Nature abhors a vacuum, and apparently Novartis does, too. The Swiss drugmaker is leaping into the void created by Johnson & Johnson’s big children’s drug recall by introducing its own children’s pain reliever and fever reducer ahead of schedule. And it’s giving the new product away–up to 250,000 bottles of it–in an effort to wean parents off children’s Tylenol.

Novartis’ new Triaminic-brand product has the same active ingredient as Tylenol–acetaminophen–so it’s a logical substitute for the J&J product. “We accelerated the timing because, given the lack of availability of some over-the-counter children’s analgesic products, we felt it was an important time to offer parents a reliable fever reducer and pain reliever product for their children from a trusted brand,” a Novartis Consumer Health spokeswoman tells the New York Times. Of course, generic children’s acetaminophen is readily available, too, but Novartis apparently is betting that the 50-year-old Triaminic name will sway nervous parents.

The Triaminic giveaway uses the slogan, “restock your medicine cabinet,” in a sly reminder of the Tylenol packages parents may have discarded after the recall was announced. ”It’s saying, O.K., you’ve gotten rid of the Tylenol because of the problems and now here’s a chance to replace it,” marketing consultant Mick Kolassa tells the Times. “It’s a savvy move.”

Source: FiercePharma

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The multiple myeloma therapy carfilzomib registered a response in about one of four drug-resistant patients in a mid-stage trial, reports Onyx Pharmaceuticals, which the biotech believes is solid enough data to win an accelerated approval for a therapy with clear blockbuster potential. Onyx CEO Anthony Coles told reporters that a regulatory filing will be made before the end of this year.

The Phase IIb data on the proteasome inhibitor is a big win for Onyx, which scooped up the therapy when it acquired Proteolix in an $816 million buyout deal–with $276 million up front–just a year ago. And Coles says the drug could be on the market a year from now for the lethal cancer. “The unmet need in the population is so huge and the disease is almost uniformly fatal,” Coles told the San Francisco Business Times.

Researchers recruited 266 patients for the trial and found that 24 percent registered at least a partial response to the therapy. The median duration of response in patients was 7.4 months. But the company declined to say for now just how long patients taking the drug survived, notes the New York Times, waiting for the right scientific conference to detail that data. For now, the company will only say that it believes carfilzomib will prolong survival. Now Onyx’s blockbuster hopes will shift to the Phase III stage. Two late-stage trials are planned for the drug, including one study that will examine the effects of a combination of a low dose of the steroid dexamethasone and Revlimid with and without carfilzomib. A European Phase III study is also planned.

As Forbes’ Robert Langreth notes today, Onyx is anxious to score another blockbuster cancer drug approval to complement its success with Nexavar. Onyx has a unique status as the only sizeable standalone cancer drug developer, he adds, making the company a likely candidate for a rich buyout offer if it can come up with a new blockbuster therapy.

Source: FierceBiotech

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The much-debated Avandia safety trial is shutting its doors to new patients. After last week’s advisory panel meeting, the FDA has ordered GlaxoSmithKline to stop enrollment in the TIDE trial, which is designed to compare the diabetes drug with its direct rival, Takeda Pharmaceuticals’ Actos. The agency also wants GSK to tell the 1,300-plus patients already enrolled that Avandia may increase cardiovascular risks.

The FDA advisory panel voted 20-12 to keep the drug on the market, with most of the “yes” votes calling for additional warnings or restrictions on the drug. Even before that vote, medical ethicists and other observers–even some at the FDA–had been calling on GSK to stop TIDE, because it’s comparing Avandia to a drug that data suggests may be safer. And the agency asked the Institute of Medicine to weigh in on the ethics of the situation.

The FDA now says that it’s continuing to study the new evidence about Avandia’s risks–and while it does so, TIDE has to stop recruiting. The agency stopped short of halting the trial altogether. ”This was the right thing for the FDA to do now while we await the final decision,” Ruth Faden, a bioethics professor at Johns Hopkins and chair of the IOM advisory group, tells the New York Times.

GSK says it will update the investigators and ethics boards in the huge trial next week, while a Canadian research institute will inform the trial participants, who are spread across the globe in 23 countries. ”This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the Committee’s recommendations,” GSK’s chief medical officer Dr. Ellen Strahlman said in a statement.

