The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.
A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.
According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.
Dr. Shruti Bhat, is a Leader in Pharmaceutical R&D and QbD specialist presents few salient points regarding the latest quality systems expected by regulators from the life science, more particularly pharmaceutical industry. But first, a brief chronology of evolution of quality systems. Definitions and scope of quality systems in pharmaceuticals has evolved over a period of time. The “Thalidomide babies tragedy” prompted the concept of continuous or cGMP. With cGMP came into existence the concept of Quality Assurance or “Zero defect”. QA advocated that quality cannot be created at the end of processing, but has to be in-built into a product at every step of manufacturing process. Further improvements in quality systems throughout the 1990’s and beyond brought about concepts of internal audits, documentation and validations. Y2K improved quality systems further...introduced 21CFR part 11 compliance measures. Year 2010 and beyond promises further refinement in quality systems- Quality-by-Design (QbD). What is quality by design? Quality by designmeans designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process.Where to implement quality by design? Quality by design implementation targets the following departments within a pharmaceutical company-Management, Procurement, R&D, Manufacturing, Testing, Quality control, Quality assurance, Regulatory, Logistics, Sales, Warehouse/ Supply chain including vendors facilities, CRO and CMO. Principles of quality by design?QbD scope assume that problems can be anticipated and their occurrence prevented by reviewing data and analyzing risks associated with operational and quality system processes and by keeping abreast of changes in scientific developments and regulatory requirements. The central goal of a quality system is the consistent production of safe and effective products and ensuring that these activities are sustainable. A robust quality system will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions. When fully developed and effectively managed, a QbD system will lead to consistent, predictable processes that ensure that pharmaceuticals are safe, effective, and available for the consumer. Framework of quality by design?Quality by design integrates quality systems and risk management approaches into its existing programs with the goal of providing the necessary framework for implementing quality by design (building in quality from the development phase and throughout a product’s life cycle), continual improvement and risk management in the drug manufacturing process and also for post development changes and optimization.Quality risk management (governed by CAPA- corrective actions preventive actions) is a valuable component of an effective quality systems framework. Quality risk management can, for example, help guide the setting of specifications and process parameters for drug manufacturing, assess and mitigate the risk of changing a process or specification, and determine the extent of discrepancy investigations and corrective actions. CAPAfocuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. QbD system models discuss CAPA as three separate concepts, all of which are used in this guidance:• Remedial corrections of an identified problem. • Root cause analysis with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem. • Preventive action to avert recurrence of a similar potential problem.Review outcomes typically include: • Improvements to the quality system and related quality processes. • Improvements to manufacturing processes and products.• Realignment of resources. The results of a management review would typically be recorded. Planned actions should be implemented using effective CAPA and change control procedures. http://www.qa-expert.com/2010/06/quality-systems-approach-to.html To be continued...
Health Canada says Accutane may cause potentially deadly skin reactions. The Canadian Press reported that in an advisory from, Health Canada warned consumers that rare but potentially deadly skin reactions have been reported with the use of Accutane [isotretinoin] for the treatment of severe acne. ... Diabetes drug may increase fracture risk in women.
According to a study published in the Journal of Clinical Endocrinology & Metabolism, women with type 2 diabetes who take a commonly prescribed drug for the problem are at a higher risk of bone fractures. Researchers found that women taking "a class of medicines called thiazolidinediones, or TZDs... Syringes with detachable needles may play role in hepatitis C incidence among drug abusers. The Los Angeles Times reported, "The high incidence of hepatitis C infections among drug abusers may be due in part to the use of syringes with detachable needles...FDA unveils risk-management plan for anti-anemia drugs. The Los Angeles Times reported that Physicians who want to prescribe Amgen Inc.'s anti-anemia drugs for cancer patients will have to register and undergo special training under a risk-management plan unveiled by the FDA... Antibiotics may be overprescribed for ear infections.
The Wall Street Journal reported that many physicians routinely prescribe antibiotics for ear infections in young children, even as current guidelines only recommend the treatment for the youngest and sickest of patients... Drug counterfeits continue to plague Middle East. Syria is reportedly aiming to reduce the use of counterfeit drugs as the problem remains widespread in the Middle East. A recent seizure of millions of dollars worth of breast cancer, leukemia ... Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.Do you have questions for the author?
