Panel supports EU approval of cell-based flu vaccine

first_imgApr 27, 2007 (CIDRAP News) – A committee that reviews medical product applications for the European Union (EU) yesterday recommended approval of a cell-based seasonal influenza vaccine made by Novartis, improving the company’s chance of becoming the first to market a flu vaccine grown in cell culture instead of in eggs.The Committee for Medicinal Products for Human Use (CHMP), which reviews applications for 27 EU countries, found that Novartis’s Optaflu vaccine, given to more than 3,400 people during clinical studies, met the CHMP’s immunogenicity criteria, the Swiss-based company said in a press release today.In a statement released yesterday, the CHMP said it concluded there is “a favourable benefit to risk ratio” for Optaflu and therefore recommended its authorization. The vaccine is intended for adults.The European Commission is not bound by the committee’s recommendations but usually follows them, delivering a decision within 2 to 3 months, Novartis said.If the European Commission approves Optaflu, it may become the first seasonal flu vaccine made with cell-culture production techniques to go on the market. Flu vaccines have been grown in chicken eggs since the 1950s, but several companies are developing processes for growing them in laboratory cell cultures. The Optaflu vaccine is grown in canine kidney cells.In 2001, the European Commission approved a cell-culture version of Solvay Pharmaceuticals’ Influvac flu vaccine for sale in the Netherlands, but the company has not yet marketed it. The company Web site says that market introduction of the vaccine is expected “in the near future.””Optaflu contributes to meeting the growing demand for seasonal influenza vaccines, and this production technology offers the potential for quick scale-up of manufacturing in the event of an influenza pandemic,” said Jörg Reinhardt, chief executive officer of Novartis Vaccines and Diagnostics, in the press release.Cell-culture production is seen as slightly faster and considerably more flexible than traditional egg-based methods. In its press release, Novartis said products made with cell-culture methods are safe for people who are allergic to eggs because they are not created with egg proteins.The new technology also offers the possibility of developing vaccine seed strains that more closely match the original “wild” virus, according to Novartis. Cell-culture methods eliminate passage of the virus through eggs, where it may need to adapt before it can replicate. The antigen in a cell-based vaccine may more closely match the wild-type virus and possibly provide a better immune response, the company said.Novartis has said that Optaflu is a subunit vaccine, meaning it contains individual viral proteins rather than whole virus particles.In a phase 3 study, conducted in Poland during the 2004-05 flu season, 1,300 volunteers between the ages of 18 and 60 and 1,354 volunteers older than 60 were randomly assigned to receive one dose of either the cell-based vaccine or an egg-based vaccine, according to a previous Novartis report.Investigators found no differences in the immunogenicity of the vaccines, both of which met CHMP criteria. Local and systemic side effects for the two vaccines were similar in both age-groups.Novartis said it anticipates applying for US licensing of its cell-based flu vaccine in 2008. The company has conducted phase 1 and 2 clinical trials of the vaccine in the United States and in July 2006 announced it would build a $600 million plant in Holly Springs, N.C., to make cell-culture flu vaccines. In May 2006 the US Department of Health and Human Services awarded Novartis a $220 million contract to develop cell-based flu vaccines, and Novartis has said the money would go toward the cost of the new facility.Depending on when its vaccine is approved by the Food and Drug Administration, the plant could begin production as early as 2011 and be ready for full production as early as 2012, with an annual output of 50 million doses of a trivalent vaccine, the company has said.In the event of a flu pandemic, the facility is designed to have the capacity to make up to 150 million monovalent (single strain) doses each year within 6 months of a pandemic declaration, Novartis said. Novartis’ other cell-based vaccine production facility is in Marburg, Germany.See also:Apr 27 Novartis press releaseOct 24, 2006 CIDRAP News article “Novartis claims success in trial of cell-based flu vaccine”Jul 18, 2006 CIDRAP News article “Novartis to build US cell-based flu vaccine plant”last_img read more

