ello, everyone, and nice to see you again after a brief respite. Although we made good use of our time away, we know the world continued spinning, so we have gathered a menu of tidbits that, hopefully, catch you up on a variety of events and doings. Meanwhile, we are easing back in with help of a few cups of stimulation — we are back to Cinnamon Dolce, by the way. So please join us and, of course, have a smashing day …
Representative Rosa DeLauro (D-Conn.) plans to introduce a bill called the Prescription Drug and Medical Device Review Board Act, which would establish an inter-agency panel to collect data on drug and device prices and manufacturing costs. In cases where manufacturers are found to charge excessive prices, penalties could include shortening monopoly protections, imposing fines, and recouping tax benefits for lifesaving treatments.
Pfizer plans to retract five papers by a former employee, after an investigation found images that were duplicated in each of the published articles, according to For Better Science. The former employee, Min-Jean Yin, had worked as a senior principal scientist since 2003 at Pfizer research facilities in La Jolla, Calif. Her LinkedIn profile indicates she joined Diagnologix last month as general manager.
Eli Lilly is racing to wrap up trial results of an Alzheimer’s drug, a closely watched experiment involving a treatment for delaying cognitive decline in patients with mild forms of the disease, STAT writes. The outcome has widespread implications not only for treatment, but for other drug makers and possibly even the US Food and Drug Administration, depending upon the strength of the results.
The FDA decided the widely used Xarelto blood thinner is safe and effective for patients with atrial fibrillation despite controversy over a key study used to gain approval of the drug. Concerns emerged last year after reports that a device for adjusting warfarin usage in the trial had been recalled due to unreliability in some patients and a BMJ report suggested Johnson & Johnson knew of accuracy concerns but withheld data from the agency.
Merck and Aetna signed a so-called value-based contracting deal for the Januvia type 2 diabetes treatment, the latest such arrangement in which insurance coverage is tied to patient outcomes. In this instance, the rebates that Merck pays to the insurer will be set based on the improvement seen in patients. Such deals are becoming more common as drug makers face pressure over their pricing.
Sun Pharmaceuticals is struggling to jump-start growth after its acquisition of Ranbaxy Laboratories dampened revenue in emerging markets and concerns over US drug prices make further deals questionable, Bloomberg News says. Meanwhile, Sun is recalling from the US 31,700 bottles of generic Wellbutrin extended-release tablets, which are used to treat depression, due to “failed dissolution specifications,” the Economic Times writes.
The FDA found a direct link between contaminated water at PharmaTech and a multi-state outbreak of B. cepacia, three months after the contract manufacturer recalled lots of Diocto Liquid, a docusate sodium solution, InPharma Technologist informs us.
A global shortage of a chemotherapy agent called etoposide, which is made by Bristol-Myers Squibb, is expected to last until April, news.com.au reports, citing Australia’s Therapeutic Goods Administration.
Synairgen says AstraZeneca stopped a mid-stage study for its lead drug candidate as a potential treatment for severe asthma, Reuters tells us.
The UK’s National Institute for Health and Care Excellence rejected Johnson & Johnson’s Imbruvica for treating a rare type of slow-growing non-Hodgkin’s lymphoma, PharmaTimes reports.
Celltrion says its biosimilar version of Rituxan has shown the same therapeutic effects as the originator drug in Phase 3 clinical trials, the Korea Herald tells us.
Roche says the FDA gave a priority review designation to its Lucentis medication as a treatment for choroidal neovascularization in patients with myopia, PMLive says.
Pfizer suffered a setback in the UK after the Court of Appeal in London ruled against it in a patent case over the use of its Lyrica for pain relief, Reuters reports.
Amgen has sold a facility in Longmont, Colo., to AstraZeneca for $64.5 million, the second time in two months that Amgen has sold a Colorado plant to the drug maker, the Pacific Coast Business Times writes.