PMDA

BC Platforms Acquires 4Pharma, a Leading International Provider of Medical Research Data and Analytics Services for Global Clinical Trials and Real World Data

Retrieved on: 
Thursday, June 1, 2023
Real, Data management, Heart, Drug development, Jolt, Q2, Biotechnology, Clinical trial, Intelligence, Infection, Research, RWD, Real world data, BCP, Gynaecology, Science, EMA, HQ, Acquisition, Patient, Machine learning, Ophthalmology, Medicine, Data, Biostatistics, FDA, Neurology, Pharmaceutical industry, Central Europe, PMDA

In addition, 4Pharma customers will benefit from additional services in the field of RWD through the BC Platform technology.

Key Points: 
  • In addition, 4Pharma customers will benefit from additional services in the field of RWD through the BC Platform technology.
  • Tero Silvola, CEO at BC Platforms, said, “This exciting acquisition of the excellent 4Pharma brings impressive healthcare data intelligence expertise.
  • We combine omics and clinical data assets around the world, without compromising data privacy and security.
  • The company’s focus is on incorporating machine learning and artificial intelligence into generating useable clinical, and drug development, insights from Real World Data.

Alpha Tau Medical Announces First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, May 23, 2023
Pancreatic cancer, Restart, Rat, Medical school, Jewish General Hospital, Alpha, Symantec Endpoint Protection, Marketing, Clinical trial, Skin cancer, Skin, Head, G&A, Toxicity, Lung, Liver cancer, Ministry, Environmental protection, Cambridge University Hospitals NHS Foundation Trust, Patient, JAMA Network Open, General Hospital, PMDA, Carcinoma, Addenbrooke's Hospital, Financial result, McGill University, Biophysical environment, Mouse, Alpha Sigma Tau, Vulva, Health Canada, Pharmaceutical industry, Dietary supplement, Nursing, Cryptocurrency, Medicine

- Opened U.S. multicenter pivotal trial in recurrent cutaneous skin cancer, which began enrolling patients in March -

Key Points: 
  • - Opened U.S. multicenter pivotal trial in recurrent cutaneous skin cancer, which began enrolling patients in March -
    - Received Health Canada approval in March to initiate a liver cancer feasibility trial, with recruitment targeted to begin mid-year -
    JERUSALEM, May 23, 2023 (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 2023 financial results and provided a corporate update.
  • In parallel, we are preparing for potential future product launches by advancing our commercial planning activities and solidifying our supply chain.
  • Alpha Tau remains adequately capitalized to support all of these programs over the coming years," he concluded.
  • Planned submission of Alpha DaRT pivotal trial results in head and neck cancer to Japan’s regulatory authority, PMDA in the second half of 2023, for potential marketing authorization.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, Alzheimer's disease, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Ministry of Health, Labour and Welfare, Brain, Medication, Pharmaceuticals and Medical Devices Agency, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, Eisai, The Different Forms of Flowers on Plants of the Same Species, Prescription Drug User Fee Act, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Medical imaging, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, BIIB, Ministry of Health, Labour and Welfare, Brain, Pharmaceuticals and Medical Devices Agency, Medication, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, The Different Forms of Flowers on Plants of the Same Species, Eisai, Prescription Drug User Fee Act, Headquarters, PMDA, National Medical Products Administration, Corporation, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Cara Therapeutics Reports First Quarter 2023 Financial Results

Retrieved on: 
Monday, May 15, 2023
Acceleration, Chronic kidney disease, Conference call, Nephrology, Medicines and Healthcare products Regulatory Agency, G&A, Atopic dermatitis, CSL Vifor, CSL, Cara, EDT, Sale, Medication, Pharmaceuticals and Medical Devices Agency, Dialysis, Dermatology, Patient, Investment, Administration, PMDA, Itch, NP, Biophysical environment, ESG, Research and development, Research, R, Therapy, Conference, Pharmaceutical industry, Cryptocurrency, Difelikefalin, Social

STAMFORD, Conn., May 15, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the first quarter ended March 31, 2023.

Key Points: 
  • – Conference call today at 4:30 p.m. EDT –
    STAMFORD, Conn., May 15, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the first quarter ended March 31, 2023.
  • “The U.S. and global launches of KORSUVA® (difelikefalin) injection / Kapruvia® gained momentum in the first quarter of 2023.
  • Wholesalers shipped 45,720 vials to dialysis centers, the majority of which were Fresenius clinics, during the first quarter of 2023.
  • Vial orders more than doubled quarter to quarter, signifying an acceleration in patient demand.

MEI Pharma Reports Third Quarter Fiscal Year 2023 Results and Operational Highlights

Retrieved on: 
Thursday, May 11, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Workforce, Commercialization, Lymphoid leukemia, Venetoclax, Calendar, Cancer, Acute myeloid leukemia, Kyowa Kirin, Development, AML, Patient, Investment, PMDA, Colorectal cancer, Infinity, Cell cycle, Bone marrow, Neoplasm, MEI, Research, CDK9, Cyclin-dependent kinase 9, Safety, Pharmaceutical industry, Cryptocurrency

MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for the quarter ended March 31, 2023, and highlighted recent corporate events.