Source: FiercePharma

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The key to fighting Alzheimer’s disease may be a single brain protein called amyloid beta, which is the subject of dozens of current scientific studies. A recent New York Times article summarized the current understanding about the role of amyloid beta in Alzheimer’s disease as such: “The disease is defined by freckles of barnacle-like piles of a protein fragment, amyloid beta, in the brain. So, the current thinking goes, if you block amyloid formation or get rid of amyloid accumulations—plaque—and if you start treatment before the disease is well under way, you might have a chance to alter its course.”

But Dr. Ottavio Arancio, a professor at Columbia University’s Taub Institute and Big Think expert, says the situation is more complicated than that. His research team is at the forefront of the race to understand amyloid proteins, but they are taking a different approach, trying to understand the beneficial side of amyloid beta. Dr. Arancio told Big Think recently that amyloid beta exists in very small amounts in normal brains, a fact which puzzled most researchers:

“What most scientists thought was that it was kind of piece of garbage in the brain of people with no relevance whatsoever, and instead we have started working on it and we have found that actually the very likely function of this protein in very low amounts is there to lead to normal memory. So without it we could not store information in the brain, we could not learn, and there would not be normal memory.”

Dr. Arancio says that understanding the normal functioning of amyloid beta might shed light on the ravages of Alzheimer’s. The question, he says, is, “how does a good protein turn into a bad protein?”

5.3 million Americans are affected by Alzheimer’s disease, and pharmaceutical companies are understandably eager to discover a cure. Currently, 100 different Alzheimer’s drugs are in development, according to the Times. But these drugs work mostly by attacking amyloid beta, which Dr. Arancio’s studies suggest plays a small but crucial role in proper memory functioning. Also, these drug studies can take up to a dozen years, so a cure is still years away.

Source: http://bigthink.com

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After two days of deliberation, we saw a mixed vote on Avandia. Twelve members voted to take off the market, while 17 recommended changing the label to various degrees. Three voted that the drug should still be sold with its present warnings unchanged.

So what does this all mean? Les Funtleyder of Miller Tabak & Co says the vote is a ”general positive” for GlaxoSmithKline, adding “the fact that everyone is having so much trouble with the data means there is no one obvious answer,” as quoted by ABCNews. And Linda Bannister of Edward Jones says, “If they have to change the label somewhat, we’re not as concerned about that. This product’s revenue has already fallen significantly because of concerns about safety. Unless the drug is pulled we’re not concerned we’re going to see this drug be cut in half again.”

Robert Langreth at Forbes says the mixed vote makes “Avandia is as good as dead as a commercial product.” While Dr. Alan Kadish, president and CEO of Touro College in New York, agrees that Avandia will take a hit: “Very clearly, even if Avandia is not removed from the market, physicians will now be much more reluctant to prescribe it, and patients to take it,” he says, as quoted by ABC.

“Avandia’s decline further opens the door for the antidiabetics that have already filled the gap created after the first Avandia safety scare in 2007–class leader Actos as well as Merck’s blockbuster DPP-4 drug Januvia (sitagliptin),” Datamonitor’s Christine Henry says in a statement. ”With Avandia hit by safety fears and Actos approaching patent expiry in 2011, there is also the possibility for newer drug classes to seize market share, maintaining the attractiveness of type 2 diabetes as a commercial and clinical target.”

Avandia critic Dr. Steven Nissen says the committee’s vote was the best he could hope for, adding that the drug is effectively gone, the New York Times reports. And as CNNMoney notes, the worst-case scenario for the company is that Avandia is pulled because of safety issues. This could open the company up for more litigation down the road, according to Damien Conover, an analyst at Morningstar, as quoted by CNN.

For its part, GSK says it will continue to work with the FDA “in the best interest of diabetes patients who face this chronic and serious disease,” and advises patients to speak with their doctors.

The company’s shares climbed 2.2 percent in pre-market trading after the decision.