UK's NICE says bevacizumab is not cost-effective, should not be prescribed. The UK's National Institute for Health and Clinical Excellence reported that Roche Holding AG's Avastin (bevacizumab) should not be prescribed for bowel cancer patients under the National Health Service because it is too costly. NICE added in its preliminary ruling that Avastin in combination with oxaliplatin should not be paid for by NHS because it is not cost-effective. The recommendation follows Roche's offer to subsidize treatment following discussions with the UK Department of Health. NICE's formula to determine the cost-effectiveness of drugs "looks at quality of life and overall cost effectiveness," but its maximum limit "has not changed in ten years despite inflation." A number of "patient groups and experts voiced their dismay" regarding the decision, and the Daily Mail adds that NICE, "which has been accused of spending more on spin than on evaluating drugs, has often been criticized for banning drugs from NHS use as too expensive." Judge dismisses Fosamax case. The Wall Street Journal reported that a federal judge dismissed a case over allegations that Merck & Co.'s osteoporosis drug Fosamax caused osteonecrosis in a 74-year-old woman. Bessie Flemings claimed that she developed the severe jaw condition from taking the drug and that Merck did not adequately warn of the risk of osteonecrosis. The judge ruled that "experts for Bessie Flemings...can't establish that Fosamax caused her osteonecrosis," and as a result, "her failure-to-warn claim is insufficient as a matter of law," An attorney for Merck noted that "Flemings did not present any reliable evidence supporting her claim," adding that "Flemings had medical problems that cause people to develop jaw problems regardless of whether they were taking Fosamax." The company, "as of Sept. 30, faced about 953 Fosamax cases, including suits with multiple patients.". Pfizer ordered to pay $103 million in punitive damages in hormone drug cases. On the front page of its Business Day section, the New York Times reported that, "Pfizer has been ordered to pay a total of $103 million in punitive damages to two women who were found to have breast cancer after they used" the hormone drugs Premarin and Prempro. Pfizer units Pharmacia and Wyeth "marketed the drugs as a standard, long-term hormone treatment for menopausal women, until medical evidence emerged indicating that such therapy raised women's risk of breast cancer." Now, a jury has "reached a $28 million judgment" in a case Monday, "while a judge unsealed a month-old $75 million judgment in the other case." Lawyers for the plaintiff Monday noted, "This is just the tip of the iceberg as Wyeth faces lawsuits from more than 10,000 additional women who also claim that Wyeth's drugs gave them breast cancer," But, a Pfizer spokesman said that "of the 34 trial-set cases to date, there have been only four plaintiffs' verdicts that have not been set aside." Also at http://www.qa-expert.com/2010/01/drug-regulatory-updates.html Disclaimer : The information presented here is for information purpose only and should not be interpreted as medical advise.
Human Genome Sciences seeks FDA approval for hepatitis C drug. Human Genome Sciences, Inc. reported that it has filed for marketing approval of its hepatitis C drug Zalbin [albinterferon alfa-2b]." Human Genome "did not say when it expected a response to its biologics license application," but did say that "its partner Novartis AG will file for European Union approval before the end of 2009." The company plans "to market the drug under the name Joulferon" outside of the US. FDA delays decision on drug to treat hospital-acquired pneumonia. Theravance, Inc. said that the Food and Drug Administration delayed a decision on whether to approve its infection drug Vitabiv [telavancin] as treatment for hospital-acquired pneumonia." The FDA "asked for more data and analysis on patients who participated in clinical trials of Vitabiv," according to the company. The agency also "wants more information about deaths in Theravance's clinical trials, comparing patients on Vitabiv to those on other treatments, as well as details on why Theravance combined data for two trials. NHS decides not to make sorafenib, bevacizumab available. In the United Kingdom, the National Health Service (NHS) has decided not to make two more cancer drugs available because of cost." According to the National Institute for Health and Clinical Excellence, the use of "sorafenib (Nexavar) for liver cancer and...bevacizumab (Avastin) for metastatic colorectal cancer" is "not cost-effective." But, the decision on bevacizumab "is preliminary, and the manufacturer, Roche, has said that it will continue to work with NICE on making the drug available." The moves "have sparked headlines about cancer patients being denied life-prolonging drugs" as well as criticism from some oncologists. Karol Sikora, MD, medical director of Cancer Patterns UK, noted that "the British decision about sorafenib puts it 'hopelessly out of step with the rest of Europe,' because every other country within the European Union makes the drug available." FDA delays decision on Exalgo. The Boston Business Journal reported that the FDA "has advised Cambridge-based CombinatoRx Inc. and Canada-based Neuromed Pharmaceuticals Inc. that it will put off making a decision on whether to approve the companies' pain drug target," called Exalgo (hydromorphone HCl), "for three months." The agency said the companies "may need to submit additional data," and that "it will now complete its review by Feb. 22, 2010." Also at http://www.qa-expert.com/2010/01/pharma-regulatory-updates.htmlDisclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
