Biopharmaceutical

Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor

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星期二, 四月 23, 2024
Neuro-Oncology (journal), First grade, FDA, Society, University, BRAF V600, Day One, Hospital, Acne, Safety, Food, Biopharmaceutical, Conference call, Nausea, Insurance, Conference, Research, Webcast, Viral, Speech, Fatigue, Human, Disease, BRAF, Vomiting, Patient, Medicine, Headache, Event, Rash, Constipation, Diagnosis, Head, Neoplasm, Upper respiratory tract infection, PRS, Xeroderma, Fever, Caregiver, Ageing, Pharmaceutical industry

BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.

Key Points: 
  • With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.
  • “We are very proud that our first approved medicine addresses this serious and life-threatening disease of childhood and adolescence.
  • BRAF is the most commonly altered gene in pLGG, with up to 75 percent of children having a BRAF alteration.
  • “This is a tremendous moment not only for Day One, but also for the broader pediatric brain tumor community.

AstraZeneca unveils latest research across key respiratory and immune-mediated diseases at ATS 2024 showcasing strength of its broad pipeline and portfolio

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星期三, 五月 1, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Mortality, FDA, Risk, ICS, Death, Weight loss, Growth, Gastrointestinal tract, Rash, TSLP, Formoterol, Biopharmaceutical, AstraZeneca, LABA, Inflammation, Salbutamol, Skin, Tezepelumab, Approval, EGPA, AMG, Allergy, Polyp (medicine), Bronchitis, Chronic obstructive pulmonary disease, Patient, Eosinophilic, Sinusitis, Rheumatology, Heart, Atmosphere, Fatigue, Immunology, Budesonide, Lung, Chronic pain, Asthma, COPD, Gastroenterology, Emphysema, Disease, Science, Conditional sentence, Dermatology, Pharmaceutical industry

In addition, we are also collaborating with AstraZeneca on AMG104/AZD8630, an inhaled anti-TSLP compound currently in development for asthma.

Key Points: 
  • In addition, we are also collaborating with AstraZeneca on AMG104/AZD8630, an inhaled anti-TSLP compound currently in development for asthma.
  • Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company.
  • With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas.
  • AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

Mythic Therapeutics Announces Publication of Preclinical Data Highlighting the Differentiating Properties of MYTX-011 in Molecular Cancer Therapeutics

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星期二, 四月 30, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Biopharmaceutical, Kidney, Pharmacokinetics, Neck, Half-life, Engineering, ADC, Patient, Mythic, Neoplasm, Toxicity, Paper, Head, AACR, Therapy, Cancer, NSCLC, Spacecraft, Lung cancer, Pharmaceutical industry

Mythic Therapeutics , a clinical-stage biotechnology company committed to the development of next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, today announced the publication of preclinical data highlighting the differentiating properties of its investigational cMET-targeting ADC, MYTX-011, in Molecular Cancer Therapeutics , a journal of the American Association for Cancer Research (AACR).

Key Points: 
  • Mythic Therapeutics , a clinical-stage biotechnology company committed to the development of next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, today announced the publication of preclinical data highlighting the differentiating properties of its investigational cMET-targeting ADC, MYTX-011, in Molecular Cancer Therapeutics , a journal of the American Association for Cancer Research (AACR).
  • “We believe that engineering pH-dependent binding could be a particularly compelling strategy for ADCs targeting medium to low levels of cMET expression in patients.
  • A single dose of MYTX-011 showed at least three-fold higher efficacy than a benchmark ADC in mouse xenograft models of NSCLC ranging from low to high cMET expression.
  • In a repeat dose toxicology study, MYTX-011 exhibited a toxicity profile similar to other MMAE-based ADCs.

FASENRA approved for treatment of children aged 6 to 11 with severe asthma

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星期四, 四月 11, 2024
Health, FDA, General Health, Research, Science, Pharmaceutical, Biotechnology, Efficacy, Safety, Gastroenterology, HES, Chronic obstructive pulmonary disease, Sinusitis, Social media, Polyp (medicine), Pharmacokinetics, Rheumatology, Conference call, Asthma, TATE, AstraZeneca, FY, Hypereosinophilic syndrome, Death, ClinicalTrials.gov, Dermatology, Conference, COPD, Webcast, Growth, Disease, Vasculitis, Respiratory Medicine, EGPA, Immunology, Metabolism, Diagnosis, Biomarker, PD, Biopharmaceutical, Ageing, Pharmaceutical industry

TATE was an open-label, Phase III trial evaluating the safety of FASENRA in children aged 6 to 11 years with severe eosinophilic asthma.

