Indoor Living

IgA Nephropathy Pipeline Dynamics Signal Further Treatment Evolution on the Horizon

Retrieved on: 
Thursday, March 14, 2024
Nephrology, Indoor Living, Novartis, Patient, Alnylam Pharmaceuticals, Perception, SGLT2, Immunoglobulin A, Budesonide, NDA, Record, Breakthrough therapy, UPCR, Atrasentan, Kidney, EGFR, Alexion, FDA, CHMP, Physician, Health, Pharmaceutical industry

For several years, Spherix Global Insights has been closely tracking the IgAN market and recently released its fourth annual US patient chart audit study.

Key Points: 
  • For several years, Spherix Global Insights has been closely tracking the IgAN market and recently released its fourth annual US patient chart audit study.
  • Spherix is the leading authority on IgAN market dynamics and will continue to provide insight into how nephrologists are treating and approaching care for their IgAN patients.
  • Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits.
  • Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences

Retrieved on: 
Monday, March 4, 2024
Pfizer, ACIP, Indoor Living, Conference, VLA, CHMP, Saint-Herblain, Chikungunya, Euronext Paris

Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe.

Key Points: 
  • Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe.
  • CEO Thomas Lingelbach will present Valneva at the TD Cowen 44th Annual Health Care Conference, taking place March 4 - 6, 2024, in Boston, MA.
  • Mr. Lingelbach and CFO Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen Life Sciences Conference, held April 16 - 17, 2024, in Amsterdam, The Netherlands.
  • VLA15, the Company’s Lyme disease vaccine candidate, is currently in Phase 3 clinical development and partnered with Pfizer for this study and global commercialization.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Mirati Therapeutics, Inc. – MRTX

Retrieved on: 
Wednesday, August 2, 2023
LLP, European Directive on Traditional Herbal Medicinal Products, Mirati Therapeutics, NSCLC, Lung cancer, Committee, EMA, Conditional, Patient, Committee for Medicinal Products for Human Use, Mirati, MAA, Indoor Living, Pomerantz, News, CHMP, Private investigator

NEW YORK, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Mirati Therapeutics, Inc. (“Mirati” or the “Company”) (NASDAQ: MRTX).

Key Points: 
  • NEW YORK, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Mirati Therapeutics, Inc. (“Mirati” or the “Company”) (NASDAQ: MRTX).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Mirati and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Mirati Therapeutics, Inc. - MRTX

Retrieved on: 
Thursday, July 27, 2023
LLP, European Directive on Traditional Herbal Medicinal Products, Mirati Therapeutics, NSCLC, Lung cancer, Committee, EMA, Conditional, Patient, Committee for Medicinal Products for Human Use, Mirati, MAA, Indoor Living, Pomerantz, News, CHMP, Private investigator

NEW YORK, July 27, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Mirati Therapeutics, Inc. (“Mirati” or the “Company”) (NASDAQ: MRTX).

Key Points: 
  • NEW YORK, July 27, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Mirati Therapeutics, Inc. (“Mirati” or the “Company”) (NASDAQ: MRTX).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Mirati and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

Ipsen delivers solid H1 2023 results and upgrades its full-year guidance

Retrieved on: 
Thursday, July 27, 2023
IPN, Heart, Cholestatic pruritus, Maintenance, CHC, FY, Ascending cholangitis, Civil service commission, ADR, Prescription Drug User Fee Act, Fibrodysplasia ossificans progressiva, Ursodeoxycholic acid, Account, Ipsen, Galderma, Bank statement, Oxaliplatin, COMP, Rare disease, New Drug Application, European Directive on Traditional Herbal Medicinal Products, Research, Committee, EMA, ICC, Primary biliary cholangitis, Report, FOP, Patient, Committee for Medicinal Products for Human Use, PDUFA, Webcast, Consumer, Growth, Ageing, Alagille syndrome, Indoor Living, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, European Commission, Safety, CHMP, Pharmaceutical industry, Medical device, Cryptocurrency, ALGS, Oncology, Neuroscience, Odevixibat, Euronext

The performance in the first half of the year is reflected in today’s upgrade to our full-year guidance.

