New Approvals

This category is used for all new drugs that is recently approved by United States Food And Drugs Administration (FDA).

Dovato: Uses, Side Effects, Precautions, Dosage & FAQs

Dovato is a recently approved HIV/AIDS medicine. It is the brand name for the two antiretroviral medications (Dolutegravir and Lamivudine) to treat Human Immunodeficiency Virus-1 (HIV-1)/AIDs in adults and in children aged above 12 years.  Dovato is the first once-daily, two-drugs, single tablet, and complete regime approved by the US Food and Drugs Administration (FDA) [01] for treating HIV infection. It is used to help reduce the amount of HIV in your body so your immune system can function properly. This reduces the likelihood of complications of HIV (for example, new infections and cancer) and improves the quality of life. The drug Dovato is marketed by GlaxoSmithKline (GSK) [02] and has been reported as a complete regimen for treating HIV-1 infection in adult patients with no history of antiretroviral treatment known or suspected substitutions associated with resistance to either dolutegravir or lamivudine. Dovato Composition 1. Dolutegravir 50mg 2. Lamivudine 300mg Dolutegravir Dolutegravir is a prescription drug approved by the US Food and Drug Administration (FDA) to treat HIV infection in combination with other drugs. Dolutegravir is an HIV-1 interferon inhibitor that blocks the filament transfer phase of the viral genome integration into the host cell. Integrase inhibitors block an HIV enzyme called integrase. Blocking the integrase enzyme prevents the proliferation of HIV and reduces the amount of HIV in the body. The effect of this drug has no similarity in human host cells, giving it excellent tolerance and minimal toxicity. Lamivudine Lamivudine is another prescription drug for treating HIV infection and hepatitis B (HBV). Lamivudine belongs to a class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). Although lamivudine does not cure HIV, it can reduce the chances of developing Acquired Immune Deficiency Syndrome (AIDS) and HIV-related diseases such as serious infections or cancer. Dovato Uses The drug is approved for the following conditions. Please note that this drug comes with a black box warning of the risk of hepatitis B virus (HBV) that’s lamivudine-resistant and worsening hepatitis B. It is the first once-daily, single-tablet for HIV1 Patients. It is a complete 2-drug regimen for treating HIV infection in adults with no history of antiretroviral therapy (ART). Dovato Mechanism Dolutegravir is an antiretroviral agent for HIV-1. It inhibits the integrase of HIV by binding to the active site and blocking the step of transferring the retroviral DNA integration filament into the host cell. The filament transfer phase is essential in the HIV replication cycle and inhibits virus activity. Lamivudine is a synthetic nucleoside analog and is intracellular phosphorylated to its active metabolite, lamivudine triphosphate (L-TP), 5′-triphosphate. This nucleoside analog is incorporated into the viral DNA by HIV reverse transcriptase and HBV polymerase, resulting in the termination of the DNA chain. Dovato Side Effects The most common side effects with Dovato were Headache, Diarrhea, Nausea, Weakness Belly Pain, Loss of appetite, Fatigue. Less common side effects (Occurred in less than 2% of People) of Dovato