August 16, 2010 - FDA Considers Rescinding Avastin Approval For Breast Cancer.

The Washington Post (8/16, A1, Stein) reports that the FDA's debate on whether or not to rescind approval for Avastin as a breast cancer treatment "has become entangled in the politically explosive struggle over medical spending and effectiveness." The Post notes that many cancer experts, patient advocates and others are citing "a dearth of evidence of the drug's effectiveness, its potential toxic side effects, and its high cost," and are therefore "welcoming the prospect that Avastin's authorization for breast cancer might be repealed. But the possibility is alarming other cancer specialists, women taking the drug, some members of Congress and advocates for giving patients as much access to as many treatments as possible." In addition, although the "FDA is not supposed to consider costs in its decisions," the agency also knows "insurers are likely to stop paying for treatment" if it's no longer approved for the indication.

August 13, 2010 - FDA Approves New Five-Day Emergency Contraceptive.

The FDA announced approval of a new type of morning-after contraceptive, Ella from HRA Pharma. This medication is a prescription-only birth control approach that is said to reduce the chance of pregnancy up to five days after sex. The Los Angeles Times (8/14, Maugh II) "Booster Shots" blog said that the drug, "known generically as ulipristal acetate, is thought to inhibit or delay ovulation by interfering with the effects of the female hormone progesterone, which stimulates ovulation. ... Women with a known or suspected pregnancy or who are breastfeeding should not use the drug." The Washington Post (8/14, Stein) said that Ella "can cut the chances of becoming pregnant by about two-thirds for at least 120 hours after a contraceptive failure or unprotected sex, studies have shown." Supporters and opponents both said the FDA's decision "marked the clearest evidence of a shift in the influence of political ideology at the FDA. ... If the history of Plan B is any indication, Ella's approval is likely to mark the beginning of many years of political and regulatory battles over the drug." This story was also covered by the New York Times (8/14, A1, Harris), The Wall Street Journal (8/14, Mathews, Dooren), Bloomberg News (8/14, Waters, Peterson), AFP (8/16), and MedPage Today (8/13, Gever).

August 13, 2010 - FDA Warns Of Aseptic Meningitis Associated With Lamictal.

The FDA warned doctors and patients that GlaxoSmithKline PLC's anti-seizure drug Lamictal (lamotrigine) "can cause inflammation of the brain and spinal cord." New warnings are expected to be added to labeling. The FDA reported receiving reports of 40 cases of aseptic meningitis between 1994 and November 2009. Thirty-five "patients needed to be hospitalized." The symptoms usually emerged in the first month and a half of treatment, and resolved after the medication was stopped. The Wall Street Journal (8/13, Dooren) reported that the drug is used to treat seizures in children and bipolar disorder in adults. Russell Katz, director of the FDA's neurology-products division, said patients who experience symptoms of aseptic meningitis "should consult their healthcare professional immediately." MedPage Today (8/12, Gever), and Reuters (8/13, Heavey) also reported the story.

August 13, 2010 – Strattera Patent Ruled Invalid.

"Eli Lilly & Co.’s Strattera faces generic competition after the drugmaker lost a U.S. court case over the attention-deficit treatment, its second patent ruling setback in a month." The ruling means Lilly expects "'near-term entry' of generic versions" and has reduced its sales forecast. Lilly will appeal the ruling. Bloomberg News (8/13, Decker) reported the ruling "favors generic-drug companies including Teva Pharmaceutical Industries Ltd. and Novartis AG's Sandoz unit."

August 12, 2010 - Drug Company Efforts To Outmaneuver The FDA Considered "Disturbingly Common."

Time (8/12, Park) reports that the FDA panel's recent decision to recommend keeping Avandia (rosiglitazone) on the market is "a move worth billions of dollars to GSK but that also may have put millions of patients at risk." The move is also an example "of the drug industry's outmaneuvering FDA regulators," which is "disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring." FDA critics and industry monitors "charge that the drug-approval process is too easy for pharmaceutical companies to game. It is in some ways an unsurprising development. The FDA serves a public insatiably hungry for new medicines. Yet the agency does not have responsibility for performing safety testing."

August 11, 2010 - Bisphosphonates May Not Increase Risk Of Cancer Of The Esophagus Or Stomach.

Bloomberg News (8/11, Doherty) reported, "A group of medicines widely used to prevent bone loss doesn't increase the risk of cancer of the esophagus or stomach." In fact, the "combined incidence of the two tumor types was the same for osteoporosis patients given the drugs, called bisphosphonates, as for those not treated with the medicines," according to a paper in the New England Journal of Medicine. "Duration of treatment didn't have an impact on the risk of either cancer." About 18 months ago, the US Food and Drug Administration (FDA) reported 23 cases of esophageal cancer in alendronate treated patients from 1995 to 2008, and another 31 cases in patients using a variety of bisphosphonates in Europe and Japan. The researches analyzed data on more than 80,000 UK patients. During an "average follow-up of about 4.5 years, there were 37 cases of stomach cancer and 79 cases of esophageal cancer diagnosed in the bisphosphonate group, compared with 43 cases of stomach cancer and 72 cases of esophageal cancer after 4.4 years in the control group," HealthDay (8/10, Preidt) reported. Thus, the Belfast-based team concluded, "these drugs should not be withheld, on the basis of possible esophageal cancer risk, from patients with a genuine clinical indication for their use." However, as reported elsewhere, there may be other concerns about long-term use of these drugs.

August 9, 2010 - Some Stroke Patients Stop Taking Their Medications Within Three Months After Discharge.

The New York Times (8/9, Singer) "Prescriptions" blog reported, "Within three months of being hospitalized for an acute stroke, nearly one quarter of patients stop taking at least one of the drugs prescribed by their doctors to prevent further cardiovascular problems," researchers found after interviewing 2,598 individuals. "After their hospital stays, many patients had been prescribed several drugs such as anti-clotting pills, diuretics, cholesterol-lowering drugs and blood pressure medications," according to the paper in the Archives of Neurology. But, "three months after hospitalization, 75.5 percent of the patients were taking all of the medicines their doctors had prescribed to them when they were discharged." The research team examined characteristics of patients to see which ones are least likely to be on their medications, the Los Angeles Times (8/9, Healy) "Booster Shots" blog reported. "They found that younger patients and those who leave the hospital with the highest numbers of medications, those who suffered the severest disability after their strokes, and those without health insurance are more likely to be off their medications three months after a stroke." In contrast, "older patients who understand why their medications are prescribed, and are either employed or at home voluntarily, are more likely to remain on medication at that point."

August 9, 2010 – More Premarket Public Relations on Boceprevir For Hepatitis C.

