Top of the morning to you. And a fine one it is. The challenging mid-week slog may have arrived, but we are feeling optimistic thanks to a warm and shiny sun that is enveloping the Pharmalot campus. To celebrate, yes, we are brewing more cups of stimulation in our coffee kettle and working to the rhythm of the snoring mascots. As for you, here are some items of interest. We hope you find them helpful and, of course, that you have a smashing day …
AstraZeneca (AZN) reported that its Brilinta blood thinner failed to help stroke patients as hoped in a major clinical trial, Bloomberg News tells us. The drug was not significantly better than aspirin, which is the current standard of care, in preventing recurring heart attacks in the 90 days after patients suffered a stroke. The drug is a critical part of plans that call for reaching $45 billion in annual revenue by 2023.
Despite a warning from Moody’s credit analysts, investors in bonds backed by risky loans are positive on deals involving Valeant Pharmaceuticals debt, The Financial Times writes. But not everyone is optimistic. “You’d need almost every market participant” in the (collateralized loan obligation) market to agree to a deal, Kevin Kendra, managing director and head of Fitch’s US Structured Credit group, tells Fortune.
Vertex (VRTX) Pharmaceuticals suffered a setback as the UK’s National Institute for Health and Care Excellence issued draft guidelines rejecting the use of its Orkambi cystic fibrosis treatment, Pharma Times reports. The cost watchdog determined the cost was “considerably higher” than the current standard of care, and so the treatment would not be an effective use of resources, despite an ability to reduce hospitalizations.
The US Food and Drug Administration plans to add black box warnings — the most serious type — to all immediate-release opioid painkillers, STAT tells us. These include combination pills containing oxycodone and non-prescription drug ingredients. The move comes three years after the FDA added stronger warnings to long-acting opioid drugs like OxyContin, which slowly release their doses.
An Indian court agreed to a hearing next week concerning a government ban on 344 fixed-dose combination drugs, including a popular Pfizer (PFE) cough medicine, The Hindustan Times reports. Meanwhile, India’s National Pharmaceutical Pricing Authority moved in to back the health ministry in its efforts to curb these drugs by returning more than 200 applications to drug manufacturers, The Economic Times informs us.
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) reported a late-stage study of the Praluent injectable drug reduced the need for patients with an inherited form of high cholesterol to have bad cholesterol removed from their blood, Reuters says.
Chinese authorities detained 37 people in Shandong province after a $90 million black market ring in vaccines was discovered last week, Reuters tells us. The vaccines — for meningitis, rabies and other illnesses — are suspected of being sold in dozens of provinces around China since 2011, and the government has promised a crackdown.
Eli Lilly won US regulatory approval for an injectable drug called Taltz to treat adults with moderate-to-severe plaque psoriasis, according to The Wall Street Journal.
A trial is under way in a Miami court where an insurer for Eli Lilly alleges Tyco failed to protect computer data that allowed thieves to break into a warehouse and steal $60 million of drugs in 2010, Security Sales & Integration says.
Germany’s Institute for Quality and Efficiency in Health Care decided there is no evidence to cover an added benefit for Novartis’s (NVS) Cosentyx to treat ankylosing spondylitis and psoriatic arthritis, PMLive writes.