ANSM

Rhythm Pharmaceuticals Reports Second Quarter 2022 Financial Results and Business Update

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화요일, 8월 2, 2022
EMANATE, Regulation of tobacco by the U.S. Food and Drug Administration, BMI, GLOBE, PCSK1, AP1, National Institute for Health and Care Excellence, Physician, HAS, Bardet–Biedl syndrome, HST, Food, EC, Hunger, Medication, Ageing, National Institute, Royal commission, BBS, POMC, Adult, Body mass index, Kidney, NICE, Degenerative disease, ANSM, Prescription, European Commission, CHMP, National Health Service, Disease, FDA, High, MC4R, Patient, LEPR, Nasdaq, Precision medicine, Polyphagia, Weight loss, Obesity, Vaccine, Pharmaceutical industry, Rhythm

-- Entered into non-dilutive revenue interest financing agreement with Healthcare Royalty Partners for up to $100 million, extending cash runway into second half of 2024 --

Key Points: 
  • ET--
    BOSTON, Aug. 02, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) today reported financial results and provided a business update for the second quarter ended June 30, 2022.
  • R&D Expenses: R&D expenses were$31.5 millionin the second quarter of 2022, as compared to$25.1 millionin the second quarter of 2021.
  • S,G&A Expenses: S,G&A expenses were $22.3 million for the second quarter of 2022, as compared to $15.5 million for the second quarter of 2021.
  • ET today to review its second quarter 2022 financial results and recent business activities.

MaaT Pharma Reports Cash and Revenues for Second Quarter 2022

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목요일, 7월 28, 2022
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Oncology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MET, CFO, IPO, Euronext Paris, Agence nationale de sécurité du médicament et des produits de santé, CGMP, Food, CERA, CEO, Forward-looking statement, Biomarker, Melanoma, CIC, Cancer, ANSM, Achievement, Clinical trial, COO, BNP Paribas, FDA, Company, Lymphatic system, Graft-versus-host disease, Patient, Survival, Hematopoietic stem cell transplantation, Population, Pharmaceutical industry, EUR, Caisse

MaaT Pharma (EURONEXT: MAAT the Company), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today reported its cash position as of June 30, 2022, and its revenues for the second quarter of 2022.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT the Company), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, today reported its cash position as of June 30, 2022, and its revenues for the second quarter of 2022.
  • The second quarter of 2022 saw further progress in our pipeline and the achievement of a crucial milestone for MaaT Pharma.
  • MaaT Pharma reported revenues4 from its compassionate access program of EUR 0.2 million for the quarter ended June 30, 2022, compared with EUR 0.3 million for the first quarter of 2022.
  • In 2021, revenues were invoiced as of February 2021 whereas in 2022 the Company benefits from a full 6 months of revenues.

BioPharma Services Inc., a Think Research Subsidiary, Achieves Another Successful FDA Inspection Result

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목요일, 6월 16, 2022
Clinical research, GLP, Electronic data capture, Pharmacist, GCP, Clinical trial, Bioanalysis, Bioequivalence, Digital, Therapy, Observation, Privacy, Medical writing, Compliance, CEO, Federal Food, Drug, and Cosmetic Act, Data management, Bed, Food, ANVISA, TSX Venture Exchange, EDC, Industry, FDA, Drug development, Achievement, View, EMR, EVP, Nursing, Health Canada, Standards Council of Canada, Failure, Good clinical practice, Contract research organization, Patient, Multimedia, Inspector, CRO, ANSM, Research, Company, CDISC, EMA, Biopharma LLC, FD, Commercial Operating System (COS), Judgement, Medical device, Pharmaceutical industry, Online shopping, Biostatistics

The successful results build on BioPharma's record of excellence with respect to regulatory audits conducted by the FDA.

Key Points: 
  • The successful results build on BioPharma's record of excellence with respect to regulatory audits conducted by the FDA.
  • BioPharma is leading the digitalization of the clinical research industry with its award-winning facilities in Toronto, Canada and St. Louis, USA.
  • Renzo DiCarlo, President of Clinical Research at BioPharmasaid, "This latest FDA inspection truly showcases BioPharma's commitment to provide robust, valuable data to our clients.
  • With an outstanding audit record spanning over 13 years, I'm so very proud of our Think Research Family."

Concarlo Expands Executive Leadership Team with the Appointment of Dr. Krishna Allamneni as Chief Development Officer

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목요일, 6월 2, 2022
American College of Toxicology, Death, Time, Company, Research, Toxicity, TGA, MHRA, Partnership, American College, Society of Toxicology, Society, Hope, Therapy, Drug resistance, ANSM, FDA, CDK2, Health Canada, Patient, Jazz Pharmaceuticals, PMDA, Cancer, Medical device, Pharmaceutical industry, Toxicology

 BROOKLYN, N.Y., June 2, 2022 /PRNewswire/ -- Concarlo, a preclinical biotechnology company whose mission is to dramatically improve outcomes for patients with drug-resistant cancers by creating transformative therapies that control the p27 target, has appointed Dr. Krishna Allamneni as the Company's Chief Development Officer. Dr. Allamneni will lead Concarlo's internal pipeline development of therapeutics, and direct its strategy from target discovery to clinical trials and regulatory filings. As part of her role, she will also strategically manage and protect the company's IP assets.