Additional news stories appeared reviewing results of clinical trials for the Merck add-on Hepatitis C treatment. Placements included stories in The Los Angeles Times (8/9, Maugh) "Booster Shots" blog, HealthDay (8/9, Mozes), and MedPage Today (8/9, Smith). The "75% response rate occurred in the patients who got standard care for four weeks, followed by peginterferon alfa-2b, ribavirin, and boceprevir for 44 weeks." According to the paper in The Lancet, the "next best was a 67% response rate seen in patients who got all three drugs for 48 weeks." Both boceprevir and telaprevir another Hepatitis C drug in development add to the side effect burden. To date, no comparisons have been offered with metformin.

August 7, 2010 - Milwaukee Teachers Ask For Order To Cover Erectile Dysfunction Drugs.

The Milwaukee Teachers' Education Association (MTEA) filed suit to order the school board to cover the costs of erectile dysfunction drugs in its health benefits plan. The teacher’s union argued that excluding these drugs “constitutes sexual discrimination against male employees." Lawyers for the school board state the drugs were dropped in 2005 to save money. The Milwaukee Journal Sentinel (8/6, Randall) reported that the Milwaukee Public School System (MPS) "first agreed to cover drugs that treat erectile dysfunction in 2002. ... During negotiations with the union for its 2003-2005 contract, MPS tried to stop coverage of the drugs, citing rising costs," a decision which was upheld by an arbitrator in 2005.

August 9, 2010 - Questions About Statin Benefits For Patients Without Signs Of Heart Disease.

The Los Angeles Times (8/9, Healy) reports that "in recent months," statins' "touted medical reputation has come under tough scrutiny." While the drugs "certainly decrease rates of heart attack in people who have clear signs of cardiovascular disease...it's not so clear they work that way in people who are healthy." In one study published in the Archives of Internal Medicine "last month, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack."

August 6, 2010 - Rituximab May Be Safe, Effective For Patients With Refractory SLE.

MedPage Today (8/6, Walsh) reported, "rituximab (Rituxan) appears to be both effective and safe for patients with refractory systemic lupus erythematosus (SLE)," according to a study published in the August issue of the journal Arthritis & Rheumatism. In a study of 136 SLE patients, researchers saw an "overall clinical response...in 71%." But, an editorial accompanying the study "cautioned that 'it cannot be assumed that treatments such as rituximab, which have failed to meet their primary endpoints in placebo-controlled trials, are effective.' However, they noted the difficulty of abandoning treatments with anecdotal and observational trial efficacy as well as biologically plausible mechanisms of action."

August 5, 2010 - Bayer's Rivaroxaban Reported Equal To Standard Treatement In Preventing DVT and PE

Bloomberg News (8/5, Kresge) reports that Bayer AG's Xarelto [rivaroxaban] drug was equivalent to standard therapy of enoxaparin and warfarin to prevent blood clots in the lungs and legs. Study participants "taking the anti-clotting pill were as likely to develop serious and uncontrolled bleeding, a potential side effect of the medicine, as those on the standard therapy combination, Bayer said in a statement, citing results of a late-stage clinical trial. Xarelto beat the standard therapy on a measure that counted only clot prevention and the most serious bleeding." Xarelto is currently approved in the EU for the prevention of clots following knee and hip replacement. The drugmaker has to refile its US application for this indication because the FDA requested more data on the drug. The company has indicated that it intends to refile later this year.

August 5, 2010 - Boceprevir May Increase Effectiveness Of Existing Hepatitis C Treatment.

The New York Times (8/5, B3, Pollack) reported, "Merck said that its drug boceprevir, when added to the existing therapy, effectively cured about two-thirds of patients with hepatitis C. That was far better than the cure rate with the existing therapy alone." Merck "is in a heated race with Vertex Pharmaceuticals to bring to market the first of a new class of hepatitis C drugs that are expected to make treatment far more effective and possibly shorter in duration." Still, the "initial reading of Wall Street was that boceprevir might be a bit less attractive than Vertex's candidate, telaprevir, in part because Merck's drug caused fairly high rates of anemia." Addition of a very inexpensive medication for diabetes – metformin – has also been associated with an increase in cure rate with the standard treatement. The Wall Street Journal (8/5, Loftus) reported that the Merck drug is to be added to the standard hepatitis C treatment of pegylated interferon and ribavirin. Merck reported sustained virologic response (SVR) rates of 66% in those taking standard treatment plus boceprevir for 48 weeks versus 59% in those taking the same combination but who could shorten treatment duration to 36 weeks if their virus counts fell to certain levels; and 21% for those on standard treatment plus placebo for 48 weeks. A second study of 1,097 patients who had no prior treatment and similar groupings found SVR rates of 66% in the boceprevir 48-week arm; 63% in the shortened-duration arm, in which patients could stop treatment after 28 weeks; and 38% in the standard-treatment arm. Reuters (8/5, Pierson, Berkrot) and Bloomberg News (8/5, Pettypiece) also cover the story.

August 5, 2010 - Epilepsy Drugs May Not Increase Risk Of Suicidal Actions Among Patients With The Disorder.

Bloomberg News (8/5, Kay) reported, "Using epilepsy drugs doesn't increase the risk of suicidal actions among patients with the disorder, a study found, contradicting a safety warning issued by the US Food and Drug Administration." An observational study examined 10 UK-approved treatments and "compared the effects of the medicines in patients with epilepsy and those with mental-health conditions including depression, according to the report published today in the New England Journal of Medicine." The FDA in May 2009 "approved new warnings that suicidal behavior or thoughts were higher among patients who received antiepileptic drugs compared with those who had taken a placebo," but this study's lead author said, "Our results do not confirm the findings previously reported by the FDA." HealthDay (8/4, Behen) also covered the story.

August 5, 2010 - Muscular Dystrophy Drug Candidate Gets Fast-Track Status.

"Acceleron Pharma, Inc. a privately held Cambridge biopharmaceutical company, announced it has been granted fast-track designation for a potential treatment of Duchenne muscular dystrophy. Fast-track status is to speed review of new drugs "intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs," Acceleron said. The drug candidate is ACE-031, "a protein therapeutic being developed to increase muscle mass and strength."

August 5, 2010 - Fabrazyme Patients Appeal To Abrogate Patent.

NPR (8/5) reported on viral contamination at Genzyme's plant that makes its drug Fabrazyme (agalsidase beta), noting that now "patients who depend on Fabrazyme are asking Health and Human Services Secretary Kathleen Sebelius to exercise "march-in rights" under a 1980 law to abrogate Genzyme's patent on the drug, allowing another company to fill the demand." NPR adds, "Such petitions have been filed several times -- never successfully. But this is the first time patients have made the case, alleging that a patent-holder isn't satisfying their needs."

