Reacting to a death associated with the multiple sclerosis drug fingolimod (Gilenya), the FDA said patients with certain cardiac risk factors should not take the oral agent...
The interleukin (IL)-1 inhibitor rilonacept (Arcalyst) reduces the number of acute gout flares during the vulnerable period while treatment with allopurinol is being started, FDA reviewers found, but they called the drug's safety into question because of an increased risk of malignancy...
The U.S. Food and Drug Administration earlier today issued an extensive update regarding the risk of developing a second cancer while being treated with Revlimid...
The U.S. Food and Drug Administration thanks the Institute of Medicine (IOM) for its thoughtful insights and recommendations in its report titled, Ethical and Scientific Issues in Studying the Safety of Approved Drugs. We are encouraged to see that many of the IOM’s recommendations align favorably with current FDA programs and processes, and with our plans for further refinements in how we ensure that marketed drugs are safe and effective for the American public...
First-time abusers of prescription painkillers such as OxyContin most often get the drugs for free from friends or family, while chronic abusers seek doctors or dealers to get their fix, a new federal analysis finds...
FDA reminds patients, caregivers, and healthcare professionals of the importance of appropriate storage, use, application, and disposal of fentanyl patches (including Duragesic and generic products) to prevent potential life-threatening harm from accidental exposure to the active ingredient, fentanyl...
Bloomberg BusinessWeek reports, "Astellas Pharma Inc. (4503)'s drug to treat overactive bladder has side effects including increased blood pressure that need to be considered when weighing whether the medicine should be approved, US regulators said." The drug, "mirabegron, also increased heart rate and was associated with hypersensitivity reactions ranging from painful rash to anemia, the Food and Drug Administration said today in a report ahead of an April 5 meeting of advisers on the drug."...
The U.S. Food and Drug Administration today announced that it is seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems as well as potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with such devices. FDA will discuss these issues at a two-day expert advisory panel meeting on June 27-28, 2012...
Yet another effort has been devised by some members of Congress to jumpstart the FDA approval process. The latest initiative is a bi-partisan bill that is called the Advancing Breakthrough Therapies for Patients Act, which would require the agency to hasten the development and review of breakthrough drugs...
The FDA on Tuesday approved Affymax’s Omontys (peginesatide) to treat anaemia in patients with chronic kidney disease on dialysis. Richard Pazdur, director of the Office of Hematology and Oncology Products in the agency’s Center for Drug Evaluation and Research, noted that "Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001...
The FDA approval of 23-mg donepezil (Aricept) conflicted with the opinions of its own reviewers and breached the agency's own regulatory standard, authors write in a BMJ article, leading to misleading consumer and physician ad campaigns that put patients at risk...
Janet Woodcock, who leads the federal government's efforts in evaluating pharmaceuticals, said Wednesday in Center City that she hopes increased use of electronic health records will help doctors prescribe the right drugs, patients understand and follow their treatment plans, and regulators learn more quickly of problems with medicines after they enter the market...
Depression during pregnancy posed problems for the developing fetus and newborns, regardless of whether the mother received treatment, investigators reported...
Drugmakers Pfizer Inc. and Bristol-Myers Squibb Co. say federal regulators have pushed back the deadline for deciding whether to approve their highly touted experimental anticlotting drug...
The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status...
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration...

U.S. health regulators will add warnings to the labels of widely used cholesterol lowering drugs, such as Lipitor, saying they may raise levels of blood sugar and could cause memory loss...

Sleeping pills prescribed by your physician are supposed to ward off the myriad health problems that come with lack of sleep. But adults who take sleeping pills in even small numbers over their lifetimes may be nearly four times more likely to die earlier compared to those who are not prescribed sleeping pills, according to new findings published Monday in the British Medical Journal. And those prescribed sleeping pills may also be more likely to be diagnosed with cancer, the study found...