Key Points: 
  • Dr. Allamneni will lead Concarlo's internal pipeline development of therapeutics, and direct its strategy from target discovery to clinical trials and regulatory filings.
  • Despite many important advances, drug resistance is one of the major reasons for the more than 600,000 deaths in America each year from cancer.
  • "Dr. Allamneni will play an instrumental role in Concarlo 's cutting-edge approach to clean up what precision oncology leaves behind," said Dr. Stacy Blain , Concarlo's Co-Founder, Chief Scientific Officer.
  • Dr. Allamneni has more than twenty years of R&D experience, including roles at Turning Point Therapeutics, Jazz Pharmaceuticals, and Roche/Genentech.

Dr. Victor Moyo, MBChB, Joins OncoPep as Chief Medical Officer

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화요일, 5월 17, 2022
Triple-negative breast cancer, Fellow, Multiple myeloma, LEAF, Multimedia, Patient, George Washington University Hospital, Quality of life, University of Zimbabwe, ANSM, Bachelor of Medicine, Bachelor of Surgery, FDA, Pediatric Hematology and Oncology, IND, Nano, EMA, University, Victor Velculescu, NDA, CMO, Cancer, IP, Internal medicine, Medicine, Pharmaceutical industry, Vaccine, Hematology

CAMBRIDGE, Mass., May 17, 2022 /PRNewswire/ -- OncoPep, Inc. has named Dr. Victor Moyo Chief Medical Officer effective May 9th.

Key Points: 
  • CAMBRIDGE, Mass., May 17, 2022 /PRNewswire/ -- OncoPep, Inc. has named Dr. Victor Moyo Chief Medical Officer effective May 9th.
  • "Dr. Moyo is a seasoned veteran with strong clinical and regulatory experience with Pre-IND/IND, Phase I through IV studies, and NDA submissions," said Michael Krepps, Chief Operating Officer of OncoPep.
  • Before joining OncoPep, Moyo worked at L.E.A.F Pharmaceuticals (LEAF) where he established and managed a strong R&D division and laboratory of 15 scientists.
  • OncoPep, Inc. is developing novel immunotherapeutics to prevent the progression of cancer, extend survival, and restore the quality of life of patients.

Atamyo Therapeutics Announces Significant Milestones for ATA-100 and ATA-200, its Gene Therapy Programs to Treat Limb-Girdle Muscular Dystrophy 2I/R9 and 2C/R5

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월요일, 5월 16, 2022
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, Muscular dystrophy, ANSM, Health care, EST, EMA, FKRP, Master of Science, European Society of Gene and Cell Therapy, Therapy, Research, National Medicinal Drugs Policy, CMC, Lists of diseases, Orphan, Quality, Supply chain, Vaccine, Patient, Degenerative disease, CTA, European Medicines Agency, Cell, MBA, Sanofi Pasteur, CNRS, LGMD, Poster, MHRA, Date, Technology, CTO, Orphan drug, Hope, Gene, Industry, AAV, Life, Weakness, Master of Engineering, CEO, Pharmaceutical industry, Management

ATA-100, a single-administration gene therapy candidate for LGMD2I/R9, delivers a normal copy of the gene for production of FKRP proteins.

Key Points: 
  • ATA-100, a single-administration gene therapy candidate for LGMD2I/R9, delivers a normal copy of the gene for production of FKRP proteins.
  • Atamyo Therapeutics is focused on the development of a new generation of effective and safe gene therapies for neuromuscular diseases.
  • A spin-off of gene therapy pioneer Genethon, Atamyo leverages unique expertise in AAV-based gene therapy and muscular dystrophies from the Progressive Muscular Dystrophies Laboratory at Genethon.
  • Atamyo conveys the spirit of its commitment to improve the life of patients affected by neuromuscular diseases with life-long efficient treatments.

Health Canada approves Eurofins CDMO Alphora Inc.’s Standard Processing License for Synthetic Phytocannabinoids

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화요일, 5월 10, 2022
Alternative Medicine, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Laboratory, THC, EMA, ANSM, CBDA, FAMHP, Contract, API, FDA, GMP, ANSES, Tetrahydrocannabivarin, CBN, Cannabidivarin, PMDA, Cannabis Act, View, Health Canada, Seed, Life, CBD, Drug reference standard, Research, Eurofins Scientific, Fine chemical

Eurofins CDMO Alphora Inc. announces receipt in April 2022 of its Health Canada Standard Processing License issued within the Cannabis Act and Cannabis Regulations for its Oakville, Ontario Operations.

