Pharmalot.. Pharmalittle.. Good Morning
October 12, 2015 | Antibiotics, Cancer, Cholesterol, FDA, Painkillers, Research & Development, Uncategorized
By Ed Silverman

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; A recent FDA decision to approve painkillers for certain children as young as 11 has triggered fierce debate; Cigna agreed to drop its requirement that patients with HIV/AIDS get some of their medications exclusively through its mail-order pharmacy; and California Governor Jerry Brown signed a bill that sets the strictest government standards in the United States for the use of antibiotics in livestock production. Read More


Up and down the ladder: The latest comings and goings at…
October 9, 2015 | Executive Hiring, Uncategorized
By Ed Silverman

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share it with others. That’s right. Send us your changes and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the ongoing layoffs. Despite the downsizing, there is movement. Here are some of the latest comings and goings. Recognize anyone? Read More


Pharmalot… Pharmalittle… As the weekend nears
October 9, 2015 | Cancer, Clinical Trials, FDA, Generics, Hepatitis C, Marketing, Patents, Uncategorized
By Ed Silverman

And so, another working week will soon draw to a close. This is, you may recall, our treasured signal to daydream about weekend plans. Once again, our agenda is rather modest. We plan to manicure the Pharmalot campus, catch up on sundry chores and escort Mrs. Pharmalot to another installment in our 'let's-see-them-before-they-die' concert series. And what about you? In some parts, this is a lovely time of year to enjoy the fall scenery. Perhaps you can catch up on your reading or reach out to someone special. Whatever you do, have a lovely time. But remember, be safe. See you soon...

Bernie Sanders will oppose Califf as the next FDA commish, citing his ties to drug makers; Pfizer representatives will meet with Gloucester, Mass., police chief Leonard Campanello, who publicized CEO contact info to drum up outrage over opioid addiction; and generic drug makers in India are engineering hepatitis C combination pills that are impossible in western nations due to patent protections. Read More


Bill would add nurse practitioners to pharma payments database
October 8, 2015 | Marketing, Research & Development
By Ed Silverman

A bill proposed yesterday would require drug and device makers to report payments to nurse practitioners and nurses assistants. The legislation is designed to close what critics call a loophole in the federal government’s Open Payments database, which was created under the 2010 Affordable Care Act in response to concerns that industry payments to doctors unduly influence medical practice and research.

“We think that the void should be filled in order to have a complete record,” US Senator Chuck Grassley (R-Iowa), who co-sponsored the bill, told ProPublica. His investigation into industry payments to physicians several years ago led to the creation of the database. “Transparency isn’t an end to itself,” he continued. “Transparency is meant to bring accountability.” Read More


Senator asks FTC to investigate Shkreli for antitrust violations
October 8, 2015 | Antitrust, Generics, Pricing & Patient Access
By Ed Silverman

A US Senator has asked the Federal Trade Commission to investigate whether drug makers are hiking prices and then restricting distribution to prevent generic drug makers from making lower-cost versions of their medicines.

In a letter to the agency, Minnesota Senator Amy Klobuchar cited Martin Shkreli and his Turing Pharmaceuticals, which created a nationwide sensation after recently buying a life-saving medicine and then raising the price from $13.50 a pill to $750. This 5,000 percent price hike triggered a new round of scrutiny of prescription drug costs that is now spilling over into the presidential election campaign. Read More


State bill would remove FDA loophole for antibiotics in livestock
October 8, 2015 | Antibiotics, FDA, Uncategorized
By Ed Silverman

Ever since the FDA announced plans in 2013 to bolster oversight of antibiotic use in food-producing livestock, critics have complained that a gaping loophole exists that could undermine the program. California, however, may adopt a first-in-the-nation law designed to plug that gap in the next few days. A bill may be signed by California Gov. Jerry Brown by Sunday.

The effort comes amid increasing concern over antibiotic resistance among humans, which has been blamed for at least 2 million illnesses and 23,000 deaths in the United States, according to federal health officials. Importantly, about 70% of antibiotics used to treat Americans are also used in food-producing livestock, according to the Natural Resources Defense Council, an advocacy group. Read More


Pharmalot.. Pharmalittle.. Rise and shine
October 8, 2015 | Cancer, Marketing, Patents, Patient Safety, Pricing & Patient Access, Research & Development, Uncategorized
By Ed Silverman

Good morning, everyone, and how are you today? A bright, shiny sun is enveloping the Pharmalot campus, where the official mascots are snoozing, a cool breeze is rustling the leafy trees and we are brewing more cups of needed stimulation. As always, we invite you to join us. Remember, a prescription is not required. While you think this over, please enjoy the menu of interesting items below. Have a smashing day and keep in touch...

Several pharma and biotech chief executives are slated to meet with President Obama today to discuss the Trans-Pacific Partnership agreement at the White House, which requested the meeting; Martin Shkreli, who was vilified on social media and became the symbol for price gouging after his company raised the price of a life-saving drug from $13.50 to $750, wants to rehabilitate his image; and the placebo effect is getting stronger and perhaps prescription drug advertising is to blame. Read More


Drug makers donate millions to fight California discount initiative
October 7, 2015 | Pricing & Patient Access
By Ed Silverman

The idea of being forced to offer discounts on drug prices to California state health programs upsets the pharmaceutical industry. In fact, some drug makers – including Pfizer and Johnson & Johnson – are so opposed to the idea that they have donated more than $10 million to fight a state ballot initiative that would impose price caps.

At issue is the California Drug Price Relief Act, which would revise state law to require state health programs, such as Medi-Cal, to pay no more for prescription medicines than the prices negotiated by the US Department of Veterans Affairs. The initiative comes at a time of growing national unrest over the cost of pharmaceuticals. Read More


Outrage over drug prices may not force change: Richard Evans explains
October 7, 2015 | Pricing & Patient Access, Uncategorized
By Ed Silverman

The controversy over prescription drug costs accelerated with some companies jacking up prices to previously unseen heights, and others slapping six-digit price tags on the latest medicines for cancer and other hard-to-treat diseases. Yet, despite the microscopic scrutiny now being applied to drug makers, efforts to clamp down on the entire pharmaceutical industry are unlikely to hamper the brazen upstarts generating headlines, according to Sector & Sovereign Research analyst Richard Evans, who once made pricing decisions for Roche. We spoke with him about the trends and implications. This is an edited version. Read More


Pharmalot.. Pharmalittle.. It’s the middle of the week…
October 7, 2015 | Cancer, Compound Pharmacies, FDA, Patient Safety, Uncategorized, Vaccines
By Ed Silverman

Good morning, everyone, and welcome to the middle of the week. You made it this far, so why not continue, yes? After all, consider the alternatives. We prefer to simply forge ahead with our mandatory cup of stimulation and the ever-growing to-do list. On that note, it is time to get cracking. So once again, here are some tidbits to help you along. Have a wonderful day and drop us a line some time when something fascinating occurs...

Robert Califf, who was nominated to head the FDA, recently coauthored a series of scientific papers raising concerns about agency oversight of clinical trials but asked that his name be removed before publication; The recent sales of priority review vouchers at ever-higher prices has transformed what had seemed to be a failed incentive model into a hot topic, but the enthusiasm is not shared by the FDA; The Indian government plans to spend about $270 million to ensure each state has a drug testing laboratory as part of an effort to bolster manufacturing quality; and the reputation of the flu vaccine has taken a bit of a beating in recent years and now research points to a single component as the weak link. Read More