Source: FiercePharma

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New Info: A two-day FDA advisory hearing on the safety of Avandia kicks off today, and there’s fresh fodder for those who would like to see the diabetes drug pulled from the market or its use restricted. The WSJ reports that Sen. Charles Grassley sent the agency a letter that included allegations by a former FDA official that GlaxoSmithKline withheld information about the drug’s cardiac risk, as well as other internal company communications about the product’s safety. Meantime, the New York Times cites documents that show the company “had data hinting at Avandia’s extensive heart problems almost as soon as the drug was introduced in 1999, and sought intensively to keep those risks from becoming public.” A company spokeswoman told the NYT the company didn’t report those data because they didn’t add any new information to what was already known.

Hospital M&A Surge: An increase in hospital M&A activity is raising questions of what will happen to low-income patients when nonprofit institutions are purchased by for-profit systems, Kaiser Health News reports, in conjunction with USA Today. The bulk of hospitals will continue to be nonprofit, but one expert tells KHN that merger activity will continue as for-profit companies seek good investments. Consumer advocates worry that will curb the availability of care in areas such as Boston and Detroit, but it’s not yet clear how changes in services will actually affect local populations over the long haul.

Medicaid Blues: Medicaid programs in many states are facing cuts given a lack of federal funding, the WSJ reports. A deficit-fearing Congress hasn’t passed legislation to increase spending for Medicaid, which has states planning to cut their rolls and reduce services. Such restrictions, however, threaten to reduce the amount states will receive from the feds to run the programs. All this is going on as Medicaid gears up for the expansion that is part of health-care overhaul legislation.

Little White Coat Lies: A study shows that 8.1% of applicants for an ophthalmology residency program claiming publication in peer-reviewed journals engaged in some form of misrepresentation about their authorship, the Los Angeles Times reports. The applicants’ misrepresentations included bumping their names up on a list of a paper’s authors, leaving out the names of other authors, and listing nonexistent papers, the paper says. The study’s author told the LAT that the misrepresentation rate is actually the lowest of all specialties studied, except for internal medicine and dermatology.

Source: The Wall Street Journal

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Faced with the resurgence of dengue in the U.S.–where it hasn’t been seen in 65 years–and around the world, Sanofi-Aventis says that it is ramping up an “industrial scale” series of late-stage trials for a new vaccine with blockbuster potential.

According to a report in the New York Times, Sanofi’s new vaccine could earn between $750 million and $1 billion a year as the virus spreads globally. In the U.S., dengue has been popping up along the Mexican border and health officials around the world are reporting fresh outbreaks with no drugs available to combat the epidemics.

“If everything goes well, we will have Phase 3 trials on an industrial scale by the end of the year,” Sanofi vaccine chief Jean Lang tells the Times. According to Lang, the disease triggers 100 million new cases a year and kills some 25,000.

The worst cases trigger dengue hemorrhagic fever and the dengue shock syndrome, which can trigger a fatal case of internal bleeding. Sanofi is planning late-stage trials which will recruit thousands of people for each study.

Source: FierceBiotech

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Imagine Avandia safety as an old-fashioned balance scale. Data on one side upholding the contention that the benefits of the GlaxoSmithKline diabetes med are worth its risks. Data on the other supporting the argument that the drug isn’t safe and should be withdrawn. Well, two newly published studies are adding their weight to the latter–just two weeks before the FDA’s advisory panel meeting on Avandia safety.

One study concludes that Avandia boosted the risk of death, heart failure, stroke or heart attack by 18 percent compared with its Takeda-made competitor Actos. You may recall that this research was done by the FDA’s David Graham, who’s been a frequent critic of Avandia and of the FDA’s response to safety concerns. ”If you treated 60 people for a year with Avandia, you would cause one extra case of heart attack, stroke, heart failure or death,” Graham tells NPR, “compared to if you had treated 60 patients with Actos.”

The other, an update of the first study that found heart-attack risks associated with Avandia, found that one of every 52 patients using the drug suffered. ”I think what we can say confidently is, looking at the totality of data in 2010, Avandia increases the risk of heart attack compared to other diabetes drugs by about a third,” Dr. Steve Nissen of the Cleveland Clinic says.

