FDA Panel Unanimously Recommends Approval for Abuse-Deterrent Painkiller Xtampza

Despite the dosing warning issued by the Food and Drug Administration (FDA) earlier last week amid concerns about the product’s labeling, an independent panel commissioned by the agency recommended approval for a experimental oral painkiller. The panel’s 23-0 vote is a major win for Massachusetts-based Collegium Pharmaceuticals, and its potential breakthrough drug marketed as Xtampza.


DuPont Faces First Trial Involving West Virginia Chemical Leak

Bartlett, a 59 year-old resident of Guysville in Athens County, Ohio was diagnosed with kidney cancer in 1997. Among other charges, Bartlett accuses DuPont management of negligence for allowing the leak, fraud and concealment for failing to inform the public of the dangers, and trespass and battery for letting the pollutants enter her bloodstream. DuPont attorneys blame Barlett’s kidney cancer on other factors instead, including obesity.


California Legislators Agree on Medical Marijuana Regulatory Framework

The bill also comes as residents will likely vote on legalizing marijuana for recreational use next year. As the current medical marijuana industry is regulated through a patchwork of city and local ordinances, Brown and other legislators have been trying to mitigate the concerns of industry lobbyists, law enforcement, local administrators, and opposition lawmakers in advance of the likely 2016 ballot measure.


‘Sort of’ Forgetting 9/11

As more cancer diagnoses related to 9/11 are discovered, the costs for the health program, as well as the over 6,500 people enrolled in the victim fund, will likely increase. This means Congress will either have to allow for the funding increase, or services may get cut dramatically. The decision could have life or death consequences for some like 52 year-old retired NYPD detective Barbara Burnette, who has a debilitating lung condition. Doctors have told Burnette that she will eventually require a double lung transplant. Burnette notes the potential lack of funding, saying “Without this program, people are gonna die, and I’m going to be one of them.”


Federal Regulators Abandon Cancer Study of Nuclear Plants

NAS began the study in 2010, and completed the first phase in 2012. The next phase had been underway for about three years when it was halted. The study was to have been an update to a 1990 review conducted by the National Cancer Institute, which analyzed cancer death rates in areas near 52 nuclear plants. That study concluded that there was no increased risk of cancer for people living close to the nuclear facilities.



FDA Issues Dosing Warning for Collegium’s Experimental Painkiller

Unlike most opioid painkillers, which are either taken on an empty stomach or without regard for food intake, users must take Xtampza after eating to release the maximum effects. The FDA warned that if Xtampza is taken without food, it will lead to inadequate pain control, and contribute to abuse and overdose by users who are seeking to remedy their pain.


Alleged Cover-up Could Blow Roof off of Asbestos Litigation

The appeals ruling involved a class-action suit filed by relatives of alleged asbestos victims who accused BASF and Cahill of a systematic cover-up involving the destruction of key documents involving Engelhard asbestos litigation. Although the case in itself is not injury related, evidence of a cover-up could revive many previously litigated cases and cases in which plaintiffs settled for less than they would have had they attained access to factual information.


Sincerely Nuts Recalls Macadamia Products due to Salmonella Scare

According to the FDA, Persons infected with the salmonella organism “often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain” that in rare circumstances, “can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.”


Appeals Court Rules for Novartis against Amgen in Biosimilar Cancer Treatment Suit

The U.S. Court of Appeals for the Federal Circuit granted a major victory for Novartis AG, the world’s pharmaceutical market leader. The court’s three-judge panel ruled 2-1 on Wednesday, declining a petition to renew a six-month injunction filed by competitor Amgen involving the marketing of a biosimilar drug comparable to Amgen’s breakthrough cancer treatment Neupogen