Republicans not in tune with our values

first_imgThe GOP added a last-minute perk to the $1.5 trillion tax reform bill which provides a multi-million-dollar windfall to real estate developers like President Trump, Trump family members, and others in his wealth class.These folks will be able to take advantage of a 20 percent “pass-through” deduction in their income taxes. One economist estimated that this provision will cost the rest of us over $400 billion over the next 10 years. Categories: Letters to the Editor, Opinion In the meanwhile, Utah Sen. Orrin Hatch explained there is “no money” to extend the Children’s Health Insurance Program (CHIP), which officially expired Oct. 1. CHIP is a low-cost insurance program for 9 million children of low-income families who don’t qualify for Medicaid. The annual cost of CHIP, which was originally passed with strong bipartisan support, is reported to be $14.1 billion.Lest we forget, there remains approximately one-third of the residents of Puerto Rico without power and, for some, no repairs in sight for the foreseeable future. But the story is old news and off the front page. Out of sight, out of mind.If this is getting you down, remember you can always watch President Trump savor his only legislative win in his first year as he soaks up the sun and tees it up at Mar-a-Lago for the next few weeks.What happened to the values I thought we all shared?Robert K. CorlissSchenectadyMore from The Daily Gazette:Schenectady department heads: Budget cutbacks would further stress already-stretched departmentsSchenectady High School senior class leaders look to salvage sense of normalcySchenectady man dies following Cutler Street dirt bike crashFoss: Should main downtown branch of the Schenectady County Public Library reopen?EDITORIAL: Urgent: Today is the last day to complete the censuslast_img read more

Letters to the Editor for Friday, Oct. 11

first_imgMadigan is the best qualified for financeI’m a life-long Republican who will vote to re-elect Saratoga Springs Commissioner of Finance Michele Madigan.She’s been doing a great job keeping our taxes flat for eight years. Her opponent has no financial experience, which should frighten us all. Luckily for me, I can vote to elect Madigan on the Independence line.Mike O’BrienSaratoga SpringsMake appointment for mammographyNational Mammography Day is celebrated on Oct. 18. On this day, and throughout the month, women are encouraged to make a mammography appointment.This day serves as a reminder to all women that the best defense is early detection. A mammogram can often detect a problem before there is any outward physical sign.According to the American Cancer Society (ACS), in 2019, an estimated 271,270 new cases of breast cancer (men and women combined) are expected to be diagnosed in the United States. The estimated new cases of female breast cancer in New York is 17,490. About 2,670 new cases of breast cancer are expected to be diagnosed in men in 2019.The good news is that deaths from breast cancer are decreasing and women are living longer after diagnosis.According to the ACS and several cancer organizations, it is recommended that all women 40 years of age and older receive yearly screening mammograms. Men can get breast cancer, too, and should be mindful of family history and/or symptoms.Reduced-cost or free mammograms are available throughout the United States. If you do not have health insurance, the Cancer Services Program offers free breast, cervical and colorectal cancer screenings to women age 40-64 and men age 50-64. Please contact the program at 518-841-3726 to see if you are eligible for these services. Remember to take the time to encourage the women in your life to get their mammogram. Their life is worth it.Wendy LucasAmsterdam Categories: Letters to the Editor, OpinionNo reason for bars to be open at 4 a.m.There is a proposal before Albany lawmakers to close the bars earlier at 2 a.m. instead of 4 a.m. I believe this is a very good idea.Currently, more violent alcohol-related instances occur with bars being open until 4 a.m.; for example fights, stabbings, muggings, shootings, auto accidents.For people who work late and enjoy socializing after their evening shifts, 2 a.m. allows plenty of time to meet with friends. There are no advantages to the local community to have bars open until 4 a.m.Mitch WalshNorth GreenbushParaprofessionals earn their wagesI am writing in response to the Sept. 25 article about the Schenectady paraprofessionals seeking a living wage. I am deeply repulsed by the words of school Superintendent Larry Spring. He stated they have “limited responsibilities” or “fewer daily responsibilities” than teachers. While yes, I will agree a teacher does work far beyond the hours of the school day, it is the paraprofessional who picks up where the teacher stops. Who watches the children before and after the bell rings? Not a teacher. Shall I even bring up the substitute-teacher  shortage in the area? No substitute? Who covers those classes? You guessed it, a paraprofessional. Because they aren’t teaching, they deserve less? Wait, aren’t the paraprofessionals helping re-enforce the lessons? What about the paraprofessionals who sit at the entrance scanning identification of those looking to enter. They keep those who should not have contact with the staff or children from the building. That is a limited responsibility? My sister is said paraprofessional. She has been yelled at, threatened, had to be alert to sex offenders and upheld orders of protection for both students and staff. I challenge you, Mr. Spring, to look her in the face and tell her she only has “limited responsibilities.”The paraprofessionals in Schenectady are being taken advantage of. They are the backbone of the schools. Mr. Spring, you do not deserve the loyalty they give your district. But they don’t do it for you. They do it for the children. I stand in solidarity. You deserve more.Ashley BakerSchenectadyPresident ignores GM strike in tweetsRegarding the General Motors strike: Isn’t it a little ironic that our president tweets that there is no truth in climate change, about a need for border walls, about a need for tariffs to improve the U.S. economy, about illegal immigration and about our exceptional relationship with North Korea, but no mention of what is currently taking place with GM?And don’t to forget to mention removing unions from the federal government.Joseph RownySaratoga Springs Trump’s message similar to Hitler’sI was interested in the comment of Hitler’s warning of the big lie. His intention was to make Germany great again.Calvin MooreArgyleMore from The Daily Gazette:EDITORIAL: Find a way to get family members into nursing homesGov. Andrew Cuomo’s press conference for Sunday, Oct. 18Foss: Should main downtown branch of the Schenectady County Public Library reopen?EDITORIAL: Thruway tax unfair to working motoristsEDITORIAL: Urgent: Today is the last day to complete the censuslast_img read more

