Adverse Events

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Y-mAbs Therapeutics, Inc. - YMAB

Retrieved on: 
Sunday, February 5, 2023
Food, CNS, Bias, Biologics license application, Survival, Oncology Drug Advisory Committee, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, FDA, Adverse Events, Therapy, News, Pharmaceutical industry, Renewable energy

NEW YORK, Feb. 04, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).

Key Points: 
  • NEW YORK, Feb. 04, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Y-mAbs 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, the Pomerantz Firm pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Y-mAbs Therapeutics, Inc. - YMAB

Retrieved on: 
Sunday, January 29, 2023
Food, CNS, Bias, Biologics license application, Survival, Oncology Drug Advisory Committee, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, FDA, Adverse Events, Therapy, News, Pharmaceutical industry, Renewable energy

NEW YORK, Jan. 29, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).

Key Points: 
  • NEW YORK, Jan. 29, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Y-mAbs 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, the Pomerantz Firm pioneered the field of securities class actions.

Azura Ophthalmics Presents Positive Results from Phase 2b Clinical Trial of AZR-MD-001 in Meibomian Gland Dysfunction at Ophthalmology Innovation Summit XII

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Friday, December 9, 2022
Health, Clinical Trials, Research, Science, Pharmaceutical, Optical, Biotechnology, Therapy, Baozou Big News Events, M. B, Exocrine gland, Selenium disulfide, Military medicine, Veteran, Diagnosis, Visual Science, Corneal ulcers in animals, Patient, Duane syndrome, Classification, Milner, MGS, OIS, Total, M. A, Drug development, Meibomian gland, News, MGD, European Ophthalmic Pathology Society, All rights reserved, Adverse Events, Luchs, Safety, Investigative Ophthalmology & Visual Science, Systematic review, Contact lens, AES, Prevalence, Pharmaceutical industry, Telescopic sight, Medical device, OSDI, Ophthalmology, Azura, Amit Majmudar

It was a pleasure to share our exciting Phase 2b results at OIS XII, and we look forward to advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.

Key Points: 
  • It was a pleasure to share our exciting Phase 2b results at OIS XII, and we look forward to advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.
  • The results from Azuras Phase 2b study of AZR-MD-001 0.5% in MGD were presented during the Spotlight on Dry Eye session at OIS XII.
  • The Phase 2b trial was a multi-center, double-masked, vehicle-controlled, parallel group study that evaluated the safety and efficacy of AZR-MD-001 in 245 patients with MGD.
  • Meibomian Gland Dysfunction is a chronic and progressive condition associated with blockage of the meibomian glands and alteration in the quality of expressed meibum which can end in gland atrophy.

Azura Ophthalmics Announces Positive Results from Phase 2b Clinical Trial of AZR-MD-001 in Meibomian Gland Dysfunction

Retrieved on: 
Thursday, November 17, 2022
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Total, Medical director, M. A, Irritation, Exocrine gland, MGS, Safety, Investigative Ophthalmology & Visual Science, Meibomian gland, European Ophthalmic Pathology Society, Veteran, MGD, AES, LASIK, United, Drug development, VAS, All rights reserved, Eyelid, Physician, Pain, Diagnosis, Patient, Duane syndrome, Prevalence, Selenium disulfide, Luchs, Corneal ulcers in animals, Classification, Gland, Military medicine, Therapy, Milner, SPEED, Business, M. B, Systematic review, Adverse Events, Contact lens, Warrenville, Pharmaceutical industry, Medical imaging, Telescopic sight, Medical device, OSDI, Ophthalmology, Amit Majmudar, Azura

Azura Ophthalmics Ltd. , a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in Meibomian Gland Dysfunction (MGD).

Key Points: 
  • Azura Ophthalmics Ltd. , a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in Meibomian Gland Dysfunction (MGD).
  • We are thrilled to build upon these positive results by advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.
  • I look forward to collaborating with the Azura team and my fellow scientific advisory board members to advance AZR-MD-001.
  • Meibomian Gland Dysfunction is a chronic and progressive condition associated with blockage of the meibomian glands and alteration in the quality of expressed meibum which can end in gland atrophy.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Y-mAbs Therapeutics, Inc. - YMAB

Retrieved on: 
Monday, November 7, 2022
GLOBE, Oncology Drug Advisory Committee, Company, Food, Bias, Regulation of tobacco by the U.S. Food and Drug Administration, Therapy, NASDAQ, News, Biologics license application, Survival, Adverse Events, Patient, CNS, FDA, Pharmaceutical industry, Renewable energy

NEW YORK, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (Y-mAbs or the Company) (NASDAQ: YMAB).