August 5, 2010 - AstraZeneca Will Pay About $55 Million To Settle Seroquel Lawsuits, Keeping Settlement Confidential.

Bloomberg News (8/5, Feeley, Milford) reported, "AstraZeneca Plc, the UK's second-biggest drugmaker, agreed to pay about $55 million to settle around 5,500 lawsuits related to side effects of the antipsychotic Seroquel [quetiapine], people familiar with the accords said." AstraZeneca's "5,500 settlements include 4,000 that AstraZeneca acknowledged in a July 29 regulatory filing as reported by Bloomberg News (7/31, Milford, Feeley). The claims were settled through mediation, and the company said it will “keep terms of the agreements confidential." Bloomberg News noted that "the consolidated Seroquel case is In re Seroquel Products Litigation, 06-MD-01769, US District Court, Middle District of Florida (Orlando)."

August 4, 2010 - Icatibant May Be Alternative For Acute Hereditary Angioedema Attacks.

HealthDay (8/4, Preidt) reported, "A drug called icatibant is effective in treating acute attacks of" hereditary angioedema (HAE). HAE is a condition that causes swelling in various soft tissues which can be life-threatening if it involves the airway. German drugmaker Jerini Inc. "conducted...two randomized, double-blind clinical trials, which included a total of 130 patients," and although "the results of one trial did not reach statistical significance, the researchers concluded that icatibant is safe and effective in treating acute attacks of HAE." The drug has already been approved in the EU. The newest medications available for HAE in the US can be costly for health plans.

August 3, 2010 - Congress Moving Toward Banning Pay-To-Delay Payments.

The Minneapolis Star-Tribune /Philadelphia Inquirer (8/3, Hepp) reported generic-drug manufacturers seem "to be losing the larger war" over pay-to-delay settlements, "as Congress moves closer to enacting a law to prevent brand-name drugmakers from paying competitors to drop their patent challenges." The Federal Trade Commission, which "says" the deals cost "consumers billions in savings each year -- a claim the generic makers dispute," is supporting the legislation.

August 2, 2010 - Drug Industry Funded Studies More Likely To Show Positive Results.

The Los Angeles Times (8/2, Roan) "Booster Shots" blog reported, "According to an analysis of drug trials published Monday, studies were much more likely to be positive -- that is, showing the drug worked -- in trials that were funded by the pharmaceutical industry." A review of 546 drug trials "found that industry-funded trials reported positive outcomes 85% of the time, compared with 50% of the time for government-funded trials and 72% of the time for trials funded by nonprofits or non-federal organizations." Among "the nonprofit or non-federal studies, those that received industry contributions were more likely to be positive (85%), compared with those that did not have any industry support (61%)." HealthDay (8/2, Preidt) reported that "32 percent of industry-funded trials published results within two years of clinical trial completion, compared with 54 percent of government-funded studies and 56 percent of nonprofit/nonfederal trials, the authors of the review pointed out." The researchers of the study also "called for more public disclosure at the start of clinical trials in order to reduce the possibility of bias in their findings."

For the study, the researchers "searched ClinicalTrials.gov for safety and efficacy trials for five classes of medications -- anticholesteremics, antidepressants, antipsychotics, proton pump inhibitors, and vasodilators -- conducted between 2000 and 2006," MedPage Today (8/2, Neale) noted. The Boston Globe (8/2, Cooney) "White Coat Notes" blog and CNN (8/2, Young) "The Chart" blog also covered the story.

August 1, 2010 – Kids Treated With TNF-α Blockers May Have Increased Cancer Risk.

MedPage Today (8/1, Walsh) reported, "The use of tumor necrosis factor (TNF)-alpha blockers in children may increase the risk of malignancy, particularly when these drugs are given for inflammatory bowel disease rather than for rheumatic conditions," according to a paper published in Arthritis & Rheumatism. "A total of 48 cases of malignancy have been reported among children and young adults taking infliximab (Remicade), etanercept (Enbrel), or adalimumab (Humira), Peter Diak, PharmD, and colleagues from the Food and Drug Administration (FDA)" explained. "But a clear causal relationship could not be established between TNF blockade and cancer in the study, because most of the children were on multiple immunosuppressive drugs, and the underlying risk for malignancy with autoimmune disease was unclear."

July 29, 2010 - Thiazolidinedione Diabetes Drugs Associated With Fracture Risk In Postmenopausal Women.

HealthDay (7/29, Gardner) reported that Avandia [rosiglitazone] and Actos [pioglitazone], "two widely prescribed diabetes drugs, may raise the risk of broken bones in postmenopausal women with type 2 diabetes," according to a study published online July 14 and to appear in the October issue of the Journal of Clinical Endocrinology & Metabolism. In addition, there was "a fracture risk seen among men who had been prescribed either Avandia or Actos plus a loop diuretic," but not with the drugs individually. HealthDay noted, "This isn't the first time such an association has been seen, raising doubts as to whether these drugs, which belong to the class of medications known as thiazolidinediones (TZDs), should be the first choice for treating type 2 diabetes."

The research found women who suffered fractures were more likely to be taking a TZD (thiazolidinedione) medication, such as Actos and Avandia. The study revealed that diabetic women over 50 with fractures were 70% more likely to use a TZD drug than women without fractures MedPage Today (7/29, Bankhead) also covered the story.

July 29, 2010 - FDA Warns Hormone Spray Linked To Breast Growth In Children.

The New York Times (7/30, A11, Grady) reports that Evamist [estradiol], "a hormone spray prescribed to stop hot flashes in menopausal women, has caused breasts to sprout in children who were inadvertently exposed to it through skin contact with women using it, the Food and Drug Administration said" on Thursday. The FDA is now "urging users to keep children away from skin that has been sprayed. The product...which contains estrogen, is supposed to be sprayed on the forearm." "The FDA said it has received eight reports of adverse effects from exposure to the drug in children ages three to five, and two reports of problems with pets," the Los Angeles Times (7/29, Maugh) "Booster Shots" blog reported. The Plain Dealer (7/30, Suchetka) provides a link to a consumer information page on the FDA's website.

July 29, 2010 - FDA Warns Cubicin May Cause Life-Threatening Eosin

The Los Angeles Times (729, Maugh) "Booster Shots" blog reported, "The Food and Drug Administration Thursday warned physicians and patients that the intravenous antibiotic Cubicin [daptomycin] can cause life-threatening eosinophilic pneumonia, which is marked by the accumulation of a type of white blood cells called eosinophils in the lungs." The drug was first approved in September 2003 "for treating serious skin infections and in 2006 to treat bloodstream infections." In 2007, however, "its label was modified to indicate an increased risk for pulmonary eosinophilia, an increased concentration of eosinophils in the blood."