include; Hepatitis Anemia Thrombocytopenia Fever Abdominal Discomfort Flatulence Hypersensitivity Pruritus and Rash Renal impairment. Insomnia Anxiety Myositis Immune reconstitution syndrome. Suicidal Thoughts Note: This is not a complete list of side effects. You may experience other side effects; consult your doctor. Although the chances of developing severe allergic reactions are low, it may, in rare cases, causes swelling under the skin, tongue, lips, hands, and eyelids. Talk to your doctor if you experience these symptoms. To avoid liver-related issues, your GP may recommend some tests from time to time to check your enzyme level. Precautions Before taking this medicine, tell your health care provider if you; Are allergic to dolutegravir or any other medicines. Have any other medical conditions? Have you ever had liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV)? Are you pregnant or plan to become pregnant? Are you breastfeeding or plan to breastfeed? Have diabetes; you should know that 3 grams of sucrose are in each tablespoon (15 mL) of lamivudine solution. Lactic acidosis and severe hepatomegaly have been reported with the use of lamivudine. Are using hormone-based birth control.’ Avoid it if you take other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products. Also, the concomitant administration of Dovato with another antiretroviral drug for HUV1 is not recommended. Their doctor should closely monitor HIV-positive and hepatitis B-infected patients who stop using this medicine. Dovato Contraindications It is contraindicated in the following conditions. Hypersensitivity to the ingredients used in Dovato.  It is also contraindicated in combination with dofetilide. Avoid Dovato in pregnancy and breastfeeding women.  Dovato in Pregnancy & Breastfeeding As there is a known risk for neural tube defects with dolutegravir, patients are advised to avoid using Dovato from conception through the first trimester of pregnancy. Also, It is not recommended for use in breastfeeding women. Interactions Talk to your pharmacist or doctor whether you’re taking any other medications, including those you obtain without a prescription from your pharmacist or health food store. Dovato should not be used with the following drugs and conditions. These drugs may increase or decrease the concentration of Dovato, which may lead to side effects. Dofetilide Carbamazepine Fosamprenavir Magnesium citrate Magnesium Aspartate Phenobarbital Fosphenytoin Oxcarbazepine Sorbitol Phenytoin Tafenoquine Rifampin St John’s wort Tipranavir Sucralfate Metformin Acid reducers are used for treating indigestion and heartburn, and iron and calcium supplements can stop Dovato absorption in the body and make it less effective. So, it’s better not to use this medication with antacid, iron, and calcium.  This is not a complete list of drugs. You can consult your doctor before using Dovato along with other drugs. Dovato Dosage It is a single tablet containing two drugs, dolutegravir 50 mg and lamivudine 300 mg. It is a once-daily regime. You can take it with or without food. Clinical Results Dovato is effective in clinical trials when the treatment has maintained low levels of HIV RNA (less than 50 copies/ml) in the blood for at least 48 weeks. The approval was based on Gemini I and II involving more than 1,400 HIV-1 infected patients. This shows

