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Drug makers beat diabetes lawsuits with an unusual ruling

November 13, 2015

Several drug makers were handed an unexpected victory this week when a federal judge ruled they weren’t required to update product labels to warn about risks of pancreatic cancer with their diabetes medicines.

In a 35-page ruling, US District Court Judge Anthony Battaglia explained the labeling changes were not required because the Food and Drug Administration would not have approved those changes. As a result, approximately 750 cases are being tossed. At issue is a legal concept known as preemption, which refers to federal law trumping state law.

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Diabetes / FDA / Litigation / Patient Safety

Pharmalot.. Pharmalittle.. As the weekend nears.. Catching up on Merck, Roche and..

November 13, 2015

And so, another working week will soon come to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. Our agenda is extremely modest this time around. We expect to remove leaves from the Pharmalot campus, promenade with our official mascots and catch up on some work. And what about you? The great outdoors continue to beckon. There is still time to plan a holiday get-away. Or you could debate Starbucks coffee cups. Whatever you do, have a grand time. But be safe. See you soon…

The Trans-Pacific Partnership trade pact could limit the availability of affordable medicines, according to World Health Organization chief Margaret Chan; A federal appeals court backed an earlier ruling invalidating four of five patents on the Cubicin antibiotic that Merck acquired with its $8.4 billion deal to buy Cubist Pharmaceuticals; Roche plans to close or sell four manufacturing sites and pare about 1,200 jobs in a restructuring program; and Mylan is poised to lose its hostile bid for Perrigo.

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AIDS / Clinical Trials / FDA / Generics / Hepatitis C / Layoffs / Mergers and Acquisitions / Patents / Pricing & Patient Access / Uncategorized / Vaccines

Pharmalot.. Pharmalot.. Good Morning.. Catching up on J&J, Mallinckrodt and..

November 10, 2015

Rise and shine, another busy day is on the way. And here on the Pharmalot campus, where clouds are hovering and leaves are falling, we are coping with our mandatory cup of stimulation. Our to-do list is so crammed, in fact, that posting may be sporadic over the next day or two as we complete some more involved efforts than usual. Meanwhile, here is the usual, although lengthy, items of interest. Hope you have a successful day and do keep in touch…

US prosecutors plan to ask the Canadian and British governments to extradite officials with an online pharmacy on charges of smuggling $78 million worth of mislabeled, unapproved and counterfeit cancer drugs into the country; Federal prosecutors in at least four states are mounting investigations into what they describe as widespread fraud by compounding pharmacies in claims to the Tricare health-insurance program; Mallinckrodt stock plummeted by more than 25 percent yesterday after Andrew Left of Citron Research, the short seller, tweeted the drug maker has “more downside” than Valeant Pharmaceuticals; A jury ordered Johnson & Johnson to pay $1.8 million to a Maryland man who developed female breasts while taking the company’s Risperdal antipsychotic drug; an Indian government official says that complaints about quality issues at Indian drug makers are part of a “turf war” with Western companies.

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Compound Pharmacies / Counterfeit Medicines / Diabetes / FDA / Litigation / Mergers and Acquisitions / Patient Safety / Quality Control / Uncategorized

Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Amgen, Pfizer and..

November 9, 2015

Good morning, everyone, and welcome to another working week. Once again, a weekend respite has come and gone. We hope it was invigorating and relaxing, because the usual routine of meetings, deadlines and what-not has returned. As always, we are attacking our own to-do list with help from a cup of stimulation. Please join us, or grab a bottle of water, if you prefer. Meanwhile, here are some tidbits. Have a great day and do keep in touch…

Harvard Pilgrim Health Care has agreed to cover Amgen’s pricey new cholesterol drug in exchange for a discount and potential rebates if the treatment fails to meet performance targets; Pfizer told investors it had a 25.5% global tax rate in 2014, but could have cut its rate to 7.5% by reporting foreign earnings the way most U.S. companies do; and a Delaware federal judge granted a request from AstraZeneca for a temporary restraining order that bars Dr. Reddy’s Laboratories from selling a generic version of the Nexium heartburn drug, because the copy allegedly infringes on the ‘Purple Pill’ trademark.

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Cholesterol / Diabetes / FDA / Generics / Legislation / Litigation / Medicaid / Mergers and Acquisitions / Patents / Pricing & Patient Access / Uncategorized

Pharmalot.. Pharmalittle.. As the weekend nears, catching up on Valeant, PhRMA and..

November 6, 2015

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you may recall, our treasured moment to daydream about weekend plans. Our agenda is quite modest. We hope to clear some leaves from the campus, visit with the Pharmalot ancestors and do some writing. And what about you? Once again, we remind you this is a lovely time of year to enjoy the great outdoors. You could also make plans for a winter get-away or simply take stock. The possibilities are endless. Well, whatever you do, have a grand time, but be safe. See you soon…

There is rising uncertainty about J. Michael Pearson’s tenure as chief executive of Valeant Pharmaceuticals after hedge fund investor Bill Ackman expressed doubts publicly; Faced with nationwide rebukes and attacks from presidential candidates over drug prices, the PhRMA trade group is confronting a public storm unlike any in years; A Food and Drug Administration advisory panel overwhelmingly called for heightened label warnings on widely prescribed antibiotics called fluoroquinolones; and Sanofi chief executive officer Olivier Brandicourt plans to put some assets such as the animal health and European generics units under review, and cut costs by $1.63 billion.

