HHS awards $102 million for new flu drug

first_imgJan 5, 2007 (CIDRAP News) – In an effort to expand the pool of antiviral drugs for influenza, the US government yesterday awarded a $102.6 million contract to BioCryst Pharmaceuticals Inc. of Birmingham, Ala., to develop peramivir, a new neuraminidase inhibitor.The Department of Health and Human Services (HHS), in a press release, said peramivir has been effective against several influenza strains in laboratory studies. HHS said the contract will cover production of the investigational drug, phase 2 and 3 clinical studies, and validation of manufacturing processes.Research under the contract will include tests involving the deadly H5N1 avian flu virus and may include research on the possible preventive use of the drug, according to HHS. BioCryst officials said the drug has been shown to help animals survive H5N1 infection.”Antivirals are an important element of our pandemic influenza preparedness efforts,” said HHS secretary Mike Leavitt in the press release. “Our antiviral strategy includes not only stockpiling existing antiviral drugs but also seeking out new antiviral medications to further broaden our capabilities to treat and prevent all forms of influenza.”Licensed drugs in the neuraminidase inhibitor class are taken orally (oseltamivir) or by an inhaler (zanamivir). However, peramivir is under development as a parenterally administered drug, meaning it can be given through intramuscular and intravenous routes.HHS said a parenteral neuraminidase inhibitor may be particularly useful in hospital emergency departments for treatment of patients who have life-threatening flu. Parenteral injection could permit rapid buildup of peramivir to high levels throughout the body and allow treatment of people too ill to take medications by mouth, the agency said.In a news release, BioCryst said its laboratory tests have shown that peramivir, an inhibitor of influenza A and B neuraminidases, is more potent than currently available drugs in its class and is active against antiviral-resistant flu strains. The company said high doses of injectable formulations have been safely administered to healthy people, and the drug has been found to promote survival in animals infected with the H5N1 virus.At a BioCryst teleconference that followed the HHS announcement, Charles Bugg, PhD, the company’s chairman and chief executive officer, said the contract allows the company to move peramivir as quickly as possible through clinical development.HHS said awarding the contract to BioCryst is part of a larger initiative to support the development of new treatments and vaccines that would allow the United States to respond quickly to a flu pandemic.Bugg said both the intramuscular and intravenous formulations of peramivir will go through phase 2 and 3 clinical trials. The intramuscular formulation will be tested against a placebo in outpatients, and the intravenous trial will likely test peramivir against oseltamivir in hospitals.Enrollment of patients for the phase 2 trials will begin this flu season in the United States, Canada, and Europe, Bugg said, adding that the company has identified sites in the southern hemisphere that could be used to fill this year’s phase 2 study groups or facilitate an early start on phase 3 studies. He said BioCryst is also identifying sites in Southeast Asia, where flu outbreaks occur year-round, that might be added to the study.Bugg said the HHS contract to develop peramivir is subject to an emergency use authorization that would allow the department to stockpile the drug before approval by the Food and Drug Administration (FDA) if clinical data show it to be beneficial.Jonathan Nugent, vice president of corporate communications at BioCryst, told CIDRAP News that the company hasn’t ruled out developing oral or inhalational formulations of peramivir in the future. He said the company couldn’t speculate on how long it might take for the drug to win FDA approval. HHS said the FDA has given peramivir “fast track” status, which would expedite the agency’s review of BioCryst’s application.See also:Jan 4 HHS press releasehttp://www.hhs.gov/news/press/2007pres/01/20070104a.htmlJan 4 BioCryst press releasehttp://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=224367last_img read more