Key Points: 
  • The performance in the first half of the year is reflected in today’s upgrade to our full-year guidance.
  • The Company’s auditors performed a limited review of the H1 2023 condensed consolidated financial statements.
  • Ipsen intends to publish its year-to-date and third-quarter sales update on 26 October 2023.
  • The performance shown in this announcement covers the six-month period to 30 June 2023 (H1 2023) and the three-month period to 30 June 2023 (Q2 2023), compared to six-month period to 30 June 2022 (H1 2022) and the three-month period to 30 June 2022 (Q2 2022), respectively, unless stated otherwise.

Darolutamide receives approval for additional prostate cancer indication in Japan

Retrieved on: 
Monday, February 27, 2023
CHMP, Death, Ministry of Health (Kuwait), Ministry, Prostate cancer, The New England Journal of Medicine, Disease, Ari, Risk, Darolutamide, Patient, ADT, Orion, Docetaxel, University of Medicine 1, Yangon, Indoor Living, European Directive on Traditional Herbal Medicinal Products, Incidence, Phase, MHLW, Pharmaceutical industry, Health, Bayer, EU

The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.

Key Points: 
  • The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • Darolutamide is being investigated in a broad development program with three additional ongoing or planned large clinical studies, to evauate its potential across prostate cancer patients from the early- to the late-stage of this disease.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.

CHMP recommends conditional marketing authorization for Spesolimab as first in class treatment option for generalized pustular psoriasis flares

Retrieved on: 
Friday, October 14, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Consensus, Quality of life, Psoriasis, Decision-making, Dermatology, Infection, Diagnosis, Patient, Teaching hospital, Skin, GPP, Multimedia, Committee for Medicinal Products for Human Use, Immune system, Department, Board, Boehringer Ingelheim, Indoor Living, Shock, Flare, CHMP, Public health, Vaccine, Pharmaceutical industry

The European Medicine Agencys Committee for Medicinal Products for Human Use (CHMP) recommended the granting of a conditional market authorization* for Boehringer Ingelheims spesolimab as first in class treatment option for generalized pustular psoriasis (GPP) flares in adults.

Key Points: 
  • The European Medicine Agencys Committee for Medicinal Products for Human Use (CHMP) recommended the granting of a conditional market authorization* for Boehringer Ingelheims spesolimab as first in class treatment option for generalized pustular psoriasis (GPP) flares in adults.
  • The positive opinion for spesolimab brings us one step closer to a new and first treatment option specifically designed to target the IL-36 pathway that is central to the pathogenesis of GPP.
  • This positive recommendation recognizes spesolimabs potential as a new targeted monoclonal antibody that could treat the underlying cause of GPP.
  • Infections were reported by 17% and 6% of patients in the spesolimab and placebo groups respectively (at week one).

Rocket Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial and Operational Results

Retrieved on: 
Thursday, February 24, 2022
Health, Pharmaceutical, Fanconi anemia, Compliance, Empire, Phase II, Awareness, Indoor Living, COVID-19, Company, General counsel, Private Securities Litigation Reform Act, Research, CGMP, Adolescence, Risk, SEC, Investment, Genetic disorder, Pyruvate kinase deficiency, Safety, Lists of diseases, Food, MMC, Quality of life, Bone marrow failure, Orphan drug, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Degenerative disease, NASDAQ, AAV, RTW, G&A, Advanced Therapy Medicinal Product, LP, Heart failure, Good manufacturing practice, Danon disease, EMA, Patient, PKD, History, Medication, FA, Industry, ASH, LVV, Adult, CD18, FDA, Conference, Lifting, Marketing, Anemia, Society, Pharmaceutical industry, Video game, Online gambling, Airline, Internet service provider, EU, Rocket

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today reports financial and operational results for the fourth quarter and year ended December 31, 2021.

