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Generex biotechnology: Generex biotechnology have had their rapidmist delivery system (an oral insulin spray that is the flagship product of their company) approved for use in Ecuador. The liquid spray is absorbed by the buccal mucosa. They hail this system as pain free and a reality, and aim to infiltrate the European market at a later date. Generex have an agreement with insulin giant Eli Lilly. HY 2021 revenue reached € 2.8 billion (+7%; +11% CER). Net sales went up by 6% to € 2 651million (+11% CER), driven by the sustainable growth of UCB’s key products. Data from a paediatric pharmacokinetic study with oral administration of a single dose of 5 mg levocetirizine in 14 children age 6 to 11 years with body weight ranging between 20 and 40 kg show that C max and AUC values are about 2-fold greater than that reported in healthy adult subjects in a cross-study comparison. The mean C max was 450 ng/ml, occurring at a mean time of 1.2 hours, weight-normalized, total body clearance was 30% greater, and the elimination half-life 24% shorter in this paediatric population than in adults. Dedicated pharmacokinetic studies have not been conducted in paediatric patients younger than 6 years of age. A retrospective population pharmacokinetic analysis was conducted in 323 subjects (181 children 1 to 5 years of age, 18 children 6 to 11 years of age, and 124 adults 18 to 55 years of age) who received single or multiple doses of levocetirizine ranging from 1.25 mg to 30 mg. Data generated from this analysis indicated that administration of 1.25 mg once daily to children 6 months to 5 years of age is expected to result in plasma concentrations similar to those of adults receiving 5 mg once daily. It’s recommended to use lotions and moisturizers on your body before spraying body spray. Best overall body spray: Bath and Body Works deodorizing body spray Bath & Body Works Bath & Body Works Don’t get us wrong: Every scent on our list of the best body sprays for men has something going for it. However, there’s just something about this Kenneth Cole body spray that delivers an elevated, enlightened scent for adding a touch of refinement to the everyday.

Caution should be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention. Children or adolescents who require daily insulin injections may find that the regimen impacts on their daily lifestyle to an even greater degree. Adverse reactions from post-marketing experience are per System Organ Class and per frequency. The frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). The efficacy and safety of levocetirizine has been demonstrated in several double-blind, placebo controlled, clinical trials performed in adult patients suffering from seasonal allergic rhinitis, perennial allergic rhinitis, or persistent allergic rhinitis. Levocetirizine has been shown to significantly improve symptoms of allergic rhinitis, including nasal obstruction in some studies. Revenue in the first six months 2021 increased by 7% (+11% CER) to € 2 778 million and net sales increased by 6% (+11% CER) to € 2 651 million. Net sales before “designated hedging reclassified to net sales” were € 2 611 million with a plus of 4% (+11% CER). This growth was driven by the resilient UCB product portfolio – despite the pandemic. The change of distribution model for E-Keppra ® in Japan supported the net sales growth. Adjusted for this impact, net sales would have increased by +7% CER.UCB estimates that more than 150,000 people in the U.S. with refractory epilepsy also experience seizure clusters. 2,3,4 These types of seizures pose multiple risks to patients, including repeated emergency room visits and related hospitalizations each year. Zilucoplan was tested in a proof of concept (phase 2a) study in immune-mediated necrotizing myopathy (IMNM): The results of this study indicate that complement activation is not relevant in the disease biology of IMNM. UCB decided to not move forward with its IMNM development program. The results in IMNM do not affect UCB’s confidence in zilucoplan for other indications with complement activation as a key disease mechanism. Binding studies revealed that levocetirizine has high affinity for human H 1-receptors (Ki = 3.2 nmol/l). Levocetirizine has an affinity 2-fold higher than that of cetirizine (Ki = 6.3 nmol/l). Levocetirizine dissociates from H 1-receptors with a half-life of 115 ± 38 min.

