Latest Fda Approved Drugs Information Systems

FDA notified healthcare professionals that the Victrelis drug label has been revised to state that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended. The findings of a drug-drug interaction study and clinical trial showed that co-administration increased of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir).

FDA granted accelerated approval to everolimus (Afinitor tablets, Novartis) for the treatment of adults with renal angiomyolipoma, associated with tuberous sclerosis complex (TSC), who do not require immediate surgery. April 26, 2012

FDA approved pazopanib tablets (VOTRIENT, a registered Trademark of GlaxoSmithKline) for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of pazopanib for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated. April 26, 2012. 

[4-26-2012]  The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir). Patients should not stop taking any of their hepatitis C or HIV medicines without talking to their healthcare professional.  Patients should contact their healthcare professional with any questions or concerns.  Healthcare professionals who started patients infected with both chronic HCV and HIV on Victrelis while the patient was taking antiretroviral th...

The ongoing restructuring underway at AstraZeneca ( $AZN ) claimed one more employee today: The chief architect.  CEO  David Brennan  has abruptly resigned--pushed out in a coup, according to the  BBC --with plans to hand over the reins to CFO Simon Lowth as the pharma giant begins the hunt for a new chief. Leif Johansson will move in to the non-executive chairman's spot June 1, moving up the date on the planned switch out at the top to provide some stability for a company undergoing wrenching changes. Brennan's departure marks the end of a 6-year stint plagued with R&D setbacks capped by layoffs and a showdown with a restive crowd of investors and analysts increasingly frustrated by the company's failure to execute an effective round of acquisitions and licensing deals. His resignation will take him out of the firing line for the annual meeting after the company reported a 44% plunge in first quarter profits, a predictable result of new generic competitio...

--Watson Pharmaceuticals agrees to buy Actavis in deal valued at $5.94B --Deal strengthens Watson's position in European markets --Deutsche Bank, which has an Actavis stake, will book a EUR257M impairment charge (Adds analyst reaction beginning in paragraph seven.) Watson Pharmaceuticals Inc. (WPI) agreed to acquire Swiss rival Actavis in a widely expected deal potentially valued at roughly EUR4.5 billion ($5.94 billion), which will give the U.S.-based group a boost in the global rankings of generic drug makers to No. 3. Watson President and Chief Executive Paul M. Bisaro said the deal -- expected to close in the fourth quarter -- ...

Pressure is growing on researchers to do a better job of communicating the results of clinical trials to the volunteers who participated. As  WSJ’s Informed Patient reports , groups like the Michael J. Fox Foundation for Parkinson’s Research are stepping up programs to help match patients to clinical trials. Meanwhile,  new FDA regulations  that went into effect last month require that trial results be included in the federal  ClinicalTrials.gov  website after studies are completed. A number of summaries are already posted on the site, but they tend to be technical and aimed primarily at experts. Deborah Zarin, director of ClinicalTrials.gov, tells the Health Blog that the  Department of Health and Human Services  is now considering whether consumer summaries can be developed in a way that is “non-promotional, complete and accurate.” Zarin adds that ultimately ClinicalTrials.gov will have to depend on industry and research sponsors t...

Pfizer announced today that it is selling its nutritional business, a leading maker of infant formula in Asia, Europe, and Latin America, to Nestle for $11.85 billion or nearly 20 times the division’s EBITDA. That’s nearly $2 billion more than analysts were forecasting the business  might get last year, when I first reported  on the idea that the drug giant might be spinning off non-core divisions. The Pfizer baby formula unit is expected to generate $2.4 billion in sales this year. That Pfizer got such a good price is obviously a win for investors. The company will be using the money to buy back shares, according to a statement by chief executive Ian Read – unless, he says, he can find a better way to put it to use. But shares edged down sixteen cents to $22.40 this morning, so, obviously, this victory was already baked in. What’s next? For one thing, investors are likely to turn their eyes to another sale. Pfizer has already said it will also explore options for its a...

Everyone knows about the Pharma industry’s R&D productivity woes, but few seem to have solutions that work. Part of treating the problem requires an accurate diagnosis, and this winter’s work in Nature Reviews Drug Discovery by  Scannell et al  from Sanford Bernstein (a must read) does a good job of explaining a number of possible drivers: the ‘better than the Beatles’ problem; the ‘cautious regulator’ problem; the ‘throw money at it’ tendency; and the ‘basic research–brute force’ bias.  Others covered the piece with additional superb commentary  here , and  here . I’m sure all these contribute to some degree, though I must admit I’m a bit skeptical that the “industrialization” of R&D are real culprits (i.e., blaming high throughput screening, target-driven reductionism, and other technologic approaches).  Drug discovery is an information-rich world today in large part due to the impressive advances in robotics, screening, -omics technologies...

Diamond Pet Foods is expanding a voluntary recall to include one production run and four production codes of Chicken Soup for the Pet Lover’s Soul Adult Light formula dry dog food. One bag of the product has tested positive for Salmonella, and the recall of the four production codes is being conducted as a precautionary measure.

By Bill Berkrot NEW YORK (Reuters) Mar 12 - As drug counterfeiters step up their sales of bogus medicines, global health regulators have few protections in place to prevent them from reaching patients, and new laws aimed at addressing the problem could be years away. Scrutiny of the supply chain has grown since fake versions of Roche's cancer drug Avastin (bevacizumab) turned up at U.S. oncology practices late last year, sparking an international investigation that so far stretches from southern California back to Turkey with a stopover in a Cairo suburb. Drug manufacturers, distributors, pharmaceutical security experts and regulators interviewed by Reuters identified vulnerabilities all along the supply chain and called for comprehensive measures to protect patients and punish perpetrators. The World Health Organization (WHO) estimates that less than 1% of medicines available in the developed world are likely to be counterfeit. Globally, however, the figure is around 10...

By Anna Yukhananov WASHINGTON (Reuters) Mar 08 - The Infectious Diseases Society of America is proposing a new approach to the problem of drug-resistant bacteria: turn infections into a rare disease. The group offered a plan on Thursday that would allow the U.S. Food and Drug Administration (FDA) to review certain kinds of antibiotics like it reviews "orphan" drugs for rare diseases, making it easier for companies to gain approval. Misuse of medications and other factors have fueled the evolution of multi-drug resistant "superbugs" for which there are few treatment options. MRSA -- methicillin-resistant Staphylococcus aureus -- alone is estimated to kill around 19,000 people every year in the United States. Many drugmakers have turned away from what has become an unprofitable area of research, leaving few medicines to fight drug-resistant strains. Today, only two large companies -- GlaxoSmithKline Plc and AstraZeneca Plc -- still have strong antibioti...

Problem Problem This month marks the tenth anniversary of ISMP's very first newsletter article about a "new and emerging technology" we coined back then as "smart" infusion pumps ("Smart" infusion pumps join CPOE and bar-coding as important ways to prevent medication errors. February 6, 2001. www.ismp.org/Newsletters/acutecare/articles/20020207.asp ). Since then, smart infusion pump technology has evolved considerably, and its application has spread substantially throughout US hospitals. Based on results from our  2011 ISMP Medication Safety Self Assessment for Hospitals , about half of the respondents now use smart pump technology throughout the organization to intercept and prevent errors due to misprogramming or miscalculation of doses or infusion rates. Another quarter of hospitals use smart infusion pumps in some patient care units. Yet, preventable errors associated with the misprogramming of smart infusion pumps still occur, sometimes cau...