WHO recommends earlier treatments for HIV patients. World Health Organization "issued new guidance" advising doctors to start giving patients AIDS drugs a year or two earlier than usual." According to the agency, "the advice could double the number of people worldwide who qualify for treatment, adding an extra 3 to 5 million patients to the 5 million already awaiting AIDS drugs." The new recommendations "also advise pregnant women with HIV to take the drugs earlier and while breast-feeding," and urged countries to discontinue the usage of "the commonly used AIDS drug stavudine because of its toxic side effects." Chemotherapy may be linked to neurological side effects in some testicular cancer survivors. Neurological side effects are among the potential problems faced by long-term survivors of testicular cancer who were treated with cisplatin-based chemotherapy," according to research published online Nov. 25 2009, in the Journal of the National Cancer Institute. In a study of "1,409 men treated for unilateral testicular cancer," researchers "found that between four and 21 years after the start of treatment, men who'd received any chemotherapy had a statistically significantly higher risk for more severe side effects, including sensory neuropathy, tinnitus, hearing impairment and a discoloration of the hands or feet when exposed to the cold...than those who didn't have chemotherapy." WHO investigates Tamiflu-resistant swine flu cases in US, BritainWorld Health Organization spokesman Thomas Abraham said the agency is investigating reports of Tamiflu-resistant cases of H1N1 in both the United States and Britain. The Health Protection Agency (HPA) in Britain confirmed five cases in Wales, each with severely compromised immune systems. "We'll see if we need to put any additional measures in place to protect this vulnerable group of patients. It might mean that they are at more serious risk than others," Abraham said.
Glaxo urges Canadian doctors to halt usage of one vaccine batch. GlaxoSmithKline, the sole provider of the H1N1 vaccine in Canada, has told Canadian doctors to "hold off" on using one vaccine batch as the company "probes reports of higher-than-expected occurrences of a side effect known as anaphylaxis." The batch, which contained 172,000 doses of Arepanrix, "was linked to more cases of acute allergic reactions, including swollen tongues, throats and respiratory distress, than is expected, spokeswoman Gwenan White said in a telephone interview." She said the findings would not "have any impact at all on the other vaccine they have received and can continue to administer." Three drug classes linked to increased risk for elderly falls. The use of antidepressants, benzodiazepines, sedatives and hypnotics significantly increased the risk of falling among the elderly, a new meta-analysis has found." John C. Woolcott, MA, of the University of British Columbia, and colleagues reported in the Nov. 23 Archives of Internal Medicine that antidepressants "had the strongest association with falls, while the weakest association was for narcotics." The researchers concluded, "The results of our meta-analysis reiterate the need for caution when prescribing these medications to seniors." Also at http://www.qa-expert.com/2010/01/pharma-qa-updates.html Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
Amgen, Roche settle anemia drug patent dispute. Swiss drug maker Roche will not be allowed to sell its anemia drug Mircera in the US until July 2014 under terms of a settlement with Amgen Inc., the companies reported. According to Amgen, "a US District Court in Boston ruled that Mircera infringes on five patents supporting Amgen's anemia drugs Aranesp and Epogen." Roche had acknowledged that the disputed patents are valid and enforceable. But, the settlement does not cover any payments between the companies. The disputed "patents cover critical steps in the production of" a "genetically engineered protein" called erythropoietin.UK drug regulators back Yondelis after Zeltia agrees to cover some of the cost. Zeltia SA's Yondelis [trabectedin] will be offered by the UK's National Health Service as a treatment for soft- tissue sarcoma after the company agreed to pay for any patient who needs more than five cycles of the drug." The UK's National Institute for Health and Clinical Excellence "reversed an earlier recommendation rejecting the drug as too expensive. NICE has recommended its use where other treatments have failed or cannot be tolerated because of side effect." Austria makes morning-after pill available without prescription. Austria's health ministry says the contraceptive morning-after pill is now available in pharmacies without a prescription." The health ministry "said that women of all ages can now buy the pill...over the counter." FDA begins hearings on Internet marketing of medical products. The Food and Drug Administration "is hearing from dozens of drug and advertising executives at a two-day meeting on Internet marketing of medical products." After complaints from both web companies and the pharmaceutical industry that marketing guidelines were too restrictive for the medium, "the agency has agreed to consider developing rules for online ads." Yahoo "is testing a new type of ad that would contain an