The pharmacokinetics of levocetirizine in hepatically impaired subjects have not been tested. Patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis) given 10 or 20 mg of the racemic compound cetirizine as a single dose had a 50% increase in half life along with a 40% decrease in clearance compared to healthy subjects. higher marketing and selling expenses of € 606 million - driven by the ongoing launches of Cimzia ® (new indication and regional expansion), Nayzilam ®, and Evenity ® and especially launch preparations for bimekizumab for people living with psoriasis, zilucoplan and rozanolixizumab in myasthenia gravis The effect of race on levocetirizine has not been studied. As levocetirizine is primarily renally excreted, and there are no important racial differences in creatinine clearance, pharmacokinetic characteristics of levocetirizine are not expected to be different across races. No race-related differences in the kinetics of racemic cetirizine have been observed. Seizure Clusters are unpredictable, even when a patient is compliant with their current anti-epileptic drugs. When it comes to managing seizure clusters, it is important that patients have an acute care plan that includes access to a treatment they can take anytime or anywhere.After single administration, levocetirizine shows a receptor occupancy of 90% at 4 hours and 57% at 24 hours. The application is supported by data from a Phase 3 clinical study (ARTEMIS 1 - Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray), which evaluated the safety and efficacy of midazolam nasal spray in 292 patients. 1 Nasal delivery into the upper airway presents severe problems, primarily that the transport system is too convoluted and would require massive, expensive quantities of insulin to reach the target area. Insulin delivery via the lungs

Nektar: Formed from Inhale Therapeutic Systems Inc, are another company that are promising oral insulin. In collaboration with pharmaceutical corporation Pfizer and the enormous drug company Sanofi-Aventis, Nektar are eagerly attempting to net a share of the oral insulin market. The Nektar Pulmonary delivery system is one facet they have developed. Exubera, a fast-acting dry powder insulin designed for inhalation has been developed and is being reviewed. No interaction studies have been performed with levocetirizine (including no studies with CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole and pseudoephedrine). A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theophylline (400 mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration.Cetirizine, the racemate of levocetirizine, has been shown to be excreted in human. Therefore, the excretion of levocetirizine in human milk is likely. Adverse reactions associated with levocetirizine may be observed in breastfed infants. Therefore, caution should be exercised when prescribing levocetirizine to lactating women. UCB is providing this information, including forward-looking statements, only as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. In a study comparing the effects of levocetirizine 5 mg, desloratadine 5 mg, and placebo on histamine-induced wheal and flare, levocetirizine treatment resulted in significantly decreased wheal and flare formation which was highest in the first 12 hours and lasted for 24 hours, (p<0.001) compared with placebo and desloratadine. Braun T.L et al. Safety and tolerability of nayzilam™ (usl261; midazolam nasal spray) in subjects with acute repetitive seizures: resultsfrom the randomized, phase 3 artemis-1 clinical trial 2017. 71st Annual Meeting of the American Epilepsy Society (AES), December 1-5, 2017; Washington, USA, abs. 3.271 Midazolam Nasal Spray has not been approved by the FDA. These statements solely reflect the opinions of the authors.

Chronic idiopathic urticaria was studied as a model for urticarial conditions. Since histamine release is a causal factor in urticarial diseases, levocetirizine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria. Diabetes Care released reports of a small study that appeared to find oral insulin as effective as injectable insulin for type 2 diabeticsEven if some clinical data are available in children aged 6 months to 12 years (see sections 4.8, 5.1 and 5.2), these data are not sufficient to support the administration of levocetirizine to infants and toddlers aged less than 2 years. UCB decided to prioritize these autoantibody mediated neuroinflammatory indications over chronic inflammatory demyelinating polyneuropathy (CIDP) representing a heterogenous and complex patient population, with approximately only 30% of patients having detectable autoantibodies. Following this strategic decision, results of the phase 2a study in CIDP will be presented during an upcoming scientific meeting. Guidance 2021 & 2025: Based on UCB’s current assessment of the Covid-19 pandemic, UCB remains confident in the fundamental underlying demand for its products in the short-term and its prospects for long-term growth. UCB will continue to closely follow evolving COVID-19 pandemic and its consequences to the business environment diligently to assess potential near- and mid-term challenges. Moreover, sales may be impacted by international and domestic trends toward managed care and healthcare cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.