Research and development in the 21st century: Web-enabled innovation comes of age.

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma industry happenings globally.

Web-enabled research and development? But of course. The Internet, built by researchers has been used to extend their reach for nearly 30 years. High-tech organizations that live and die by new product development have exploited the Web to speed communications and share information.

More recently, but just as enthusiastically, biotech and pharmaceutical companies have turned to Web-enabled research and development (R&D) processes. But the landscape of Web-enabled research and development is changing. New tools and approaches may now enable organizations to make their R&D processes faster, more reliable and also more innovative.

What have also evolved are two clearly different approaches to Web-enabled research and development: For pharmaceutical and biotech companies, it is how the Web can be used to supercharge a research hotbed. For high-tech computer, communications and electronics companies, the focus is on using the Web to create a seamless product-development process.

Within these two different approaches lies the potential of Web-enabled capabilities to smooth the handoff between research and development. This potential has caught the attention of C-level executives who recognize the need to champion what is, for many companies, a fundamentally new way of developing products.

Looking ahead, executives at pharmaceutical and biotech companies and at high-tech companies may be able to make even bigger strides by learning from one another. By evaluating and adapting the innovative approaches each industry is using, they can stimulate research and streamline development through the Web.

Wish to Improve your research and development performance? A free technical whitepaper is available for interested readers to know more about this very important topic.

Disclaimer- The views and opinions expressed in this article are meant to stimulate thought and discussion. As each business has unique requirements and objectives, these ideas should not be viewed as professional advice with respect to your business.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Three Major US Drugmakers Create Asian Cancer Research Group.

The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large. As in any other business, the success of any pharma company lies on 2 factors- investment potential and risk taking ability. In addition, the R&D portfolio becomes a huge numerator to ensure successful profit quotient.

So what efforts go behind the scene till a new drug hits the market? Do patients benefit ? Are they cured? How do we control health care costs? What are the new drugs in the making? To know more, visit http://www.drugsinthemaking.com

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

FDA warns against using four asthma drugs as stand-alones or for extended periods.

The Los Angeles Times reported that the FDA "on Thursday called for putting new limits on powerful and long-lasting bronchial drugs" containing both long-acting beta agonists, commonly called LABAs, and inhaled corticosteroids, in "a move designed to lower the risk of complications leading to hospitalization or even death." The agency "said patients should use products containing only the corticosteroids or other asthma-relieving medication whenever possible." Meanwhile, "patients who cannot control asthma symptoms any other way should use LABAs for the shortest possible time, but the drugs should never be used alone in treating asthma in adults or children, the agency said."

FDA Clears Drug To Treat Respiratory Symptoms Of Cystic Fibrosis.
The Food and Drug Administration has approved for marketing Gilead Sciences, Inc.'s "drug Cayston [aztreonam for inhalation solution] as a treatment for respiratory symptoms of cystic fibrosis, the company said Tuesday." The company "said it plans to make the drug available by the end of next week." The San Francisco Business Times reported that "Cayston, administered three times a day over a 28-day period, treats the bacteria Pseudomonas aeruginosa, which causes mucus to build up in the lungs and digestive tract of cystic fibrosis patients," and which is also "the single greatest cause of death for CF patients."

FDA Panel Recommends Approval Of Xifaxan To Treat Hepatic Encephalopathy.
A Food and Drug Administration panel "recommended Salix Pharmaceutical's drug Xifaxan [rifaximin] be approved to treat" hepatic encephalopathy, which is "brain damage caused by liver failure." In a 14-to-4 vote, the panel found that "the drug's benefits warrant its approval. In a separate vote, the panel also voted 14-4 in favor of the drug's safety." The agency will consider its panel's vote when it makes a final decision anticipated by Mar. 24. Reuters also noted that the FDA has already approved Xifaxan to treat travel-related diarrhea.

Three Major US Drugmakers Create Asian Cancer Research Group.
Three major US drugmakers, Eli Lilly and Co., Merck & Co., and Pfizer Inc., said Tuesday they have formed a not-for-profit company in Asia to focus on cancer research and treatments." The Asian Cancer Research Group will "focus on the most commonly diagnosed cancers in Asia, including lung and gastric cancers." The companies aim to "create an extensive database that will be made available to researchers."