The FDA has now released data on seven cases of eosinophilic pneumonia, "most likely associated with use of Cubicin, between 2004 and 2010," the Boston Business Journal (7/30, Donnelly) reports. The "FDA also identified 36 possible cases of eosinophilic pneumonia associated with Cubicin use." Thus, the agency "said that the new product insert must include more prominent information on the potential risk of eosinophilic pneumonia." The FDA has requested this information be added to the drug's label under 'Warnings and Precautions' and 'Adverse Reactions, Post-Marketing Experience.'" Additional information is provided on the FDA website.

July 29, 2010 - Cephalon Attempts to Block Fentora Generic.

The Dow Jones Newswire (7/29, Loftus) reports that Cephalon Inc. earlier this month filed a citizen petition to the FDA seeking to withdraw its approval of Watson Pharmaceuticals Inc.'s application to market a generic version of Cephalon's pain drug Fentora (fentanyl-buccal). Cephalon claims the proposed generic version of the drug differs chemically from the original and that Watson should have to go through a lengthier approval process. Cephalon also says its patents on Fentora don't expire until 2019.

July 29, 2010 - Lilly Loses Bid To Block Generic Sales Of Gemzar After November.

Bloomberg News (7/29, Decker, Tirrell) reports, "Eli Lilly & Co...lost a bid to block generic sales of the cancer medicine Gemzar [gemcitabine HCl] after November." Yesterday, "a US appeals court...upheld a lower court that had invalidated a patent on a method of using the medicine that expires in May 2013. The patent is similar to one on Gemzar that expires in November, the Court of Appeals for the Federal Circuit said in a ruling (pdf) on its website." The court's "decision is a victory for India's Sun Pharmaceutical Industries Ltd., which had challenged the patent." Gemzar generated $1.4 billion in sales last year.

July 28, 2010 - FDA Advisory Panel Recommends Brilinta Approval Even Though Patients in USA Did Worse Than Elsewhere.

Bloomberg News (7/29, Larkin, Kelley) reports that an FDA panel "voted 7-1 yesterday in favor of using the AstraZeneca's Brilinta [ticagrelor] to reduce the risk of heart attacks, strokes and death in patients with severe chest pain or earlier heart attacks." The advisers "said concerns that US study participants did worse on the drug than people in other countries may be the result of chance and could be examined in a future trial after the drug is approved." But, Bloomberg points out that, "in a report released this week, FDA staff rejected AstraZeneca's suggestion that higher US aspirin use contributed to the outcome."

MedPage Today (7/28, Walker) reported that "if the FDA approves ticagrelor, it will have to decide how to explain the US data, if at all, on the drug's label." The agency "will also have to decide whether to mention the potential link between aspirin dosage and efficacy, and whether to adopt the company's recommendation that ticagrelor be given with a low dose of aspirin."

July 28, 2010 - Sanofi Sues FDA To Block Lovenox Generic.

Bloomberg News (7/28, Fridson, Torsoli) reports, "Sanofi-Aventis SA, France's leading drugmaker, sued the US Food and Drug Administration to make it withdraw clearance of a lower-cost rival to the company's Lovenox [enoxaparin] blood thinner." In a federal court in Washington on Tuesday, Sanofi filed a lawsuit asking "a judge to force the FDA to suspend its approval of the generic produced by Novartis AG's Sandoz unit with Momenta Pharmaceuticals Inc.'s technology." A spokesman for Sanofi said the agency's approval "was not made in accordance with the agency's statutory obligations."

July 27, 2010 - Glaxo Admits To Creating Paid Journal Supplement Promoting Unapproved Use.

Dow Jones Newswire (7/27, Loftus) reports that GlaxoSmithKline PLC admitted its mistakes in creating a paid supplement to the journal Urology in May 2009. The supplement included information about Avodart's (dutasteride) ability to reduce the risk of prostate cancer, which the drug has not received regulatory approval to treat. The Wall Street Journal (7/26, Loftus) "Health Blog" also covered the Dow Jones story.

July 26, 2010 – Older Epilepsy Medications May Not Increase Risk For Suicide, Study Suggests.

HealthDay (7/26, Behen) reported that, according to a study "of more than 44,000 epilepsy patients" published in the July 27 issue of Neurology, "those who took relatively new antiepileptic drugs with a higher risk of causing depression, such as levetiracetam (Keppra), topiramate (Topamax), and vigabatrin (Sabril), were three times more likely to harm themselves or attempt suicide than those who weren't taking any epilepsy medications." But, "the researchers found that patients who took conventional epilepsy medications, such as divalproex (Depakote, Depakote ER, Depakene) or phenytoin (Dilantin), or newer drugs with a low risk of depression, such as gabapentin (Neurontin) or lamotrigine (Lamictal), faced no increased risk of self-harm of suicidal behavior." An accompanying editorial noted that "clinicians often prescribe the newer drugs along with the older ones only after patients have failed to respond to the older drugs alone," It is not clear what role poor adherence to prescribed treatment may have played.

July 24, 2010 - FDA Approves Three-In-One Blood Pressure Drug.

The AP (7/26) reported, "Daiichi Sankyo Inc. said Monday that regulators have approved the sale of its three-in-one high blood pressure drug Tribenzor [hydrochlorothiazide, amlodipine, olmesartan medoxomil] ." MedPage Today (7/26, Petrochko) added that the drug is intended "to treat patients whose blood pressure is not controlled on angiotensin receptor blockers, calcium channel blockers, or diuretics." The FDA issued several warnings regarding the use of the drug, including that "pregnant patients should not take the new combination drug," and "those who become pregnant while on the polypill should discontinue therapy immediately." Two of the three components of this formulation have long been available as inexpensive generics. Olmesartan has limited patent life, and faces generic competition amoung other angiotensin receptor blockers.

July 24, 2010 - FDA Approves Higher Dose Line Extension of Aricept For Alzheimer's.

The Eisai (7/23) and Pfizer announced FDA approval of a reformulation of it's Alzheimer's disease drug Aricept [donepezil]. The drugmakers claim the higher dose improved scores on a patient test that measures cognition, compared to continued treatment on a lower twice-daily dose. There was no difference on a different test that measures global function. Bloomberg News (7/26, Gale) reports that the FDA's "approval on July 23 of a 23-milligram once-daily tablet will help Tokyo-based Eisai and partner Pfizer, Inc. of New York counter a potential fall in sales once the drug faces competition from lower-cost generic copies of a 10-milligram pill." About "5.1 million Americans may have Alzheimer's, the most common form of dementia in older people, according to the US National Institutes of Health. While there's no cure for the disease, drugs such as Aricept can ease the symptoms."