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AIDS / Diabetes / FDA / Generics / Mergers and Acquisitions / Patents / Pricing & Patient Access / Quality Control / Uncategorized

Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Pfizer, Valeant, Shkreli and..

November 5, 2015

Hello, everyone, and how are you today? We are just fine, thank you. Our outlook is brightened by the delightful combination of a shiny sun enveloping the leafy Pharmalot campus and a few cups of stimulation, which are as needed as ever. Feel free to join us. Remember, no prescription is required. And now, time to get cracking. We trust that you can relate. So here are a few items of interest to help you along. Have a great day and keep in touch…

Pfizer is increasing its financial assistance to patients, doubling the allowable income level for people to receive dozens of its medicines for free; What does Martin Shkreli think of the US Senators investigating pricing practices at his company? “The senators have their facts wrong,” he says; Gilead Sciences’ blockbuster hepatitis C medicine Sovaldi may trigger an abnormally slow heartbeat and put patients at risk of passing out; and Roche’s Kadcyla, an expensive breast cancer drug, will remain on the list of medicines available on the UK’s National Health Service after the drug maker agreed to lower the price.

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Bribes / Cancer / Diabetes / FDA / Generics / Hepatitis C / Marketing / Mergers and Acquisitions / Painkillers / Pharmacy Benefit Managers / Pricing & Patient Access / Quality Control / Uncategorized

AstraZeneca sees red over a ‘purple pill’ and sues a generic drug maker

November 2, 2015

For more than two decades, the drug maker has capitalized on a marketing campaign that labeled its two widely prescribed heartburn medicines – first, Prilosec and, later, Nexium – as ‘The Purple Pill.’ The phrase and distinct look were used in a plethora of marketing materials, and largely succeeded in becoming synonymous with the medicines.

Recently, though, AstraZeneca began facing generic competition in the US for Nexium, the newer of its two drugs, and last month accused two different generic drug makers of ripping off its trademark purple look. But will consumers be confused by a Dr. Reddy’s pill that is not entirely purple? And can AstraZeneca successfully argue that purple is closely associated among consumers with its drugs?

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Litigation / Marketing / Patents

Pharmalot.. Pharmalittle.. Good Morning.. We’re catching up on Valeant, Glaxo and…

October 26, 2015

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, as you may guess, we are brewing several cups of needed stimulation and invite you to join us. And why not? A prescription is not required, after all. Meanwhile, here are some items of interest. Have a smashing day and do stay in touch…

Valeant Pharmaceuticals maintains its accounting practices for the Philidor Rx Services pharmacy are appropriate, but created a board committee to review the relationship; The top executives of the largest Indian generic drug makers, including Dr Reddy’s Laboratories, Sun Pharma and Lupin Pharmaceuticals, met informally in Mumbai to discuss ways of coping with FDA warnings and bans; and

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FDA / Mergers and Acquisitions / Pharmacy Benefit Managers / Pricing & Patient Access / Quality Control / Rare Diseases / Uncategorized

Pharmalot.. Pharmalittle.. We’re catching up on Gilead, Theranos and…

October 22, 2015

Top of the morning to you. And another fine one, it is. The sun is shining, the Pharmalot campus is blissfully quiet and more cups of stimulation are brewing in the Pharmalot cafeteria. All of which means that we are in the midst of yet another busy day. No doubt, you can relate. So time to dig in to the usual routine and, to help you along, we have assembled a few items of interest. Good luck, today, and of course, do keep in touch…

Theranos ceo Elizabeth Holmes plans to release a 16-page point-by-point rebuttal to articles in The Wall Street Journal that questioned the accuracy of its blood tests and the extent to its unique technology is used; Oh, say, can you see? An Illinois businessman is angry because his display of patriotism was removed from ads for a new cancer drug that are being run by Bristol-Myers Squibb; and Gilead Sciences is now known to be developing an experimental drug for Ebola after a London hospital revealed that the treatment had been given to a nurse who had been readmitted with the illness.

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Cancer / Counterfeit Medicines / FDA / Laboratory Tests / Layoffs / Litigation / Marketing / Mergers and Acquisitions / Uncategorized

The problem with using surrogate markers to approve cancer drugs

October 20, 2015

In 2003, the FDA approved a lung cancer drug called Iressa, but not because the medicine helped patients live longer. Instead, the agency endorsed the drug based on the fact that it reduced the size of tumors in about 10 percent of patients. This “surrogate” measure was expected to predict future increases in survival time. But it didn’t. A subsequent trial found that Iressa did not prolong patient lives. And in 2012 — after nearly a decade on the market at a cost to the US health care system of around $285 million — the FDA, at the manufacturer’s request, revoked the drug’s approval.

This is a cautionary tale of what can happen when regulatory decisions are based on proxy measures without proof that drugs are extending lives. In the case of Iressa, the FDA eventually corrected course and pulled the ineffective drug. But a new study suggests that many more cancer agents of questionable benefit remain on the market — even as Congress is debating a bill that would increase use of surrogate measures to approve drugs.

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Cancer / Clinical Trials / Drug Development / FDA / Uncategorized

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