European Medicines Agency

Bavarian Nordic’s Chikungunya Vaccine Candidate Granted Accelerated Assessment by European Medicines Agency

Retrieved on: 
Friday, February 23, 2024
Marketing, EMA, Marketing Authorisation Application, Committee, MAA, Food, BLA, Nature, Vaccination, CHMP, European Medicines Agency, Public, Chikungunya, OMX, Ageing, CHIKV, Vaccine

Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.

Key Points: 
  • Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.
  • COPENHAGEN, Denmark, February 23, 2024 – Bavarian Nordic A/S (OMX: BAVA) (“the Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for CHIKV VLP, the Company’s investigational chikungunya vaccine.
  • Bavarian Nordic is on track and plans to submit its MAA for CHIKV VLP to the EMA during H1 2024.
  • “We are pleased to receive the accelerated assessment in recognition of our chikungunya vaccine candidate and our efforts to bring this novel product to the market.

Curium Announces Submission of the Marketing Authorization Application for PYLCLARI®, an Innovative (18F)-PSMA PET Tracer Indicated in Adults With Prostate Cancer to Swissmedic

Retrieved on: 
Thursday, February 22, 2024
Radiopharmaceutical, European Commission, SPECT, Physician, Marketing, FDA, Food, Cancer, PSMA, Agency, INN, Death, Civil service commission, European Medicines Agency, AG, Patient, Nuclear medicine, Prostate cancer, Diagnosis, PCA, PET, Medical imaging

Dr. Michel Wuillemin, Head of Radiopharmaceuticals at b.e.imaging, commented, “b.e.Imaging is proud of the submission of the marketing authorization application for PYLCLARI® to Swissmedic ahead of schedule.

Key Points: 
  • Dr. Michel Wuillemin, Head of Radiopharmaceuticals at b.e.imaging, commented, “b.e.Imaging is proud of the submission of the marketing authorization application for PYLCLARI® to Swissmedic ahead of schedule.
  • We are fully dedicated to improving the situation of prostate cancer patients in Switzerland.”
    Benoit Woessmer, PET Europe CEO at Curium, commented, “The acceptance of the marketing authorization application by Swissmedic for PYLCLARI® is another important milestone for prostate cancer patients in Switzerland.
  • We look forward to providing an improved choice of tools available to physicians for the diagnosis of prostate cancer patients.
  • Marketing authorization for PYLCLARI® (also known as (18F)-DCFPyL) was granted in July 2023 by the European Commission.

Rhythm Pharmaceuticals Reports Fourth Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, February 22, 2024
EMANATE, New Drug Application, Investment, Obesity, BMI, Webcast, Initiate, BBS, Stage 2, Hyperpigmentation, Documentation, Polyphagia, European, GAAP, European Medicines Agency, PCSK1, Type, Type 2, G&A, LG Chem, BV, Completeness, Shanda, Bardet–Biedl syndrome, Clinical trial, LEPR, Medicaid, IND, Prescription, Research, Hunger, Acquisition, Quarter, EMA, MC4R, FDA, Prevalence, PMDA, Patient, POMC, Body mass index, Pharmaceutical industry

-- Acquired global rights to oral MC4R agonist LB54640 from LG Chem --

Key Points: 
  • ET --
    BOSTON, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today reported financial results and provided a business update for the fourth quarter and full year ended December 31, 2023.
  • Fourth Quarter and Full Year 2023 Financial Results:
    Cash Position: As of December 31, 2023, cash, cash equivalents and short-term investments were approximately $275.8 million, as compared to $333.3 million as of December 31, 2022.
  • S,G&A Expenses: S,G&A expenses were $32.4 million in the fourth quarter of 2023 and $117.5 million for the year ended December 31, 2023, compared to $26.3 million in the fourth quarter of 2022 and $92.0 million for the year ended December 31, 2022.
  • ET today to review its fourth quarter and year end 2023 financial results and recent business activities.

Greenwich LifeSciences Flamingo-01 Manufacturing & Protocol Accepted by European Regulators

Retrieved on: 
Thursday, February 22, 2024
Clinical trial, Breast cancer, EMA, Patient, BLA, European Medicines Agency, Immunotherapy, CTIS, Pharmaceutical industry

The Company's application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA's Clinical Trials Information System (CTIS).

Key Points: 
  • The Company's application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA's Clinical Trials Information System (CTIS).
  • The Company was informed that the manufacturing, non-clinical, clinical, statistical, and regulatory sections of its application are acceptable and the regulators' requests for information have been addressed.
  • The regulators have thus approved the clinical trial, marking a major milestone for the Company.
  • Once an individual site has been activated patients can be screened and enrolled.

Rhythm Pharmaceuticals Announces Clinical Development Plan of Setmelanotide for Hypothalamic Obesity in Japan

Retrieved on: 
Thursday, February 22, 2024
Incidence, EMA, MC4R, Obesity, FDA, Growth, Astrocytoma, Polyphagia, Prevalence, Hunger, PMDA, European Medicines Agency, Weight gain, Patient, Brain, Craniopharyngioma, Pharmaceutical industry

BOSTON, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced plans to add a cohort of patients with hypothalamic obesity in Japan to its ongoing global Phase 3 clinical trial of setmelanotide, with dosing expected to begin in the third quarter of 2024.