The combination formulation of phentermine and topiramate should be approved as a weight-loss treatment, with a risk-management plan that addresses the teratogenic effects of topiramate and a postmarketing study that evaluates cardiovascular outcomes associated with treatment, the majority of a Food and Drug Administration panel agreed at a meeting on Feb. 22...

Mifepristone has been approved for the treatment of the orphan disease Cushing’s syndrome, without a risk evaluation and mitigation strategy, despite the drug’s other use as an abortifacient, according to a statement by the Food and Drug Administration...

Federal health officials continue to voice safety concerns over an experimental diet pill from drugmaker Vivus Inc., which will make its second attempt to convince experts of the drugs' safety next week. The drug Qnexa helped people lose weight but may cause long-term health problems in overweight and obese patients, Food and Drug Administration reviewers said...

Amylin Pharmaceuticals, Inc. (AMLN) and Alkermes plc (ALKS) recently announced the availability of their type II diabetes treatment, Bydureon (exenatide once-weekly) in the US...

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together...
Amgen Inc., the world’s biggest biotechnology company, failed to win the backing of a U.S. advisory panel for its drug to delay tumors spreading to bones in patients with advanced prostate cancer...

This year, Congress will have to reauthorize the Prescription Drug User Fee Act (PDUFA), which funds the Food and Drug Administration’s (FDA) drug approval process. As noted by Amanda Kronquist, a Heritage Health Policy Graduate Fellow, the FDA drug approval process has become “increasingly unpredictable, uncertain, and inefficient.”...

The European Medicines Agency, together with the European Union member states and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995. Over the next five months, the Agency says it will finalize its preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), planned for July 19, 2012...

inVentiv Medical Management, an inVentiv Health company and leading provider of physician-directed, nurse-supported and technology-enabled medical management solutions, announced today the national launch of a series of new solutions that help to prevent the inappropriate and ineffective care often associated with some of the most complex and costly health conditions...
The medical marijuana drug Sativex, which could be approved in the United States in the coming years as a treatment for pain relief, has little potential for abuse, experts say...
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Centre for Innovation in Regulatory Science, Ltd. (CIRS) have announced that PhRMA has transferred its Benefit-Risk Action Team (BRAT) framework to CIRS in order to further the program’s technical development and broaden input from the scientific community...

You're taking a new medication and have dry mouth and feel dizzy. Want to know how many other people have reported those side effects—and how your drug compares with similar drugs? The U.S. Food and Drug Administration has millions of such "adverse event" reports, ranging from fatigue to fatal heart attacks, for thousands of prescription drugs dating back to 1969. But the information hasn't been readily accessible—until now...

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today's action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment...

Read more here: http://www.sacbee.com/2012/01/31/4229004/fda-approves-gleevec-for-expanded.html#storylink=cpy
A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country's main chain retail pharmacy lobby...

Health regulators approved Vertex Pharmaceuticals' Kalydeco, the first drug designed to treat the underlying cause of cystic fibrosis, a rare genetic disease...

Amylin Pharmaceuticals won federal approval on Friday for its new, more convenient drug for Type 2 diabetes, ending years of setbacks...
Drug Safety Alliance, Inc., a privately held, woman-owned business, is helping life-science partners gain new agility in responding to change with safety and pharmacovigilance solutions that blend industry knowledge, targeted services, technology and functional expertise. The company will sponsor and present at the DIA Pharmacovigilance and Risk Management Strategies meeting on Monday, January 23 through Wednesday...
A demonstration project at nine hospitals in southern Pennsylvania, aimed at improving the safe use of hydromorphone through a combination of educational programs, computerized order entry improvements and enhanced prescribing oversight, has yielded mixed results, according to its developers...
The poppy is a stunning flowering plant, with a species of flower (opium poppy) that yields a natural agonist for the μ-opioid receptor. This receptor is a G-protein coupled receptor found extensively in the brain and spinal cord, whereby activation causes potent analgesia, with such ancillary effects as sedation, respiratory depression, itching, constipation, nausea and dependence, among others...
To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment...