Key Points: 
  • TATE was an open-label, Phase III trial evaluating the safety of FASENRA in children aged 6 to 11 years with severe eosinophilic asthma.
  • The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death.
  • Benralizumab in children with severe eosinophilic asthma: pharmacokinetics and long-term safety (TATE study).
  • Severe uncontrolled asthma in children: practical approach on diagnosis and management.

Absci Reports Business Updates and Fourth Quarter and Full Year 2023 Financial and Operating Results

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星期四, 三月 21, 2024
Research, Computational biology, AstraZeneca, Drug discovery, Half-life, Partnership, Executive, Patient, Conditional sentence, Biopharmaceutical, Insurance, Medicine, Dermatology, Investment, Therapy, Cryptocurrency

VANCOUVER, Wash. and NEW YORK, March 21, 2024 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a data-first generative AI drug creation company, today reported financial and operating results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • "In 2023, Absci further solidified its leadership in AI-driven biologic drug discovery," said Sean McClain, Founder and CEO.
  • In January, Absci presented positive preclinical data for ABS-101, a potential best-in-class anti-TL1A antibody, which exhibited properties consistent with a potentially superior product profile.
  • Based on further confirmatory studies, Absci selected a development candidate and initiated IND-enabling studies for ABS-101 in February 2024.
  • Cash, cash equivalents, and short-term investments as of December 31, 2023 were $97.7 million, compared to $113.5 million as of September 30, 2023.

Scorpius Holdings Accepted as a Member of the US Government’s BioMaP-Consortium

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星期四, 三月 14, 2024
Annual report, CDMO, Development, Infection, Health, Biopharmaceutical, HHS, Human services, Pandemic, Pharmaceutical industry

The BioMap-Consortium has a $20 billion funding ceiling, through which it provides growth funding, as well as streamlined access to servicing government-funded manufacturing programs.

Key Points: 
  • The BioMap-Consortium has a $20 billion funding ceiling, through which it provides growth funding, as well as streamlined access to servicing government-funded manufacturing programs.
  • Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX.
  • With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing.
  • This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

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星期二, 四月 2, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Breast cancer, Goserelin, Patient, Lung, Social media, Immunoglobulin G, National Cancer Institute, Neoplasm, Merck & Co., TNBC, Capecitabine, DXD, BRCA, Clinical Cancer Research, Metabolism, Immunology, Biopharmaceutical, World Health Organization, Cancer, Safety, ADC, BLA, Daiichi Sankyo, Vinorelbine, IHC, Mutation, NSCLC, Disease, Merck, AKT, Death, MD, AstraZeneca, PARP, Oncotarget, PFS, FDA, OS, HER2, Eribulin, Cleavage, Progression-free survival, Triple-negative breast cancer, Female, Emerging, Olaparib, Biology, Sapporo Medical University, Medicine, Pharmaceutical industry

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

Long-Acting Drug Delivery Technologies and Services Market, 2033: Patient-Centric Approaches Fueling Growth, Small Molecules Dominate, Biopharmaceutical and Life Science Companies Lead - ResearchAndMarkets.com

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星期四, 三月 28, 2024
Biotechnology, Medical Devices, Health, Pharmaceutical, Medical Supplies, Growth, Prevalence, End user, Conditional sentence, Polymer, Biopharmaceutical, Research, Overalls, Investment, Traction, Pharmaceutical industry

As of 2022, the global long-acting drug delivery technologies and services market held a value of $11.41 billion.

Key Points: 
  • As of 2022, the global long-acting drug delivery technologies and services market held a value of $11.41 billion.
  • The global long-acting drug delivery technologies and services market (by type of molecule delivered) was dominated by the small molecules segment in FY2022.
  • The Biopharmaceutical and Life science Companies segment accounted for the largest share of the global long-acting drug delivery technologies and services market (by End User) in FY2022.
  • Biopharmaceutical and life science companies are poised to sustain their dominant role in the global long-acting drug delivery technologies and services market as primary end users.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

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星期三, 三月 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

Retrieved on: 
星期三, 三月 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.