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

Duterte seeks to create body to oversee Boracay

first_img“If it’s only coconut, white sand and water, wala ‘yan…pero you add the visitors there, then it becomes a very tempting destination,” the chief executive said. Boracay was the first top tourist spot to reopen since lockdowns were enforced due to COVID-19, but only visitors from the Western Visayas are allowed to go there for now. “We have shared remarkable emergence of the island back to its former glory. I want this sustained. I ask Congress to enact a law creating, importante ito, the Boracay Island Development Authority or BIDA,” Duterte said. Western Visayas, which remains under modified general community quarantine, is comprised of the provinces of Aklan, Antique, Capiz, Guimaras, Iloilo, and Negros Occidental./PN In his penultimate State of the Nation Address (SONA) yesterday, Duterte said lawmakers should push for the creation of the Boracay Island Development Authority. For his part, Acting Malay Mayor Frolibar Bautista said: “Very good comment gid kay ti gin-appreciate nya (Duterte) man ang status sang Boracay.” In 2018, Duterte ordered the six-month closure of the top beach destination, saying Boracay has become a “cesspool.” “Ang implementasyon man naton sa existing regulation isa man ina sa nakabulig para ma-back to glory ang island,” the mayor added. MANILA – President Rodrigo Duterte urged Congress to put up a body that would oversee the world-famous Boracay Island in Malay, Aklan. He likewise cited that Boracay is doing well “because of its scenery.” “We enjoin our people to boost the economy by travelling locally,” President Duterte said. This agency, according to the President, would ensure that the effects of the months-long rehabilitation of the island are sustained.  He also said that part of the island will be placed under the government’s land reform program to be distributed to the island’s resident Indigenous Peoples.Earlier in the speech, the President urged Filipinos to boost the economy by traveling locally “once necessary systems are in place.”last_img read more

Liverpool eyeing further signings

first_img Striker Rickie Lambert has already been brought in from Southampton, his former team-mate Adam Lallana is expected to sign for the Anfield club in the next few days, while a fee has been agreed for Bayer Leverkusen midfielder Emre Can. With Liverpool challenging for honours both domestically and in the Champions League in 2014/15, Rodgers is keen to bolster a squad that will be without talisman Luis Suarez until the end of October as a result of his infamous bite on Giorgio Chiellini at the World Cup. Press Association Liverpool manager Brendan Rodgers has revealed the club intend to make further signings ahead of the forthcoming season.center_img “I think there has been a lot of work that has been done,” Rodgers told Sky Sports News. “If you look at us as a club and recruitment, we haven’t been resting over the course of the off-season – a lot of great work has gone on. “We’ve targeted players, we’ve signed some and we’ll have more signings to come over the course of the pre-season. The idea is by the end of August we’ll have the squad together and it will be a really exciting time for us next season. “Next season will be equally as tough, we knew it would be tough. We had an incredible performance level and we’ll have players who want to prove themselves, and the beauty is that we as a club will improve too. “We’ve a lot of young players who will have gained experience last season and we will bring in more players with added quality, so we will also improve as well and that’s something I’m really looking forward to seeing.” last_img read more