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FDA Approves (Opdivo and Yervoy) for Treating Mesothelioma

The US food and drug administration has recently approved a combination therapy (Opdivo and Yervoy) to treat adults with unresectable malignant pleural mesothelioma. This is the first combo drug approval for mesothelioma in 16 years. Mesothelioma is a rare and aggressive type of cancer that is caused by inhaling asbestos. Opdivo and Yervoy Opdivo (nivolumab) Opdivo (nivolumab) alone is used to treat a specific type of cancer. It works with your immune system to stop the growth of cancer cells. It may also be used in combination with other medicines to treat and prevent certain types of cancer that have already spread or can’t be removed through surgery. It is used in combination with other medications to treat many different kinds of cancers such as skin cancer, advanced lung cancer, renal cell carcinoma, head and neck cancers, blood cancers. The most common side effects associated with the use of this medicine include fatigue, skin rash, itchy skin, weakness, cough, pain in muscles, bones, and joints, vomiting, shortness of breath, diarrhea, nausea, constipation, decreased appetite, back pain, upper respiratory tract infection. A severe side effect of Opdivo is the immune-mediated reactions that can target your end organs. This can be serious and life-threatening. Always consult your doctor. The usual recommended dose of Opdivo in metastatic melanoma is 240 mg in a slow IV infusion over 30 minutes every two weeks until the disease progression. It is given as a single and slow intravenous dose. How do Opdivo and Yervoy work? Before going into the mechanism of action, let me first clear a few things; What is PD-L1: It is a protein that works as a natural “brake” in your body, keeping the body’s immune responses in check. PD-L1 can be found in higher than average amounts in some normal cells and some types of cancer cells. When PD-L1 binds to another protein called PD-1 (a protein found on T cells), it prevents the T cells from killing cells that contain PD-L1, including cancer cells. Cancer drugs, so-called immune checkpoint inhibitors, bind to PD-L1 and block its binding to PD-1. This releases the “brakes” on the immune system and releases the T cells to kill cancer cells. Opdivo (nivolumab) is a human immunoglobulin G4 (IgG4) monoclonal antibody. It binds to the PD-1 receptor and inhibits/blocks its interaction with PD-L1 and PD-L2, thereby inhibiting the PD-1 pathway-mediated inhibition of the Immune response is canceled. , including the anti-tumor immune response. The binding of the PD-1, PD-L1, and PD-L2 ligands to the PD-1 receptor found on T cells inhibits T cell proliferation and cytokine production. PD-1 ligands are upregulated in some tumors, and signal transmission through this pathway may help deter active T cell immune surveillance of tumors. Yervoy (Ipilimumab) Yervoy (Ipilimumab) is another prescription-only medicine used in the treatment of different types of cancers such as melanoma. It is also used in combination with other drugs such as Nivolumab to treat metastatic non-small cell lung cancer whose tumors express PD-L1, with no EGFR or ALK genomic tumor abnormalities. Fatigue, diarrhea, itching, nausea, vomiting, and skin rashes are some of the widespread side effects affecting 30% of patients taking this medicine. Other less common side effects (10-29%) include decreased appetite, constipation, cough, headache, abdominal pain, shortness of breath, anemia, and fever. An infrequent but more serious side effect includes an immune-mediated reaction. How do Opdivo and Yervoy work? It is a recombinant human monoclonal antibody that inhibits the cytotoxic T-lymphocyte–associated protein 4 (CTLA-4). CTLA-4 is a T cell molecule that inhibits the immune response. CTLA-4 is a negative regulator of T cell activation. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands. Blockade of CTLA-4 has been shown to increase the activation and proliferation of T cells. The mechanism of action of the action of ipilimumab in melanoma patients is indirect, possibly through T-cell-mediated anti-tumor immune responses.   Is Yervoy chemotherapy? No, it fights cancer cells differently. It helps your immune system launch a response against cancer that’s greater than when either medication is used alone. FDA Approvals of Opdivo and Yervoy Recently, the US food and drug administration (FDA) has approved these two drug combinations to treat a sporadic type of cancer that is also known as mesothelioma. Opdivo and Yervoy are already approved for the first-line treatment for metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1. It is also used in combination with limited chemotherapy for the first-line treatment of adults with metastatic or recurrent NSCLC with no EGFR or ALK mutations regardless of PD-L1 expression. It is the first new combo drug approved for mesothelioma in 16 years and only the second systemic therapy in history. The historic approval of a treatment for this cancer without a cure was the first since the FDA approved the chemotherapy combination of pemetrexed and cisplatin in 2004. The drug company Bristol Myers Squibb, which makes Opdivo and Yervoy, respectively, was approved on October 2. The approval follows a multicentre international clinical phase III study in which the combination demonstrated superior overall survival compared to chemotherapy alone. The name of the survey sponsored by Bristol Myers Squibb was CheckMate 743. Patients treated with the immunotherapy combination Opdivo and Yervoy had a median overall survival of 18.1 months compared with 14.1 months for patients who received chemotherapy alone. The 2-year survival rate was 41% for those who received the combined immunotherapy, but only 27% for the chemotherapy group. Although the overall improvement in survival was modest, it was dramatic for the traditionally difficult-to-treat subtypes of mesothelioma. In patients with sarcomatoid or biphasic mesothelioma (non-epithelioid histology), the median survival was only 8.8 months for those who received chemotherapy. For those who received immunotherapy, it was 18.1 months. The two-year survival rate increased from 8% to 38% for the same two categories. The results were presented at the virtual meeting of the World Conference on Lung Cancer earlier this year. After the promising data from the Phase 3 CheckMate-743 trial (NCT02899299),

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FDA Approved a Combo Drug (Lonsurf) for Gastric Cancer

