And so, another working week will soon draw to a close. It has taken a while to reach this point, though, yes? Well, this is an opportunity, nonetheless, to daydream about weekend plans. Our modest agenda includes catching up on reading and chores when not hanging with the short people. And what about you? There is still time for summer fun. You could make new friends or find old ones. Or simply ponder the future now that the political conventions are over. An interesting prospect, yes? Well, whatever you do, have a grand time, but be safe. See you soon …
Eli Lilly received a civil investigative demand from the US Attorney in New York, requesting documents and information relating to contracts with pharmacy benefit managers, according to a filing with the US Securities and Exchange Commission. There was no further information provided, although the drug maker did say it is cooperating with the investigation.
A new law makes it more difficult for the government to take action against drug makers as it battles the opioid crisis, the Los Angeles Times reports. The law allows drug makers accused of not reporting suspicious orders of dangerous drugs to submit a “corrective action plan” to convince the Drug Enforcement Administration to postpone or abandon proceedings against them. Drug makers can avoid the DEA’s administrative penalties, which can include the loss or suspension of a federal license for making, selling, or dispensing controlled substances.
England’s Cancer Drugs Fund reopened, but critics say it fails to resolve problems with assessing and covering cancer drugs, according to Pharmaphorum. In the past, England’s National Health Service had pulled funding for several cancer medicines to save costs. Under new rules, if the fund exceeds its $450 million budget, which has happened before, drug makers will pick up the tab and, Bloomberg News points out, there is no cap on that bill.
A New York federal judge ended nearly 1,300 lawsuits filed by women who say they suffered internal injuries from Bayer’s Mirena intra-uterine contraceptive device, Reuters reports. US District Judge Cathy Seibel decided the lawsuits could not continue after her earlier ruling barring crucial testimony from plaintiffs’ experts. Mirena, a small, T-shaped plastic device, can perforate the uterus during insertion. Bayer warns about the possibility on the label.
As the New York governor and legislature pushed proposals that would have affected prescription drugs, the pharmaceutical industry increased campaign donations in Albany, Politico reports. A review of financial disclosures found drug makers spent $384,000 on campaign contributions between January and July of this year, up nearly $100,00 from the same time a year earlier, although it was about $66,000 less than in 2014.
With companies expected to file more applications to win approval for drugs and biologics next year, the US Food and Drug Administration has lowered some application fees by more than $300,000, Regulatory Focus says.
Sanofi won FDA approval of its long-awaited GLP-1 diabetes drug, called Adlyxin, although the drug maker will be playing catch-up in a market where Novo Nordisk and Eli Lilly have had a head start.
A recent survey found 62 percent of companies are more likely to engage a clinical research organization to run studies than five years ago, Outsourcing Pharma reports.
Takeda Pharmaceutical expects plans to revamp R&D will cost $725 million as it looks to build a new pipeline and considers closing some R&D operations in the UK, Bloomberg News tells us.
The Indian government is considering making the voluntary uniform code for pharmaceutical marketing practices mandatory, according to the Economic Times.
Pfizer released late-stage study results bolstering hopes to win approval to use its Xeljanz medicine as a maintenance therapy for patients with ulcerative colitis, PMLive writes.