[1]Good morning, everyone, and welcome to another working week. We hope the weekend respite was reinvigorating, because the usual routine of meetings and deadlines and what-not has returned. Although not for everyone on this side of the pond since a holiday is under way. In fact, we will have a light blogging schedule as we use the time to run our own version of R&D. Nonetheless, another day calls for another cup of stimulation. So please join us. Meanwhile, here are some tidbits. Enjoy and stay in touch…
Eli Lilly is ending development of its evacetrapib cholesterol-lowering drug because of insufficient efficacy, after an independent data monitoring suggested there was a low probability the drug would hit its primary endpoint. The move dashes hopes the drug would become a blockbuster and sent Lilly stock down more than 9 percent in pre-market trading. The drug was supposed to raise good cholesterol and lower bad cholesterol. Similar drugs from Pfizer and Roche also failed clinical studies.
A recent FDA decision to approve painkillers for certain children as young as 11 has triggered fierce debate, The Wall Street Journal [2] writes. On one side are some elected officials and addiction specialists who say the move could expand access to a drug at the center of an epidemic of painkiller and heroin abuse in the U.S. that was responsible for 24,000 overdose deaths in 2013. On the other are some physicians and families who say this provides necessary guidance to doctors treating children with serious conditions, instead of relying on adult dosing information.
Cigna agreed to drop its requirement that patients with HIV/AIDS get some of their medications exclusively through its mail-order pharmacy, Reuters [3] reports. Consumer Watchdog, which sued the insurer, claimed the mail-order requirement discriminated against HIV/AIDS patients in order to boost profits. Cigna agreed to the settlement before the court certified the case as a class action.
California Governor Jerry Brown signed a bill [4] that sets the strictest government standards in the United States for the use of antibiotics in livestock production. The move comes amid growing concern that the overuse of such drugs is contributing to rising numbers of life-threatening human infections from antibiotic-resistant bacteria. The first-in-the-nation law is designed to plug a loophole in voluntary industry guidelines issued by the FDA.
Positive results for a Roche treatment for multiple sclerosis may have shown positive results, but some experts questions the magnitude of benefits in the primary progressive multiple sclerosis, Perfect Science [5] writes.
The FDA expanded approval of Bristol-Myers Squibb’s immunotherapy drug Opdivo for patients with non-squamous non-small cell lung cancer, Reuters [6] informs us.
Novartis is investing a further $15 million in Israeli stem cell specialist Gamida, raising its stake to 2.5 percent, after turning down a buyout option earlier this year, Pharma Times [7] says.
Eli Lilly and Innovent Biologics have expanded their collaboration deal and defined the distribution rights for up to three co-developed, experimental cancer drugs, The Wall Street Journal [8] reports.