Bristol offices

first_imgWould you like to read more?Register for free to finish this article.Sign up now for the following benefits:Four FREE articles of your choice per monthBreaking news, comment and analysis from industry experts as it happensChoose from our portfolio of email newsletters To access this article REGISTER NOWWould you like print copies, app and digital replica access too? SUBSCRIBE for as little as £5 per week.last_img

Welcome to your own piece of luxury on the southern Gold Coast

first_img194 Pacific Pde, Bilinga. “This substantial residence boasts an immediate vista of surf, sand and sunrises,” he said.“There is so much interest in Bilinga right now, it’s become quite the sought-after suburb by high end buyers who are interested in its relaxed lifestyle and village vibe.”More from news02:37International architect Desmond Brooks selling luxury beach villa17 hours ago02:37Gold Coast property: Sovereign Islands mega mansion hits market with $16m price tag2 days agoThe luxury trophy home is fitting to a high degree with imported marble floor tiles, German appliances, glass flooring, soaring ceilings and custom water features. 194 Pacific Pde, Bilinga. 194 Pacific Pde, Bilinga.WELCOME to your own luxury beachfront home.Ray White Mermaid Beach agent Troy Dowker said the residence 194 Pacific Pde was built in 2012 to take advantage of its prime stretch of southern coastline.center_img “From home automation to an extravagant parent’s retreat this home has it all, even a prayer room. “There’s a tiered home theatre with 4D sound and 10 leather recliners.“The residence comprises designated spaces and modern inclusions for every occasion. “An integrated sound system crowns the self-contained leisure and entertainment precinct on the fourth floor encompassing a rooftop terrace with panoramic coastline and hinterland views, outdoor spa, lounging area, full kitchen, sauna, bathroom and gymnasium.” 194 Pacific Pde, Bilinga.Central to the second floor lifestyle zone is the main kitchen equipped with a walk-in pantry and servery to the full butler’s pantry with a gas cooktop and twin sink.The large wet bar, with beverage fridges and granite surfaces, wilfully interacts with the dining room and living area fronting the picturesque foreshore and stunning sands of Bilinga beach.The property is going to auction on May 5.last_img read more

Civil Aviation scheme awards £4bn fiduciary mandate

first_imgThe Civil Aviation Authority Pension Scheme (CAAPS) has appointed BlackRock as fiduciary manager handling £4bn (€4.4bn) for both its CAA and NATS – formerly known as the National Air Traffic Services – sections.After a competitive tender process, facilitated by IC Select, CAAPS selected BlackRock to plan and execute both sections’ asset allocation and manager selection decisions across all asset classes.The CAAPS trustees will also be provided with training, guidance and transition management services, an announcement disclosed.Sarah Melvin, head of UK at BlackRock, said: “A vast number of schemes are currently navigating an uncertain global environment, and more and more making the decision to outsource.” At the beginning of the year BlackRock appointed Alex Pollak as head of clients for its UK fiduciary management business as it prepared for an expected increase in new business enquiries in 2020.Following rules that came into force last December, UK pension schemes must tender any fiduciary mandate that outsources more than 20% of assets. Existing mandates must also be tendered within a set timeframe, which has led several providers and consultants to hire new staff to cope with the increased workload.The announcement said that BlackRock responded to CAAPS’ requirements for a bespoke approach and the firm was selected due to its consistent focus on partnership, risk management, and a differentiated approach to asset allocation.Joanna Matthews, independent chair for CAAPS, said that BlackRock was selected because “they were a good cultural fit and they clearly demonstrated the strength of their investment offering and the scale and depth of their resources.”BlackRock will build a custom portfolio according to each sections’ needs while aiming to build in greater portfolio resilience, which may provide less volatile results in increasingly uncertain times.Additionally, the use of Aladdin, BlackRock’s risk platform, will play a central role helping to understand the risk and return characteristics driving funding levels.The platform’s thorough analysis will assist BlackRock in building the sections’ portfolios with more stable returns, with the goal of helping CAAPS members receive their pension benefits.Sion Cole, head of UK fiduciary business at BlackRock, added: “Providing a whole portfolio approach when making asset allocation decisions allows us to create and deliver a truly tailored and innovative portfolio for CAAPS, helping them to secure the retirement benefits of their members.”Looking for IPE’s latest magazine? Read the digital edition here.last_img read more

