Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Valeant, Allergan, Novartis and..
Hello, everyone, and how are you today? We are doing fine, thank you, especially given that this is the middle of the week. Perhaps you can relate. Of course, we will forge ahead, as always, since the alternatives appear bleak. This calls for a cup of stimulation and we invite you to join us. By the way, we would like to note that, next week, we will shift over to Stat, so please adjust your reading habits. Meanwhile, here are some tidbits. Have a smashing day…
Valeant Pharmaceuticals is offering discounts and, in some cases, giving dermatological drugs away for free in a bid to retain market share; The Japanese health ministry plans to censure Novartis for failing to report serious side effects from some of its drugs within a certain period of time; Pfizer and Allergan are moving toward a plan to make Brent Saunders chief executive officer if the two drug giants reach a takeover agreement; and India has taken step to ease norms for testing and clinical trials needed for introduction of drugs already approved in other countries.
Clinical Trials / Drug Development / FDA / Mergers and Acquisitions / Pricing & Patient Access / Research & Development / Uncategorized
Supreme Court asked to review Namenda product switching case
The US Supreme Court is weighing a request from Allergan to rule on whether drug companies can pull a medication from the market as generic competition looms in order to force patients to switch to new versions of the drug. The move, which may hinge on antitrust laws, will be closely watched by the pharmaceutical industry.
Allergan's request follows a heated battle between the drug maker and New York Attorney General Eric Schneiderman over a tactic known variously as product-hopping or forced switching, which involves pushing consumers from one product to another. A federal appeals court earlier this year ruled that a switch Allergan had planned would harm consumers.
Antitrust / FTC / Generics / Litigation / Marketing / Patents
Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Amgen, Pfizer and..
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.
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..
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.
AIDS / Diabetes / FDA / Generics / Mergers and Acquisitions / Patents / Pricing & Patient Access / Quality Control / Uncategorized
Pharmalot.. Pharmalittle.. As the weekend nears.. we're catching up on Valeant and…
And so, another working week will soon draw to a close. You were waiting for this moment, yes? This is, of course, our treasured signal to daydream about weekend plans. As usual, our agenda is rather modest. We plan to putter around the castle and catch up on some reading. And what about you? This is, of course, a nice time of year to watch the leaves fall, preferably in a location that does not require you to do any raking. Or better yet, you could search for the Great Pumpkin. Intriguing, yes? Whatever you do, have a jolly old time. But please, be safe. See you soon…
Valeant Pharmaceuticals has cut ties with Philidor Rx Services, which is now shutting down. And yesterday, CVS Health, Express Scripts and Optum Rx, the three largest pharmacy benefits managers in the US, decided not to work with the mail-order pharmacy; As drug makers race to launch CAR T cells, which may be the most effective treatments ever seen for leukemia and other blood cancers, they are grappling with how to make them widely available in a reliable and cost-efficient way; Pfizer faces political risks in Washington if it proceeds with a bid for Allergan, but with little chance of legislation to curb such tax inversion deals, the Obama administration may be able to throw up only limited obstacles; and In nearly 100 news articles describing 36 cancer drugs, words like "breakthrough" and "miracle" were used, even though 50 percent of the time those drugs were not approved by the FDA.
Cancer / Drug Development / FDA / Generics / Legislation / Mergers and Acquisitions / Pharmacy Benefit Managers / Pricing & Patient Access / Research & Development / Uncategorized
Former Warner-Chilcott president arrested for alleged kickback scheme
A former president of Warner-Chilcott, which is now owned by Allergan, was arrested today for conspiring to pay kickbacks to physicians. At the same time, the company agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil charges in connection with illegally promoting several drugs.
An indictment alleges that between 2009 and 2012, W. Carl Reichel created a strategy to give doctors money, free meals and phony speaking fees in exchange for writing prescriptions of Warner-Chilcott drugs. The authorities also charged him with providing sales reps with unlimited expense accounts in order to wine and dine doctors, and said he suggested targeting doctors who were already frequently prescribers. The arrest marks one of the rare instances in which federal authorities are attempting to hold the executive of a drug maker accountable for allegedly breaking the law.
Bribes / Litigation / Off-Label Promotion / Uncategorized / Whistleblower
Doctor indicted for taking kickbacks and giving drug maker patient data
In an unusual move, federal authorities indicted a physician for releasing patient data and accepting $23,500 in exchange for writing prescriptions for a pair of drugs sold by Warner-Chilcott, which is now owned by Allergan.
The indictment, which was filed last week, states that Warner-Chilcott sales reps approached Dr. Margaret Luthra, a gynecologist in Springfield, Mass., to serve as a so-called speaker, according to court documents. The drug maker approached her in 2010 because she was a "high volume prescriber" of Actonel and Atelvia, which are treatments for osteoporosis, the court records say. The move is an outgrowth of a whistleblower lawsuit filed by two former Warner-Chilcott sales reps, although it's unusual for physicians to be caught up in this way in such litigation.
Bribes / Litigation / Patient Privacy / Uncategorized