Pharmalot.. Pharmalittle.. We’re catching up on antipsychotics, Califf and…
October 20, 2015 | AIDS, Cancer, Clinical Trials, Diabetes, FDA, Marketing, Patents, Pricing & Patient Access, Research & Development, Schizophrenia, Uncategorized
By Ed Silverman

Hello, everyone, and how are you today? A bright, shiny sun is enveloping the Pharmalot campus, where the shortest of short people has left for the local schoolhouse, the official mascots are lolling about and we are, as usual, quaffing cups of stimulation. Thankfully, a prescription is not required. Perhaps you can relate. Meanwhile, here are some items of interest to keep things moving along. Have a smashing day and keep us in mind for fascinating tidbits...

A landmark government-funded study finds that schizophrenia patients receiving smaller doses of antipsychotics and more one-on-one talk therapy and family support fare better over the first two years of treatment than patients who got the usual drug treatment; Robert Califf, whose nomination to lead the FDA is under scrutiny for his ties to drug and device makers, previously directed a business that specializes in helping health care companies hire faculty members and other academic researchers to influence regulatory decisions; and prices have been rising for priority review vouchers, which FDA awards developers of drugs for rare pediatric conditions or tropical diseases. Read More


Daiichi plans its second big round of US job cuts this year
October 19, 2015 | Layoffs, Uncategorized
By Ed Silverman

Big job cuts by drug makers have not made much news lately, given the bloodletting of the past few years that shrunk the pharmaceutical industry considerably. But Daiichi Sankyo is issuing a reminder how tenuous fortunes can be in this volatile sector.

The Japanese drug maker plans to eliminate anywhere from 1,000 to 1,200 jobs in its US commercial operations over the next several months. The cuts include an unspecified number of sales reps across the country as well as other positions in its US headquarters in Parsippany, NJ. The cuts are not expected to involve R&D operations based nearby. Read More


AHA fixes cholesterol guidelines to include payment from Lilly to panel member
October 19, 2015 | Cholesterol, Uncategorized
By Ed Silverman

In 2013, the American Heart Association issued new guidelines for treating cholesterol, causing a stir that more patients may wind up being treated with medicines. As part of that process, the expert panel members who oversaw the document disclosed their financial ties to drug makers. But one large payment was not divulged.

The panel vice chair did not disclose nearly $110,000 in research grants received from Eli Lilly for running tests for an experimental cholesterol treatment. The grants, however, can be viewed on the federal Open Payments database that tracks payments made by drug and device makers to physicians. And now, the AHA is correcting the documentation. Read More


Pharmalot.. Pharmalittle.. Good Morning.. We’re catching up on Shire, J&J and…
October 19, 2015 | AIDS, Compound Pharmacies, FDA, Litigation, Over-the-Counter Medicines, Patient Safety, Quality Control, Research & Development, Uncategorized
By Ed Silverman

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that all-too-familiar routine of meetings, deadlines and what-not has returned. To cope, we are relying, as always, on that mandatory cup of stimulation. Southern Pecan is our choice today and, of course, we invite you to join us. Meanwhile, here is the usual menu of tidbits. Have a good day and keep in touch...

Johnson & Johnson defeated a lawsuit claiming it had improperly designed its Tylenol pain reliever, in the first case to go to trial over the link between the widely used over-the-counter drug and liver damage; The FDA declined to approve a dry-eye drug being developed by Shire, dealing a blow to its most important pipeline medicine; and the FDA approved an antidote to Pradaxa, the Boehringer Ingelheim bloodthinner, to reverse the effects of the treatment during emergency situations. Read More


Up and Down the Ladder: The latest comings and goings…
October 16, 2015 | Executive Hiring
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, we’re catching up on Sanders, Shkreli, opioids and…
October 16, 2015 | Diabetes, Drug Development, FDA, Painkillers, Pricing & Patient Access, Uncategorized
By Ed Silverman

And so, another working week will soon draw to a close. Not a moment too soon, yes? As you may recall, this is our treasured signal to daydream about weekend plans. Our agenda is modest, but we do look forward to spending time with our short people, one of whom has been away, picking a few apples and manicuring the Pharmalot grounds. And what about you? 'Tis the season to enjoy the outdoors, such as a ride in the country. You could catch up with friends. Or simply plan the rest of your life. Whatever you do, be safe. Enjoy and see you soon...

