Healthcare Improvement Scotland

Pharvaris Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, April 10, 2024
Abele, AAAAI, FDA, Citizenship, Research, Healthcare Improvement Scotland, Trial of the century, SMC, IND, Record, Intellectual property, National Congress, American Academy, Attack, Food, ACAAI, Conference, Hereditary angioedema, MHRA, HAE, Therapy, Network, EOP, Book, PRO, Chemistry, CMC, G&A, Investigational New Drug, Doctor of Philosophy, Medication, Research and development, American College, Mass meeting, Health care, Administration, Bank statement, Annual general meeting, Heredity, Pharmaceutical industry

Pharvaris is currently enrolling in RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule (PHVS416) for the on-demand treatment of HAE attacks.

Key Points: 
  • Pharvaris is currently enrolling in RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule (PHVS416) for the on-demand treatment of HAE attacks.
  • Effective April 15, 2024, David Nassif, J.D., will join Pharvaris as Chief Financial Officer and will be responsible for refining and implementing Pharvaris’ corporate financial strategy and activities including financial reporting and operations.
  • Loss for the fourth quarter of 2023 was €32.7 million, resulting in basic and diluted loss per share of €0.74.
  • Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board.

Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism

Retrieved on: 
Tuesday, January 23, 2024
Congenital hyperinsulinism, Patient, MHRA, Healthcare Improvement Scotland, Medication, Innovation, Health care, SMC, Hypoglycemia, Pharmaceutical industry

Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of hypoglycemia due to congenital hyperinsulinism (HI).

Key Points: 
  • Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of hypoglycemia due to congenital hyperinsulinism (HI).
  • The Innovation Passport designation in the U.K. is the entry point to the Innovative Licensing and Access Pathway (ILAP).
  • “Congenital hyperinsulinism is the most frequent cause of severe, persistent hypoglycemia in newborn babies, infants and children,” said Susan Stewart, J.D., Chief Regulatory Officer at Rezolute.
  • “The Innovation Passport opens the door for Rezolute to discuss access considerations for potential future indications for RZ358.

ADvantage Therapeutics Has Commenced Enrollment for Its Phase 2b Clinical Trial of AD04™ for Treatment of Alzheimer’s Disease

Retrieved on: 
Monday, November 27, 2023
Biology, Quality of life, Neuropsychiatry, Science, Hippocampus, NHS England, SMC, NPI, Healthcare Improvement Scotland, Disease, Brain, Innovation, Therapy, MHRA, NHS Improvement, Human, Advantage, Ageing, Inflammation, Patient, Safety, NHS, Pharmaceutical industry

The Phase 2b randomized, double-blind, placebo-controlled trial aims to confirm proof-of-concept and establish the safety and efficacy of AD04™ in patients with mild AD.

Key Points: 
  • The Phase 2b randomized, double-blind, placebo-controlled trial aims to confirm proof-of-concept and establish the safety and efficacy of AD04™ in patients with mild AD.
  • We look forward to providing updates on the progress of this potentially landmark trial,” added Jeffrey Madden, ADvantage Therapeutics CEO.
  • ADvantage Therapeutics is dedicated to advancing the science of neurodegenerative diseases and committed to developing innovative therapies that can make a meaningful difference in the lives of patients.
  • For more information on ADvantage Therapeutics, Inc., please visit www.advantagetherapeutics.com .

Amarin Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 1, 2023
Research, SMC, Medicare, Prescription, Risk, Forecasting, CVRR, Telephone, Health technology assessment, GAAP, HTA, Commercial, Marketing, Healthcare Improvement Scotland, Professional corporation, Investment, Patient, Hypertriglyceridemia, National Medical Products Administration, Conference, Organization, IPE, Medicaid, NMPA, File, Socialist Alternative (England, Wales & Scotland), ASEAN, Rare-earth element, Management, Pharmaceutical industry, Health insurance, Video game, Cryptocurrency, Bank, Amarin

-- Company to Host Conference Call Today at 8:00 a.m. ET --

Key Points: 
  • ET --
    DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced financial results for the quarter ended September 30, 2023 and provided an update on company operations.
  • “As we focus on demonstrating results that will drive shareholder value, there are reasons to be optimistic about the future of Amarin,” said Patrick Holt, President & CEO of Amarin.
  • U.S. product net revenue was $62.4 million in the third quarter of 2023, a decline of $2.2 million versus the second quarter of 2023, a decrease of 3% sequentially.
  • The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial measures provide investors with a better understanding of the company’s historical results from its core business operations.