The report on Lonsurf  was published on the official website of U.S Food and Drug Administration. Gastric adenocarcinoma is a type of stomach cancer and is considered the second most common cancer in the world. According to reports, the combined drug Lonsurf  can cure those patients who are suffering from gastric adenocarcinoma. Gastric cancer is the fifth most common cancer in the world and the third leading cause of cancer deaths (after lung and liver cancer) with about 723,000 deaths a year. In recent years, the result in gastric cancer has improved dramatically, and survival has increased dramatically over the last 10 years. With the advancement of cancer, but can limit many drug-usable complications and rule out intensive chemotherapy. The extension of survival and alleviate the symptoms of advanced treatment of metastatic gastric cancer are problems for which it is considered important to increase the possibilities of new therapeutic drugs. At present recommended for metastatic gastric cancer in Japan nivolumab and irinotecan as standard treatment of the third line. The new drug is a combination of trifluridine, Tipiracil, a nucleoside metabolic inhibitor, and a thymidine phosphorylase inhibitor. This dose will benefit the patients who have gastric cancer and can no longer be treated with other therapies. Lonsurf consists of a nucleoside analogue that is based on thymidine, and the trifluridine thyridine phosphorylase inhibitor Tipiracil. After taking in tumor cells trifluridine is incorporated into the DNA, interfering with DNA synthesis and inhibiting cell proliferation. In addition to the indication for metastatic gastric cancer Lonsurf is also indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan, an anti-cancer therapy. Biological VEGF, anti-EGFR treatment. The research was conducted on 507 patients with unresectable metastatic adenocarcinoma in the stomach. The research included two different groups, the trifluridine / tipiracyl group and the placebo group. David Cunningham, a consultant oncologist, says: “We have nothing else we can offer those patients, and this study shows that we can extend life expectancy and improve disease control rates up to a very significant level.” According to the researchers, this new treatment would meet the needs of patients. How Lonsurf  Work? Its dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. The trifluridine (FTD) is an antineoplastic nucleoside analog that is embedded directly into the DNA and therefore interferes with the function of DNA. The blood concentration of FTD is maintained by tipiracil (TPI), an inhibitor of the FTD thymidine phosphorylase degradation enzyme. Dosage The scientists recommended an oral dose of Lonsurf of about 35 mg / m2 / dose twice a day. The drug should be taken during the 28-day cycle from day 1 to day 5 and from day 8 to day 12. In Japan, Taiho Pharmaceutical has been marketing Lonsurf for the treatment of advanced or recurrent advanced colorectal cancer. In the United States, Taiho Oncology, Inc., a US subsidiary of Taiho Pharmaceutical, began the pharmacological treatment of patients with mCRC previously treated with fluoropyrimidine-based chemotherapy as of 2015. Oxaliplatin and irinotecan, an anti-VEGF biological therapy and in wild-type RAS an anti-EGFR therapy. In 2015, Taiho Pharmaceutical and Servier entered into an exclusive licensing agreement for the joint development and marketing of LONSURF in Europe and other countries compared to the United States, Canada, Mexico and Asia. TTY Biopharm, a commercial partner of Taiho Pharmaceutical, launched LONSURF in July 2018 in parts of Asia outside of Japan in Taiwan. Jeil Pharmaceutical is preparing to commercialize the drug in South Korea.

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New Oral Capsule can deliver insulin through microneedles in the stomach

Researchers at the Koch Institute have created a blueberry-sized capsule that can be used to administer oral insulin doses. It can replace the injections that people with type 2 diabetes should give up every day. Insulin is a peptide hormone produced by the β-cells of the pancreas. This enables the body to regulate the amount of glucose in the blood. The new capsule is made of a biodegradable polymer. The internal microneedles components are quite complex: compressed, freeze-dried insulin and a biodegradable material and it is a lyophilized microparticle of insulin and a stainless steel spring that is rinsed and held in a sugar table. When sugar dissolves in gastric acid, the spring melts and pushes the microparticles into the stomach. For people with type 2 diabetes, regular insulin injections are part of everyday life, but this is not the most convenient routine. Much work has been done to develop an insulin pill as a less invasive alternative, but it presents it’s own challenges. Now, an MIT team has developed a new design for a capsule containing insulin microparticles that inject the hormone through the stomach lining. Oral administration of insulin may seem easy as the usual pills consist of too many medications. However, the stomach is a hostile environment and hard acids that can neutralize many compounds before they can get to work. Not surprisingly, the development of insulin pills has been largely applied to protective coatings that survive the journey until you can deliver the insulin load. MIT researchers, however, have chosen a different approach. Several years ago, the team made a tiny needle-filled pill, which injected the drug into the case as it passed. Now the design has been refined to include only one needle, which injects the substance into the stomach, into the stomach. Once the needle tip is inserted, the insulin dissolves in the blood at a constant rate. It took about an hour in this test, but researchers can change the frequency. Once the payload has been dispensed, the capsule passes through the digestive system without damage. To make sure the needle touches and stays in the abdominal wall, the capsule has a tall, steep dome so it always turns on the flat side and rests where the needle comes out. According to the team, this design was inspired by the Leopard Turtle, with a uniform shell that allows it to stand up if it was ever on the back. The team tested the New Capsule for Diabetes on pigs and found that 5 mg of insulin was effective in the animal’s blood. This is at a level comparable to that of regular insulin injection. The researchers explain that the tests show that the method can be an effective alternative to insulin self-injections as well as to other treatments administered in the same way. The research was funded by Novo Nordisk, National Science Foundation Graduate Research Fellowship, The National Institutes of Health, Brigham and Women’s Hospital, A Viking Olaf Bjork Research Scholarship, and The MIT Undergraduate Research Opportunities Program. Source: MIT

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Does Gammora Really Kills 99% Of HIV/Aids Virus?