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.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

Do you have questions for the author?

Aspirin may boost survival, cut risk of recurrence in breast cancer survivors- Pharma and clinical research updates.

The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large. As in any other business, the success of any pharma company lies on 2 factors- investment potential and risk taking ability. In addition, the R&D portfolio becomes a huge numerator to ensure successful profit quotient.

So what efforts go behind the scene till a new drug hits the market? Do patients benefit ? Are they cured? How do we control health care costs? What are the new drugs in the making? To know more, visit http://www.drugsinthemaking.com

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

Aspirin may boost survival, cut risk of recurrence in breast cancer survivors.
A new study says breast cancer survivors who take aspirin regularly may be less likely to die or have their cancer return." The researchers found that "women who had been diagnosed with early breast cancer and who just happen to be taking aspirin, somewhere between two and five days, had a 50% reduction in dying of the breast cancer." In women who took "aspirin just once a week, there was no benefit," but, those who took "aspirin two to five times a week" experienced a 71 percent reduction in dying from a return of the cancer.

The study of 4,164 breast cancer patients, published in the Journal of Clinical Oncology, showed that those "who took aspirin two to five days per week were 60 percent less likely to have a recurrence and 71 percent less likely to die from the disease."The findings challenge "at least five large studies" that "have shown that taking aspirin regularly has no effect on the risk of developing breast cancer in the first place. The researchers said that aspirin may help control cancer by fighting inflammation,as breast cancers produce more inflammatory chemicals than normal breast cells.But, they cautioned that more research is needed to confirm the findings before recommending that breast cancer patients take aspirin to increase their chances of surviving.

The study did not ask women what dose of aspirin they were taking, nor why they were taking it." The findings "also suggested other nonsteroidal anti-inflammatory drugs...may reduce breast cancer recurrence, although that effect was evident only in women who took those medicines 6 to 7 days a week." Notably, "no link could be established between acetaminophen...and reduced breast cancer mortality."

Discovery Laboratories to run additional preclinical trials for respiratory stress syndrome drug.
Following discussions with the FDA, "Discovery Laboratories Inc. said Tuesday it won't have to run new clinical trials of its respiratory stress syndrome treatment Surfaxin [lucinactant], which could save the company money and help get the drug approved sooner." Discovery Labs also "said it will focus on testing the drug on prematurely born lambs instead of premature infants." Discovery will conduct additional preclinical studies, rather than a limited clinical trial.

Additional trials may underscore prostate cancer drug's early successes.
Further tests have underlined abiraterone's "potential" as a prostate cancer drug, and "larger trials are underway." If the latest trials prove "successful, it could be prescribed to men in the advanced stages of the disease as early as next year, giving them the hope of precious extra months with their families.In a phase II study, about half of the 47 men given abiraterone experienced a substantial reduction in levels of prostate specific antigen in their blood.

Statins may increase diabetes risk.
According to a study published online Feb. 17 in The Lancet, statins may increase the risk of developing diabetes. After analyzing 13 studies of statins encompassing "more than 90,000 patients," researchers found that "the risk" for developing diabetes is "tied to the entire class of medications, and the danger increases with age."

"More than six million adults currently taking statins are being advised to carry on taking them by researchers and leading medical charities, who stress that the benefits far outweigh the risks, specifically, "researchers say that treating 255 patients with statins for four years results in one extra case of diabetes, but saves five major coronary events, such as heart disease death or heart attack." Nevertheless, "the review will put the brakes on growing calls for statins to be given to 'healthy' people.

Botox may help prevent some types of migraines.
Allergan Inc.'s Botox [botulinum toxin type A], given in the doses used to reduce facial wrinkles, may stop certain kinds of migraines that patients describe as crushing or 'eye-popping' more than other types," according to research published in the Archives of Dermatology. The company "has filed for approval with the [FDA] to market Botox as a treatment for chronic migraines...said" a spokeswoman for Allergan. A study of 18 patients showed that 13 "saw a reduction in migraine pain," from "almost seven days a month to less than one day a month." Researchers speculated that Botox "may work by blocking pain receptors or reducing inflammation." MedPage Today (2/15, Bankhead) also covered the story.