Key Points: 
  • MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for the quarter ended March 31, 2023, and highlighted recent corporate events.
  • In February 2023, MEI Pharma and Infinity Pharmaceuticals announced a definitive merger agreement for an all-stock transaction pursuant to which Infinity will become a wholly owned subsidiary of MEI Pharma.
  • Research and development expenses were $15.1 million for the quarter ended March 31, 2023, compared to $22.3 million for the quarter ended March 31, 2022.
  • MEI recognized revenue of $5.9 million for the quarter ended March 31, 2023, compared to $9.7 million for the quarter ended March 31, 2022.

Catalyst Pharmaceuticals Reports Record First Quarter 2023 Results, Achieving 98% Total Revenue Growth Year-over-Year

Retrieved on: 
Wednesday, May 10, 2023
LEMS, Anticipation, Bank statement, Medicines and Healthcare products Regulatory Agency, New Drug Application, COVID-19, Intangible asset, NDA, GAAP, Accounting, Medication, Development, Acquisition, Lambert–Eaton myasthenic syndrome, Administration, PMDA, Intangibles, Webcast, Biophysical environment, Depreciation, ESG, Yoy, Research, Amifampridine, Catalysis, Pharmaceuticals and Medical Devices Agency, Bank, Video game, Beauty salon, Reinsurance, Cryptocurrency

Achieved Q1 2023 FIRDAPSE® net product revenue of $57.5 Million, representing a substantial 34% YoY increase.

Key Points: 
  • Achieved Q1 2023 FIRDAPSE® net product revenue of $57.5 Million, representing a substantial 34% YoY increase.
  • Research and Development Expenses: Research and development expenses in the first quarter of 2023 were $3.6 Million, compared to $3.4 Million in the first quarter of 2022.
  • Amortization of Intangible Assets: Amortization of intangible assets was $6.5 Million in the first quarter of 2023, compared to $0.00 in the first quarter of 2022.
  • 2023 Financial Guidance: The Company forecasts full-year 2023 total revenues, including FYCOMPA®, to be between $375 Million and $385 Million, representing a 75% - 80% increase in total revenues compared to 2022.

BioCardia Reports First Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, May 10, 2023
Partnership, Probability, Therapy, Heart failure, BCDA, DSMB, Echocardiography, New Drug Application, Pharmaceuticals and Medical Devices Agency, Quality of life, American College of Cardiology, Data monitoring committee, MSC, Patient, IRB, PMDA, Cardiology, Heart, Security (finance), Research, Phase, FDA, American College, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, Breakthrough, Food, Safety, Pharmaceutical industry, Medical device, Cryptocurrency

SUNNYVALE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the first quarter of 2023 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2023 with the Securities and Exchange Commission.

Key Points: 
  • SUNNYVALE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the first quarter of 2023 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2023 with the Securities and Exchange Commission.
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • In March, positive echocardiography data from the trial was presented at the 2023 American College of Cardiology annual meeting in New Orleans.
  • First Quarter 2023 Financial Results:
    Revenues were approximately $64 thousand for the three months ended March 2023, compared to approximately $60 thousand for the three months ended March 2022.

Arcturus Therapeutics Announces First Quarter 2023 Financial Update and Pipeline Progress

Retrieved on: 
Tuesday, May 9, 2023
Biotechnology, Infectious Diseases, Health, Genetics, Pharmaceutical, Vaccine, Diversified Specialty Institute Holdings, Inc., Travel, Therapy, Arcturus Therapeutics, Ornithine transcarbamylase deficiency, Medicines and Healthcare products Regulatory Agency, COVID-19, Infection, NDA, ARCT, Research, Pfizer–BioNTech COVID-19 vaccine, RNA, Messenger, Patient, PMDA, OTC, Cystic fibrosis, Liver, CF, Safety, Pharmaceutical industry, Cryptocurrency, Airline, Arcturus

We believe this meaningful milestone is indicative of the broader platform opportunity for our mRNA medicine technologies to result in novel vaccines and therapeutics over the coming years,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

Key Points: 
  • We believe this meaningful milestone is indicative of the broader platform opportunity for our mRNA medicine technologies to result in novel vaccines and therapeutics over the coming years,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
  • Arcturus is amending the protocol to allow the dosing of patients with CF and expects to initiate the enrollment in Q3 2023.
  • Additionally, we expect to collect $90.0 million in the second quarter of 2023, associated with the CSL Seqirus milestones which are in accounts receivable on March 31, 2023.
  • The cash runway remains extended through the beginning of 2026 based on the current pipeline and programs.

Lisata Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 9, 2023
Transfer, Pancreatic cancer, Therapy, Conference call, Neoplasm, Medicines and Healthcare products Regulatory Agency, Glomerular filtration rate, New Jersey Economic Development Authority, Research, RNA, Immunotherapy, CD34, Trial of the century, Pharmaceuticals and Medical Devices Agency, Medication, Chemistry, Patient, PMDA, FREEDOM, Microcirculation, Kidney, CLI, DKD, Tumor microenvironment, Kidney disease, Disease, Pharmaceutical industry, Nursing, Conference

BASKING RIDGE, N. J., May 09, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, provides a business update and reports financial results for the three months ended March 31, 2023.

Key Points: 
  • Conference call scheduled for today at 4:30 p.m. Eastern time
    BASKING RIDGE, N. J., May 09, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, provides a business update and reports financial results for the three months ended March 31, 2023.
  • LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies.
  • The combination of LSTA1 with corresponding standards-of-care in other solid tumor indications is planned for clinical study commencing before the end of the second quarter of 2023.
  • Lisata will hold a live conference call today, May 9, 2023, at 4:30 p.m. Eastern time to discuss financial results, provide a business update and answer questions.