Results from Sanofi's ($SNY) dengue vaccine trial are in, and once again, the data confirm its overall efficacy. But notably, this trial also saw an improvement in protection against dengue serotype 2, a viral strain that's tripped up the vaccine in previous studies.
In the trial, which involved 20,875 children aged 9 to 16 in 5 Latin American countries, the vaccine cut down disease cases by 60.8% and reduced the risk of dengue-related hospitalization by 80.3%, the French drugmaker said Wednesday.
The vaccine also posted a 42.3% efficacy rate in battling serotype 2, topping the relatively weak 35% rate it put up in a large-scale trial in Asia.
These new positive phase III results from Latin America are very encouraging because they are consistent with the results reported in July in the Asian phase III trial," Duane Gubler, chairman of the Partnership for Dengue Control, said in a statement. "Together, the results of these trials suggest that for the first time, a vaccine solution that can help control dengue, is on the horizon."
That solution can't come soon enough, as dengue threatens nearly half the world's population and infects up to 100 million people per year, the World Health Organization (WHO) estimates. Currently, there's no vaccine to protect against the disease, but Sanofi CEO Chris Viehbacher has said his company is aiming to sell its first doses by the second half of next year.
The pharma giant, too, is eager to see its investment of more than €1.3 billion ($1.71 billion) and 20 years of research pay off. And pay off it will, analysts predict: Some say the three-dose vaccine could rake in €1 billion ($1.31 billion) a year, giving Sanofi's vaccines business a hefty boost.
By Ben LevisohnAmgen (AMGN) said it had applied for approval for a new type of cholesterol drug, making it the leader in the race to get to market first. UBS analyst Matthew Rhoden explains why Amgen’s filing is a big deal:
We are maintaining our Buy rating on Amgen shares (and Neutral onRegeneron (REGN)) following Amgen’s announcement of its submission of its regulatory filings to the FDA for evolocumab (fka AMG 145), a PCSK9 inhibitor for lowering LDL cholesterol in patients at high risk for cardiovascular events. The timing is in line with management’s 3Q guidance, but in our view, slightly sooner than expectations, and answers the question as to which company is first to file among PCSK9′s. We expect Amgen to receive FDA Priority Review based on  it is first to file in a new class of innovative medicines with unparalleled lipid-lowering capacity (even on top of standard of care) and  Amgen will include special populations like familial hypercholesterolemia (HoFH and HeFH), for which there is significant unmet medical need. If first to market, Amgen would be in the position to set the price and establish a nominal first mover advantage (although we expect Regeneron/Sanaofi’s (SNY)’s alirocumab to be a fast follower). It is also plausible that if alirocumab is filed in the near term, the FDA could convene a single Advisory Committee meeting, in effect harmonizing the timing of approvals
OF POT AND PERCOCET
From The New York Times.
Pinpointing the effect of laws on health is notoriously difficult. For one thing, states that have passed medical marijuana laws are no doubt different in important ways from states that have not passed such laws. Differences in, say, social attitudes about drug use or overall health trends might affect rates of opioid painkiller deaths, independent of whether medical marijuana is legal.
Furthermore, from 1999 to 2010 (the period of time we studied), states implemented various measures in response to the threat of opioid painkiller overdoses, including central registries of controlled substance prescriptions, laws allowing pharmacists to request identification before filling a prescription and laws increasing oversight of pain management clinics. These measures, too, might affect rates of opioid painkiller deaths, regardless of the legality of medical marijuana.
We designed our study to allow us to compare state-level rates of opioid painkiller overdose deaths before and after the passage of medical marijuana laws, while controlling for these and other concurrent state and national trends.
Using death certificates compiled by the Centers for Disease Control and Prevention, we found that the rate of prescription painkiller overdose deaths increased in all states from 1999 to 2010. But we also found that implementation of a medical marijuana law was associated with a 25 percent lower yearly rate of opioid painkiller overdose deaths, on average. In absolute terms, we estimated that states with a medical marijuana law had a total of about 1,700 fewer opioid painkiller overdose deaths in 2010 than would be expected based on trends before the laws were passed.
This is the first study that we know of to suggest that medical marijuana laws could contribute to a decline in drug overdose deaths, and therefore it should be read with caution. Our study was not a controlled experiment, and it is possible that states with and without medical marijuana laws differed over time in important ways that we did not or cannot measure and that could explain, at least in part, our results.
However, if medical marijuana laws are in fact reducing opioid overdose deaths, the next step is to figure out how and why. That people are replacing opioid painkillers in part or entirely with medical marijuana for chronic pain treatment is one possibility. Another possibility is that the availability of medical marijuana is changing the behavior of people who are addicted to and abuse or misuse opioids. We know that marijuana and opioids stimulate a common receptor in the brain’s reward pathways, but we don’t know whether people who misuse or abuse opioids for recreational purposes would switch to marijuana in states where it is legal for medical purposes.
We hope the results of our study will spur further scientific investigation into the effects of these laws as well as the ways in which medical marijuana can and should be used in clinical practice.
Marcus Bachhuber, an internist, is a clinical scholar at the Philadelphia V.A. Medical Center. Colleen Barry is an associate professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health.
Chikungunya test vaccine shows promise
Paris (AFP) - A candidate vaccine against the joint disease chikungunya, endemic to Africa and south Asia but moving north- and westward, showed promise by provoking an immune response in human trials, its developers said Friday.
The trial drug is made with nanoparticles that resemble a West African strain of the virus, which causes high fever and intensely painful arthritis, said a study in The Lancet medical journal.
These virus-like particles (VLPs) are meant to mimic the immune-stimulating effects of the actual virus particles, but cannot cause disease as they contain no viral DNA.
In tests on rhesus macaques, the vaccine provided protection from infection and its first human tests have now also yielded positive results.
"All injections were well tolerated, with no serious adverse events reported," wrote the authors of the study conducted in 25 healthy human volunteers from the United States, aged 18 to 50.
"Neutralising antibodies were detected in all dose groups after the second vaccination" out of three, and even the lowest doses were effective.
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