U.S. health regulators said on Friday they have submitted to Congress new recommendations for how manufacturers will help fund their review of new branded drugs, conventional generic medicines and a new generation of generic biotech treatments...

The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label. At the time of Adcetris' approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label...

A second drug company has confirmed it plans to market a new form of the powerful and addictive painkiller hydrocodone, worrying experts who fear a narcotics "arms race" that could worsen a national problem with prescription drug abuse...
Sen. Charles Schumer (D-N.Y.) is urging federal regulators to be extra cautious as they decide whether to approve new super-potent painkillers...

Vivus Inc said U.S. health regulators asked the company to remove a contraindication in the proposed label of its obesity drug Qnexa, a move that could help it reach a broader patient population...

VIVUS, Inc. today announced that following recent discussions with Food and Drug Administration (FDA) officials, the company has been asked to remove the Qnexa® contraindication for women of childbearing potential contained in the proposed label.  Qnexa would remain contraindicated for women who are pregnant.  A contraindication typically indicates that a drug should not be used because the risk of use clearly outweighs any possible therapeutic benefit...
New York Sen. Kristen Gillibrand is accusing federal agencies of dragging their feet on a decision over whether to tighten controls on the addictive painkiller hydrocodone...
The number of new prescription drug shortages in 2011 shot up to 267, well above the prior record and about four times the number of medication shortages in the middle of the last decade...
Arena Pharmaceuticals Inc said on Tuesday it submitted data to health regulators that should squash cancer concerns tied to the company's experimental weight loss drug lorcaserin, and believes it will gain U.S. approval...
The Food and Drug Administration approved a label expansion Tuesday for CSL Behring ’s Berinert product, a treatment for acute attacks of hereditary angioedema...
San Diego’s Zogenix is downplaying concerns by some addiction experts that its powerful new painkiller Zohydro could become widely abused if the drug is approved by the U.S. Food and Drug Administration...
Not taking your medicines as prescribed can hurt your wallet as well as your health and far outweigh any savings on your pharmacy bill...

A wave of new prescription painkillers presents a potential danger to society, some medical researchers warn...

The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system...
BioDelivery Sciences International, Inc. responded to the approval and announcement by the U.S. Food and Drug Administration (FDA) that a Risk Evaluation Mitigation Strategy (REMS) covering all transmucosal fentanyl products has been approved. The program, which will be referred to as the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Program, was designed to ensure informed risk-benefit decisions before initiating treatment with a transmucosal fentanyl product, and while patients are on treatment, to ensure appropriate use...
It's good to be the CEO of Biogen Idec. The stock has surged, there's a top late-stage candidate in the pipeline for MS, and everyone seems to like George Scangos. In a wide-ranging interview with Investors Business Daily, Scangos discusses his excitement for new research in neurodegeneration and cancer, as well as his views of the FDA now that the new PDUFA discussions are under way...

High-risk, high-reward investors looking for an investment opportunity should consider Nestragel from Antares (AIS.) The company offers a new product with unlimited potential to generate long-term revenue...

On December 28th, the U.S. Food and Drug Administration (FDA) approved a single, shared system Risk Evaluation and Mitigation Strategy (REMS) for the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines...
Some opioid painkillers used by cancer patients are governed by U.S. Food and Drug Administration plans to manage possible health risks. The FDA is changing how it manages these drugs and these changes should help Raleigh, North Carolina company BioDelivery Sciences International. Here’s how...
Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa...
Teva Pharmaceutical Industries Ltd. said its chief executive will retire in May and be succeeded by a Bristol-Myers Squibb Co. executive...
Law enforcement agents and drug users in Portland are saying street abuse of Suboxone, a prescription drug intended to help individuals become less dependent on opiates such as heroin, is a new counterculture fad in Maine’s largest city...
Europe's main drug regulator said it was starting a review of the Novartis AG hypertension pill aliskiren after a large clinical trial linked the drug to possible risks of nonfatal stroke and kidney problems...
Drugmaker Pfizer Inc. says the Food and Drug Administration has accepted its application for approval of its experimental drug for adults with moderate to severe rheumatoid arthritis...
Three top European pharmaceutical companies announced on Tuesday disappointing news from clinical tests on drugs they had hoped would turn out to be big sellers...
The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation...
The U.S. Food and Drug Administration (FDA) has completed a safety review of the heart drug Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF)...
The Food and Drug Administration (FDA) has released a Complete Response Letter to Arena Pharmaceuticals declining an immediate approval for the weight drug lorcaserin...
Berlin Heart GmbH, a closely held German device maker, said it won U.S. regulatory approval for the first heart pump used to help children survive as they await a transplant...
Alexza Pharmaceuticals, Inc. announced today that that it has retained Lazard to assist in exploring strategic options to enhance stockholder value, including a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions...

