Subcutaneous Elafin Tiprelestat Injection Articles & Analysis
21 news found
CD Bioparticles, a leading manufacturer and supplier of numerous drug delivery products and services, is proud to announce its expanded capabilities in Customized Liposomes. This advancement allows researchers and developers to leverage the power of liposome technology for a wider range of applications. Liposomes are small spherical artificial vesicles (typically 50-500 nm in diameter) composed ...
MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner Roche (SIX: RO, ROG; OTCQX: RHHBY) provided an update on the GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimer’s disease (AD). The studies did not meet their primary endpoint of slowing clinical decline. The level of beta-amyloid removal, the protein that builds up to make plaques ...
- OXLUMO Now Indicated for the Treatment of Primary Hyperoxaluria Type 1 (PH1) to Lower Urinary and Plasma Oxalate Levels in Pediatric and Adult Patients - - Approval is Based on Positive Efficacy and Safety Results of the ILLUMINATE-C Phase 3 Study of OXLUMO in PH1 Patients with Severe Renal Impairment, Including Those on Hemodialysis - CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 6, 2022-- Alnylam ...
Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA’s mission to facilitate modernization in ...
– AMVUTTRA Demonstrated Halting or Reversal in Neuropathy Impairment with Subcutaneous Administration Once Every Three Months – – Decision Follows Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2022 – CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 20, 2022-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), ...
IRVINE, Calif. – AUG. 29, 2022 – AIVITA Biomedical, Inc., a biotech company specializing in innovative cell applications, today announced the publication of safety and efficacy results from Phase 1 and Phase 2 clinical trials investigating its anti-SARS-CoV-2 vaccine candidate AV-COVID-19 that is made at point-of-care by third-party personnel. The results were published in the article ...
Rani Therapeutics Holdings, Inc. recently announced the development of a high-capacity oral biologics device known as the RaniPill HC (High Capacity), capable of delivering up to a 500%-plus higher drug payload than Rani’s existing oral biologics capsule. In preclinical testing, RaniPill HC demonstrated successful delivery of adalimumab and achieved high bioavailability. “The ...
A new study with TikoMed’s platform lead clinical drug candidate ILB®, provides positive safety and tolerability results and the first clinical evidence of encouraging clinical efficacy of ILB® in the treatment of Amyotrophic Lateral Sclerosis (ALS). The study was published in PLOS ONE today. In a phase II study of ILB administered to patients with ALS for five weeks, the ...
Gerresheimer AG is expanding its portfolio of highly-innovative platform technologies for drug delivery. Gerresheimer, a leading provider of healthcare & beauty solutions and drug delivery systems for pharma, biotech and cosmetics, today announced an investment into US-based Portal Instruments, a developer of a next-generation needle-free drug delivery technology. Together, the partners aim ...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised ...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory ...
Camurus (NASDAQ STO: CAMX) today announces that the European Medicines Agency (EMA) has accepted the company’s submission of a Type II variation application for Buvidal (buprenorphine) prolonged release injection to include treatment of chronic pain. “We are pleased that the review procedure has been initiated. There is a high unmet medical need in chronic pain, particularly among ...
Upgrading Bevacizumab from IV to subcutaneous (SubQ) administration may now be possible with Qprotyn's HILOPRO technology. Innovator Bevacizumab was first sold under the brand name Avastin(R) by Genentech - a member of the Roche Group. First approved in the United States in 2004 and in the European Union in 2005, Bevacizumab is now used to treat different types of cancers and age-related ...
– Phase 1/2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of Micron’s Microneedle-Based Measles-Rubella Vaccine – ATLANTA, July 13, 2021 /PRNewswire/ – Micron Biomedical, Inc. (“Micron” or the “Company”), a leader in dissolving, microneedle-based vaccine and drug delivery, today announced that it has initiated a Phase 1/2 clinical ...
The National Transgender Discrimination Survey Report on Health and Health Care recorded at least 80% of transgender people have either taken gender-affirming hormone therapy (GAHT) or want to take GAHT at some point.¹ We sat down to learn from Joelle Jacoski about the drug delivery challenges of taking GAHT. “I came out as non-binary about four months ago and ...
A new study on TIKOMED’s lead drug candidate, ILB®, was published in npj Regenerative Medicine today. The peer-reviewed data from rodent and human disease models showed that ILB® leads to tissue remodelling, reduced fibrosis and functional tissue regeneration – observations indicating the potential of ILB® to alleviate fibrotic diseases. Professor Ann Logan, from the ...
tiakis Biotech AG (formerly Proteo Biotech AG) has attained another milestone in its Pulmonary Arterial Hypertension (PAH) development program by receiving the final clinical phase 1 trial report demonstrating the very good safety profile of Tiprelestat (no severe adverse occurred). tiakis’s research partners and investigators at Stanford University School of Medicine, Dr. Marlene ...
Our Phase IIa clinical trial evaluating the safety, tolerability and possible efficacy of subcutaneous injections of ILB® in ALS is finalized and has been reported to the Swedish Medical Products Agency. The results indicate that, for the variants of ALS and the given dose investigated in the study, ILB® seems to have beneficial clinical effects without significant side effects. A ...
Allovate Therapeutics (“Allovate®”), a New York-based biotechnology company focused on improving treatment for allergies, is pleased to announce the appointment of Robert "Bob" Pomrenke to the position of Chief Executive Officer, effective April 1, 2019. Mr. Pomrenke brings over 25 years of sales, marketing and business development experience in the allergy immunotherapy market. ...
tiakis BIOTECH AG today announced the start of the clinical development for the subcutaneous use of tiakis lead investigational drug candidate Elafin (INN: Tiprelestat). ...