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.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

Potential kidney transplant drug wins orphan drug designation from FDA, Pharma biz news updates

The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large. As in any other business, the success of any pharma company lies on 2 factors- investment potential and risk taking ability. In addition, the R&D portfolio becomes a huge numerator to ensure successful profit quotient.

So why read Pharma R&D, business news? Because it offers following benefits-

1. Enables investors to take “wise decisions”.
2. Assists Job seekers to realize “where to invest their career”.
3. Helps community to abreast themselves of new medicine introductions, availability of low cost generics and overall to think wise about “how they can control their health care costs”.

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma business news-

Pfizer's Viagra patent partially rejected.
"Pfizer Inc.'s patent on its impotence drug Viagra [sildenafil citrate] was partially rejected after the US Patent and Trademark Office said it wasn't different enough from a Chinese herb known as Horny Goat Weed." An agency appeals board "upheld the decision that an element, or claim, of the patent for a method of treating male erectile dysfunction didn't cover a new invention." The claim "was key to an infringement suit Pfizer filed in 2002 against Eli Lilly & Co. over its rival Cialis [tadalafil] drug." Now, "Pfizer has until April 12 to seek a rehearing from the PTO's Board of Patent Appeals and Interferences, or appeal to the US Court of Appeals for the Federal Circuit in Washington, which specializes in patent law, according to a letter Lilly lawyer Richard K. Herrmann." Bloomberg News .


Potential kidney transplant drug wins orphan drug designation from FDA.
"Quark Pharmaceuticals Inc.'s potential treatment for kidney transplant patients won orphan drug designation from the Food and Drug Administration." The company "said QPI-1002 is a synthetic small interfering RNA, or siRNA, that blocks expression of a gene called p53 and, as a result, could protect normal cells from injury." QPI-1002 also "is in a Phase I/II study," and "is the first systemic siRNA drug to enter human clinical trials." The San Francisco Business Times.


Lilly, Arkansas settle Zyprexa marketing suit for $18.5 million.
Arkansas Attorney General Dustin McDaniel on Tuesday announced an $18.5 million settlement of a lawsuit with Eli Lilly & Co. over off-label marketing of the anti-psychotic drug Zyprexa [olanzapine]." McDaniel had accused Lilly of engaging in "illegal and fraudulent off-label marketing of Zyprexa," alleging that "the company promoted the drug for unapproved use in children." The American Press.


Spending on cancer drugs in UK is 40 percent less than in other European countries.
NHS cancer patients have 40 percent less spent on their medicines than those in other European countries,according to a "report from the centre-right think tank Policy Exchange." The analysis "says cancer currently costs the economy more than £18billion a year, and the figure is expected to rise to almost £25billion over the next decade." The report notes that "spending on cancer medicines is only about 60 percent of that in the EU and other advanced European countries." The UK's Daily Mail.


Roche ordered to pay $25 million in Accutane damages.
Roche Holding AG "must pay $25.16 million in damages to a former user of its Accutane [isotretinoin] drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled." Most of the jurors "agreed that Roche failed to provide an adequate warning, and that the company's failure was a 'proximate cause' of...inflammatory bowel disease" in the plaintiff. The drug maker now "faces almost 1,000 other lawsuits over Accutane." Sales of the drug were halted "in June 2009" over "generic competition and the high cost of defending personal injury lawsuits." Bloomberg News.


India's generic drug industry may attract more interest from larger companies.
India's generic-drug industry has more FDA-approved facilities than any other country outside the US, which is boosting speculation that larger foreign pharmaceutical companies will join the industry. However, the Journal notes that the future of India's generic drug makers is more likely to see intense competition and dwindling margins than high-priced buyouts. The Journal also adds that foreign drug companies have plenty of reason to wait on expensive acquisitions in India for now. The Wall Street Journal.


