FDA Grants Bristol-Myer’s Kidney Cancer Drug ‘Breakthrough’ Status

Opdivo was first approved in Japan in July 2014 for the treatment of melanoma and nivolumab was approved by the European Commission this past July for the treatment of lung cancer. The FDA also approved Opdivo for the treatment of melanoma in December and lung cancer in March. In addition to being granted breakthrough designation prior to its two FDA approvals, it has also been given the status for the treatment of Hodgkin lymphoma.


‘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.


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


Marcy Borders, 9/11 ‘Dust Lady,’ Dies of Cancer at 42

Borders’s death is a stark reminder that many of those who endured the 9/11 tragedy are suffering from long-term health problems. Borders was asked if she thought that the debris from the terror attack, which contained glass and other carcinogenic dust, among other dangerous particles led to her cancer. She responded, “I’m saying to myself, ‘Did this thing ignite cancer cells in me?’ I definitely believe it because I haven’t had any illnesses. I don’t have high blood pressure, high cholesterol, diabetes.”


Celgene to Acquire Receptos for $7.2 Billion in Continuation of Buying Spree

7/15/2015 Biotech manufacturer Celgene is making an earnest push to become one of the industry’s leaders following a wave of transactions aimed at increasing long-term sustainability. Celgene’s current success is largely based on the popularity of its breakthrough cancer drug, Revlimid; however Celgene is attempting to set itself up for future growth when Revlimid’s patent



How long until Power Morcellators are Banned?

5/29/2015 Despite the ongoing FBI investigation of Johnson & Johnson’s manufacturing division, Ethicon, and a strong Food and Drug Administration (FDA) warning issued last year, power morcellators are still legal. The device grinds up tissue mass, and is then removed through a series of small incisions. The device, which is used to provide minimally invasive


Are Surrogate Markers Too Low a Bar for FDA Approval?

The recent approval of a drug for use in combating leukemia by the US Food and Drug Administration has shed light on the relatively controversial, albeit common practice by that organization of using surrogate markers of efficacy for determining the benefit of a given drug or therapy.  Some believe this constitutes a low bar for


Asbestos, tobacco, and now tanning salons?

The first thing any industry faced with negative scientific evidence does is form a trade group.  And the first thing that trade group does is gin up “scientific” evidence that claims the industry is being falsely maligned.  The asbestos industry did (and does) it, and of course so did the tobacco industry.  Now, it’s the