extra link to detailed drug information, including risks," while Google "is proposing a similar design that would list a short summary of drugs risks, followed by a link to full prescribing information." Cephalon, Barr settle patent infringement suit. Cephalon Inc. will give Barr Pharmaceuticals Inc. a license to sell a generic version of the pain drug Fentora in 2018 as part of a patent lawsuit settlement, according to a Securities and Exchange Commission filing. Under the deal, Cephalon "will give Barr a non-exclusive, royalty-free right to sell a generic version of Fentora in October of 2018," even though "the patent is not set to expire until 2019." But, "if another generic version of Fentora reaches the US market before October 2018, Barr is allowed to launch its version.. Cancer prevention drugs said to be widely ignored. Some researchers state that "the few medicines proved to deter cancer are widely ignored," because "people are not enthusiastic about taking anticancer pills, or are worried about side effects or not really convinced the drugs work." As a result, drug makers say that "it makes little economic sense to spend decades developing drugs to prevent cancer," and instead, "the better business plan seems to be looking for drugs to treat cancer." Meanwhile, researchers say that many "measures that are often assumed -- and marketed -- as ways to prevent cancer may not make much difference." In fact, studies linking cancer to such measures typically "cannot assess cause and effect," while studies that do come up with these associations "are likely to be published, even though often the associations turn out to be spurious." Canadian officials nix recommendation for second flu shot in children. Federal health officials in Canada have determined that "all but the youngest children need only a single half-dose of H1N1 vaccine." The new recommendation will "free up vaccine and make more shots available to the general public sooner," and also "means many parents of healthy children who have already endured waits hours long to have them vaccinated will not have to line up again for a second shot."
Also at http://www.qa-expert.com/2010/01/drug-regulatory-qa-updates.html
Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
Report says information technology may improve medication adherence among older adults.
Information technology is key to improving medication-related errors and improving medication adherence among older adults, according to a recent report from the Center for Technology and Aging in Oakland, CA. According to the report, "'widespread use' of technology aimed at this population could save thousands of lives and billions of dollars."
Column offers advice on treatment with bone-enhancing drugs.
Who should be treated with bone-enhancing drugs? Until recently, many doctors and drug companies that make these medications were saying almost everyone -- especially older white women, who are at highest risk of one day suffering an osteoporotic fracture." However, "the drugs currently available to enhance bone density" are "expensive...can have side effects, and they are only about 50 percent effective at preventing fractures." Brody suggests that patients with osteopenia should rely instead upon their FRAX risk assessment score, a "bone mineral density test," and their physician's guidance to weigh "possible risks...against known benefits" before starting treatment with such medicines.
Arena seeks FDA approval of weight loss drug.
The first of a new class of obesity drugs moved one step closer to the market as Arena Pharmaceuticals Inc. said it filed for approval of its drug candidate lorcaserin." If approved, the drug is likely to "compete against Vivus Inc.'s Qnexa and Orexigen Therapeutics Inc.'s Contrave32, both of which are still in development." According to Arena, two late-stage trials showed that obese and overweight patients with type 2 diabetes taking lorcaserin experienced significant weight loss, and that the drug was safe and tolerable.
The results appear to meet one of two FDA-recommended goals for obesity drugs: that at least 35 percent of patients taking its drug lose at least five percent of their body weight, and that the group is approximately double the percentage of patients with similar weight loss on the placebo.
Shire seeks full FDA approval of Replagal.
British drugmaker Shire allegedly filed for US marketing approval of its Fabry's disease treatment Replagal [agalsidase alfa]." The drug is currently "available under Food and Drug Administration restrictions.Shire established an early access program in the midst of a shortage in treatments marketed in the US for Fabry disease. The shortages have been caused by the temporary shutdown last summer of Genzyme's Allston Landing manufacturing plant, where the company discovered a virus in a bioreactor in June. If approved, the drug "would compete against" Genzyme's Fabrazyme [algasidase beta].
Also at http://www.qa-expert.com/2010/01/pharma-regulatory-qa-updates.html
Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
Safety review board recommends Vical continue trial of cancer drug candidate. A safety review board recommended" that Vical Inc. "continue a late-stage clinical trial of its cancer drug candidate Allovectin-7 and is expecting a full complement of 375 patients to be enrolled in the Phase III trial" of the melanoma vaccine "in the next few weeks “ according to the company. Artemisinin-resistant malaria found near Thai-Cambodian border.