Terry Allen Jackson

first_imgTerry Allen Jackson, 73, of Lawrenceburg, Indiana, and formerly Aurora, passed away Wednesday, November 2, 2016 in Cincinnati, OH.He was born October 14, 1943 in Aurora, IN and graduated from Aurora High School. Terry served his Country as a member of the United States Navy. He worked as a Boiler Operator for Henkel Chemical Company for over 30 years, and married his wife Jacqueline Sue HastingsHe was a member of Hebron Lutheran Church, Hebron KY, Lawrenceburg Masonic Lodge and Southeastern Indiana Shrine Club. He participated in fund raising, including serving at the steak dinners held by the Shrine club. Terry also drove the van to take children to Shriners Hospital for Children in Lexington, and later organized the runs for the hospital. He loved to fish, tell jokes, was an IU Basketball fan and enjoyed spending time with his family. He was especially close to his grandson, Aaron. Terry was a kind and gentle man who served his fellow man not only through his military service and later through the work with the Shriners. He was a great example to all who knew him and he will be sadly missed.Surviving are his loving wife of 54 years, Jacqueline “Jackie” Jackson, Son, Michael (Cindy) Allen Jackson, grandchild, Aaron Michael Jackson.He was preceded in death by his parents and a sister, Bonnie Oatman.Friends will be received Friday, November 4, 2016, 5:00 pm – 8:00 pm at the First Baptist Church, Aurora, Indiana.Services will be held at the Church Saturday at 11:00 am.Interment will follow in the Greendale Cemetery, Greendale, Indiana 47025. Military graveside services will be conducted by members of local Veterans Service Organizations.Contributions may be made to the Shriners Hospital for Children. If unable to attend services, please call the funeral home office at (812) 926-1450 and we will notify the family of your donation with a card.Visit: www.rullmans.comlast_img read more

McAuley: No egos in Baggies squad

first_img He went on: “You always hear how players miss the dressing room when they retire. We’ve a good dressing room at the moment. It works both ways, I said there was no egos when I came here. Everyone wants the same things, we play to win. “Do the headlines affect the dressing room? Once you’re on the pitch, you’re focused, things in the background don’t come into your mind. You’re too busy focusing on the game and what’s going on in front of you.” McAuley was not allowed to comment on Odemwingie’s behaviour but revealed that Macedonian international Popov had apologised for his actions. He said: “Goran has said sorry for his actions, we draw a line under it and he’ll serve his time on the sidelines. “Liam Ridgewell will come into the side now and make it hard for him to get back in “Was it cultural? I’m not sure. It was out of character. He’s actually a nice guy. “You can put it down to a head loss. It’s something he wishes he hadn’t done. It was one of things you can’t believe. I’d have reacted differently. But he knew he was in the wrong after the game. He held his hands up.” Press Association Defender Gareth McAuley insists the strong nature of the West Brom dressing room will ensure the club bounces back from the current series of unsavoury incidents surrounding key players.center_img Peter Odemwingie has been fined for his series of Twitter attacks on the club and turning up at Loftus Road without permission on transfer deadline day, only to see his proposed move to QPR collapse, while left-back Goran Popov was also disciplined for spitting in the direction of Tottenham right-back Kyle Walker. But McAuley is adamant the players will police themselves, and said: “Everyone keeps everyone in check. When players are low you pick them up. When they’re getting carried away you bring them back down to earth. That’s how dressing rooms always have been.” last_img read more

Cricket News Umesh Yadav’s death overs bowling horror revisited after loss to Australia