AstraZeneca purchases RA treatment from Rigel for up to $1.2 billion.
AstraZeneca has signed a deal worth up to $1.2 billion with Rigel for its rheumatoid arthritis drug, called R788, which is "the furthest developed in a new class of oral drugs being tested for treating RA and is designed for patients who do not respond to the older drug, methotrexate." Under the deal, "AstraZeneca will make an up-front payment of $100m to Rigel for its R788 drug, with up to $345m more payable after achieving regulatory and first-sale milestones, plus a potential $800m on further sales-related payments." AstraZeneca will also design a phase III trial to begin later this year. The Daily Telegraph (UK).


Merck may seek approval to sell Gardasil for new uses.
Merck's "Gardasil is about 89 percent effective in blocking cervical cancer, genital warts and lingering HPV infections in women aged 24 to 45." Another new study "shows it is about 77 percent effective in blocking anal cancer and precancerous lesions in homosexual men." The drug maker plans to "seek approval to sell the vaccine for those uses." The American Press.


New Medicare rules may help Affymax grab market share from Amgen.
New Medicare rules "will cap fees for kidney dialysis, including the cost of anemia drugs, at about $250 per treatment starting on Jan. 1, 2011, and combine all services under one bill or 'bundle,' said Yaron Werber, a Citibank analyst." The move "may push dialysis clinics to use smaller amounts of cheaper drugs, Werber said." The rules could help "Affymax Inc., a 10-year-old company with no marketed products," grab "market share from Amgen Inc.'s $2.6 billion anemia drug Epogen [epoetin alfa] with a treatment in line to be approved next year." The company has yet to announce "a price for its treatment, called Hematide," but the drug is "given only once a month while Epogen is usually administered three times a week." Bloomberg News.


Affymax readies blockbuster alternative to Epogen.
Affymax hopes to get an FDA approval for its experimental anemia treatment Hematide next year, and that could leave the developer perfectly positioned to take advantage of new Medicare rules capping the cost of kidney dialysis at $250. And if Affymax can scoot into the market under the hefty price for Amgen's Epogen, analysts say the new drug could easily squeeze out what has long been the standard of care.

"When we go under the bundle, everything's going to be about money," specialist Julia Inrig at UT Southwestern Medical Center tells Bloomberg. If Hematide is cheaper to buy and use than Epogen, "its use could significantly increase, and it could potentially drive Epogen out of the market."

Cowen & Co. analyst Phil Nadeau says an approval next year would leave Affymax poised to reap $1.1 billion in blockbuster sales by 2015. Amgen, which currently has the only anemia drugs used in kidney dialysis, charges $8,445 per year for Epogen. And as a synthetic peptide Hematide should be cheaper to make than Epogen.Bloomberg news. http://www.bloomberg.com/apps/news?pid=20601202&sid=a1meTJTyj3g8

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.

http://www.drshrutibhat.com/
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

Pharmaceutical R&D, business news- Expert updates.

The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large. As in any other business, the success of any pharma company lies on 2 factors- investment potential and risk taking ability. In addition, the R&D portfolio becomes a huge numerator to ensure successful profit quotient.

So why read Pharma R&D, business news? Because it offers following key benefits-

1. Enables investors to take “wise decisions”.
2. Assists Job seekers to realize “where to invest their career”.
3. Helps community to abreast themselves of new medicine introductions, availability of low cost generics and overall to think wise about “how they can control their health care costs”.

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some updates from current pharma business news-

Big pharma companies look to tap generic drug business in emerging markets.
On the front of its Business Day section, the New York Times reported, "Some prestigious brand-name pharmaceutical companies that once looked askance at the high-volume, low-cost business of generic drugs are now becoming major purveyors of generic medicines." Drug makers, such as Sanofi-Aventis and GlaxoSmithKline "are pursuing a growing consumer base in emerging markets like Eastern Europe, Asia and Latin America where many people pay out of pocket for their medicines but often cannot afford expensive brand-name drugs." In addition, "in some emerging markets, where the fear of counterfeit drugs or low-quality medicines runs high, consumers who can afford it are willing to pay a premium for generics from well-known makers, industry analysts said."