Key Points: 
  • Eurofins CDMO Alphora Inc. announces receipt in April 2022 of its Health Canada Standard Processing License issued within the Cannabis Act and Cannabis Regulations for its Oakville, Ontario Operations.
  • This is complementary to the Institutional Research License obtained through Health Canada in June 2021 for its Mississauga development site.
  • Eurofins CDMO Alphora Inc. entered a licensing agreement with Kare Chemical Technologies Inc. in August 2021 for use of Kares innovative technology to synthetically produce high quality phytocannabinoids.
  • Eurofins CDMO Alphora Inc. has since developed scalable processes for several naturally occurring phytocannabinoids including CBD, CBDv, THC, THCv, and is preparing processes for others such as CBN, CBDA.

MaaT Pharma Reports Cash and Revenues for First Quarter 2022

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목요일, 5월 5, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Forward-looking statement, MET, Agence nationale de sécurité du médicament et des produits de santé, Company, ANSM, Biomarker, CGMP, EUR, Patient, Maat, Partnership, Survival, Program, Euronext Paris, Annual conferences, Cancer, Graft-versus-host disease, AP-HP, Achievement, Conference, IPO, Melanoma, Pharmaceutical industry, Fine chemical

MaaT Pharma (EURONEXT: MAAT the Company), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer today reported its cash position as of March 31, 2022, and its revenues for the first quarter of 2022.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT the Company), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer today reported its cash position as of March 31, 2022, and its revenues for the first quarter of 2022.
  • As of March 31, 2022, total cash and cash equivalents were EUR 41.1 million, as compared to EUR 43.3 million as of December 31, 2021.
  • MaaT Pharma reported revenues of EUR 0.3 million for the quarter ended March 31, 2022, compared with 0.1 million for the same period of 2021.
  • MaaT Pharma is the first company developing microbiome-based therapies listed on Euronext Paris (ticker: MAAT).

Cardiawave announces French National Agency for the Safety of Medicines and Health Products (ANSM) green light to launch VALVOSOFT® Pivotal Study in France

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화요일, 5월 3, 2022
Biotechnology, Surgery, Medical Devices, Other Health, Health, ANSM, Safety, Cardiovascular disease, National Agency for Education (Sweden), Aortic stenosis, Patient, Trial of the century, Aortic valve, Medication, FIH, CE marking, Hospital, TAVI, Quality of life, CEO, Medical imaging

This announcement is a major milestone for Cardiawave, and we look forward to demonstrating through this new pivotal study the performance and efficacy of our non-invasive ultrasound therapy to treat a greater number of patients with aortic valve stenosis.

Key Points: 
  • This announcement is a major milestone for Cardiawave, and we look forward to demonstrating through this new pivotal study the performance and efficacy of our non-invasive ultrasound therapy to treat a greater number of patients with aortic valve stenosis.
  • France is the first country to authorize this European clinical study, which will also be rolled out in Germany and the Netherlands.
  • Cardiawave will enroll c.60 patients with aortic stenosis in 11 hospitals between May and December 2022, with the aim of obtaining CE Marking.
  • The clinical protocol involves patient follow up at 1, 6 and 12 months after treatment.

XBiotech Announces French National Agency (ANSM) Approval and National Cancer Institute (INSA) funding to Support Phase I/II/III Clinical Study for Natrunix™ in Combination with Trifluridine/Tipiracil (TASKIN) for Treatment of Metastatic Colorectal Canc

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목요일, 4월 28, 2022
Star Trek: Phase II, Metastasis, INCA, INSERM, Purging disorder, Medication, Colorectal cancer, National Agency for Food and Drug Administration and Control, The True Cost, Fatigue, Death, III, Oncology, Patient, Blood, Risk, GLOBE, American Cancer Society, Large intestine, Connective tissue, Cancer, Anxiety, Neoplasm, Technology, Quality of life, Forward-looking statement, Immunohistochemistry, Oxaliplatin, Trifluridine/tipiracil, Fluoropyrimidine, Dijon, Achievement, Antibody, Serum, Research, Terminology, VEGF, NASDAQ, Safety, Phase, Industry, SEC, National Cancer Institute, ANSM, Survival, Disease, Irinotecan, Pharmaceutical industry, Vaccine

The French National Cancer Institute (INCA) has also awarded a grant to fund all clinical costs for the study.

Key Points: 
  • The French National Cancer Institute (INCA) has also awarded a grant to fund all clinical costs for the study.
  • Investigators will combine Natrunix and trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer in subjects that have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine.
  • Headed by Dr. Franois Ghiringhelli and Dr. Come Lepage, the clinical program will include over 20 participating clinical centers and enroll at least 160 subjects.
  • Any forward-looking statements that we make in this press release speak only as of the date of this press release.