Tag Archives: 爱上海HN

18Nov/20

FDA approvals clear way for flu vaccine marketing

first_imgEditor’s note: This story was updated Aug 7 to include information about the start of influenza vaccine shipments by Novartis.Aug 6, 2008 (CIDRAP News) – The six companies that make influenza vaccine for the US market have won federal approval for their version of this year’s vaccine, in which all three flu strains used in last year’s product have been replaced, the Food and Drug Administration (FDA) announced yesterday.The FDA announcement clears the way for marketing of the vaccines. At least three vaccine makers have begun shipping vaccine to distributors and providers, according to recent company announcements.The six manufacturers and their vaccines are CSL Limited, Afluria; GlaoxSmithKline Biologicals, Fluarix; ID Biomedical Corp. of Quebec (a unit of GlaxoSmithKline), FluLaval; MedImmune, FluMist; Novartis Vaccines and Diagnostics, Fluvirin; and Sanofi Pasteur, Fluzone.In the wake of a relatively poor match between the vaccine and circulating flu strains last season, experts at the World Health Organization and the FDA in February recommended changing all three strains of virus used in the vaccine. In most years only one or two of the three strains are changed.”One of the biggest challenges in the fight against influenza is producing new vaccines every year,” Jesse Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release. “There is no other instance where new vaccines must be made every year.”Two of the three strains in the 2008-09 vaccine are included in vaccines now being used in the Southern Hemisphere, where the flu season is under way, the FDA noted.The decision to change all three strains in the vaccine had generated some concern about possible production delays or low yields of the viruses, which are grown in eggs. But Curtis Allen, a spokesman for the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC) in Atlanta, said today he hasn’t heard of any problems growing the strains.”Vaccine production is always fraught with risk and anywhere along the line things can go wrong, but so far they have not, and we’re looking forward to a season with adequate supplies of vaccine,” Allen told CIDRAP News.At a meeting in May, manufacturers estimated they would produce a record total of 143 million to 146 million doses of flu vaccine for the US market this year. Allen said the estimates of vaccine production have not changed since then. Last year 140 million doses were produced.Allen listed the manufacturers’ production estimates as follows: Sanofi Pasteur, 50 million doses; GlaxoSmithKline (including ID Biomedical), 35 million to 38 million; MedImmune, 12 million; Novartis, 40 million; and CSL, 6 million.Sanofi announced Aug 1 that it had begun shipping the first 1.3 million doses of Fluzone. “Vaccine shipments to healthcare providers and to the [CDC] for distribution through the Vaccines for Children Program will continue through the fall and are planned to be completed in October,” the company said in a news release.The statement indicated that replacing all three strains of virus has not caused any major production problems.”Introduction of three new strains for the influenza vaccine was unprecedented and could have resulted in a low yield or delay given our tight production timeline. Despite these challenges, we are pleased that once again Sanofi Pasteur has demonstrated its reliability in supplying Fluzone vaccine to the US market,” said Wayne Pisano, the company’s president and chief executive officer, in the news release.MedImmune announced yesterday that shipments of FluMist, a nasal-spray vaccine that uses a weakened form of live virus, had begun on Jul 31. In a news release, the company affirmed that it plans to produce about 12 million doses, a record number.FluMist will be available at some retail pharmacies and supermarkets and in nearly 200 school-based vaccination programs and university health centers, the company said. In addition, the federal government, as in past years, is buying some doses for use in military personnel, officials said.Novartis announced Aug 7 that it has begun shipping Fluvirin to US healthcare providers. The company said it expects to deliver 20 million doses by the end of September and aims to deliver the remaining 20 million by Oct 31. Officials said the company has added a second manufacturing facility, located in Rosia, Italy, to help supply flu vaccine earlier in the season. The firm’s other facility is in Liverpool, England.”Despite the new composition [of the vaccine], Novartis made sure we were able to deliver a timely and robust supply of influenza vaccine this year,” said Rajiv De Silva, president of Novartis Vaccines in the US, in a news release.This is the first year the CDC is formally recommending flu shots for school-age children, adding about 30 million people to the ranks of those targeted for vaccination. Allen said the total number of those targeted for vaccination—including people at risk for serious flu complications and their close contacts—is about 258 million, or roughly 84% of the population.See also: Aug 5 FDA news releasehttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116933.htmFDA page with chart of vaccine lot releaseshttp://www.fda.gov/cber/flu/flu2008.htmAug 4 MedImmune news releaseAug 1 Sanofi Pasteur news releasehttp://www.vaccineplace.com/docs/first_shipment_release.pdfMay 13 CIDRAP News story “Flu experts try to ensure record vaccine doses get used”Feb 22 CIDRAP News story “FDA endorses overhaul for 2008-09 flu vaccine”last_img read more