Aurinia Pharmaceuticals Reports Third Quarter and Nine Months 2023 Financial and Operational Results

Retrieved on: 
Thursday, November 2, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Other Health, SLE, PSF, FDA, Insurance, American College, EGFR, U.S.–Canada Team Tournament (Go), Conversation, SG, EDGAR, SEDAR, American Society of Nephrology, AURORA, Nephrology, Lupus, Persistent environment, EC, Glomerular filtration rate, R, Society, Arthritis & Rheumatology, Bank statement, Growth, Risk, Marketing, Webcast, Analysis, Healthcare Improvement Scotland, American College of Rheumatology, Safety, LN, Investment, Management, Patient, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Rheumatology, Cryptocurrency, Pharmaceutical industry, Rare-earth element, Aurinia

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the three and nine months ended September 30, 2023.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the three and nine months ended September 30, 2023.
  • Total net revenue was $54.5 million for the three months ended September 30, 2023 and $55.8 million for the same period in 2022.
  • Financial Results for the Three and Nine Months Ended September 30, 2023
    Total net revenue was $54.5 million and $55.8 million for the three months ended September 30, 2023 and September 30, 2022, respectively.
  • Aurinia will host a conference call and webcast to discuss the quarter ended September 30, 2023 financial results today, Thursday, November 2, 2023 at 8:30 a.m.

BRUKINSA® Receives Positive Recommendation from NICE in U.K. for Adult Patients with Chronic Lymphocytic Leukemia

Retrieved on: 
Friday, October 20, 2023
Biotechnology, Pharmaceutical, Health, Oncology, National Institute for Health and Care Excellence, SSE, United Kingdom, BGNE, BR, Leeds Teaching Hospitals NHS Trust, TP53, NICE, FCR, NHS, Disease, Leukemia, Healthcare Improvement Scotland, FDG, BTK, Patient, SEQUOIA, Pharmaceutical industry, CLL, EU, BeiGene

“This follows the previous approval of BRUKINSA by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia.

Key Points: 
  • “This follows the previous approval of BRUKINSA by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia.
  • “This decision represents a significant milestone for patients in England and Wales with CLL, the most common form of leukemia in adults,” said Nick York, Patient Advocacy Healthcare Liaison Officer, U.K. Leukemia Care.
  • “Despite continued treatment advances, many patients with CLL will relapse and need additional treatment options.
  • Furthermore, a proportion of patients have a disease which is refractory to initial treatment.”
    BRUKINSA is the third BTKi for CLL to be recommended by NICE for routine commissioning.

Scottish Medicines Consortium Accepts VAZKEPA® (icosapent ethyl) to Help Reduce Cardiovascular Risk for Patients in Scotland(1)

Retrieved on: 
Monday, August 7, 2023
Knowledge, Heart, National Health Service, Myocardial infarction, MI, Hospital, Moyamoya disease, Acute coronary syndrome, Stroke, Cardiovascular disease, Splenic infarction, British Heart Foundation, Risk assessment, CVD, Glasgow Royal Infirmary, History, Healthcare Improvement Scotland, Professional corporation, Death, SMC, Molina Healthcare, Patient, ACS, Risk, LDL, Eicosapentaenoic acid, NHS, NICE, National Institute for Health and Care Excellence, Pharmaceutical industry, Nursing, Amarin, NHS Scotland

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announces that the Scottish Medicines Consortium (SMC) has accepted VAZKEPA® (icosapent ethyl) for reimbursement with a Patient Access Scheme* for secondary prevention in patients treated with a stable dose of statins, low-density lipoprotein (LDL) cholesterol levels >1.04mmol/L and ≤2.60mmol/L, raised fasting triglycerides (≥1.7mmol/L) and with established cardiovascular disease (CVD) defined as a history of any of the following: acute coronary syndrome (ACS) such as myocardial infarction (MI) or unstable angina needing hospitalization; coronary or other arterial revascularization procedures; coronary heart disease; ischaemic stroke; or peripheral arterial disease.1

Key Points: 
  • This represents an important step forward in the fight against CVD in Scotland,” said Professor Adrian Brady, Consultant Cardiologist at Glasgow Royal Infirmary.
  • Amarin is working with Health Boards across Scotland to secure formulary inclusion and ensure that as many patients as possible among the eligible population will have access to VAZKEPA® by the end of 2023.
  • * Patient Access Schemes are confidential pricing agreements proposed by pharmaceutical companies to enable patient access to new medicines and treatments.
  • The Patient Access Scheme Assessment Group (PASAG) reviews and advises NHSScotland on the feasibility of proposed schemes for implementation.