Corcept Therapeutics Incorporated a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders, today announced that it has been advised by the U.S. Food and Drug Administration (FDA) that no Risk Evaluation and Mitigation Strategy (commonly known as a "REMS" program) will be required in connection with Corcept's proposed distribution of its lead product candidate, mifepristone, to which Corcept has given the brand name Korlym...

Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act...
Novartis confirmed Monday that a patient with multiple sclerosis died within 24 hours of starting treatment with Gilenya (fingolimod). The drugmaker noted that "this is the first reported death event occurring within 24 hours of the first dose of Gilenya in more than 28,000 patients who have received Gilenya to date." Novartis added that "at this stage, the exact cause of death has not been established, and a role for Gilenya can neither be confirmed nor excluded at this time."...
Shares in Alexza Pharmaceuticals climbed as much as 73 percent Tuesday after an FDA advisory panel voted 9-8, with one abstention, to recommend approval of Adasuve (Staccato loxapine) for the treatment of agitation in patients with schizophrenia or bipolar mania. The regulator is expected to make a final decision on whether to approve the inhaled drug by February 4...
A study of 150,000 adults taking drugs for attention deficit hyperactivity disorder (ADHD) found no conclusive evidence that the medications increase the risk for heart attack, stroke, or sudden death from heart-related causes...

Advisors to the Food and Drug Administration on Dec. 9 voted 19 to 5 that the benefits of the Ortho Evra contraceptive patch outweighed its risks, although they agreed with epidemiologic evidence that use of the patch is associated with an increased risk of venous thromboembolic events...

Teva Pharmaceutical Industries Ltd.’s Cephalon unit won an appeals court decision that prevents Watson Pharmaceuticals Inc. from selling a generic copy of the painkiller Fentora until 2019...
In 1984 the Hatch-Waxman Act made it cheaper and easier to put generic versions of a drug on the market. As a result of the expedited approval process, generics now make up more than 60 percent of prescription drugs sold in the U.S. and have saved the health care system $734 billion between 1999 and 2008 alone...

Alexza Pharmaceuticals Inc. (ALXA)’s inhaled antipsychotic drug may put some patients at risk for respiratory failure, according to U.S. regulators considering whether to approve the treatment for sale...

Affymax Inc. (AFFY) won a U.S. panel’s backing for an experimental anemia medicine that would compete with treatments marketed by Amgen Inc. (AMGN) and Johnson & Johnson (JNJ) for patients with chronic kidney disease...

Drugs for the treatment of chronic back pain and arthritis-related pain will continue to be the most lucrative segments of the market for chronic pain treatments up to 2020, according to new forecasts...
In this supplement, we present the background to the REMS program, a brief review of BTP along with the clinical data supporting the use of FENTORA and ACTIQ for BTP in appropriate opioid-tolerant patients, and an overview of the recently approved REMS for FENTORA and ACTIQ...
Two FDA Committees will discuss the benefits and potential harms of oral contraceptives that contain drospirenone, after safety concerns have emerged which appear to show a slight elevation of venous thromboembolism risk. According to recent studies, such contraceptives have a higher blood clot risk compared to oral contraceptives containing the progestin, levonorgestrel. The two Committees are the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee...


