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Paediatric And Infant Patients Articles & Analysis
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In the ever-evolving pharmaceutical landscape, CD Formulation is emerging as a pioneer in the development of oral thin film (OTF) delivery systems. These cutting-edge drug delivery technologies enhance therapeutic efficiency and patient compliance, offering a versatile alternative to conventional tablets and capsules. CD Formulation specializes in providing comprehensive contract development and ...
At best, most of us tolerate needles. Whether a vaccine, an IV drip, or a blood draw, we can talk ourselves through it with the knowledge that it is for the greater good and will only cause temporary discomfort. On the other side of the spectrum, there are people with such an intense fear of needles that they are considered to have a phobia, trypanophobia to be precise. Many articles have been ...
Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12. Quillivant ER will be available as both an oral ...
Intermountain Primary Children’s Hospital First in the Country to Implant this Next Generation FDA-Cleared Device Company Welcomes Vice President of Sales & Marketing, Mark Geiger, Who Lives with Hydrocephalus Anuncia Medical Inc. (“Anuncia” or the “Company”), a Company specializing in advancing innovations for implantable and external cerebrospinal fluid ...
Third Pole Therapeutics, a privately held company developing critical life-sustaining cardio-pulmonary therapies, announced today a $32M equity investment, from a large medical device innovator. Bill Athenson, CEO of Third Pole, stated, “We are thrilled to receive this investment, which raises Third Pole Therapeutics’ series B financing and commitments to date to over $85M. I am ...
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that gammaCore Sapphire has been issued a National Code Number (CNK) in Belgium. CNK numbers are unique product code identifiers allocated by the Belgian Pharmaceutical Association (APB) for products and medicines commercially available from pharmacies throughout ...
Recommendation is based on the Phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT Retinopathy of prematurity (ROP) can lead to severe visual impairment and blindness Bayer will apply for a patent term extension for the patent covering aflibercept, the active ingredient in Eylea™, of six months once the European Commission adopts a decision for a label extension ...
ByBayer AG
Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that data from the Company’s compassionate use program on anti-leukemic activity of STRO-002, a novel folate receptor-α (FR-α) targeting ADC, in infants and children with relapsed/refractory ...
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that gammaCore Sapphire™, the first and only FDA-cleared, non-invasive device to treat and prevent multiple types of headache pain via the vagus nerve, will be distributed and billed exclusively by Joerns Healthcare, LLC (Joerns) within selected managed care health systems. ...
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced data from an oral presentation at Neurocritical Care Society’s (NCS) 20th Annual Meeting held in San Antonio, Texas on October 17 – 21, 2022 on the possible role of gammaCore (nVNS) in the acute treatment of Traumatic Brain Injury (TBI). The presentation is being given by Dr. Afshin ...
- 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 ...
New post-hoc analyses from the prespecified pooled analysis FIDELITY will provide insights into the effects of finerenone on kidney and cardiovascular outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline, as well as by baseline HbA1c, HbA1c variability, and diabetes duration in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) An exploratory ...
ByBayer AG
Agreement provides exclusive access to state-of-the-art GMP manufacturing suites to support Phase 2 clinical studies Potential to expand the agreement to support commercial-scale manufacturing NEW YORK and LOUISVILLE, Ky, Sept. 15, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell ...
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer reviewed manuscript, Transcutaneous Cervical Vagus Nerve Stimulation Reduces Behavioral and Physiological Manifestations of Withdrawal in Patients with Opioid Use Disorder: A Double-Blind, Randomized, Sham-Controlled Pilot Study in the journal, Brain Stimulation. The ...
U.S. Food and Drug Administration (FDA) granted label update for Kerendia (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV ...
ByBayer AG
xCures, Inc., a clinical study platform provider, and Oblato, Inc., a biotechnology company, are pleased to announce the availability of OKN-007 through an intermediate size expanded access program (iEAP) for eligible patients with pediatric diffuse midline glioma (DMG), inclusive of diffuse intrinsic pontine glioma (DIPG). Oblato is currently developing OKN-007 as a treatment for glioblastoma ...
ByxCures
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced Mayo Clinic is initiating an investigator-initiated study to assess the efficacy of gammaCore Sapphire non-invasive vagus nerve stimulation (nVNS) in patients with post-COVID syndrome. Post-COVID syndrome, also known as Long COVID, is a collection of symptoms that persist greater than 28 days ...
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure and premature death Kerendia (finerenone) is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with CKD associated with T2D The approval in China ...
ByBayer AG
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) will be available for purchase through many of the more than 130 National Spine and Pain Centers (NSPC) affiliated locations across the United States for patients suffering from pain associated with different forms of ...
RP-L201 well-tolerated with durable CD18 expression for all patients in Phase 2 pivotal trial 100% overall survival in patients at one year after RP-L201 infusion based on Kaplan-Meier estimate All patients showed clinical reversal of disease course, including statistically significant reduction in all-cause hospitalizations and incidence of severe infections Initiating discussions with ...