[1]pic thx to soe lin on flickr creative commons
Top of the morning to you. And a fine one, it is. Although a bit cloudy here in New England, our spirits remain sunny. As you know, our philosophy, courtesy of the Morning Mayor, is quite simple: Every brand new day should be unwrapped like a precious gift. So while you tug on the ribbon, we will search for a cup of stimulation. And of course, here is your menu of morning tidbits. Have a smashing day and do keep us in mind for interesting developments…
The FDA issued inspection notices to Theranos for using its blood-collection device without securing needed approval (one notice [2] and here is the other [3]). And while Theranos indicated much of its income comes from running tests for drug makers, GlaxoSmithKline says it never relied on the start up and Pfizer rarely used its services, according to The Verge [4]. The denials follow questions raised about the accuracy of Theranos’ blood testing technology and the disclosure that most testing was, instead, done by using readily available medical equipment.
The FDA approved a virus called Imlygic for treating advanced-stage melanoma, a development that could herald a new age of viral therapies, Stat [5] tells us. The Amgen product is a modified version of the herpes virus that attacks cancer and sparks the immune system into action against tumors. “The field is exploding, and this would be another arrow in the quiver that oncologists use,” says John Bell, a senior scientist at the Ottawa Hospital Research Institute.
The debate over drug prices, and complaints from consumer advocates about safety concerns, have fueled Senate Democratic resistance to pharma-friendly provisions in the 21st Century Cures Act, which sailed through the House, sweetened by billions in new funding for NIH and FDA, Politico [6] reports. Committee aides are working hard to find money, but lobbyists said straightforward, mandatory Cures-like funding is a long-shot.
Walgreen Boots Alliance agreed to buy Rite Aid for about $9.4 billion, in a move that would create a drug store giant as companies across the US health care industry look for ways to bulk up, The Wall Street Journal [7] reports. But the deal, which would unite two of the country’s three biggest drug store owners, would be likely to draw scrutiny from antitrust regulators.
Breast Cancer Now, a UK health charity, is urging Roche to drop the price of its Kadlyca key breast cancer drug before the National Health Service stops funding it next week, The Daily Mail [8] writes. NHS England receives an undisclosed discount, but Kadcyla, which costs about $107,000 a year, will be cut from the UK’s Cancer Drug Fund, along with 15 other medications, unless Roche and other drugs makers reduce their prices further.
Merck ceo Ken Frazier says he discussed prescription drug pricing with President Barack Obama during a recent White House meeting, CNBC [9] tells us.
Arena Pharmaceuticals will shelve some trials related to its weight-loss drug and lay off about 80 employees, or 35 percent of its U.S. workforce, to cut costs and focus on other drugs under development, Reuters [10] writes.
Sandoz, the generic drug arm of Novartis, received a warning letter from the FDA last week for its two Indian sites at Kalwe and Turbhe, The Economic Times [11] tells us.
The Patent Trial and Appeal Board agreed to review [12] two patents challenged by hedge fund manager Kyle Bass, finding his organization had shown two Celgene patents related to Thalomid and Revlimid are likely invalid.
A new study showed that withdrawing the commonly used Aricept drug in moderate-to-severe Alzheimer’s patients doubled the risk of moving into nursing care within a year, Reuters [13] reports.
The FDA agreed to hear from Texas and Arizona prison officials after agents seized drugs that both states were trying to import for use in executions, the Associated Press [14] says.
A team of researchers has modified a lectin protein found in bananas to diminish its inflammatory properties, potentially setting it on the path to use as an antiviral, InPharma Technologist [15] informs us.
A shift in rules is expected to make litigation tougher for trolls that habitually file patent lawsuits with weak claims against companies that are more likely to settle than face expensive litigation, Corporation Counsel [16] writes.
Market share between Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda in second-line non-small cell lung cancer will likely hinge on how important oncologists view use of diagnostics, Medical Marketing & Media [17] says.