A new drug from Zion Medical named—Gammora claims to kill 99 % of the HIV virus during the first human trial. The therapy was made to kill HIV-infected cells without damaging uninfected ones. Compared to current antiretroviral medications that only suppress the spread of this virus, Gammora provides hope that a real cure may one day be discovered. According to the company, The drug was proven to eliminate around 99 % of HIV in four months of therapy. Gammora is a complex remedy composed of a synthetic peptide compound derived from the HIV-derived integrase. Taking advantage of the procedure, Gammora arouses the integration of numerous HIV DNA fragments to the host cell’s genomic DNA. But the question is, does it really kill 99% of HIV? First, let’s find out how does it work? How does Gammora work? Zion Medical describes the mode of activity as follows. Gammora is a synthetic peptide compound derived from the HIV enzyme integrase, responsible for integrating the virus’s genetic material into the infected cell’s DNA. Gammora arouses the integration of multiple HIV DNA fragments to the host cell’s genomic DNA, which activates the self-destruction of the infected cell, known as apoptosis. The drug seems to be a broad-spectrum disrupter of viral replication (such as ribavirin, a drug previously utilized in hepatitis C therapy ). It may restrict viral proliferation in established diseases and the disease of cells that are further (as other antiretroviral medications do). “These initial clinical outcomes were beyond our expectations and assure confidence in finding a cure for a disease that has been detected within 35 years,” said in a statement Dr. Esmira Naftali, head of growth in Zion Medical. “Given the restricted nature of the study, we’re eager to show the efficacy of our medication in Phase 2b using a larger number of participants within a longer period.” If this stage proves equally effective, its consequences will be life-altering. Now, present commercially available HIV retroviral treatments work by curbing the spread of this virus but don’t provide any treatment for the disease. Therefore, HIV patients may only hope for a better lifespan, not an actual respite. Nevertheless, Zion Medical’s peptide can destroy all cells carrying the HIV virus genome, offering a true cure for contaminated patients. Zion Medical’s Stage 1/2a Gammora human clinical trial found that many patients revealed a substantial decrease in the viral burden of around 90 percent in the baseline through the initial four months. In Part II of this analysis, Gammora was further combined with added retroviral remedies, resulting in patients showing around a 99 percent decrease in viral load from baseline in four months. Additionally, during the whole process of evaluations, Gammora has been proven to be secure and well-tolerable. In reality, no side effects at all have been reported. What’s more, Gammora was discovered to boost individual CD4 cell count — around 97 percent in the baseline. CD4 cells also called some T cells or T cells, are the cells that HIV kills. They’re white blood cells that play an integral part in the human immune system, the body’s natural defense mechanisms against germs, diseases, and disorders. “Zion Medical’s Gammora is a synthetic peptide compound derived from the HIV enzyme integrase, which helps insert genetic material into cells. This process stimulates apoptosis in infected tissues and triggers their self-destruction.” The drug appears to have anti-viral properties. It might work by limiting the amount of virus in an existing infection and preventing it from spreading further (like other antiretrovirals). However, no evidence suggests this particular medication can clear out latently infected cells that already contain integrated HIV DNA; if we were curing patients, they would need something entirely different for their treatment plan since all current drugs target actively recruiting cell surfaces. Since HIV infections advancement, CD4 cells have considerably decreased. Someone will be diagnosed with AIDS if their numbers fall below 200 and subsequently be considered at high risk of developing serious illnesses. A healthy person’s typical range for CD4 cells is roughly 500-1,500. The favorable news caused quite a few frenzies directing Zion Medical to describe the company still has a long way before a remedy could be ensured, but it has gotten a measure nearer. The business also disclosed that its peer-reviewed research ought to be accessible in 2019. An Israeli-based pharmaceutical firm, Zion Medical, which recently broke the news of an adequate initial clinical trial because of what they predicted as a possible HIV remedy, has issued a further statement on Twitter which makes it crystal clear that more trials will be required, and also their official outcomes need to get peer-reviewed and published. Since the organization was announced on 31 October, there’s been a tide of enthusiasm on social websites, particularly with people clamoring to learn more about this”possible cure.” Zion Medical is a relatively new firm based in 2014. According to the business site, it manufactures AIDS and Cancer treating products on peptides derived from HIV and targeted lentivirus (LV) particles. The FDA has recently approved Dovato— a combination of two antiretroviral drugs like dolutegravir and lamivudine for the treatment of HIV. You can also read more information related to medicine and supplements on DrugsBank. Read more trending topics. Focus Factor Review: Does It Works? Zyrexin Review: Uses, Dosage, Side Effects, Customer Reviews 15 Best Vein Finders Available On The Market Tebo Massage Chair: Everything From A-Z

