Chicago Subpoenas J&J Over 'Deceptive' Opioid Marketing
In the latest imbroglio over prescription painkillers, the city of Chicago has filed a petition accusing Johnson & Johnson and its Janssen unit of deceptive marketing of two medicines – the Duragesic patch and Nucynta tablet – and wants the drugmaker to relinquish six years’ worth of documents, Crain’s Chicago Business writes.
The city claims J&J improperly marketed the opioids for long-term treatment of chronic pain, but that assertions the drugs are safe and effective over an extended period of time are not supported by scientific evidence. “Janssen also may have misled health care providers and patient...
Source: Pharmalot - November 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Up And Down The Ladder... Job Changes
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 with it others. That’s right. Send us your announcements 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 layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone?
And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that the International Society for Pharmaceutical Engineering, or ISPE, hired ...
Source: Pharmalot - November 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... The Weekend Nears
And so, another working week is about to draw to a close. As you may recall, this is our treasured signal to daydream about weekend plans, atlhough we are getting an early start, since we have another use-it-or-lose it day at hand. What does this mean? We will post a couple of stories and then off we go. In any event, our weekend agenda is modest. We plan to attend yet another soccer match played by short people and then hang with some old friends. And then there are those leaves to rake. But what about you? Anything groovy planned? This is a lovely time of year to enjoy the outdoors, of course. You could boost the economy...
Source: Pharmalot - November 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
WikiLeaks Reveals White House View On Trade And Drug Prices
For months, consumer advocates have railed that the Obama administration was taking a secretive approach toward the Trans-Pacific Partnership trade talks and likely jeopardizing access to essential medicines throughout the Asia and the Pacific region. They warned that a restrictive deal would increase the power of the pharmaceutical industry and, eventually, bind Americans to the same terms.
Now, those concerns appear to have been validated after WikiLeaks released a trove of negotiating documents dated as recently as three months ago that indicate the White House was pushing Asian countries to reach such a deal by the end...
Source: Pharmalot - November 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Cholesterol Guidelines Panel And Conflicts Of Interest
Earlier this week, the American Heart Association and the American College of Cardiology released new guidelines that will dramatically change the calculus for prescribing cholesterol-lowering medicines. And while there is debate about the extent to which prescribing habits will change quickly, the big winners are expected to be drugmakers that sell statins, since other types of pills were not recommended (back story).
However, here is an interesting note. Of the 15 panelists that authored these new guidelines, six reported having recent or current ties to drugmakers that already sell or are developing cholesterol medicati...
Source: Pharmalot - November 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Perfect Storm: Will The Mess At Teva Lead To A Merger?
In light of the tumult at Teva Pharmaceuticals, there is chatter the drugmaker could become an acquisition target. Certainly, there are barriers to give bidders pause – the sizeable price that would have to be paid, management turmoil and the likelihood that the Israeli government would object. Just the same, the stock is seen as an underperformer and one analyst calls this a “perfect storm.”
“In a low-interest rate environment, Teva is now sitting in a very attractive position for an acquirer,” writes Sanford Bernstein analyst Ronny Gal in an investor note. “It does not have a ceo, cost cut plans are in place ...
Source: Pharmalot - November 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? We are doing just fine, thank you. After all, a shiny sun is warming the chilly Pharmalot corporate campus, where the short people are, as usual, hustling off to their houses of learning and the official mascots are, as always, barking at passersby. As for us, we are busy conducting our own version of R&D and brewing yet another cup of stimulation to help the process along. Feel free to grab a cup of something stimulating yourself. Meanwhile, here is the usual menu of tidbits. Hope you accomplish much today and do stay in touch...
Aurobindo Suffers A Fire At Manufacturing Facilit...
Source: Pharmalot - November 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
EMA May Delay Finalizing Policy For Disclosing Clinical Trial Data
Last June, the European Medicines Agency released a draft proposal of a new policy concerning the release of clinical trial data (see this) and the effort quickly became controversial. Why? The EMA wants to proactively make trial data, which is submitted in connection with marketing approval for a drug, available to researchers once an approval decision has been made.