Key Points: 
  • Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today reports financial and operational results for the fourth quarter and year ended December 31, 2021.
  • Results demonstrated sustained benefit across clinical, functional and biomarker endpoints in all four patients with long-term follow up.
  • Preliminary Phase 1 data and Phase 2 trial initiation activities are expected in the fourth quarter of 2022.
  • Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes.

VARIANT Receives European Orphan Drug Designation for its Gene Therapy Product Candidate, VAR002, for the Treatment of Both Leber Congenital Amaurosis and Cone-Rod dystrophy

Retrieved on: 
Wednesday, November 24, 2021
Health, Other Science, Pharmaceutical, Science, Optical, Biotechnology, Royal commission, Patient, COMP, Retina, Retinitis pigmentosa, Indoor Living, Committee, ODD, Program, CRX, Leber congenital amaurosis, CORD, Mutation, IRDS, Kaay Raav Tumhi, LCA, EMA, Patent, Biotechnology, RP, European Commission, AAV, ASO, Factor X, Pharmaceutical industry, Vaccine

Variant, a company dedicated to developing innovative treatments for inherited eye orphan diseases, announces the decision of the European Commission to grant Orphan Drug Designation (ODD) for VAR002 for the treatment of Leber congenital amaurosis (LCA) and Cone-rod dystrophy (CORD).

Key Points: 
  • Variant, a company dedicated to developing innovative treatments for inherited eye orphan diseases, announces the decision of the European Commission to grant Orphan Drug Designation (ODD) for VAR002 for the treatment of Leber congenital amaurosis (LCA) and Cone-rod dystrophy (CORD).
  • The decision is based on a positive opinion from the European Medicine Agencys (EMA) Committee for Orphan Medicinal Products (COMP).
  • VAR002 is a CRX-expressing AAV vector designed as a relevant therapeutic approach for gene supplementation and a promising drug candidate for mutation-agnostic gene therapy.
  • Denis CAYET, Variant CEO, comments, With the VAR002 ODDs and patent, VARIANT develops solid protection of its know-how on retinal transcription factors.

Ascendis Pharma A/S Receives Positive CHMP Opinion for TransCon™ hGH for Patients with Pediatric Growth Hormone Deficiency

Retrieved on: 
Friday, November 12, 2021
Safety, Failure, Science, Health, MAA, Flight, U.S. Securities and Exchange Commission, European Commission, Hormone, Ageing, Pituitary gland, Technology, Senior, European Medicines Agency, Growth, Investment, COVID-19, Transgender hormone therapy, Standard of care, Research, Forward-looking statement, Annual report, Southern Transcon, Enlightenment, GHD, GLOBE, Growth hormone, Indoor Living, SEC, DevOps, Committee on Herbal Medicinal Products, Royal commission, Marketing, Nasdaq, Patient, Autoinjector, CHMP, Pharmaceutical industry, Birth control, Fine chemical

COPENHAGEN, Denmark, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization for Lonapegsomatropin Ascendis Pharma (TransCon hGH). TransCon hGH is a long-acting once-weekly, transiently pegylated somatropin that in the body releases somatropin (also called human growth hormone, or hGH), indicated for growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency, or GHD). The European Commission final decision on the Company’s Marketing Authorisation Application (MAA) for TransCon hGH is expected within 67 days after the positive opinion, or by the end of January 2022.

Key Points: 
  • TransCon hGH is a once-weekly prodrug of somatropin designed to reduce the treatment burden for patients with growth hormone deficiency.
  • Final European Commission decision on TransCon hGH MAA for pediatric growth hormone deficiency expected within 67 days after positive opinion.
  • We are delighted to receive a positive CHMP opinion for once-weekly TransCon hGH, said Dana Pizzuti, M.D., Ascendis Pharmas Chief Medical Officer and Senior Vice President of Development Operations.
  • Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, and SKYTROFA are trademarks owned by the Ascendis Pharma Group.