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The US Food and Drug Administration (FDA) has approved the Novartis drug, Cosentyx, (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults. HS is a chronic, progressive and painful disease which affects one in 100 people worldwide, and has limited treatment options. "Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS," said the Swiss company. The FDA approval was based on robust Phase III data (SUNSHINE and SUNRISE studies) in which Cosentyx showed rapid relief from HS symptoms as early as Week 21.

Pharmanovia, the lifecycle management company has signed a licence and supply agreement with Aquestive Therapeutics for its patented diazepam buccal film formulation across the EU, UK, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA)- up to 48 markets in total. Aquestive Therapeutics has been granted tentative approval by the US Food and Drug Administration (FDA), for its diazepam buccal film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. Pharmanovia will be responsible for seeking appropriate regulatory approval across EU and MENA. Pharmanovia CEO, James Burt commented: "Pharmanovia and Aquestive are aligned in our mission to find new and innovative ways to enhance and revitalise iconic medicines. We have extensive experience with diazepam through the Valium brand and, together with Aquestive's unique PharmFilm technology, we're intending to bring a novel alternative diazepam delivery option to caregivers and patients at a time of critical need."

The global company in information and data analytics, Elsevier launched a platform, PharmaPendium for drug candidates. It is an effective tool that provides data including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages for drug development. The platform is supported by the FDA, the Medical Devices Agency (PMDA) and the top 20 global pharma companies. Olivier Barberan, Director of Translational Medicine Solutions spoke about how "improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies." "Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the new PharmaPendium to solve this," he added.

Medical professionals often prescribe semaglutide to patients who have type 2 diabetes. Along with a balanced diet and regular exercise, it has also shown to be an incredibly efficient weight loss aid for patients. As the active ingredient in well-known brand-name drugs such as Wegovy, Ozempic, and Rybelsus, semaglutide is currently on everybody's lips. But what exactly is semaglutide? Does it really work for weight loss? We'll find an answer for you in this article, and explain the main benefits of using semaglutide for weight loss. What Is Semaglutide? A number of diabetic and weight loss medications, including Wegovy, Ozempic, and Rybelsus, have semaglutide as their active ingredient. This substance is a synthetic form of the hormone glucagon-like peptide-1 (GLP-1), that occurs naturally. Developed by the company Novo Nordisk, semaglutide was first approved by the FDA in 2017 as an injection for the treatment of adult type 2 diabetes (as part of the approval procedure for Ozempic). In 2019, the Food and Drug Administration approved a novel semaglutide form known as Rybelsus. Rybelsus was the first oral GLP-1 receptor agonist for the treatment of type 2 diabetes in the United States.

In a recent announcement, Mundipharma, a leading global pharmaceutical company, has announced its acquisition of all assets and rights related to rezafungin from Cidara Therapeutics. This solidified Mundipharma's dedication to managing infectious diseases and specialty care therapeutic areas, especially invasisve candidiasis which over the 15 years has seen no new therapeutic developments underscoring for alternative options. The FDA and MHRA approved rezafungin is a groundbreaking once-weekly echinocandin antifungal drug specifically designed for the treatment of invasive candidiasis in adults. While Mundipharma will oversee global commercialization efforts, Melinta Therapeutics will retain commercialization rights for rezafungin in the United States. Moreover, the acquisition empowers the pharmaceutical company with global ownership of rezafungin, encompassing its ongoing development and distribution.

PBR Staff Writer Published 24 February 2014 US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic fibrosis (CF).

Germany-based pharmaceutical firm Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for Pradaxa (dabigatran etexilate) to treat venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE).

GSK has received approval from FDA for its Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adult patients with type 2 diabetes.

PBR Staff Writer Published 01 May 2014 The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) Incruse Ellipta (umeclidinium) for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Umeclidinium is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.

The US Food and Drug Administration (FDA) has now approved the use of Omalizumab, commercially known as Xolair, for the treatment of chronic hives

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK. Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in  the UK Medical Devices Regulations 2002. Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market. Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving an oral therapy to treat myelofibrosis patients with moderate to severe anaemia. Myelofibrosis is a rare blood cancer that affects the body's normal production of blood cells, and the affected patients are likely to develop anaemia over the course of the disease. British drugmaker GSK, the manufacturer of the oral therapy known as momelotinib, said that it can be used to treat "both newly diagnosed and previously treated myelofibrosis patients." The medicine helps address disease-related splenomegaly (enlarged spleen) or symptoms in adult patients who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib, as stated by the company. Nina Mojas, Senior Vice President of Oncology Global Product Strategy at GSK, said that receiving the positive CHMP opinion "is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer."

Japanese drugmaker Eisai said on Tuesday (January 10) it had submitted a marketing application to the European health regulator for review of its Alzheimer's drug lecanemab, which was recently granted accelerated approval in the United States. The drug, developed in partnership with Biogen, is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of those in the early stages of the mind-wasting disease. Nearly all previous experimental drugs using the same approach have failed. The company's application to the European Medicines Agency is based on results from a late-stage study in which the drug was shown to slow down the rate of cognitive decline in patients with early Alzheimer's by 27 per cent, compared with a placebo. Eisai also reiterated its plans to apply for marketing authorization of the drug in Japan by the end of its business year on March 31.

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RU486 is the most competent abortion pill used for the annihilation of an unwanted pregnancy of fewer than 7 weeks. It is an FDA-approved abortion pill, which has gained a high preference among other available abortion pills due to its efficacy and safety in causing the abortion...

Millions of people take dietary supplements every day, hoping to improve their health in some way. But how much do you know about these supplements? Are they safe? Do they work? And are there any risks associated with taking them? Here are six important things to know about dietary supplements if you're one of the people who take them. NOT ALL SUPPLEMENTS ARE REGULATED Since dietary supplements are not drugs, they do not need to be approved by the Food and Drug Administration (FDA) before they can be sold. This means that some products may not contain what is stated on their labels or may even include ingredients that could be dangerous. Therefore, it's important to always read labels and do your research before committing to one. Furthermore, make sure you purchase your supplements from a reputable source. This means that you should look for companies that have been independently tested and certified to provide high-quality products. MAKE SURE THE SUPPLEMENT IS RIGHT FOR YOU Before taking any dietary supplement, check with your doctor or healthcare professional first. This is especially important if you have a medical condition or are on medication, as certain supplements may interact in unwanted ways. Just because something is labeled as "natural" doesn't necessarily mean it's good for you or that you even need to take it. Before taking any supplement, talk to your doctor about whether or not it could be beneficial for you and how much you should take.

Pfizer's oral Covid-19 therapy will be evaluated as a potential treatment for patients hospitalised with the illness in a major British trial, scientists said on Monday, as cases rise in some parts of the world. The world's largest randomised study of potential medicines for Covid-19, dubbed the RECOVERY trial, will assess Paxlovid across hospitals in Britain, which has already approved the drug for early-stage treatment. "Paxlovid is a promising oral antiviral drug but we don't know if it can improve survival of patients with severe Covid-19," said Peter Horby, a professor at the University of Oxford and joint chief investigator of the RECOVERY trial. The scientists said they aim to mainly find whether Pfizer's Paxlovid reduces the risk of death among patients admitted to hospitals with Covid-19.