#DayOne: Earlybird tickets on sale, seats limited

first_imgThe conference should present all niches and all our development opportunities. That’s right Berislav Sokač from Run Croatia to bring an interesting vision of Croatia as a racing destination. One of the currently leading tourism experts, Doug Lansky, for the first time in Croatia will talk about positive global examples of how tourist destinations are positioned, developed and grown. Doug’s lectures have always attracted a large number of listeners and the attention, especially of the tourist public and the profession, and he has a large base of followers in Croatia as well. “We all talk about how we have an incredible amount of potential wherever we turn and how we need a change in the context of market development, in order to turn those potentials into our resources. But in order to turn these potentials into resources, we need to start proactively dealing with market development and growth, there must be dialogue and common communication and consensus on common themes and challenges. The question we all need to ask ourselves: How to move faster and better? What can we do to make tomorrow better? Where do we see Croatian tourism in 2030? ”, pointed out the director of the conference, owner and founder of the HrTurizam portal Goran Rihelj. This conference, which takes place just before the start of the tourist season, will bring together all those who mean something in the tourism sector. Croatian branding is a special story that we talk about a lot, and the importance of branding does not need to be emphasized too much because it is one of the imperatives today. The conference will also seriously address branding, a complex process in which we simply must not go wrong. Božo Skoko he will be presenting on this topic at the Day One conference. When we hear the challenges facing the continent in Croatia and the solutions that have proven to be excellent in Austria, we will probably get ideas on how we can do better and in which direction we need to go to reach the place where Croatian tourism in 2030 must be. Buy tickets at Earlybird price, number of seats limited We constantly talk about continental tourism and emphasize the importance of the development of the continent that has the greatest opportunities for year-round tourism. The best campaign in the East was definitely the great HeadOnEast / Hedonis campaign, as part of the Croatian Tourism Day in Slavonia. At the conference in block 1 VS 1 we will talk about the hedonist with Ivan Jurić from the Osijek-Baranja Tourist Board. How they are developing tourism in Austria, which is one of the best examples of continental year-round tourism, will tell us Michael Fend, LAG manager from Steirischen Vulkanlandes. Ticket sales for the conference of the year for the B2B tourism sector have begun, which will be held on April 2 at the Forum Congress Center in Zagreb with the support of the Ministry of Tourism and the Croatian National Tourist Board, organized by the leading B2B tourism portal HrTurizam.hr. You can buy tickets directly on our portal at connectors. For Earlybird registrations, which last until March 20, the ticket price is 750 kuna, or 40% of the total ticket price. Namely, after March 20, the ticket price will be 1250 kuna. The number of places is limited, so hurry up, secure a place at the conference of the year for the B2B tourism sector where you will hear how to position yourself in the tourism market, where Croatian tourism goes, you will learn concrete examples of how to develop a good tourism story, hear examples of good practice. tourist products are created outside Croatia. Minister of Tourism Gari Cappelli, who supported the conference and expects a lot from it, will present at the panel a tourism development plan and a vision where we will see each other in 2030. The fact that the Minister of Tourism and his associates will follow the entire conference already gives hope for detecting real problems and creating the concept of concrete solutions. At the same panel, we should hear the Croatian National Tourist Board, which should be represented by the director Kristjan Staničić and this panel will give clear guidelines to the private sector where we are going and where we want to be. The moderator of this panel is our renowned communication expert Krešimir Macan. Who are the conference participants? It is clear that the private sector in tourism has a lot to say. We will find out what the challenges and biggest problems are, what they expect from the public sector and what solutions they propose on a large panel in which we expect representatives of hoteliers, travel agencies, family accommodation and caterers. This panel will bring very concrete proposals that we will insist on and work on, and we expect that we will finally have proposals for solutions on one piece of paper, not just problems, which are unfortunately numerous. Portal HrTurizam.hr just wants to be at the center of this story as a kind of mediator, a channel that connects through dialogue and communication, and provides concrete solutions. According to the tourist dictionary, a complete tourist product should be defined, ie market barriers for the development of the entire tourism sector should be removed. How dialogue and cooperation between the private and public sectors can and should look like will be revealed to us on the example of the development of health tourism Ognjen Bagatin from the Bagatin Polyclinic. A great story about working with big brands and a positive example of the synergy of public and private will tell Denis Ivošević from the Tourist Board of Istria. We will discuss all the challenges and opportunities of cooperation between family farms and destinations in the format 1 VS 1 s Petrom Butković from the Destination Lika Cluster. The key thing to emphasize is that after the conference, there will be meetings with the private sector from each area, in order to gather all the concrete solutions in one strategic document, which will make a list of all challenges in the field, the so-called. “White paper”, with a clear argumentation of the whole issue, and most importantly with the offered concrete solutions on how to accelerate market changes. A document that will unite the views of the private and public sectors, with the aim of consensus on the main challenges with a specific time interval on how to overcome them. “And that’s why there is a need to launch the #DayOne platform, the focus of which is to connect the” incompatible “or start communication. The main focus is not on problems and the past, but on constructive open dialogue and solutions. The focus is on the positives, not the negatives. The focus is on synergy and collaboration. As I pointed out, #DayOne is not just another conference, but a platform. Because we cannot talk about the future of our tourism only one day, during the conference, but every day ”, adds Rihelj. Paul Bradbury owner of the portal Total Croatia News, conference partner and great ambassador of Croatian tourism is the only one who sees the whole story from the outside through the eyes of a foreigner with a Croatian passport, but also an internship in Lijepa naša that gives him the breadth of the picture “5 tourism gifts that Croatia completely ignoring, and how to fix them” certainly arouse great interest. SAVE THE DATE / OneDay Or DayOne, 02.04.2020. , Forum Congress Center, Zagreblast_img read more