The proposal has endured withering criticism. The European Federation of Pharmaceutical Industries and Associations, the industry trade group, blasted the policy and suggested the approach would weaken safeguards for protecting patient privacy, undermine trus...
Source: Pharmalot - November 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Senate Moves Closer To Passing Pharmacy Compounding Bill
A long-awaited bill designed to provide greater oversight of compounding pharmacies passed a procedural hurdle in the US Senate last night, shortly after the US House of Representatives approved the same measure. As a result, a final Senate vote is expected tomorrow and the law could be ready for President Obama to sign the legislation into law by Friday (here is the bill).
The measure, known as the Drug Quality and Security Bill, offers greater authority to the FDA in the wake of a scandal a year ago involving an outbreak of fungal meningitis that was traced to a compounder. So far, there are 751 reported cases, including...
Source: Pharmalot - November 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Op-Ed: The FDA Should Not Change Generic Labeling Rules
Last week, the FDA proposed a rule to revise regulations that prevent generic drugmakers from updating labeling, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugmakers can update labeling before obtaining FDA approval. The proposal was made in response to a US Supreme Court ruling that generic drugmakers are not required to update product labeling, even when alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine (the case was known as Pliva vs. Mensing). The decision sparked an outcry that product labeling would be ...
Source: Pharmalot - November 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Cholesterol Guidelines Are Changed, But Will Prescribing Rise?
In a move that will greatly alter the use of the cholesterol-lowering pills known as statins, the American Heart Association and the American College of Cardiology have released new guidelines that change the calculus for prescribing these medicines. To the extent the changes will generate more prescriptions and, therefore, more revenue for the pharmaceutical industry, however, is unclear.
The biggest change dispenses with the idea that people with a specific cholesterol level should automatically be given treatment and puts an end to the notion of treating patients until their cholesterol level is lowered to a specific ta...
Source: Pharmalot - November 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and welcome to the middle of the week. A strong sun is beaming over the Pharmalot corporate campus this morning, where another a very busy day is shaping up. But busy is good as they say. So no time to dawdle. Please join us as we reach for a cup of stimulation - our choice today, however, is mango ceylon tea with a dollop of honey. A little change of pace can be a good thing, yes? Meanwhile, here are some tidbits. Have a grand day and drop us a line if you hear something we would want to know...
J&J May Pay $4B To Settle Hip Implant Litigation (Bloomberg News)
FDA Review Supports Vanda Sleep Di...
Source: Pharmalot - November 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Former FDA Commishs To White House: Limit Antibiotics In Livestock
A pair of former FDA commissioners has written a letter to the White House Office of Management and Budget to urge the Obama administration to end the use of antibiotics in food-producing livestock for preventing disease and fattening the animals.
The missive, which was sent today by David Kessler and Donald Kennedy, is the latest attempt to address concerns that the widespread and, allegedly, inappropriate use of these medications jeopardize human health by causing resistance to the drugs. As part of their overture, they want the White House to push the FDA to finalize a draft guidance issued last year that would create g...
Source: Pharmalot - November 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
A Wall Street Darling No More: FDA Sends Sarepta Plunging
One of the hottest biotech stories over the past year went ice cold today when Sarepta Therapeutics revealed the FDA decided it would be “premature” to proceed with paperwork for its eteplirsen drug to treat Duchenne muscular dystrophy, or DMD. The disclosure sent Sarepta shares plunging nearly 60 percent this morning and appears to have ended its run as a Wall Street darling, at least for now.
In explaining the setback, Sarepta was told the FDA believes there is “considerable doubt” about a proposed biomarker – an increased production of dystrophin, which is a protein that Duchenne patients are lacking. The agen...
Source: Pharmalot - November 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Op-Ed: What Patent Reform In Brazil And South Africa Can Mean
In recent months, two countries with large economies and large populations both took steps to rework their patent laws, in part, to expand access to medicines. The moves come amid increasing concerns that treatments for certain ailments, such as AIDS and cancer, are out of reach for many people. Their actions also underscore growing tension with the pharmaceutical industry over pricing policies and an increasing willingness among some governments to rely on international trade agreements to consider compulsory licenses as a work-around solution. Brook Baker, a professor in the Program on Human Rights and the Global Economy...
Source: Pharmalot - November 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
