Novartis, slammed by Korean scandal, tweaks its ethics, compliance policies
Rocked by a corruption scandal in Korea and facing a kickbacks probe in Greece, Novartis says it's strengthening and simplifying its global ethics and compliance approach. The Swiss drug giant is aiming to shift from policing to coaching, with a compliance unit focused on helping local units make the right decisions. Novartis also wants to simplify its policies so they are easy to understand. Last month, Korean authorities handed out a $50 million fine and suspended coverage on several Novartis meds in relation to a bribery probe in the country. Novartis employees conducted a kickbacks scheme through medical journal-sponsored meetings, with the total spent on bribes estimated to be $2.3 million, according to officials.
China's latest Western-style FDA tweak puts orphan drug approvals in the fast lane
China's FDA, long criticized for its cumbersome and slow drug-review process, is offering to grant conditional OKs for orphan meds already approved abroad, even without in-China trial data. The new orphan drug move is one in a series of new proposals posted online May 11. China’s FDA is once again planning major changes to its clinical trial and drug approval policies, further aligning them with its Western counterparts. A key feature is the new “conditional marketing authorization” for orphan meds. The CFDA is offering (Chinese) to grant conditional approval for meds that treat life-threatening conditions where significant unmet medical needs exist, if early- or mid-stage data can predict the drugs’ clinical benefits. This policy resembles the EMA's “conditional marketing authorization” and the U.S. FDA’s “breakthrough therapy” program, which itself is just short of 5 years old.
Dendreon eyes real-world data boost for lagging prostate cancer med Provenge
Years after winning a hotly anticipated FDA approval for its cancer immunotherapy Provenge—and struggling to build sales of the prostate cancer med—Dendreon has racked up some real-world survival data it hopes can help. At the American Urologic Association’s annual meeting, the company presented real-world findings showing a survival benefit especially pronounced in African American patients with metastatic castrate-resistant prostate cancer (mCPRC). African-American Provenge patients lived a median 37.3 months after treatment compared with 28 months after treatment for Caucasian patients. The data were consistent with the clinical trials Dendreon used to win Provenge approval back in 2010, according to the company, bought out by China's Sanpower last year.
Amgen adds online cancer team narratives to Neulasta Onpro push
Cancer patients and their care teams are taking center stage in Amgen's newest online campaign. The Neulasta Onpro effort, dubbed Neulasta Onpro Narratives, highlights patients’ and professionals’ cancer stories to encourage conversations, specifically about the risk of infection from low white blood cell counts—a risk Neulasta is approved to reduce. Sharing the personal experiences can help raise awareness and encourage patients to discuss the potential risk with their healthcare professional, as per company sources. The online campaign comes just over a year into Amgen’s first Neulasta Onpro-specific TV ad, titled "Support at Home," which began running last March. Amgen has spent more than $38 million on national TV airings of the ad, according to data from real-time TV ad tracker iSpot.tv. The Onpro DTC campaign includes similarly themed print ads.