July 23, 2010 - FDA Approves Generic Version Of Lovenox.

The AP (7/23) reported that "Momenta Pharmaceuticals Inc. said Friday the US Food and Drug Administration approved its generic version of Sanofi-Aventis SA's Lovenox [enoxaparin], an injected drug for preventing life-threatening blood clots." The Los Angeles Times (7/24, Zajac) reported that "in its decision, the FDA also rejected an argument by Lovenox's maker, Sanofi-Aventis, that its drug, which is made from sugar molecules found in heparin, a substance derived from pig intestines, is too complex to be copied with precision by makers of generic versions of the medication." The New York Times (7/23, Pollack) "Prescriptions" blog reported that "Momenta, which applied for approval of its drug five years ago, claims its technology can accurately characterize such complex mixtures." The Wall Street Journal (7/24, Mundy), the Boston Globe (7/24), MedPage Today (7/23, Neale), and the Boston Business Journal (7/23, Donnelly) also covered the story.

.July 23, 2010 - Tapentadol Reformulation Studied Versus Oxycodone

MedicineNet (7/23, Hendrick) reported, "An extended-release form of the pain medication tapentadol has fewer gastrointestinal side effects than oxycodone when it's used for pain relief in people with osteoarthritis or chronic low back pain." In fact, the "painkiller, called tapentadol ER, could provide a new alternative for the relief of chronic pain if approved by the FDA." According to the paper in Pain Practice, the "incidence of gastrointestinal side effects including constipation, nausea, or vomiting leading to discontinuation in the study was 2.5 times greater in patients taking oxycodone than those taking tapentadol ER," and it "provided sustainable relief of moderate to severe chronic knee or hip osteoarthritis pain or chronic low back pain for up to a year." Usually recommended treatment for osteoarthritis, and lower back pain does not include chronic use of opiates.

July 23, 2010 - AstraZeneca To Pay $2 Million To Settle Some Seroquel Suits.

Bloomberg News (7/23, Feeley) reports that pharmaceutical maker "AstraZeneca Plc agreed to pay $2 million to settle more than 200 cases over its antipsychotic...Seroquel [quetiapine] in the first resolution of lawsuits alleging the medicine causes diabetes, people familiar with the accords said." Bloomberg News explains, "The settlement, which provides an average payout of more than $10,000 per case, came as the result of a US court-ordered mediation involving 26,000 cases filed against London-based AstraZeneca over Seroquel, the people said."

July 22, 2010 - Insulin Pump Beats Injections In Patients With Type 1 Diabetes.

According to a study published in the July 22 issue of the New England Journal of Medicine, patients who used an insulin pump with a continuous glucose sensor "achieved better control of their blood sugar than patients taking insulin injections." Researchers followed "485 people with type 1 diabetes, ranging in age from 7 to 70, who had been unable to achieve optimal blood sugar control with insulin injections," half of whom received standard treatment and half of whom used the pump. Notably, "after one year of treatment, patients in the pump group had significantly lower hemoglobin A1c levels than those in the insulin injection group."

July 22, 2010 - New Hepatitis C Medicines In Development Could Transform Care.

The New York Times (7/22, B1, Pollack) reports: "New medicines are being developed that are expected to transform the care of patients with hepatitis C, making treatment far more effective and far less grueling." In fact, the "new drugs, which could start reaching the market as early as next year, could help subdue a virus that infects roughly four million Americans, most of them baby boomers, and 170 million people worldwide." Notably, "hopes for new treatments were buoyed in May by the first results from a late-stage clinical trial of one of the new drugs, telaprevir from Vertex." Still, "some experts and doctors warn that this virus may be particularly tough to vanquish."

July 22, 2010 - FDA Halts Enrollment In Trial Comparing Avandia, Actos.

The New York Times (7/22, B6, Wilson) reports that the FDA "on Wednesday ordered GlaxoSmithKline to stop enrolling people in a controversial clinical trial comparing" Avandia (rosiglitazone) with Actos (pioglitazone). The FDA also ordered Glaxo "to inform the 1,324 people already testing the drugs that its product Avandia may increase heart risks." The FDA notice also "said it was studying whether to take further action after most members of an advisory panel voted last week to withdraw Avandia from the market or severely restrict its use." The Wall Street Journal (7/22, Dooren) adds that FDA deputy commissioner Joshua Sharfstein has suggested that if the Avandia trial is ultimately ended, the FDA may stop sales of the drug. MedPage Today (7/21, Walker), HealthDay (7/22, Preidt), the Boston Globe (7/21, Rowland) and NPR's (7/22, Hensley) "Shots" blog also cover the story.

July 21, 2010 – Teva Settles With Attorneys General Over Medicaid Overcharges.

Teva Pharmaceuticals and its affiliates will pay Florida $27 million to settle allegation of fraudulently inflating medication prices. In announcing the settlement, Attorney General Bill McCollum reported that Florida's Agency for Health Care Administration's Medicaid program will be reimbursed $7.1 million and Florida's general revenue fund will receive about $3.5 million from the settlement. The allegations related to inflated AWP prices for Teva's generic medication offerings.

The Philadelphia Business Journal (7/20) covered the story.

Meanwhile, "Texas Attorney General Greg Abbott reached a settlement with Teva Pharmaceuticals, Inc. in a case involving allegations that Teva and two other companies overcharged the Texas Medicaid program," the San Antonio Business Journal (7/20) reported. "Texas was a party to the lawsuit along with the states of Florida, California and the US government. In all, Teva has agreed to pay a total of $169 million. Texas will receive $51.4 million of that amount."

July 21, 2010 - FDA Approves Phentermine Generic.

The Philadelphia Business Journal (7/21, George) reports, "Lannett Co. said Tuesday it received Food and Drug Administration approval for a generic version of the obesity drug phentermine." The drug "is an amphetamine that helps suppress appetite, and it is used as a short-term obesity treatment along with diet and exercise."

July 21, 2010 - Thousands Of Medi-Cal Patients May Be Taking "Dangerous" Amounts Of Acetaminophen.

The Sacramento Business Journal (7/21, Robertson) reports "thousands of Medi-Cal patients may be taking dangerous amounts of acetaminophen," according to new research from University of California Davis. The OTC analgesic, sold under the Tylenol brand name, is generally "considered safe at four grams a day or less," but is prescribed to some patients in quantities "far exceeding that," a paper in the Annals of Pharmocotherapy concludes. Researchers found "during 12 months in 2004 and 2005, 961,320 of the 3.27 million Medi-cal beneficiaries enrolled at the time – 29.4 percent – received one or more prescriptions that included acetaminophen." Among other details, the study found 2,664 beneficiaries "were exposed to 100 days of doses of more than four grams." Notably, 61 patients "with claims for four grams per day" or more for 100 days or more "had a diagnosis of primary liver or kidney dysfunction."