The FDA on Tuesday announced that it modified the requirements of the Risk Evaluation and Mitigation Strategy (REMS) for Amgen’s Nplate (romiplostim) and GlaxoSmithKline’s Promacta (eltrombopag) so that prescribers and patients are no longer required to enroll in the safety monitoring programme for the drug. In addition, healthcare professionals will no longer be required to complete periodic safety checks for patients receiving either chronic immune thrombocytopenic purpura (ITP) therapy...

The U.S. Food and Drug Administration (FDA) has approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs Nplate (romiplostim) injection and Promacta (eltrombopag) tablets. The modifications include the removal of certain elements of the REMS, including the requirements for restricted distribution and additional safety data collection...
Drug reviewers found Affymax Inc's treatment for anemia in dialysis patients with chronic kidney disease to be as effective as market-leading drugs by Amgen Inc, but cautioned they were not convinced of its safety...

Watson Pharmaceuticals reported Tuesday that US regulators cleared the company's oral contraceptive product Vestura, which is a generic version of Bayer's Yaz (drospirenone/ethinyl estradiol)...

The FDA accepted and assigned priority review status to Bristol-Myers Squibb and Pfizer's marketing application seeking approval of Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), the companies said Tuesday...
Pfizer’s Lipitor (atorvastatin) is scheduled to lose patent protection in the US on Wednesday and it remains uncertain how much of the market share the company can retain and how much will be lost following the introduction of generic alternatives...
Blood thinners and diabetes drugs cause most emergency hospital visits for drug reactions among people over 65 in the United States, a new study shows...
Statins are safe and effective in the long run, providing lasting reductions in vascular events and no increased risk of cancer, researchers found...
The U.S. Food and Drug Administration (FDA) granted accelerated approval for eculizumab (Soliris, Alexion Inc.) for the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS)...
Analysts on Friday indicated that expanded US regulatory approval of Johnson & Johnson and Bayer's Xarelto (rivaroxaban) to include the prevention of stroke in people with atrial fibrillation is now expected...
An FDA advisory panel on Friday voted 17-6 in favour of recommending that the labels of bisphosphonates be updated to clarify how long patients should take them in order to reap the greatest benefit and least risk..
Bone drugs from Warner Chilcott Plc, Roche Holding AG, Merck & Co. and Novartis AG need labeling changes to reduce the risk of fractures, a U.S. panel said...
In documents released Tuesday ahead of an FDA panel meeting on September 8, agency staff suggested that the regulator issue a complete response letter in reply to a marketing application seeking to expand approval of Johnson & Johnson and Bayer's Xarelto (rivaroxaban) to include the prevention of stroke in people with atrial fibrillation (AF)...
Discovery Laboratories announced Tuesday that it responded to an FDA complete response letter issued over Surfaxin (lucinactant), the company’s experimental drug for the prevention of respiratory distress syndrome in premature infants...
Data from a mid-stage study presented at the European Society of Cardiology meeting suggest Astellas' experimental oral anticoagulant darexaban increased bleeding two- to four-fold in patients with acute coronary syndrome...
NuPathe shares plunged as much as 56 percent Tuesday after the company announced it received a complete response letter from the FDA regarding its application for the Zelrix (sumatriptan) migraine patch.
Pfizer and Bristol-Myers Squibb presented data at the European Society of Cardiology Congress from a late-stage trial which demonstrated that Eliquis (apixaban) significantly reduced the risk of stroke or systemic embolism, major bleeding, and mortality compared to warfarin...
The FDA has approved tapentadol (Nucynta), an extended-release oral opioid, to treat severe chronic pain...
The FDA on Tuesday issued a drug safety communication that warned that patients treated with Pfizer’s antibiotic Zyvox (linezolid) in combination with certain antidepressants may be at risk of serotonin syndrome...
Bristol-Myers Squibb has informed healthcare professionals about the Risk Evaluation and Mitigation Strategy (REMS) for belatacept (Nulojix) required by FDA to ensure that the benefits outweigh the risks for transplant patients who receive the drug...