The American Press mentions that there is a "spot on the Thai-Cambodian border [that] is home to a form of malaria that keeps rendering one powerful drug after another useless." Now, "scientists have confirmed the first signs of resistance to the only affordable treatment left in the global medicine cabinet for malaria: Artemisinin." In addition to this emergence, "after decades of the overuse and misuse of antibiotics, diseases like malaria, tuberculosis, and staph have started to mutate. The result: The drugs are slowly dying." More XXDR-TB cases may be unaccounted for, experts suspect. A case of extremely drug-resistant tuberculosis -- being referred to as XXDR-TB -- in Florida is one of only a handful reported worldwide," and "there may be many more, according to Dean Schraufnagel, MD, a TB expert at the University of Illinois in Chicago and president-elect of the American Thoracic Society." The surge could be attributed to the fact that "first-line medications are not used properly." But, "what is 'worrisome' about the Florida case, Schraufnagel said, is that" the patient "had reportedly not been previously treated for TB, which might mean he contracted the strain from someone else." Emergence of drug-resistant E. coli strain causes concern. "First-line use of carbapenem antibiotics for urinary tract infections may become necessary if the spread of drug-resistant E. coli continues, a prominent infectious disease expert warned." According to Johann Pitout, MMed, of the University of Calgary, "an E. coli strain expressing a beta-lactamase enzyme known as CTX-M-15 has suddenly emerged in community-acquired infections worldwide." Pitout pointed out in his paper in Faculty of 1000 Medicine that "this strain is among the most worrisome of a series of recently emerging, community-acquired E. coli clones," because the "so-called extended spectrum beta-lactamases" may "break down cephalosporin and monobactam antibiotics which have been first-line treatments for" UTIs. Also at http://www.qa-expert.com/2010/01/regulatory-affairs-updates.htmlDisclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.
FDA says Vytorin link to cancer risk is unlikely. According to reports from the US Food and Drug Administration, it is not likely that two cholesterol medications, Vytorin (ezetimibe and simvastatin) and Zetia (ezetimibe), increase an individual's cancer risk. However, the agency said that it cannot completely rule out an association between the drugs and an increased risk of cancer. Further it states that it has examined all of the data from the" Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, which "first raised the alarm about a possible risk and showed that significantly more subjects treated with Vytorin developed and died from all types of cancer when compared with those taking placebo." The FDA report supposedly further states that it is not advising doctors or consumers to stop using any of the...medications, but will continue to evaluate the clinical benefits and potential risks of Vytorin and Zetia compared to other cholesterol-lowering drugs it has approved." Chemotherapy drugs may cross blood-brain barrier, disrupt brain cell regeneration. According to research published in the journal Cancer Investigation, four chemotherapy drugs "caused a significant breakdown in brain cell regeneration" in rodents. In fact, researchers found "a 15.4 percent reduction in new brain cells after use of fluorouracil, a 30.5% reduction following cyclophosphamide, a 22.4% reduction following doxorubicin, and a 36% reduction following paclitaxel." The researchers suggested that "all...chemo drugs cross into the brain after all, or that they act via peripheral mechanisms, such as inflammation, that could open up the blood-brain barrier." Some doctors, researchers concerned generics may not work as well as brand-name drugs. A column in the NewYork Times, Lesley Alderman wrote that "there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts." Cardiologists and neurologists in particular are concerned about variations in generic formulations that "could have a serious effect on a patient's health." But, insurers cite research that shows "no difference in hospitalizations or emergency-room visits for people on brand-name epilepsy drugs compared with those taking generics." For its part, the FDA "says it stands behind generic medications and its methods of approving them." Gary J. Buehler, director of the FDA's office of generic drugs, said the agency has "not seen any scientific studies that show generics do not hold up as well as brand name drugs." Cold capsules recalled. According to a report published in the American Press, consumer-product maker "Procter & Gamble Co. is recalling 700,000 packs of Vicks DayQuil [acetaminophen, dextromethorphan, doxylamine, pseudoephrine] capsules because they are not childproof," in spite of "labeling claims on the box" that they are. Specifically, P&G is recalling DayQuil Cold & Flu 24-Count LiquiCaps Bonus Pack. According to a P&G spokeswoman, "the product was distributed nationally between September 2008 and February 2009, and more recently between September and December this year." Small infection risk with antibiotic-free intravitreal drug injections.
According to report published in the Dec. issue of the Archives of Ophthalmology, "intravitreal drug injections led to an infection rate of less than one in 1,000 with a protocol that avoided antibiotics and sterile gloves and drape." After analyzing data on "a total of 3,838 intravitreal injections" of ranibizumab or triamcinolone "administered to 733 eyes by 124 physicians," researchers found that "only three cases of culture-positive endophthalmitis occurred following intravitreal injection." Notably, "in about a third of cases, patients received antibiotics before and after injection, but in the remaining two-thirds, patients received antibiotics before or after the procedure or not at all." Also at http://www.pharm-education.com/2009/12/quality-and-safety-updates.html Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.