July 20, 2010 - GlaxoSmithKline Settles Some Paxil Lawsuits.

The Wall Street Journal (7/20, Stovall) reported that GlaxoSmithKline announced it has settled certain suits claiming that its antidepressant Paxil (paroxetine) caused birth defects in the babies of certain users who took the medication while pregnant. "GlaxoSmithKline Plc has agreed to pay more than $1 billion to resolve more than 800 cases...according to people familiar with the settlements," Bloomberg News (7/21, Feeley, Kelley) reports. "The accords, which provide an average payout of more than $1.2 million to families of affected children, leave more than 100 birth-defect cases pending, the people said."

July 20, 2010 – FDA Panel Recommends Revoking Avastin Approval For Breast Cancer.

On the front of its Business Day section, the New York Times (7/21, B1, Pollack) reports that an advisory FDA panel called to "revoke approval of the drug...as a treatment for breast cancer, saying the drug was not helping patients." The Times adds that the panel voted 12 to 1 to remove the indication, which "represents a stinging setback for Avastin." The panel determined that “at least for advanced breast cancer, the initial data that led to approval was not borne out by subsequent studies." Avastin would remain on the market as it is approved to treat forms of colon, lung, kidney and brain cancers."

The Los Angeles Times (7/21, Maugh) adds that new studies of the drug showed "progression-free survival improved by as little as a month and, again, overall survival did not improve. In fact, because of complications from the drug, survival was actually slightly less for some women." The panel also "voted 13 to 0 that the new studies failed to confirm the original findings." An FDA spokesperson confirmed that the new trials also showed "that there were, indeed, more side effects when patients took Avastin." AFP (7/21) and
Bloomberg News (7/21, Peterson, Doherty) notes that Roche Holding AG "may shed $1 billion in annual revenue if US regulators follow a panel recommendation to revoke approval of the drug for use in breast cancer." The panelists "also rejected Roche's application to expand use of Avastin in breast cancer for pairings with more varieties of chemotherapy." Additional reporting was provided by the Wall Street Journal (7/21, Dooren), Reuters (7/21), MedPage Today (7/20, Walker), and HealthDay (7/20) also covered the story.

In a positive report for Avastin, HealthDay (7/20, Reinberg) reported, "The cancer drug Avastin [bevacizumab], when used in combination with standard chemotherapy, is safe and can effectively treat an advanced form of one of the most common lung cancers," according to a paper in The Lancet Oncology. "Previously, it had been thought that this combination might have serious adverse side effects, including life-threatening bleeding, for patients with non-squamous non-small-cell lung tumors." However, a "phase 4 trial, which used Avastin (bevacizumab) plus chemotherapy in a large population, found these problems were minimal."

July 20, 2010 - Record Number Of Drugs Under Research & Development For Mental Illness.

The New York Times (7/20, Wilson) "Prescriptions" blog reports "there are a record 313 drugs under research and development to treat mental illness," according to a report from the pharmaceutical manufacturers' association. The drugs, either in clinical trials or seeking approval by the FDA, "are being tested for conditions from Alzheimer's to schizophrenia." The Times says "mental health drugs have huge profit potential" because the symptoms and diagnoses "can be nebulous and subjective."

July 20, 2010 - More Avandia Travails

USA Today (7/20, Rubin) reports, "In the grand scheme of treating diabetes, it might not matter much whether the Food and Drug Administration halts sales of the drug Avandia [rosiglitazone]" because "doctors already have given their verdict. Avandia prescriptions have plummeted since a study in The New England Journal of Medicine in May 2007 raised concerns about whether the drug increased heart attack risk."

The Wall Street Journal (7/20, Mundy) reports that FDA panelist and endocrinologist David Capuzzi was one of three panelists to vote in favor of keeping the drug on the market with no additional warnings and he is also a paid speaker for the drug's maker GlaxoSmithKline PLC. Capuzzi said in an interview, "I have not given any talks [to doctors' groups] promoting Avandia." He added, "The danger I worried about was that if we pulled Avandia, people might automatically switch to Actos and think it's all hunky-dory."
The Pharmalot blog added some additional insights on this story.

July 18, 2010 - HAART May Curb Rate Of New HIV Infections.

The Los Angeles Times (7/18, Maugh) reported, "In the absence of a vaccine against the AIDS virus, the most effective treatment method is aggressive treatment of HIV infections with cocktails of antiretroviral drugs, an approach known as highly active antiretroviral therapy or HAART." Attesting to the efficacy of that strategy, research from Canada reveals "that the infection rate in the province" of British Columbia "has been halved since 1996 by the widespread adoption of HAART." About a "decade ago," a study conducted "in Africa found that people with...very low levels of virus were less likely to infect others," the AP (7/19, Marchione) reports. Specifically, "treating pregnant women with HIV lowers the amount of virus they have and the risk they'll pass it on to their babies," and the "new study is the first clear evidence that the same principle holds true on a population level, in everyday community settings." Simply put, "'the more people you put on therapy, the less transmission there is,' said Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases." The "drop in new cases in Canada 'likely could not be explained by anything else,' he" added, according to the Minneapolis Star Tribune (7/18). HealthDay (7/18, Preidt) also covered the story.

July 18, 2010 - New Guidelines Again Expand Number Of Americans Eligible For HIV Therapy.

The Los Angeles Times (7/18, Maugh) reported, "An international panel of AIDS experts Sunday recommended earlier treatment for HIV infections in an effort to prevent the development not only of full-blown AIDS, but of other complications of infection as well." Previously, the "International AIDS Society-USA Antiretroviral Therapy Guidelines Panel, which makes nonbinding recommendations about HIV treatment, had...recommended that treatment be initiated when CD4 levels fall below 350 cells per cubic millimeter." Now, however, the "group said it is...recommending that treatment begin when levels fall below 500," according to the article in the Journal of the American Medical Association. HealthDay (7/18, Preidt) also reported on the guidelines.

July 17, 2010 - FDA Says Avastin Does Not Improve Survival In Breast Cancer Patients.