Physicians generally should avoid prescribing either methylene blue or linezolid (Zyvox,Pfizer) in combination with serotonergic agents such as paroxetine or duloxetine to avoid a potential drug interaction causing a dangerous condition called serotonin syndrome, the US Food and Drug Administration (FDA) announced today...
Japan's largest drugmaker Takeda Pharmaceutical Co (4502.T) said it resubmitted two new drug applications (NDA) to the U.S. Food and Drug Administration (FDA) for investigational type 2 diabetes therapies...
The FDA announced that it launched a review of Sanofi’s Multaq (dronedarone) after a late-stage study involving patients with permanent atrial fibrillation (AF) suggested an increased risk of death, stroke and hospitalisation from heart failure among patients given the drug...
Johnson & Johnson's Janssen Biotech unit announced Friday the receipt of a complete response letter from US regulators regarding the company's filing for expanded approval of Simponi (golimumab) for limiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis...
Cephalon, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the Risk Evaluation and Mitigation Strategy (REMS) for FENTORA® (fentanyl buccal tablet) [C-II] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]...
The discussion at today’s meeting of the FDA’s Circulatory System Devices Panel, which is evaluating the Sapien transcatheter heart valve (Edwards Lifesciences) for an expected recommendation to the FDA this afternoon, has been largely focused on the complication of stroke associated with transcatheter aortic valve implantations (TAVI) found in the PARTNER Cohort B trial...
The FDA on Wednesday approved AstraZeneca’s Brilinta (ticagrelor) to reduce the risk of cardiovascular death and heart attack in patients with acute coronary syndromes...
AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday...
The US Food and Drug Administration (FDA) has published its latest quarterly list of drugs to monitor after having identified potential signs of serious risks or new safety information, and dronedarone (Multaq, Sanofi-Aventis), appears on it for the fifth straight time...
There are concerns that the US Food and Drug Administration (FDA) is failing to consider the views of patients who need access to life-saving drugs, including those treatments that carry some risk, a Congressional leader has said...
The government is making it easier to test new Alzheimer’s drugs, hoping to speed progress toward new treatments for the mind-robbing disease...
Bristol-Myers Squibb informed healthcare professionals about the REMS that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of PTLD and PML, both of which can be fatal. Patients treated with Nulojix are at an increased risk for developing PTLD, predominantly involving the CNS...
Eli Lilly, Amylin and Alkermes announced that in a study designed to satisfy a request from US regulators, the type 2 diabetes drug Bydureon (extended-release exenatide) didn't affect the heart rate in healthy people...
Clinicians prescribing belatacept (Nulojix, Bristol-Myers Squibb), a kidney transplant drug, need to keep in mind the increased risk for 2 potentially fatal complications, which were known when the medication was approved on June 15, the US Food and Drug Administration (FDA) announced today...
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, testified Thursday before the US House Energy and Commerce's health subcommittee that first-cycle drug approvals are at a 20-year high and that more than two-thirds of new treatments are being cleared within the time frames given to new drug applications...
Novartis announced that the FDA has approved once-daily Arcapta Neohaler (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema...
A concerted effort by the FDA to demand risk evaluation and mitigation strategies (REMS) for pharmaceuticals at high risk of diversion, such as opioid analgesics, could help drive adoption of track-and-trace technology such as serialisation in the USA...
A new study shows an increase in the risk of heart attacks and other cardiovascular events among smokers who take the drug Chantix to help them quit...
The US Food and Drug Administration (FDA) has approved fentanyl nasal spray (Lazanda) for the management of breakthrough pain in adults with cancer...
A post-approval study investigating Pfizer's epilepsy drug Neurontin (gabapentin) was in fact a "seeding trial" designed to "promote…and increase prescribing" of the drug, according to a report published in the Archives of Internal Medicine...

