FDA says Novartis withheld data problem before drug approval

TRENTON, N.J. — U.S. regulators want to know why Novartis didn’t disclose a problem with testing data until after the Swiss drugmaker’s $2.1 million gene therapy was approved.The Food and Drug Administration said Tuesday the manipulated data involved testing in animals, not patients, and it’s confident that the drug, called Zolgensma, should remain on the market. The agency said it’s investigating and will consider criminal or civil penalties if appropriate.Zolgensma was approved in May for children under 2, becoming the most expensive treatment ever. It’s a one-time treatment for a rare inherited condition, spinal muscular atrophy, which destroys a baby’s muscle control.The FDA said in a statement that AveXis Inc., the Novartis AG subsidiary that manufactures Zolgensma, told the agency five weeks after the approval about a “data manipulation issue” that resulted in inaccurate information about testing in animals. The agency said the company knew about the problem before the FDA approved Zolgensma. The inaccurate data is a small subset of the testing information that the FDA evaluated.Acting FDA Commissioner Ned Sharpless tweeted that “the agency will use its full authorities to take action.”In a statement Tuesday evening, Novartis said that after AveXis learned of alleged data manipulation in one animal testing procedure, the company immediately began investigating. Once it had “interim conclusions,” it shared them with the FDA.Novartis didn’t say why it didn’t notify the FDA before it approved Zolgensma. Novartis stated that the animal test in question isn’t used in making the therapy for patients and that Zolgensma is safe and effective.FDA staff inspected the company’s Irvine, California, manufacturing plant in recent weeks, then issued a report finding several deficiencies, including not fully following quality control procedures.Spinal muscular atrophy strikes about 400 babies born in the U.S. each year and is a top genetic cause of infant death. Zolgensma works by supplying a healthy copy of the faulty gene that causes the condition.___Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma .___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.Linda A. Johnson, The Associated Press read more

Susan Jones out Ken Seitz in as head of Nutrien potash operations

Nutrien to temporarily shut down three Saskatchewan potash mines Nutrien aims for ‘mine of the future’ as Cory operation marks 50 years of potash Nutrien to move chief strategy officer, chief legal officer jobs to Saskatoon It is not clear what implications Jones’s departure will have for Nutrien, which launched a major public relations campaign after its lack of executives in the province drew the ire of the government and the local business community.Earlier this year, after the StarPhoenix reported on the locations of its senior leaders outside Saskactchewan, the company committed to move its chief strategy officer and chief legal officer positions to its corporate office in Saskatoon.Tigley said the company’s strategies and business plan remain on track, and Nutrien expects “minimal impact” to its customers.Jones’s departure comes at a moment of weakness for the potash industry, which has seen major producers including Nutrien slash production in the face of weakening global demand after around two years of steady growth.Canpotex will be led by Derek Gross, its current senior vice president of finance and strategy, until its board of directors chooses a permanent CEO, spokeswoman Natashia Stinka said Thursday morning in an email. amacpherson@postmedia.comtwitter.com/macphersonaRelated Just over a year after she was appointed to manage Nutrien Ltd.’s potash operations in Saskatchewan, Susan Jones is leaving the world’s largest fertilizer company.Jones, who was seen by some as a potential heir to chief executive Chuck Magro, will be replaced by Ken Seitz, the current head of the international potash marketing firm Canptoex Ltd.Nutrien spokesman Will Tigley said Jones’s departure was a “difficult and personal decision,” and that while she will remain on until the end of 2019, Seitz will assume his new role on Oct. 1.Seitz grew up on a farm outside Regina and worked at Cameco Corp. before taking over as head of Canpotex in 2015. Canpotex is wholly owned by Nutrien and Mosaic Co., and sells potash overseas for both mining companies.Nutrien owns and operates six of the 10 active potash mines in the province. Last year, it shipped more than 13 million tonnes of potash — around 20 per cent of all potash estimated to have shipped worldwide in 2018. Susan Jones, Nutrien Ltd.’s president of potash operations, was responsible for six of Saskatchewan’s 10 mines. Greg Pender / The StarPhoenix Liam Richards / Saskatoon StarPhoenix Canpotex Ltd. CEO Ken Seitz in his Saskatoon office on Oct. 30, 2015. read more

Monadelphous secures construction contract at Rio Tinto Iron Ores Cape Lambert Port

first_imgAustralian based Monadelphous has announced that it has secured a major construction contract with Rio Tinto Iron Ore at its Cape Lambert Port B project in Western Australia. The contract, valued at roughly $235 million includes structural mechanical piping works for the supply and installation of a screenhouse, two car dumpers and associated conveyors and transfer stations. The project, which is scheduled for completion in the fourth quarter of the 2014 calendar year, follows other recently completed screenhouse and car dumper supply and installation works at Cape Lambert.Rob Velletri, Monadelphous Managing Director said: “This award builds on our long term relationship with Rio Tinto. We look forward to the successful delivery of another large-scale project which continues our extensive support for Rio Tinto in the expansion and maintenance of its Pilbara iron ore operations over many years”.last_img read more