Follow-up studies of Avastin, a Roche breast cancer drug, demonstrate that this treatment failed to extend the lives of patients. This finding creates the possibility that Avastin could be withdrawn for use in treating that disease. The FDA "approved Roche's blockbuster Avastin [bevacizumab] in 2008 based on a preliminary trial showing it slowed breast tumor growth. The approval was not based on the usual standard of demonstrating that the cancer treatment actually extended life. The Wall Street Journal (7/17, Dooren) noted that when the FDA approved Avastin, it disregarded the recommendation of an advisory panel which voted 5-4 against the approval. Still, the approval was contingent on Roche conducting two follow-up tests to confirm the efficacy of Avastin. The agency now says that these studies "failed to confirm the magnitude" of the benefits suggested by the research on which Avastin's approval was based, and on Tuesday, a group of experts will review the studies. Bloomberg News (7/17, Peterson, Doherty) and MedPage Today (7/17, Walker) provided additional reporting. Avastin costs around $50,000 per year of treatment.

July 16, 2010 - GSK Takes $2.36 Billion Charge Over Legal Cases Involving Paxil, Avandia.

The New York Times (7/16, B2, Jolly, Harris) reports that UK pharmaceutical maker GlaxoSmithKline announced on July 15 that "it would take a second-quarter charge of $2.36 billion related to legal cases involving its drugs Avandia [rosiglitazone] and Paxil [paroxetine]." This announcement comes one "day after an American medical advisory panel recommended that Avandia, a controversial diabetes drug, should either be withdrawn from the market or be severely restricted in its sales because it increases the risks of heart attacks." The Wall Street Journal (7/16, Whalen) pointed out the charge eliminates most of GSK's second quarter profit this year, but largely resolves the company's liability regarding Avandia. Bloomberg News (7/16, Kelley) reports that "in December...the company had paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases." GSK "also resolved a dispute over Paxil with generic-drug maker Apotex Inc. for 'alleged violations of federal antitrust laws, as well as those involving advertising and state antitrust and consumer protection laws.'"

July 16, 2010 - FDA To Conduct Formal Safety Review Of ARBs.

The New Jersey Star-Ledger (7/16, Todd) reports that spurred by a "recently published study," the "Food and Drug Administration is investigating whether some of the most commonly used blood pressure medicines may increase the risks of cancer." Apparently, the authors of The Lancet paper observed a 7.2 percent rate of new cancer cases among the participants of several trials who had taken angiotensin receptor blockers, Reuters (7/16, Richwine) reports. By contrast, the rate was six percent for those who had not taken ARBs. Still, the FDA stated that there were a number of limitations "that make it difficult to determine the validity of the findings" without further investigation. MedPage Today (7/15, Gever) also reported on the implications of this study.

July 16, 2010 - FDA Panel Does Not Recommend Approval For Anti-Obesity Drug.

On the front of its Business Day section, the New York Times (7/16, B1, Pollack) reports that the panel "voted 10 to 6 that the safety concerns, like increased heart rate, possible birth defects and psychiatric problems, overrode the potential benefits of the drug." The AP (7/16) adds that the panelists "unanimously agreed" that Qnexa helped "patients lose pounds, with most reporting more than 10% weight loss. But those benefits were outweighed by a slew of safety concerns that cropped up in company trials, including memory lapses" and suicidal thoughts. The Los Angeles Times (7/16, Healy) also reports that the FDA "is acutely aware that any weight-loss product it approves will probably be broadly marketed and taken by a potentially vast population of patients already beset by obesity-related conditions. Given those circumstances, any hint of a drug-related safety problem could quickly mushroom." The San Diego Union-Tribune (7/16, Darce), CNN (7/16), AFP (7/16), MedPage Today (7/15, Walker) and Reuters (7/16, Heavey, Lentz) also covered the story.

July 15, 2010 - FDA Approves Generic Version Of Nabumetone.

The AP (7/15) reported that Mylan Inc. announced that the "Food and Drug Administration approved its generic version of the osteoarthritis and rheumatoid arthritis drug nabumetone [Relafen]." The company is now cleared "to sell 500 milligram and 750 milligram tablets of Nabumetone...a nonsteroidal anti-inflammatory drug."

July 15, 2010 – Extended-Release Formulation Of Donepezil May Benefit Patients With Moderate To Severe Alzheimer's.

Bloomberg News (7/15, Matsuyama) reports that patients with Alzheimer's disease who switched to an "experimental, 23-milligram tablet" of Aricept (donepezil) taken once a day "were more likely to maintain or improve brain function” compared to those who took a 10mg of Aricept twice daily. The study involved 1,467 patients with moderate to severe Alzheimer's disease, and results were released at the International Conference on Alzheimer's Disease. The FDA is now reviewing the new formulation and is expected to "make a decision by July 24."

July 15, 2010 - Experimental Compound May Aid In Weight Loss, Provide Heart Benefits.

The Los Angeles Times (7/15, Roan) reports that "a phase-three study of more than 3,000 obese or overweight adults showed that those taking the experimental compound lorcaserin lost more weight after one year than people taking a placebo pill." Researchers found that "just over 47% of the people taking" Arena Pharmaceuticals' "lorcaserin lost 5% or more of their body weight, compared to 20.3% of people in the placebo group." The research, published "in the New England Journal of Medicine, also showed that lorcaserin produced slight improvements in blood pressure, heart rate, cholesterol, and insulin resistance."
Bloomberg News (7/15, reports that "An FDA advisory panel is scheduled to review lorcaserin on Sept. 16, Arena said." MedPage Today (7/14, Neale) also covered the story.

July 15, 2010 - Keryx's Perifosine Achieves Second Orphan Drug Designation From FDA.

Reuters (7/15, Ho, Kuber) reports that Keryx Biopharmaceuticals Inc. received a second orphan drug designation from the FDA for perifosine, an experimental drug it is using in early stage clinical trials for neuroblastoma, the cancer that is the most common in infants. Keryx also has orphan status for the drug for the treatment of colorectal cancer, for which it is in late-stage trials for advanced cases and also for multiple myeloma.

July 15, 2010 - FDA Panel Decides Avandia Fate, Adds Restrictions.

The Washington Post (7/14, Stein) reports that the panelists "disagreed sharply” on the first day of Avandia safety hearings about whether Avandia "is unsafe and should be removed from the market." During the hearing, "the FDA's Thomas A. Marciniak presented a detailed critique of a study GlaxoSmithKline sponsored and has held up as the best evidence of the drug's safety." However, "in an unusual display of conflict within the agency, other FDA researchers challenged Marciniak's analysis of the pivotal study, known as Record.” USA Today (7/14, Rubin) reports, "Only one randomized controlled trial -- considered the gold standard for testing medications -- has been completed since 2007, and even FDA reviewers were divided on its value." The New York Times (7/14, A16, Harris) points out that five "of the experts who gave presentations were largely supportive of the drug, saying the clinical trial did not make Avandia appear as risky as some other officials have claimed." CNN (7/14) also covered the story.

