Quoted from http://www.pharmaceutical-journal.com/news-and-analysis/news-in-brief/stronger-warning-on-iclusig-blood-clot-risk/20066975.article
Stronger warning on Iclusig blood clot risk
The Pharmaceutical Journal, 30 OCT 2014
Warnings about the risks of developing a blood clot or blocked artery with Iclusig (ponatinib), a leukaemia treatment, are to be made more robust, following the results of a European Medicines Agency (EMA) review.
The EMA said that any risks would be likely to be linked to dosage but insufficient data meant that it did not have enough information to recommend that the existing starting dose of 45mg a day should change. The agency announced that it is launching a study into the safety and benefits of Iclusig, with a focus on dosage, to help clarify whether lowering the dose would also reduce the associated risks.
Quoted from http://www.bloomberg.com/news/2014-10-27/takeda-lilly-get-9-billion-actos-award-cut-99-percent.html
Takeda, Lilly Win 99.6% Cut in Actos Punitive Damages
By Jef Feeley 2014-10-28
Takeda Pharmaceutical Co. and Eli Lilly & Co. won a more than a 99 percent cut in a $9 billion punitive damages award over claims the drugmakers hid the cancer risks of their Actos diabetes medicine.
Jurors properly found officials of Osaka, Japan-based Takeda and Indianapolis-based Lilly intentionally hid the health risks of the drug and should pay punitive damages, U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, ruled. Still, the panel’s decision to order Takeda to pay $6 billion and Lilly $3 billion was excessive and should be reduced to a total of $36.8 million, she said.
The reduction brings the award “to the maximum amount a jury could have properly awarded” under current U.S. law, Doherty said. The judge denied Takeda’s and Lilly’s request for a new trial.
Quoted from http://news.yahoo.com/biogen-profit-surges-tecfidera-sales-shy-street-view-120731126--finance.html
Biogen's Tecfidera sales miss estimates; confirms first PML case
By Bill Berkrot October 22, 2014
(Reuters) - Biogen Idec Inc said on Wednesday sales of its big-selling new multiple sclerosis drug Tecfidera fell short of Wall Street's lofty expectations, and the company confirmed a serious brain infection in a patient who took the oral medication, sending its shares 7 percent lower.
Biogen reported the first case of progressive multifocal leukoencephalopathy (PML) in a Tecfidera patient, who had been part of a clinical trial and was taking the drug for 4-1/2 years.
The patient, who died of pneumonia, had been suffering severe lymphopenia, a low white blood cell condition, for more than three years, which Biogen said was a risk factor for developing PML.
Biogen, which has notified health regulators of the PML case, said 100,000 patients have taken Tecfidera.
Quoted from http://www.pmlive.com/pharma_news/ema_safety_panel_rules_no_change_needed_for_ariads_iclusig_605906
EMA safety panel rules no change needed for Ariad's Iclusig
Positive news comes after blood clot concerns
The European Medicines Agency (EMA) has ruled the continued use of Ariad's cancer therapy Iclusig unchanged in the EU.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) brought an investigation into the safety of Iclusig (ponatinib) to a close late last week, concluding that there was no need to reduce the approved dose of the drug.
Iclusig was approved in the US and EU last year for the treatment of adult patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), but quickly ran into problems after it was linked to an increased risk of blood clots.
The safety concerns culminated in the drug being temporarily withdrawn from the market in the US and placed under a clinical hold - suspending all clinical trials of the drug - which prompted Ariad to slash its workforce. Around the same time, the EMA announced it was also reviewing the safety of the drug but would allow it to remain on the market in the meantime.
The FDA allowed Iclusig back on the market in January, subject to certain restrictions and a comprehensive Risk Evaluation and Mitigation Strategy (REMS), while the EMA concluded last November it could stay on the market provided it was not prescribed to patients with a history of heart attack or stroke.
FLORENCE, Alabama - All of the nearly 2,900 lawsuits claiming pharmaceutical giant Pfizer Inc.'s smoking cessation drug Chantix triggered suicidal thoughts and other psychological problems in patients have been settled - for about $300 million - so the nationwide litigation should now be dismissed, a federal judge in Alabama ruled Monday.
Despite the end to those lawsuits, Pfizer next week will continue its fight with the U.S. Food and Drug Administration for a less severe warning label for Chantix.
U.S. District Court Judge Inge Johnson on Monday held the final status conference in the litigation at the federal courthouse in Florence. Johnson had been appointed by United States Judicial Panel on Multidistrict Litigation in late 2009 to preside over all the Chantix cases being filed in the United States.
Quoted from http://www.bloomberg.com/news/2014-10-03/takeda-ordered-to-pay-more-than-2-million-to-ex-actos-user.html
Takeda Ordered to Pay More Than $2 Million to Actos User
By Jef Feeley and Christopher Yasiejko 2014-10-03
Takeda Pharmaceutical Co. was ordered by a jury to pay more than $2 million to a woman who claimed the company’s Actos diabetes medicine caused her bladder cancer, in the latest of thousands of lawsuits involving the drug to go to trial.
Jurors in state court in Philadelphia deliberated more than five hours today before finding that officials of Osaka, Japan-based Takeda failed to properly warn Frances Wisniewski’s doctors about Actos’s cancer risk.
The jury found Takeda “clearly failed to warn, and it clearly caused her damage,” Wisniewski’s attorney, Mike Miller, said in an interview. “She’s got a life of bladder cancer; it’s a fair verdict,” he added.
Wisniewski, 79, a retired accountant, is the seventh Actos patient to take her suit to trial. Her case follows a $9 billion verdict this year in Louisiana against Takeda and Eli Lilly & Co. for hiding the diabetes medicine’s risks. The companies have asked a judge to grant them a new trial in that case.
Quoted from http://www.bloomberg.com/news/2014-10-02/takeda-accused-in-trial-of-putting-actos-profits-ahead-of-safety.html
Takeda Accused of Putting Actos Profit Ahead of Safety
By Jef Feeley Oct 2, 2014
Takeda Pharmaceutical Co. was accused by a lawyer for a woman who blames Actos for her cancer of sacrificing safety for profit by failing to warn patients and doctors about the diabetes medicine’s risks.
Executives at Osaka, Japan-based Takeda knew by 2004 that studies found links between Actos and cancer, and didn’t issue a warning until seven years later to protect billions of dollars in sales of the drug...
Wisniewski, a retired accountant who has bladder cancer, is the seventh Actos patient to take her suit to trial. Her case follows a $9 billion verdict this year in Louisiana against Takeda and Eli Lilly & Co. for hiding the diabetes medicine’s cancer risks. The companies have asked a judge to grant them a new trial in that case.
Takeda, Asia’s largest drugmaker, scrapped development of another diabetes drug this year when research linked it to liver damage. More than 3,500 Actos suits have been consolidated before U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, for pretrial information exchanges, according to court dockets. The company faces another 4,500 cases in state courts in Illinois, West Virginia, California and Pennsylvania, according to court records.
Takeda’s Stance
In Wisniewski’s case, Takeda contends smoking rather than Actos is the most likely cause of the Norristown, Pennsylvania, resident’s bladder cancer. The 79-year-old Wisniewski “had many risk factors” for cancer other than the medicine, Craig Thompson, one of the drugmaker’s lawyers, told jurors in his closing arguments.
The prescription drugs discussed on this site are approved for use by the the Food and Drug Administration (FDA). Patients should not stop taking any prescription drug without seeking the advice of their medical doctor. This site is not affiliated with any of the drug companies or the FDA.
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