Key Points: 
  • “Following constructive discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), we are pleased to have developed a clear and efficient plan to support the potential approval of setmelanotide for hypothalamic obesity in Japan,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm.
  • The condition most frequently follows the growth and surgical removal or other treatment of craniopharyngioma, astrocytoma, or other rare brain tumors.
  • These individuals often experience rapid weight gain, a reduction in energy expenditure, and an increase in hunger leading to severe obesity within six to 12 months following the hypothalamic lesions.
  • Rhythm also announced today that it completed enrollment in the pivotal, 120-patient cohort in its global Phase 3 trial of setmelanotide in hypothalamic obesity with patients, aged 4 years or older with hypothalamic obesity randomized 2:1 to setmelanotide therapy or placebo for a total of 60 weeks, including up to eight weeks for dose titration.

Intellia Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Thursday, February 22, 2024
Research, Intellia Therapeutics, Regeneron Pharmaceuticals, Fatigue, Haemophilia, NK, CTA, Liver, Cystic fibrosis, ATM, A1AT, Amyloidosis, HAE, Therapy, European Medicines Agency, ATTR, Haemophilia B, DNA, European Commission, Hereditary angioedema, Recode, Conference, Cardiomyopathy, AATD, Civil service commission, Clinical trial, Facial muscles, CRISPR, Gene editing, Food, NTLA, KLKB1, Lung, NEJM, TTR, Patient, Medicine, Disease, Tissue, Pharmaceutical industry

Collaboration Revenue: Collaboration revenue decreased by $15.5 million to negative $1.9 million during the fourth quarter of 2023, compared to $13.6 million during the fourth quarter of 2022.

Key Points: 
  • Collaboration Revenue: Collaboration revenue decreased by $15.5 million to negative $1.9 million during the fourth quarter of 2023, compared to $13.6 million during the fourth quarter of 2022.
  • R&D Expenses: Research and development expenses increased by $9.0 million to $109.0 million during the fourth quarter of 2023, compared to $100.0 million during the fourth quarter of 2022.
  • G&A Expenses: General and administrative expenses increased by $5.4 million to $29.0 million during the fourth quarter of 2023, compared to $23.6 million during the fourth quarter of 2022.
  • Net Loss: The Company’s net loss was $132.2 million for the fourth quarter of 2023, compared to $113.4 million during the fourth quarter of 2022.

Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review

Retrieved on: 
Wednesday, February 21, 2024
Bone marrow, Marketing, FDA, Food, Regeneron Pharmaceuticals, BLA, Safety, European Medicines Agency, Patient, Priority, Disease, Biologics license application, Tissue, Cancer, Pharmaceutical industry

Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Key Points: 
  • Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
  • The BLA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023.
  • Earlier this month, the European Medicines Agency accepted for review the Marketing Authorization Application for linvoseltamab in the same indication.
  • Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy® (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

Retrieved on: 
Tuesday, February 20, 2024
Allergy, Epinephrine autoinjector, SAN, EMA, PD, Caregiver, Committee, CRL, Doctor of Philosophy, RN, ARS, Absorption, FDA, Food, File, Anaphylaxis, Heart rate, NAC, PDUFA, Agency, Entrepreneurship, Complete Response Letter, FARE, Symantec Endpoint Protection, Safety, Health, Lower respiratory tract infection, University, Rhinitis, Nasal mucosa, CHMP, European Medicines Agency, Nitrosamine, Patient, Pediatrics, IM, Adrenaline, Translational research, Trial of the century, Pharmaceutical industry

SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions.

Key Points: 
  • “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge.
  • With these results, we are completing the necessary work to submit our response to FDA in the next couple of months.
  • The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023.
  • In addition, multiple PADAC members highlighted the favorable profile of neffy in our single dose NAC study.

Herbal medicinal product: Fumariae herbaArray, F: Assessment finalised

Retrieved on: 
Tuesday, March 12, 2024
European Medicines Agency, Date, Dietary supplement

Overview

Key Points: 
  • Overview
    The European Medicines Agency is currently developing this information.
  • Key facts
    - Latin name
    - Fumariae herba
    - English common name
    - Fumitory
    - Botanical name
    Fumaria officinalis L.
    - Therapeutic area
    - Gastrointestinal disorders
    - Status
    - F: Assessment finalised
    - Date added to the inventory
    - Date added to priority list
    - Outcome of European assessment
    - European Union herbal monograph

Herbal medicinal product: Foeniculi amari fructusArray, F: Assessment finalised

Retrieved on: 
Tuesday, March 12, 2024
Urinary system, European Commission, Civil service commission, Community, European Medicines Agency, Date, Dietary supplement

Overview

Key Points: 
  • Overview
    The European Medicines Agency is currently developing this information.
  • Key facts
    - Latin name
    - Foeniculi amari fructus
    - English common name
    - Bitter Fennel
    - Botanical name
    Foeniculum vulgare Miller subsp.
  • vulgare var.
  • vulgare
    - Therapeutic area
    - Urinary tract and genital disorders
    - Cough and cold
    - Status
    - F: Assessment finalised
    - Date added to the inventory
    - Date added to priority list
    - Outcome of European assessment
    - European Union herbal monograph
    - European Union list entry
    - Additional information
    - Date of adoption of Community list entry by HMPC: 07/09/07
    - Transmission to the European Commission: 21/12/07
    - Commission Decisions on Community list entries