21Sep/20

Sexton happy to uphold tradition

first_img “Everything you win is very special, but this is just unique. You are playing with guys you barely know, and you have to forge that bond. You saw by the celebrations that we did that. We did the Lions tradition proud. “The big motivation as a player is you want to be remembered when you hang up your boots, and you try to win as much as possible and do the right things as much as possible. Winning a Lions series is definitely part of that.” Unlike in Melbourne seven days previously, the Lions took the game to Australia early on, and they were rewarded by building a 19-3 lead just before half-time. And although the Wallabies clawed back that deficit to just three points, Sexton’s try was part of an unanswered 22-point blitz that meant the Lions claimed the second biggest-winning Test margin in their 125-year history. “It’s very easy when the momentum goes that you think it’s not your day,” he added. “I am really proud of the way we stuck in there. No-one changed the plan and no-one panicked (at 19-16), and we swung it back. “The set-piece was the difference. Obviously, our scrum was dominant, and in the lineout we got a bit of ball and we used George (North), Jamie (Roberts) and Tommy (Bowe) to get us over the gain-line and on the front foot. “I ran the inside line for my try, but when I saw it on the replay, I thought ‘oh no, he (referee) is going to do it for a forward pass which would have been the biggest let-down ever. But thankfully, Leigh’s (Halfpenny’s) hands went backwards and I caught it behind me.” Ireland star Jonathan Sexton will head to a new career in France satisfied that Warren Gatland’s class of 2013 “did the Lions tradition proud”. The fly-half playmaker scored a try during the British and Irish Lions’ 41-16 third Test demolition of Australia, and he proved a major attacking catalyst throughout. And he was quick to recognise the scale of a Test series victory that was the Lions’ first since they toppled South Africa 16 years ago. “This is huge for me,” said Sexton, who will now join wealthy Paris club Racing Metro from Leinster on a lucrative six-figure deal. center_img Press Associationlast_img read more

19Sep/20

Champions Trophy pullout unlikely as BCCI meets on Sunday

first_img(REUTERS) – The Indian cricket board (BCCI) will meet on Sunday to consider an additional revenue offer from the game’s world governing body but regardless of what decision they come to, a Champions Trophy pullout by the holders looks unlikely.Unaccustomed to being snubbed at the International Cricket Council (ICC) meetings, the BCCI was outvoted 13-1 last week in its bid to stall a new revenue model which considerably slashes India’s share from global events in the 2015-2023 cycle.Unimpressed by the $293 million forecast, down from the $570 million it would have received under the 2014 arrangement, the BCCI responded by refusing to name the squad for next month’s Champions Trophy before the April 25 deadline.ICC president Shashank Manohar, a former BCCI chief, has tabled an additional $100 million and the India board will discuss the offer at Sunday’s special general body meeting.The operations of the BCCI are currently being supervised by four court-appointed administrators and the head of the committee, Vinod Rai, told Reuters last week that it was “too early” to comment on a possible pullout of Champions Trophy.Another of the quartet, Ramchandra Guha, has since made it clear he wants India to defend the title they won in 2013 at the June 1-18 tournament in England and Wales.“Speaking in my personal capacity, as a cricket fan, I believe the Indian cricket team must absolutely take part in the Champions Trophy,” Guha, a historian, tweeted.“Boycotting or threatening to boycott a prestigious international tournament does not become a great cricketing nation.”Under the Members Participation Agreement for the Champions Trophy, there is no scope for sanctions for missing the deadline for naming squads.last_img read more

12Jan/20

GRA’s release of tax info unethical – Ram

first_img… as Education Minister given preview of recordsChartered accountant and prominent lawyer, Christopher Ram has noted with concern the announcement by Government that its Finance Ministry has records of private schools’ tax information and has since called for clarity.Ram raised the issue when he made a contribution to the consultation between Government and stakeholders on the removal of the Value Added Tax (VAT) on private education.The accountant highlighted that the Guyana Revenue Authority (GRA) is the only body in Guyana that should have tax records of taxpayers and that any such information must be confidential.Education Minister, Dr Rupert Roopnaraine, in defending the need to charge an education tax on private schools, said records in the Finance Ministry show that many of the institutions have been slipping on their tax requirements.“The records from the Ministry of Finance demonstrate that the schools are able to absorb the VAT. Of the private schools that are operating in Guyana, 57 per cent of them are currently registered with the GRA,” the Minister said as he began disclosing some statistics regarding the status private institutions in the country with respects to paying taxes.But, Ram challenged the Minister’s presentation and contended that neither he nor any Government official should be privy to tax records of taxpayers.“I’m not aware that the Ministry of Finance is in anyway a regulator of schools in Guyana and the situation was compounded when he said the Government has information on the schools that are not paying taxes. That’s a very serious statement to make, only the GRA has that information and the GRA and its officers are under a statutory duty of secrecy and confidentiality when it comes to information on any taxpayer,” he stated.Ram further told <<>> on Saturday during a telephone interview that he finds the statement “disturbing” and that it would be best for the Minister to clarify what he meant.“I think it’s in the interest of the integrity of the GRA that that statement be clarified because the GRA has a rule that it ought not to be giving out information on taxpayers,” he posited.The Education Minister had also disclosed that 10 per cent of private institutions are registered at non-profit organisations, and 14 per cent as profit-making entities.He also revealed that most private schools make approximately over $300,000 in tuition fees per year per person, depending on the level of studies.Dr Roopnaraine said the revenues generated by the top private schools exceed $2 billion annually.He noted that the estimate does not include extra charges by the institutions for additional services.He further announced that there is a high level of noncompliance of the timely submission of the required income, property and corporation returns and the payment of taxes.He said in some cases, teachers are treated as contract employees and employers are not deducting the appropriate NIS and PAYE from their salaries.The Minister also announced that there are incidents of under declaration and inflated expenditure so as to avoid paying taxes. “Payments are made to individuals other than institutions to facilitate these under declarations,” he noted.In this regard, the Minister had argued that “it is clear” that private institutions can absorb VAT without passing it on to the students.Finance Minister Winston Jordan had previously disclosed to the media some information regarding the tax status of private schools in the country.last_img read more