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FDA-approved First cannabis-based drug (Epidiolex) For Epilepsy

Epidiolex, the very first cannabis-based drug approved by the US Food and Drug Administration, is currently available by prescription in all 50 states. It was found in 1940 and originally thought to not be pharmaceutically active. It’s one of 113 cannabinoids found in hemp plants, accounting for as many as 40 percent of the plant extract. The twice-daily oral remedy is approved for use in patients 2 or older to treat two different types of epileptic syndromes: Dravet syndrome, an uncommon hereditary disorder of the brain which starts in the very first period of existence, also Lennox-Gastaut syndrome, a sort of epilepsy with a number of types of seizures which starts in early childhood. Animal studies reveal anticonvulsant efficacy in numerous species and versions. Anecdotal reports indicate effectiveness in children with treatment-resistant epilepsies (TRE), notably Dravet syndrome. Here we report preliminary outcomes in kids with TRE within an expanded access therapy plan. Epidiolex Uses Medicine suggested for the treatment of seizures related to Lennox-Gastaut syndrome or Dravet syndrome, Two rare, acute childhood-onset epilepsies – Mechanism The specific mechanism where the cannabidiol comprised in EPIDIOLEX® generates anticonvulsant effects isn’t known. Clinical data indicates that the cannabidiol doesn’t produce the anticonvulsant effects through interaction with cannabinoid receptors. Cannabidiol has very low affinity for its cannabinoid CB1 and CB2 receptors but is also said to act as a direct antagonist of those receptors. In the Exact Same time, it might potentiate the effects of THC by Raising CB1 receptor density or via a different CB1receptor-related mechanism. Epidiolex Side effects Common medication side effects, such as: Reduced appetite Diarrhea Elevated liver enzymes Infection Diseases Insomnia Malaise and fatigue Rash Sedation and lethargy Sleep disease and poor sleep Serious risks might occur with Epidiolex, including the following: Efforts to commit suicide Aggression Feelings of agitation Panic attacks New or worsening depression Thinking about suicide Growth in liver enzymes “We are delighted to announce that EPIDIOLEX is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals. “Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures. We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.” Epidiolex Dose Epidiolex dosing is based on body weight. The recommended beginning dose of Epidiolex is 2.5 mg/kg twice per day. After one week, the dose could be raised to a maintenance dose of 5 mg/kg twice each day. If additional seizure reduction is needed, the maximum dose of Epidiolex in 10 mg/kg twice per day or 20 mg/kg once daily could be given. The higher dose may lead to an increase in adverse reactions, though research have shown that Epidiolex is successful and has a favorable safety profile in both doses studied.

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The FDA Approves a Game Changer Flu Drug (Xofluza)

The Food and Drug Administration approved a Brand New flu Medicine on Wednesday Called Xofluza. The drug is given as one dose and might lessen the duration of influenza symptoms by about a day. A exceptional characteristic about XOFLUZA, in comparison to neuroaminidase inhibitors such as Tamiflu and Relenza, is that you simply take one dose. Not multiple doses for numerous days. By way of instance, Tamiflu generally requires 2 doses daily for 5 days. It’s a whole lot easier to remember to take zero doses then very first dose compared to 9 longer doses. Taking the whole path of a influenza medication isn’t merely critical for you but for everybody else. Not completing the whole prescription of an antiviral drug might select for viruses which are resistant to this medicine and so foster the spread of drug-resistant viruses across the populace. And immunity may make things useless, whenever you’ve got a life-threatening flu disease, which might occur with seasonal influenza or pandemic influenza. How Xofluza Works? The new procedure, which blocks the enzyme required by the virus to replicate itself, was proven to operate against the numerous drug-resistant strains which have arisen lately, like the frequent A and B strains. “If it is effective, it is going to be a game changer.” Baloxavir marboxil may stop replication by inhibiting the cap-dependent endonuclease activity of the viral polymerase.It accomplishes this by lessening the procedure called cap snatching, which can be a mechanism controlled by viruses to hijack the host mRNA transcriptionmethod to permit synthesis of viral RNAs Use in children and Pregnancy It can not be utilised in children under the age of 12. It has not been studied in pregnant women or individuals who have underlying medical conditions that put them at greater risk for flu complications. Xofluza Side effects As per FDA The most common side effects of Xofluza contain Diarrhea and bronchitis; While In Tamiflu, the most frequent side effects are Nausea, vomiting, and headache. Xofluxa is going to be accessible from the U.S. at the upcoming few weeks, according to a press release from Genentech, making the medicine, so it must appear in time for your core of influenza season. The price will probably change based upon your insurance plan, so speak with your physician or pharmacist regarding your alternatives. Therefore, while it is exciting that we are getting a couple more flu-fighting alternatives, it is no excuse to bypass your influenza shot.