First-ever study of the impact of REMS on supply chains finds that collaboration is a critical requirement...

Revised prescribing information reflects FDA guidance to update labeling for all drugs within ESA class...
The FDA has approved a short-acting opioid painkiller with abuse-deterrent properties, the drugmaker Pfizer announced Monday...
The FDA on Friday recommended modified language in the prescribing information for the use of erythropoiesis-stimulating agents (ESAs), including Johnson & Johnson’s Procrit (Epoetin alfa) and Amgen’s Aranesp (darbepoetin alfa) and Epogen (Epoetin alfa), in patients with chronic kidney disease (CKD)...
Pfizer and Pain Therapeutics received a complete response letter from the FDA with regards to a regulatory filing for the experimental abuse-resistant pain drug Remoxy (oxycodone), the companies announced Friday...
The FDA has approved a short-acting opioid painkiller with abuse-deterrent properties, the drugmaker Pfizer announced Monday...
A new eye medicine from Regeneron Pharmaceuticals Inc and Bayer AG is safe and effective for treating a common cause of vision loss, a panel of U.S. experts said on Friday...
An advisory committee of the Food and Drug Administration (FDA) today voted in favor of the overall efficacy but not the overall safety of ACZ885 (canakinumab) to treat gouty arthritis attacks in patients who cannot obtain adequate relief with non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. Committee members raised the potential for use in a more narrow population of gouty arthritis patients...
Big pharmaceutical companies have found replacements for the army of sales representatives they've laid off in recent years: digital sales tools that seek to sell doctors on drugs without the intrusion of an office visit...
The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer...
The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease...
Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza...
A Tennessee man has filed suit against Abbott Laboratories for failing to sufficiently issue a complete REMS program for its Humira rheumatoid arthritis treatment, because he developed a life-threatening fungal infection that he claims could have been avoided had the drugmaker acted when prompted by the FDA.

The complaint, filed in federal court in Tennessee by Fred Delano, may be one of the first product-liability lawsuits to accuse a drugmaker of moving insufficiently to develop and enact a complete REMS, or Risk Evaluation and Mitigation Strategy, which the FDA can require a drugmaker to implement to ensure safe use of drugs. Typically, such lawsuits have cited failures by drugmakers to issue black box warnings on labels...

BioDelivery Sciences International, Inc. (BDSI®) (Nasdaq: BDSI) provided an update on progress with the modified REMS (Risk Evaluation and Mitigation Strategy) program for ONSOLIS (fentanyl buccal soluble film), which among other changes, is expected to allow for dispensing of ONSOLIS from retail pharmacies...
On May 31, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public about new information that is being assessed as part of FDA's ongoing safety review of birth control pills that contain drospirenone. This review will further evaluate the risk of blood clots in women who use these products...
In the first national meeting on pain since the US Food and Drug Administration (FDA) announced its long-awaited opioid plan, specialists came out on the side of the move, but they did so with reservations...
The U.S. Food and Drug Administration (FDA) is informing the public about new information1,2 that is being assessed as part of FDA's ongoing safety review of birth control pills that contain drospirenone. This review will further evaluate the risk of blood clots in women who use these products...
The U.S. Food and Drug Administration today approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin...
FDA Drug Safety Podcast for Healthcare Professionals: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl...
FDA announced May 18 to the public new restrictions to the prescribing, dispensing, and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline [GSK]) as part of a Risk Evaluation and Mitigation Strategy (REMS). The new restrictions require healthcare providers, including pharmacists, and patients to enroll in a special program in order to prescribe, dispense, and receive these drugs...

Abbott Laboratories (ABT) should continue marketing the cholesterol pill Trilipix with standard statin therapy while conducting a new study to examine what effect the combination has on heart risks, a U.S. panel said...