Arvinas and Pfizer Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Vepdegestrant, an Investigational PROTAC® ER degrader being developed in ER+/HER2- Breast Cancer

Retrieved on: 
Monday, July 31, 2023
Pfizer, Health care, PFE, Clinical trial, Medication, ER, Medicine, Healthcare Improvement Scotland, Wales, ARVN, Patient, National Institute for Health and Care Excellence, Innovation, Congress, Therapy, NYSE, NICE, SMC, MHRA, Breast cancer, Pharmaceutical industry, HAVEN

The Innovation Passport is the entry point for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • The Innovation Passport is the entry point for the Innovative Licensing and Access Pathway (ILAP).
  • The goal of ILAP is to accelerate the time to market facilitating patient access to medicines in the U.K.
  • “Arvinas is hopeful our investigational PROTAC® ER degrader, vepdegestrant, will have the potential to be an endocrine therapy backbone for ER+/HER2-breast cancer."
  • The companies also plan to submit additional data from the Phase 1b combination trial with palbociclib at a medical congress during the second half of 2023.

NATIONAL COALITION LAUNCHES ACTION PLANS TO IMPROVE NURSING HOME QUALITY

Retrieved on: 
Tuesday, July 18, 2023
Nursing, Coalition, National Academies of Sciences, Engineering, and Medicine, Quality of life, Doctor of Philosophy, Government, Organization, National academy, Healthcare Improvement Scotland, Outline, John A. Hartford Foundation, Moving Forward, RN, Safety, FAAN, Engineering, Medicine

WASHINGTON, July 18, 2023 /PRNewswire/ -- A large group of diverse stakeholders advocating for better nursing home care announced a series of actions to improve nursing homes over the next 12 months.

Key Points: 
  • Comprehensive action plans outline concrete steps for collaboration with government, providers, and advocates to address major nursing home quality issues
    WASHINGTON, July 18, 2023 /PRNewswire/ -- A large group of diverse stakeholders advocating for better nursing home care announced a series of actions to improve nursing homes over the next 12 months.
  • The national Moving Forward Nursing Home Quality Coalition released nine detailed action plans today to improve quality of life for residents and quality of work for staff in nursing homes.
  • Comprised of more than 120 individuals and organizations focused on nursing home reform, the Coalition launched in September 2022 to act on the National Academies of Sciences, Engineering, and Medicine report, The National Imperative to Improve Nursing Home Quality .
  • The Moving Forward Nursing Home Quality Coalition is funded by The John A. Hartford Foundation, and draws on leadership from LeadingAge, the Institute for Healthcare Improvement, other national organizations and advisors.

ADvantage Therapeutics Secures Approvals for Clinical Trial of AD04™ in Alzheimer’s Disease Treatment in Poland, Bulgaria, and Slovakia

Retrieved on: 
Tuesday, June 20, 2023
Inflammation, Innovation, NICE, Clinical trial, Quality of life, CTA, Human, Brain, England, Healthcare Improvement Scotland, Advantage, Science, NHS Improvement, NPI, Patient, United Kingdom, NHS England, National Institute for Health and Care Excellence, NHS, AD, Therapy, Caregiver, Safety, Neuropsychiatry, SMC, MHRA, Hippocampus, Pharmaceutical industry, Medical imaging

The 12-month study will evaluate various outcomes including hippocampal volume as a primary objective and biomarker endpoint.

Key Points: 
  • The 12-month study will evaluate various outcomes including hippocampal volume as a primary objective and biomarker endpoint.
  • The Company plans additional European study sites, incorporating additional countries such as France, Germany, and Austria.
  • Achim Schneeberger, M.D., chief medical officer of ADvantage Therapeutics, commented, “This represents an important milestone in the launch of our confirmatory trial.
  • For more information on ADvantage Therapeutics, Inc., please visit www.advantagetherapeutics.com