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FDA Clears New Antibiotic Arikayce for Lung Disease

The FDA announced it has given Insmed, Inc. approval for Arikayce, a brand new drug developed for the treatment of lung disorder brought on by Mycobacterium avium complicated. “As bacteria continue to develop to currently available antibiotics, we must promote the development of drugs which may treat resistant infections,” FDA Commissioner Scott Gottlieb, MD, stated in a news release. “That usually means using novel tools meant to streamline growth and promote investment within these critical endeavors.” Arikayce (amikacin liposome inhalation suspension) was accepted for a restricted patient population for whom traditional remedy of M. Avium complicated is inefficient. As a necessity of acceptance below the LPAD pathway, the medication label includes statements to show it is safe and effective to be used only in a restricted population, according to the release. Arikayce was approved under the accelerated approval pathway together with the condition which Insmed run another postmarket research detailing the clinical advantages of the medication. Since Infectious Disease News formerly reported, the passing of this 21st Century Care Act at 2016 allows”progress development and acceptance of antibacterial and antifungal drugs to treat life-threatening or serious ailments at a restricted population of patients with unmet need.” Under this action, Congress created the LPAD pathway to encourage drug development through compact clinical development applications. Furthermore, the rapid approval pathway permits the FDA to approve drugs such as”life-threatening or serious diseases or conditions in which the drug is demonstrated to have an effect on a surrogate endpoint that’s reasonably likely to predict a clinical benefit to patients.” A randomized, controlled trial demonstrated that the efficacy and safety of Arikayce obtained via nebulizer. The prescribing information for Arikayce carries a boxed warning regarding the increased danger of respiratory ailments that, sometimes, have resulted in transplant. These ailments include hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disorder and hemoptysis. “This approval is the first time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, and it marks an important policy milestone,” Gottlieb said. “This pathway, advanced by Congress, aims to spur development of drugs targeting infections that lack effective therapies. We’re seeing a lot of early interest among sponsors in using this new pathway, and it’s our hope that it’ll spur more development and approval of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs.” The FDA also allowed Arikayce fast monitor, breakthrough therapy, priority inspection, qualified infectious disease merchandise and orphan drug designations.

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FDA Approves A New Drug (Galcanezumab) For Migraine Treatment