The New York Times (7/15, A1, Harris) reported on the conclusion of the meeting on its front page. The 33 panelists "took six votes on a variety of issues" and when asked what the FDA should do, "12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug's label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label's present heart warnings." Dr. Janet Woodcock, director of the FDA's drug center, "said that the agency took the panel's advice seriously and that it would consider its regulatory options." The Washington Post (7/15, Stein) reported that a "majority" of the panel urged to keep the drug "available, perhaps with tough new restrictions and warnings." The votes "came after the panel concluded that there was sufficient evidence to be concerned that Avandia increases the risk of heart attacks and strokes but insufficient evidence that the drug increases the risk of death." USA Today (7/15, Rubin) also reports that the panel "voted 18-6 that the data raise significant concerns that Avandia carries a higher risk of those heart problems than does Actos [pioglitazone], the only other drug in its class. Nine were undecided."

The Hill 's (7/15, Lillis) Healthwatch blog reports, "Sen. Tom Harkin (D-Iowa), chairman of the Senate Health Committee, is calling on the Food and Drug Administration (FDA) to reach a quick verdict on the fate of Avandia." The Hill also notes that the panel's "mixed verdict puts the ultimate decision in the hands of Margaret Hamburg, who heads the FDA." The Los Angeles Times (7/15, Zajac, Maugh), The Wall Street Journal (7/15, Mundy, Dooren), The Boston Globe (7/15, Rowland), Bloomberg News (7/15, Larkin, Peterson), HealthDay (7/14, Gardner), MedPage Today (7/14, Walker), and Time (7/15, Park) also covered the story.

July 14, 2010 - GlaxoSmithKline Settles Many Avandia Patient Lawsuits For $460 Million.

Bloomberg News (7/14, Feeley, Kelley) reports, "GlaxoSmithKline Plc agreed to pay about $460 million to resolve a majority of lawsuits alleging the company's Avandia diabetes drug can cause heart attacks and strokes, people familiar with the accords said." According to these unnamed sources, Glaxo has "agreed to settle about 10,000 suits for an average of at least $46,000 apiece." The drugmaker "had been facing more than 13,000 suits alleging" that it "hid the drug's heart-attack risk, according to a UBS AG analyst." According to Reuters (7/14, Richwine), this week's FDA panel review of Avandia's safety may have played a role in Glaxo's decision to begin negotiations with attorneys representing patients who used to use the drug. The Philadelphia Business Journal (7/13, George) also covered the story.

July 13, 2010 - RA Drug Leflunamide Label To Include Possible Fatal Liver Damage Warning.

MedPage Today (7/13, Petrochko) reported, "The FDA has expanded the black box warning to the label of the rheumatoid arthritis drug leflunomide (Arava) to include possible fatal liver damage." The decision was made after the "agency received 49 adverse event reports -- including instances of jaundice, coagulopathy, encephalopathy, and 14 fatalities -- about the drug from August 2002 to May 2009." The "greatest risk occurred in patients taking other drugs that may cause liver damage while taking leflunomide and in patients with preexisting liver disease." The FDA leflunamide announcement is available on the agency's website.

July 13, 2010 - Application For Drug To Prevent Preterm Births Resubmitted To FDA.

The St. Louis Business Journal (7/13, Barr) reported that KV Pharmaceutical Co. of Bridgeton on Tuesday said a drug application for Gestiva was resubmitted to the FDA by Massachusetts-based Hologic, the firm selling the drug to KV. If the application is approved, Gestiva, "the trademarked hydroxyprogesterone caproate injection, 250 mg/mL," which is "also referred to as '17P,' would be the first and only FDA-approved treatment” to prevent preterm birth in women with a prior spontaneous preterm delivery. Reuters (7/13, Kuber) added that news of the filing increased KV's share price on the NASDAQ Tuesday. At 73 cents, the share price was up a high of some 14 percent.

July 13, 2010 - Company Applies To Sell Generic Version Of Latisse.

The Wall Street Journal (7/13, Gryta, Kamp) reports that an unnamed drugmaker has applied for FDA approval to sell a generic version of Allergan Inc.'s eyelash-enhancing drug Latisse (bimatoprost ophthalmic solution) before the drug's patent expires in September 2012. The unnamed company filed the application with a "Paragraph IV" certification, which means it believes the relevant patent is invalid or will not be infringed by the generic.

July 13, 2010 - Banning "Pay For Delay" Deals Could Save CMS Billions.

The Hill (7/13, Pecquet) reports in its Healthwatch blog, "The War supplemental bill passed by the House just before the July recess would restrict drug makers' ability to pay their generic competitors for delaying the introduction of cheaper generics, among several health-related provisions.” Notably, the "so-called 'Pay for Delay' provision would strengthen the Federal Trade Commission's ability to restrict the practice," and the CBO "estimates this would save the federal government more than $2.4 billion over 10 years in lower drug costs for Medicare, Medicaid, military and veterans' health programs."

July 13, 2010 - Glaxo Hid Avandia Risk Data

Bloomberg News (7/10, Feeley, Cortez) reported that Dr. Rosemary Johann-Liang, "a former US Food and Drug Administration official” alleged in a deposition that the manufacturer “withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks” The New York Times (7/13, A1, Harris) provided additional front page coverage of the story, reporting that recently obtained documents indicate that SmithKline Beecham, the precursor to GlaxoSmithKline, spent 11 years trying to cover up a study that found Avandia (rosiglitazone) was "no better than Actos [pioglitazone]," and also "that it was riskier to the heart." Dr. Martin I. Freed, a SmithKline executive, "wrote in an email message dated March 29, 2001, about the study results that [were] obtained by The Times, 'Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.'" Meanwhile, Dr. John Jenkins, director of the FDA's office of new drugs, "has argued internally that Avandia should remain on the market," and "briefed the company extensively on the agency's internal debate." The Wall Street Journal (7/13, Mundy) reported that Dr. Rosemary Johann-Liang, a former FDA official who quit the agency after being unable to convince her superiors about the need for stronger warnings on Avandia, said there were early reports written by company researchers that noted scientists' concerns about the heart risks with the drug.

Apologies for the Delay in Posting

For the readers, please accept our apologies for the gap in new posts to this health news blog. Our primary purpose for this space was to create an online respository of health news with relevance for Helm Benefit Design, Inc. and to avoid cluttering the corporate computers with these stories. Examining the statistics, It appears there is more external interest in this summary than initially expected. We shall endeavor to serve our visitors/readers with more frequent updates. Comments w