product sales for the first quarter of 2024 were $40.0 million, compared to $24.2 million for the same period in 2023.

Key Points: 
  • Net product sales for the first quarter of 2024 were $40.0 million, compared to $24.2 million for the same period in 2023.
  • Travere Therapeutics will host a conference call and webcast today, Monday, May 6, 2024, at 4:30 p.m.
  • ET to discuss company updates as well as first quarter 2024 financial results.
  • The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results.

BVI Launches PODEYE Hydrophobic Monofocal IOL in Japan

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четверг, апреля 18, 2024
Surgeon, GFY, Lens, POD, Intraocular lens, Health, PMDA, Ophthalmology, Pharmaceutical industry

WALTHAM, Mass., April 17, 2024 (GLOBE NEWSWIRE) --  BVI, the most dynamic, diversified company in ophthalmology, announced today the official launch of the PODEYE hydrophobic monofocal IOL in Japan following approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The achievement represents another significant step in BVI’s plan to launch its range of IOLs in Japan over the near-term.

Key Points: 
  • BVI continues to execute its roadmap of IOL launches in Japan, the world's third-largest IOL-valued market1
    The PODEYE hydrophobic monofocal is perfectly suited to the Japanese market, where hydrophobic IOLs constitute almost 96% of the total monofocal IOL units in Japan1
    Following the 2023 launch of FINEVISION HP Hydrophobic Trifocal IOL, PODEYE becomes the second BVI IOL to be available in Japan
    WALTHAM, Mass., April 17, 2024 (GLOBE NEWSWIRE) --  BVI, the most dynamic, diversified company in ophthalmology, announced today the official launch of the PODEYE hydrophobic monofocal IOL in Japan following approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
  • Anticipate more groundbreaking product launches from us in Japan and many other major markets globally.” said Shervin Korangy, President and CEO of BVI.
  • Given that Japan is primarily a hydrophobic market, surgeons in Japan, like their counterparts worldwide, will appreciate the proprietary, hydrophobic ‘GFY®’ material from which BVI IOLS are made providing 100% glistening-free material.
  • Alongside its patented GFY material featured exclusively in BVI lenses, BVI also develops and supplies approximately 20% of IOL material for competing IOL companies globally from its facility in Florida, US.