In 2004 Acambis temporarily halted one of its phase 3 trials comparing ACAM2000 with Dryvax, the currently licensed smallpox vaccine that is no longer produced, after myopericarditis developed in at least three of the research subjects. The HHS, in an Apr 20 release of its plan for developing and buying medical countermeasures against a range of biological, chemical, and other threats, said it was planning to stockpile a weaker version of the smallpox vaccinemodified vaccinia Ankara (MVA)for certain groups, such as pregnant women and immuncompromised people, who can’t receive the conventional smallpox vaccine. The agency “is well advanced in the pre-award stage” of a program to buy an MVA vaccine. Two companies have developed MVA vaccines: Acambis and Copenhagen-based Bavarian Nordic. Acambis has a contract with the US Department of Health and Human Services (HHS) to make 209 million doses of smallpox vaccine for the Strategic National Stockpile (SNS) to use in the event of a terrorist release of smallpox virus. Marc Wolfson, a spokesman for the HHS Office of Public Health Emergency Preparedness in Washington, told CIDRAP News in an e-mail that the company has delivered 192.5 million doses of ACAM2000 so far and has been paid $573,650,000. May 18, 2007 (CIDRAP News) A US Food and Drug Administration (FDA) panel yesterday recommended that the agency approve a smallpox vaccine made by British biotechnology company Acambis plc that is currently being stockpiled for the US government. “This vaccine should not be used lightly,” said Pamela McInnes, a panelist who directs the Center for Integrative Biology and Infectious Diseases at the National Institutes of Health. See also: Panel members said if the FDA approves the vaccine it should require the company to continue clinical trials and other measures, Reuters reported. The US Centers for Disease Control and Prevention (CDC) and Acambis are discussing an arrangement for Acambis to provide long-term production of the vaccine using a US-based supply chain and production (ie, warm-base manufacturing), Acambis said in its press release. Having an FDA-licensed product is a prerequisite to finalizing a warm-base manufacturing contract with the CDC, Garland said. HHS countermeasures implementation planhttp://www.hhs.gov/aspr/ophemc/enterprise/strategy/strategy.html Panelists said they had to weigh the risks of heart inflammation, which would be unacceptable for routine vaccination, against the threat that US military personnel and others in high-risk settings face regarding smallpox exposure, Reuters reported. Ian Garland, Acambis’ chief executive officer, said in a company press release that the FDA panel’s recommendation reinforces the company’s confidence that ACAM2000 will be licensed. The FDA told Acambis its target date for an approval decision is Aug 31, 2007. The panel unanimously voted 11 to 0 that ACAM2000 is both safe and effective, Karen Reilly, an FDA spokesperson, told CIDRAP News in an e-mail after the meeting. The FDA is not bound by the advisory panel recommendations but usually follows them. The positive recommendation came despite some concerns panel members raised about the side effects of the vaccine. Some outside experts who spoke at the meeting said the risk of heart inflammation in people who had been vaccinated warranted further review, according to a Reuters report yesterday. May 17 Acambis news releasehttp://www.acambis.com/default.asp?id=1893 ACAM2000 uses vaccinia virus, a close relative of smallpox, and is grown in cell culture. It is derived from Dryvax, a first-generation vaccine that was used in global smallpox eradication programs. The newer vaccine is grown in cell culture rather than on the skin of calves, which is thought to produce a purer and safer vaccine that has less risk of rare but serious complications.
FSB selects Glenn Elliott as new COO August 12, 2020 Related Articles Share Share StumbleUpon XLMedia completes takeover of 101GreatGoals.com July 17, 2020 Submit Nektan ceases trading on London AIM May 18, 2020 London AIM-listed mobile gambling specialist Nektan Plc has today confirmed the departure of Leigh Nissim as its Chief Executive Officer.Issuing a corporate update, Nektan governance detailed that Nissim will officially leave the business this coming August, with founder and Non-Executive Director Gary Shaw retaking the firm’s CEO position on an interim basis.Nissim a former IGT and GTECH executive joined Nektan in May 2016, replacing former leader David Gosen who had departed the company five months prior to Nissim’s appointment.Taking over the leadership of Nektan, Nissim was charged with spearheading the mobile specialist’s commercial initiatives and further transitioning the business from a ‘white label’ operator to a B2B solutions and services provider.Updating investors, the Nektan board detailed that it had begun its executive search for Nissim’s replacement, with an appointment expected to be made in the coming months.Nektan governance further highlighted that the company was in advanced discussions with regards to concluding its next round of funding, the details of which it expects to announce in due course.
An unspecified number of layoffs and programming cutbacks have taken place at Time Warner Cable’s El Segundo-based TWC SportsNet —home of the Lakers— SportsNet LA —home of the Dodgers— and TWC Deportes, according to several sources and confirmed by the company this morning.Details on how many were let go and how it broke down by departments was not detailed. Sources indicated more than 30 people have been let go at Deportes, including all of its on-air talent, meaning no more pre- or post-game shows for the Galaxy or any kind of programming not related to live event coverage.TWC SportsNet will also cut back on ancillary coverage surrounding the Lakers, Sparks and Galaxy. The Dodgers’ SportsNet LA will stop producing news shows such as Dodgers Clubhouse and Larry King At Bat.The popular “Backstage” shows, which are produced in-house, will remain, a spokesman said. Newsroom GuidelinesNews TipsContact UsReport an Error Sources also say that because of the Charter merger with Time Warner Cable, these kind of business moves are not uncommon in the consolidation process.The Galaxy released a statement: “Time Warner is a valued partner. We’ll continue to work with them to provide the most robust coverage of the Galaxy in LA.”Jaime Cardenas contributed to this report A TWC statement on the matter: “We recently made some changes to our programming for Time Warner Cable SportsNet, Time Warner Cable Deportes and SportsNet LA. As we fine-tuned the programming, it naturally meant that we would make some staffing changes as well. Like many other networks, we’re now past the ‘start-up’ stage and we have a greater handle on what our viewers want to see, and how to staff for that.”TWC SportsNet and the Spanish-language Deportes, owned by TWC, launched in Oct., 2012. The launch of SportsNet LA, owned by the Dodgers and distributed through TWC, came in Feburary, 2014.In a memo to staff employees, TWC Sports indicated the struggling ratings were the reason for the cutbacks.Ratings are related to sluggish distribution.The Dodgers’ SportsNet L.A. continues to struggle creating a carriage deal with main carries such as DirecTV, Dish, Verizon FIOS, AT&T Uverse. Time Warner Cable, recently purchased by Charter, remains the two major distributors in Southern California.