People given a drug known as erythropoietin alfa after a heart attack may experience new heart problems and even greater cardiac damage from the attack, a new study finds...
Merck & Co. won U.S. approval for the first hepatitis C drug in almost a decade after studies showed it cured more patients than existing treatments...
The U.S. Food and Drug Administration is requesting input from stakeholders and the public relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications...
Even short-term use of some painkillers could be dangerous for people who've had a heart attack, according to research published in Circulation: Journal of the American Heart Association...
An expert panel on Thursday unanimously voted in support of a second new hepatitis C drug, Vertex Pharmaceuticals' telaprevir, which studies suggest can boost cure rates of the liver disease...
Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved AndroGel® (testosterone gel) 1.62%, a clear, odorless, gel formulation shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared to AndroGel 1%.
To further evaluate the safety of Long-Acting Beta-Agonists (LABAs) when used in combination with inhaled corticosteroids for the treatment of asthma, the U.S. Food and Drug Administration (FDA) is requiring the manufacturers of LABAs to conduct five randomized, double-blind, controlled clinical trials comparing the addition of LABAs to inhaled corticosteroids versus inhaled corticosteroids alone...
The U.S. Food and Drug Administration today approved Actemra (tocilizumab), given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in children ages 2 years and older...
AstraZeneca may have missed the blockbuster opportunity of treating lung cancer with vandetanib, but it picked up a significant consolation prize yesterday when the FDA approved the treatment for advanced cases of a rare form of thyroid cancer...
The Center for Healthcare Supply Chain Research, the research foundation of the Healthcare Distribution Management Association (HDMA), today released Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain...

The agency is looking into the creation of a new position that would oversee FDA’s multiple drug safety initiatives...

The Food and Drug Administration's requirements for e-prescribing and risk evaluation for controlled substances can be burdensome for pain physicians, according to a MedPage Today news report...
Antidepressants may narrow the arteries of middle-aged men, potentially putting them at risk for heart attacks and stroke, researchers said...
Boehringer Ingelheim announced the study outline for the pivotal Phase III clinical trials designed to evaluate BI 201335, its investigational once-daily oral protease inhibitor, in both treatment-naïve and -experienced patients with chronic genotype-1 hepatitis C virus...
Orexo AB (STO: ORX) announces today that its partner ProStrakan Group plc (LSE: PSK) has launched Abstral in the United States...
Questions and Answers on Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)...
By tracking the use and side effects of a medicine, biotechnology companies can help physicians prescribe those medicines more safely and effectively, as proven in a study released today by BIOCOM, the life sciences trade association representing Southern California. Safety First: The Role of Physician Level Data in Supporting Risk Evaluation and Mitigation Strategies (REMS) for Optimal Patient Care—A Case Study documents the use of physician level data...
The American Pharmacists Association (APhA) and LearnSomething announced a new partnership to develop educational tools and resources for drugs that require Risk Evaluation and Mitigation Strategy (REMS) programs...
Physicians from Purdue Pharma LP, Stamford, CT, showcased study results that demonstrate the analgesic efficacy and safety of Butrans for the relief of moderate to severe chronic low back pain in opioid-naive patients. Butrans is a transdermal delivery system that provides systemic delivery of buprenorphine, a Schedule III medication, continuously over a 7-day period...
The US Food and Drug Administration (FDA) announced today the approval of ipilimumab (Yervoy, Bristol-Myers Squibb) for the treatment of advanced melanoma as a second-line therapy.

Ipilimumab is the first agent ever proven to improve survival in advanced melanoma. Its Biologics License Application was granted priority review designation in August 2010...

FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication “Drug Facts” label is not indicated at this time. Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low dose PPI use is unlikely...
The U.S. Supreme Court, allowing a suit over a withdrawn cold remedy, gave shareholders more power to sue drugmakers and biotechnology companies for failing to reveal indications about dangerous side effects...
Previous page: REMS Daily Next page: REMS Events
 
Register for periodic industry updates:

2013-2014© 2014 ParagonRx. All rights reserved.