Key Points: 
  • NEW YORK, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (Y-mAbs or the Company) (NASDAQ: YMAB).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Y-mAbs 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, the Pomerantz Firm pioneered the field of securities class actions.

 Siolta Therapeutics Announces First Newborn Dosed in Their Phase 2 ADORED Study Evaluating a Potential First-In-Class Live Biotherapeutic Product for the Prevention of Atopic Diseases

Retrieved on: 
Wednesday, July 20, 2022
Research, Baby, Maternity, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Science, NIH, Atopic dermatitis, Allergic rhinitis, Piper LBP, Food allergy, Ageing, Incidence, Allergic inflammation, Health, Part, Asthma, Therapy, Safety, Adverse Events, Clinical trial, Vital signs, MD, AES, A1, LBP, Șaeș, Immunoglobulin E, Pharmaceutical industry, Vaccine, A2

We are excited to dose our first newborn in the Phase 2 portion of our adored study ( www.adoredstudy.com ) with STMC-103H, a novel LBP consortium.

Key Points: 
  • We are excited to dose our first newborn in the Phase 2 portion of our adored study ( www.adoredstudy.com ) with STMC-103H, a novel LBP consortium.
  • There are no approved treatments available to prevent the onset of atopic diseases, said Richard Shames, MD, Chief Medical Officer of Siolta.
  • STMC-103H is a Live Biotherapeutic Product (LBP) being developed by Siolta Therapeutics for the prevention and treatment of atopic diseases (atopic dermatitis, atopic asthma, food allergy, allergic rhinitis) in at-risk newborns based on an immediate family history of atopic diseases.
  • Siolta Therapeutics is a clinical-stage biopharmaceutical company developing targeted microbiome-based therapeutics to prevent and treat diseases of high unmet medical need.

Akari Therapeutics Announces Publication of Phase II Data of Investigational Nomacopan for the Treatment of Bullous Pemphigoid (BP) in JAMA Dermatology

Retrieved on: 
Tuesday, May 10, 2022
Drug development, Treatment, Failure, NEW, Safety, Eye, Infection, Common Terminology Criteria for Adverse Events, Annual report, IPPF, PMID, Ageing, Meta-analysis, Lindri Juni Wijayanti, SEC, Itch, CEO, Risk, JAMA, Phase, Mortality, LTB4, Dermatology, Patient, Validity, JAMA Dermatology, FDA, Hospital, Thrombotic microangiopathy, Disease, Dermatology Life Quality Index, Akari, Inflammation, Blister, Therapy, Seasonal adjustment, Private Securities Litigation Reform Act, DLQI, EMA, U.S. Securities and Exchange Commission, Quality of life, CTCAE, American Medical Association, Degenerative disease, Leukotriene B4, Adverse Events, Responsiveness, Reliability, OCS, Intellectual property, TMA, MCID, COVID-19, Nasdaq, GLOBE, Autoimmunity, Death, Adult, Journal, YORK, AE, Pharmaceutical industry, BP, C5

NEW YORK and LONDON, May 10, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, plc (Nasdaq: AKTX), a late-stage biotechnology company focused on development of advanced therapies for autoimmune and inflammatory diseases, announced positive results from the Phase II study of investigational nomacopan in bullous pemphigoid (BP) were published online in the Journal of the American Medical Association (JAMA) Dermatology. https://jamanetwork.com/journals/jamadermatology/article-abstract/2791461

Key Points: 
  • https://jamanetwork.com/journals/jamadermatology/article-abstract/2791461
    These positive Phase II data advanced our understanding of the nomacopan safety profile and informed duration of treatment in the ARREST-BP Phase III clinical trial, which is open for enrollment now, said Rachelle Jacques, President and CEO of Akari Therapeutics.
  • The Phase II trial was a multicenter, single-group, nonrandomized controlled study conducted in the dermatology departments of hospitals in the Netherlands and Germany.
  • Adult patients (aged >18 years) with mild to moderate, new-onset or relapsing BP were recruited into the study.
  • The Reliability, Validity and Responsiveness of Two Disease Scores (BPDAI and ABSIS) for Bullous Pemphigoid: Which One to Use?