first_imghighlights Australia won a Twenty20 International against India in India for the second time.Umesh Yadav bowled the final over against West Indies in Vizag which ended in a tie.Australia were boosted by a fifty from Glenn Maxwell. It was deja-vu for Umesh. At this same venue, four months ago during the ODI clash against West Indies, the Vidarbha right-hander was once again found wanting in the death overs. Virat Kohli became the fastest to 10,000 runs in ODIs and his 157, combined with Ambati Rayudu’s 73 helped India reach 321/7. In response, Shimron Hetmyer blasted 94 and was well supported by Shai Hope as West Indies seemed on course for a win. A flurry of late wickets resulted in the Windies needing 14 runs off the final over bowled by Umesh.A first ball yorker was dug out by Hope for a single but on the second ball, a reverse-swinging delivery hit the back leg of Ashley Nurse and went past MS Dhoni for four leg byes. The third ball was slogged to deep midwicket for a couple by Nurse and West Indies needed seven off three balls. However, Nurse played the scoop shot and holed out to third man and Hope managed to squeeze a yorker to deep midwicket for two runs. Windies needed five runs off the last ball but Umesh bowled a full ball slightly wide of off stump and Hope carved the square drive to the deep backward point fence for a boundary to tie the game. Umesh ended up as the most expensive Indian bowler in that match, conceding 78 runs for one wicket.Vizag is a venue where MS Dhoni made a mark on the world stage with a brilliant 148 against Pakistan in 2005. It was the venue that saw Kohli script an epic to upstage Sachin Tendulkar. But for Umesh, Vizag is the venue of horror for his death bowling.  New Delhi: Umesh Yadav, death overs bowling and Vizag. It is a horror story that is the stuff of nightmares. The first Twenty20 International between India and Australia saw fortunes swaying constantly. KL Rahul hit a fifty but India managed just 126/7. Australia were boosted by Glenn Maxwell’s brilliant 56 but once he fell, India found the opening and Jasprit Bumrah bowled a sensational 19th over where he conceded just two runs and took two wickets. Australia required 14 off the last over which was to be bowled by Umesh Yadav. The advantage was with India and in the first ball, Pat Cummins mistimed a slog to long on and Australia needed 13 off five balls. Then it went horribly wrong.Jhye Richardson moved to the off side and Umesh bowled a short delivery outside off which the batsman thumped to deep midwicket for a boundary. Nine runs needed off four balls. A brilliant yorker was bowled but Richardson dug it out superbly and ran two runs. A low full toss was hit down the ground for a single and six runs were needed off two balls. Umesh bowled a low full toss and wide outside off stump, Pat Cummins latched on to it and creamed the drive to the deep extra cover fence.Before the final ball was bowled, former India skipper Sunil Gavaskar pointed out that long on was a bit too deep and the fielder should move in. Umesh bowled a full ball on middle stump and Cummins mistimed the drive past the bowler. However, since there was no timing, the ball did not go quickly to the fielder who ran in and flung the ball at Dhoni’s end. This was enough for Australia to steal the game and win by three wickets off the final ball. Umesh could not defend 14 runs in the final over. For all the Latest Sports News News, Cricket News News, Download News Nation Android and iOS Mobile Apps.last_img read more

UMES, Coppin State meet in conference play

first_img Associated Press UMES, Coppin State meet in conference play ___For more AP college basketball coverage: and was generated by Automated Insights,, using data from STATS LLC,,Update on the latest sports Share This StoryFacebookTwitteremailPrintLinkedinRedditMaryland Eastern Shore (3-20, 2-6) vs. Coppin State (7-18, 3-7)Physical Education Complex, Baltimore; Monday, 7:30 p.m. ESTBOTTOM LINE: Coppin State plays host to Maryland Eastern Shore in a MEAC matchup. Both teams are coming off of losses this past Saturday. Coppin State lost 68-63 at home to NC Central, while Maryland Eastern Shore came up short in a 61-53 game at Morgan State.center_img February 9, 2020 SUPER SENIORS: Maryland Eastern Shore has benefited heavily from its seniors. AJ Cheeseman, Da’Shawn Phillip, Canaan Bartley and Ahmad Frost have combined to account for 47 percent of the team’s scoring this year and 67 percent of all Hawks points over the team’s last five games.MEAC IMPROVEMENT: The Hawks have scored 58.9 points per game and allowed 67.4 points per game against MEAC opponents. Those are both moves in the right direction from the 50.5 points scored and 76.4 points given up per game to non-conference opponents.TERRIFIC THOMAS: Koby Thomas has connected on 21.4 percent of the 42 3-pointers he’s attempted and has made 3 of 12 over his last five games. He’s also made 56 percent of his foul shots this season.WINLESS WHEN: The Eagles are 0-11 when they score 63 points or fewer and 7-7 when they exceed 63 points. The Hawks are 0-20 when they fail to score more than 64 points and 3-0 on the season, otherwise.FLOOR SPACING: Coppin State’s Andrew Robinson has attempted 230 3-pointers and connected on 31.7 percent of them, and is 12 for 34 over the last three games.DID YOU KNOW: Coppin State has made eight 3-pointers per game as a team this year, which is most among MEAC teams.last_img read more