The new medication is named Emgality (Galcanezumab) and can be used particularly to stop migraines,and it is manufactured by drug giant Eli Lilly. The medication has a record price of $575 per month, approximately $6,900 annually. Until May, there were not any drugs available now which were initially approved for relieving migraines, even however other remedies such as Botox and anti seizure drugs have already been utilized. Pain relievers may also help treat a number of those symptoms of migraines. But in the last couple of weeks, the FDA has approved three preventative drugs which act on the goal. Clinical Trials On Galcanezumab In two phase 3 clinical trials which included over 1,700 patients with episodic migraine, individuals who obtained 120 or 240 mg of the drug had fewer yearly migraine headache times than those who obtained a placebo.A third trial, which included more than 1,100 patients with chronic migraine, had similar results. Issues reported from the 3rd trial was nausea, Vomiting, and skin reddening at the site of the shot. That is compared to this 2.15 and 1.85 day decrease that has been detected in the placebo groups. 11.5 percent of those patients on among those trials had a 100% decrease in their own migraines, as opposed to the 5.7percent of people who received placebo and undergone a 100% reduction in migraines. Thus far, Aimovig, a medication created by Amgen and Novartis, and Teva’s Ajovy have come in at a cost of $575 to get a daily dose, roughly $6,900 annually, exactly the same as Emgality. Analysts expect Aimovig exclusively to achieve 1 billion in yearly earnings by 2022. Amgen’s been giving two months out of free trials, followed closely by a patient assistance application that supplies up to a year of policy when commercial insurance does not cover it. The yearly market for migraine medication can reach $2.2 billion by 2025 based on one recent quote . How It Work Galcanezumab inhibits calcitonin gene-related peptide (CGRP), an enzyme which researchers are targeting as the 1980s.CGRP is not just a new goal. CGRP was known to play a substantial role in migraines as the 1980s and 1990s, even though it’s taken a while to come up with the technologies which may leverage it. All three of those approved migraine drugs need delivery by injection, however Allergan is focusing on tablets that would provide comparable migraine-fighting chemicals for preventative and severe therapy. Alder Biopharmaceuticals also offers a possible migraine treatment in human trials and yet another in preclinical study . Side Effects Side effects of the Galcanezumab include nausea, Vomiting, and reddening of skin on the injection site. There are other possible side effects, and anybody interested in looking for the new medication should discuss treatment choices — and possible side effects  completely with their physician. Dose: The injections are successive and needs to be administered daily. The suggested dose of Emgality(Galcanezumab) is 240 mg, administered in two separate injections. The FDA plans for it to be a medication that consumers may administer themselves. Very similar to the way diabetic patients need to manage their own insulin, their caregiver will discover to provide themselves the medication using a pre-filled pencil or syringe. Related Article: FDA Approves Drug (Jivi®) for Hemophilia A

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FDA Approves Drug (Jivi ®) for Hemophilia A

There was positive news now for Germany’s biggest pharma firm, with acceptance for its most recent hemophilia A medication in the united states, which will offer a near term boost for its hemophilia portfolio. The Biologics License Application was filed with the bureau in October this past year. Jivi is a recombinant factor VIII (rFVIII) replacement treatment, meaning it replenishes the decreased or lost FVIII (a protein required to form blood clots) in hemophilia A patients. During its site- specific PEGylation, Jivi includes a half-life of 17.9 hours which produces sustained levels in blood flow.1 Jivi is qualified for the regular prophylactic therapy of hemophilia A in previously treated adults and teenagers 12 decades old or older. Jivi’s first recommended dosing regimen is twice per week (30-40 IU/kg) with the capability to dose each five times (45-60 IU/kg) and additional individually adjust to more or less regular dosing according to bleeding episodes. The FDA also accepted Jivi for on-demand Therapy along with the perioperative control of bleeding at Precisely the Same population The drug can be approved for on-demand therapy along with the perioperative control of bleeding at precisely the exact same population. This endorsement is based on information in the 36-week stage 2/3 PROTECT VIII clinical trial, which comprised 126 formerly treated patients 12 decades or older with severe hemophilia A. Treatment with BAY94-9027 demonstrated bleed protection and security of up to a median of 1.9 decades. The medication was well tolerated in the vast majority of adolescent and adult patients. Remedy with Jivi was tolerated in the vast majority of adolescent and adult patients in clinical trials. The most often reported adverse reactions in previously treated patients 12 decades old or older were nausea, headache, nausea, and fever. Repeat testing didn’t confirm the existence of a FVIII inhibitor The initial advocated prophylactic program for Jivi is twice per week with the capability to dose each five days and farther separately adjust to more or less frequent dosing according to bleeding episodes. The FDA also accepted Jivi for on-demand therapy along with the perioperative control of bleeding at precisely the exact same population. This acceptance is based on results in the Stage II/III PROTECT VIII trial, which revealed bleed protection and security of around a median of 1.9 years (range of 0-2.6 decades ). Jivi is your next FDA-approved hemophilia A remedy in Bayer’s hematology portfolio. Joerg Moeller, Bayer’s mind of R&D, stated Jivi provides”established efficacy with the capacity for decreased infusion frequency” Dr Moeller stated the FDA’s acceptance of Jivi is a significant step ahead for hemophilia A patients in the united states. Present-day remedies are reliant on variable replacement treatments, especially from Shire (LSE: SHP), Bayer and Roche (ROG: SIX), in addition to Sanofi (Euronext: SAN), which earlier this year took over US hemophilia expert Bioverativ within an $11.6 billion bargain. The hemophilia B and A marketplace forecasted to approach a value of $8 billion by 2026.

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