Bernie Sanders, who regularly lambasts drug makers, has rejected a $2,700 campaign donation from Martin Shkreli, who is the object of national scorn for raising the price of a life-saving medicine by 5,000 percent; Who is the most highly rated chief executive in the world? The number one spot goes to Lars Rebien Sorensen at Novo Nordisk; and The FDA declined to approve an AstraZeneca fixed-dose combination of its Onglyza and Farxiga diabetes drugs, dealing a blow to a key part of the drugmaker's strategy. Read More


FDA ‘Weirdness?’ Separate meetings for BioMarin and Sarepta DMD drugs
October 15, 2015 | Clinical Trials, FDA, Research & Development
By Ed Silverman

In a surprise move, the Food and Drug Administration has set separate dates for advisory panels to review two different drugs for Duchenne muscular dystrophy, a rare genetic disorder that leaves young boys wheelchair bound. Most people expected the agency to hold back-to-back meetings next month.

Instead, one panel meeting will be held on Nov. 24 to review a drug from BioMarin Pharmaceutical, while a Sarepta Therapeutics medicine will be scrutinized on Jan. 22, 2016. Normally, such doings do not generate much notice, especially for rare disease drugs. But the Duchenne drugs have been the focus of intense interest over the past few years thanks to a combination of unusual circumstances. Read More


Pharma wins lawsuit over orphan drug discounts to hospitals
October 15, 2015 | Litigation, Pricing & Patient Access
By Ed Silverman

In a victory for the pharmaceutical industry, a federal judge decided the US Health Resources and Services Administration cannot enforce a rule that would allow so-called safety-net hospitals and clinics to obtain orphan drugs at a discount. Orphan drugs are used to treat rare diseases.

The decision caps more than two years of feuding between drug makers and the agency over a federal program known as 340B. This requires drug makers to offer discounts of up to 50 percent on all outpatient drugs to hospitals and clinics that serve indigent populations. There are roughly 2,000 such institutions, although the number was recently expanded thanks to the Affordable Care Act. Read More


Valeant faces federal probe over patient assistance programs
October 15, 2015 | Pricing & Patient Access, Research & Development
By Ed Silverman

For the past few months, Valeant Pharmaceuticals has been investigated for jacking up drug prices to new heights. Now, the probes are expanding to another of its business practices.

Last night, the beleaguered Canadian drug maker disclosed that federal prosecutors in New York and Boston are eyeing its patient assistant programs, a sign that has investors worried the company’s fast-growth business model may face unexpected and significant pressure. Read More


Pharmalot… Pharmalittle… We’re catching up on Bush, Theranos and much more..
October 15, 2015 | Antibiotics, Cancer, FDA, Off-Label Promotoin, Pricing & Patient Access, Uncategorized
By Ed Silverman

Good morning, everyone, and how are you today? A warm and shiny sun is enveloping the Pharmalot campus, where the shortest of short people has left for the local schoolhouse and the official mascots are happily snoozing away. As for us, yes, we are engaging in our familiar ritual - downing cups of stimulation. Our flavor today is Malt Shoppe Mocha. Like a curious drug developer, we also like to experiment. While you consider doing the same, here are some tidbits to get you going. Have a smashing day...

Despite criticism over tax inversions, Mylan ceo Heather Bresch says the tactic is needed for growth; New study results confirm Ebola can linger in semen for many months after patients recover from its life-threatening symptoms; Theranos claims to use its own technology to quickly process many different lab tests from "a few drops of blood," but the company is mostly using machines provided by Siemens; and in case you missed it, Jeb Bush released his health care plan this week and among the proposals are two items that dovetail with pharmaceutical industry sentiment. Read More