Mereo BioPharma announces Positive Top-Line Efficacy and Safety Data from “ASTRAEUS” Phase 2 Trial of Alvelestat in Alpha-1 Antitrypsin Deficiency-associated Emphysema

Retrieved on: 
Monday, May 9, 2022
People, Aspartate transaminase, Interim, QT interval, Osteogenesis imperfecta, ULN, Biomarker, Safety, Cystic fibrosis, Șaeș, Degenerative disease, Cough, Atalanta, Annual report, Death, Respiratory disease, Bronchiectasis, Respiratory tract, Standard of care, Forward-looking statement, Headache, AES, AATD, Bilirubin, Company, FEV1, Plasma, WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents, AST, Patient, Infection, COPD, Fibrosis, Desmosine, Ovarian cancer, CF, AAT, U.S. Securities and Exchange Commission, LSM, Neoplasm, Interest group, Security (finance), Adverse Events, Form 6-K, COVID-19, Arm, BOS, Monaco Age Oncologie, Therapy, History, OI, AE, Medical imaging, Pharmaceutical industry, Alanine transaminase, AstraZeneca

LONDON and REDWOOD CITY, Calif., May 09, 2022 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or “the Company”), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced positive top-line efficacy and safety results from “ASTRAEUS” a Phase 2 study of the investigational oral neutrophil elastase (NE) inhibitor, alvelestat (MPH-966), in patients with severe alpha-1 antitrypsin deficiency-associated emphysema.

Key Points: 
  • Consistent with the known safety profile of alvelestat, no safety signals were observed in adverse event (AE) monitoring.
  • Most AEs were mild to moderate, including within Adverse Events of Special Interest (AESI) which were observed in 23 subjects.
  • Prior to Mereo BioPharma licensing alvelestat from AstraZeneca (AZ), trials across COPD, bronchiectasis and cystic fibrosis (CF) had been performed.
  • Mereo reported a positive Phase 1b/2 trial in COVID-19 which was completed in 2021 and showed alvelestat was safe and well tolerated.

Theralase® Provides Update on Phase II Bladder Cancer Clinical Study

Retrieved on: 
Tuesday, April 5, 2022
TSX Venture Exchange, Company, Virus, Cancer, Risk, Data monitoring committee, Safety, Center for Drug Evaluation and Research, Interim, Trial of the century, Center for Biologics Evaluation and Research, NMIBC, Quality assurance, Bacteria, PR, Incidence, PDC, Patient, Oxidative stress, Cystoscopy, Endpoint security, TSX, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Light, Quality of life, Center, Review, Partial-response maximum-likelihood, Adverse Events, Time, COVID-19, Șaeș, CR, News, AES, Reactive oxygen species, Nootropic, FDA, Toxicity, Pharmaceutical industry, Gasoline, Medicine, Tanning (leather), Dietary supplement, Medical device, Vaccine, Medical imaging, Public relations, Research, Studie II

Study II is presently ongoing and new clinical data collected may or may not continue to support the current reported trends.

Key Points: 
  • Study II is presently ongoing and new clinical data collected may or may not continue to support the current reported trends.
  • Study II has delivered significant clinical results to date for the primary, secondary and tertiary objectives.
  • This provides clinical support for achieving the primary and secondary objectives of Study II.
  • Theralase believes these 7 SAEs are unrelated to the Study Drug or Study Device.

Seven and Eight Biopharma’s BDB001 in Combination with an anti-PD-L1 mAb Shows Favorable Safety and Clinical Responses in Interim Phase 1 Data Presented at the 2021 SITC Annual Meeting

Retrieved on: 
Saturday, November 13, 2021
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Safety, SITC, Cancer, PD-L1, Time, Mab, Squamous cell carcinoma, Neoplasm, Infrared spectroscopy correlation table, TLR, Immune system, Society for Immunotherapy of Cancer, Adverse Events, MSI, Probability, B cell, Radiation, TLR7, Cytokine release syndrome, Annual general meeting, Large-cell lung carcinoma, Immunology, ASCO, Immunotherapy, Patient, Risk, Pharmaceutical industry, Vaccine, Palladium, Medical imaging

The presentation at SITC 2021 provides interim safety and efficacy results for a Phase 1 dose escalation / expansion trial of BDB001 in combination with atezolizumab in advanced solid tumors ( NCT04196530 ).

Key Points: 
  • The presentation at SITC 2021 provides interim safety and efficacy results for a Phase 1 dose escalation / expansion trial of BDB001 in combination with atezolizumab in advanced solid tumors ( NCT04196530 ).
  • The results show that BDB001 in combination with atezolizumab is well tolerated with evidence of robust immune activation leading to clinical responses in multiple tumor types.
  • These promising interim results show that BDB001 in combination with atezolizumab represents a novel and viable treatment for advanced solid tumors.
  • On-Demand Session Release Date and Time: November 13th, 2021 @ 7:00 AM
    The poster presentation will be available at the SITC 2021 Annual Meeting website.