GSK released a statement contending that data from randomized clinical trials–rather than these analyses of clinical data and records–shows that Avandia is, in fact, safe. “[T]hese trials show that Avandia does not increase the overall risk of heart attack, stroke or death,” the company says. And as PharmaTimes reports, another new study hit at the American Diabetes Association meeting yesterday, showing no increased risk of death, stroke or heart attack (but does boost fracture risk).

FDA Deputy Commissioner Joshua Sharfstein tells the New York Times that the newly published studies “will be part of the discussion that FDA has as we consider the important question of Avandia’s safety.” The FDA is also planning to release its own research on the drug. That advisory panel meeting is coming up July 13-14.

Source: FiercePharma

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When is a recall not a recall? Perhaps when it’s called a “retrieval.” In the Congressional investigation of recent J&J recalls, documents are emerging that show the company and FDA tussling over terminology. And to hear investigators tell it, the documents suggest that J&J’s McNeil Consumer Healthcare unit did in fact direct the alleged “phantom recall” of suspect Motrin tablets.

Internal e-mails and other communications indicate that McNeil directed contractors to surreptitiously buy up stocks of the Motrin tablets, despite the company’s contention that the contractors were instructed only to purchase a sampling of product for testing, the New York Times reports. “Just purchase all available product,” one McNeil instruction stated, while another told the contractors, “Do not communicate to store personnel any information about this product.”

A McNeil spokeswoman told the Times that “the objective was to remove the affected product from a unique distribution channel, mainly convenience stores and gas stations, with as little disruption and consumer confusion as possible.” But it’s that very objective that ended up raising the ire of FDA. The company told the agency it would “retrieve” the products from stores; the agency fired back, saying, “It seems that your company is doing a recall even though you are calling it a ‘retrieval.’”

“The agency’s position is that your company should do a voluntary recall of the product,” an FDA investigator in Puerto Rico–where the suspect tablets were made–told the company, “since it appears to be that you are already doing a recall of the product.”

Meanwhile, other documents indicate that McNeil was working with FDA reps in Puerto Rico to avoid a public recall if possible, Portfolio reports. And emails obtained by Pharmalot include one message from a contractor to various J&J employees saying his employees would “buy all product as mystery shoppers” and suggesting some disingenuous responses to “curious retailers.”

Of course, this is just a tiny sampling of the documents J&J has provided to the House Committee on Oversight and Government Reform. They certainly don’t tell the whole story. We’ll keep you posted as more details emerge.

Source: FiercePharma

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Is Johnson & Johnson cooperating fully with a Congressional probe into its recent consumer-drug recalls? The company says yes–but investigators say no. Rep. Edolphus Towns, chair of the House Committee on Oversight and Government Reform, said J&J has dragged its feet when asked for information and documents. “[W]e are not getting the kind of information and cooperation from Johnson that I would like,” Towns told the New York Times, while a spokesperson told Reuters that the committee is “deeply concerned” about the J&J response.

Towns said other corporations investigated by the committee–such as Bank of America and A.I.G.–have been more forthcoming. And when the company has responded, Towns said, it hasn’t always told the whole truth. He cited instances in which documentary evidence contradicted executive statements: “We need to know where the spin is and where the truth begins,” he maintains.

The company, however, says it has been “very cooperative” with the committee and that any discrepancies could be simple misunderstandings.

For instance: Peter Luther, president of McNeil Consumer Healthcare, told investigators that the Pennsylvania plant implicated in the latest recall did not manufacture drugs for any other companies. But soon after, Blacksmith Brands instituted a “precautionary” recall of its PediaCare products made at the plant. A J&J spokeswoman said that J&J sold the PediaCare brand to Blacksmith last fall and the McNeill plant was only manufacturing the drugs temporarily.

The upshot of all this: Another black eye for J&J. As McNeil’s manufacturing troubles have surfaced–and FDA and Congress have been digging around to find out how it all happened–the company seen a lot of less-than-flattering press. So much so that some say it’s going to have to work hard to regain its reputation. “The only way for [J&J] to reclaim any measure of credibility,” Rep. Eleanor Holmes Norton, who sits on the oversight committee, told the NYT, “is to let it all out now.”.

Source: FiercePharma

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