Quintiles to invest in more drug development research.
Quintiles Transnational Corp., which is the world's biggest contract research organization, is now using its deep pockets to entwine itself with the pharmaceutical companies, fronting them cash and services for a piece of the profits once a drug is approved. Last month, Quintiles also said it wants to invest even more in drug development and is hoping its new investments will produce enormous payoffs in the future, but the buffer between drug makers and testers are again blurred. However, Ron Wooten, a Quintiles executive vice president who heads the company's capital investment group, doesn't see his company's increased interest in bringing drugs to the market affecting its testing objectivity. Instead Quintiles is the outsider turning a hard eye on which pharmaceuticals will become profitable.


Medicare recipients have appeal options when coverage for certain drugs is denied.
The Wall Street Journal reported that, each year, millions of Medicare recipients discover that their drugs are no longer covered by their Part D plans. While seniors in this situation can often substitute generic drugs for brand-name ones, they also have the option of appealing the denial, particularly if their plan did not notify them in a timely manner of the changes. The Journal said that typically, seniors who appeal have a good chance of success, but, in case their appeal is denied, they have 60 days to file a second appeal to Maximus Federal Services (http://mailview.custombriefings.com/mailview.aspx?m=2010021601dia&r=3377085-9ac4&l=031-709&t=c ).


Lilly to use outside contractors to help its drug pipeline.
The Wall Street Journal reported that Eli Lilly & Co. is hiring outside contractors to run tests on its drug candidates as part of new efforts to be more productive. Lilly will use scientists outside of its own research team to decide whether to move a promising molecule to treat rheumatoid arthritis into late-stage testing, based on mid-stage data. The Journal adds that Lilly is among a number of pharmaceutical companies adopting new strategies to stimulate its research-and-development and to reduce the chance that compounds will fail in more expensive late-stage trials.


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.

http://www.drshrutibhat.com/
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

Pharma business news-

Here are some important developments in pharma business world-

Pfizer to enter Japan's generic drug market as early as 2011.
Pfizer Inc. "will enter the generic-drug market in Japan as early as 2011 to bolster sales of its medicines that have lost patent protection." Matsumori, head of the off-patent and generic drugs business at Pfizer Japan, said the company "will establish a new unit to sell 68 generic and off-patent drugs." Pfizer "will also expand the sales force in Japan to sell more brand-name products, Ichiro Umeda, appointed president of Pfizer Japan Inc."

India introduces new ethics policy for physicians.
The Wall Street Journal "Health" blog reports that India has become the latest country to place restrictions prohibiting doctors from accepting drug-industry gifts. However, India's Business Standard says that the new ethics rules from the Medical Council of India may not be effective unless penalties for violating them are also introduced.

UN applauds efforts to end HIV travel restrictions.
The United Nations praised the United States and South Korea on Monday for lifting travel bans on people with HIV and urged 57 other countries with travel restrictions to end them quickly.UN Secretary-General Ban Ki-moon "applauded South Korea's President Lee Myung-bak on Monday 'for his country's leadership in ending restrictions towards people living with HIV that have no public health benefit.Likewise, UNAIDS executive director Michel Sidibe said the policy changes were "a victory for human rights on two sides of the globe.

US healthcare spending in 2008 increased at slowest pace in 48 years.
The New York Times reported that, "Health spending grew in 2008 at the slowest pace in 48 years as the recession throttled back the explosive growth of health costs," according to a CMS report. "Health spending topped $2.3 trillion in 2008, up 4.4 percent from the previous year," but "the rate of growth in 2008 was down from 6 percent in 2007 and an average increase of 7 percent a year in the decade from 1998 to 2008." The Times adds, "By slowing the growth of health spending, the recession achieved what a generation of public officials tried unsuccessfully to accomplish."

The Wall Street Journal noted that while healthcare spending growth did slow, it still grew faster than the overall economy in 2008. Government statistician Micah Harman said, "The fact that the recession had a more profound and immediate impact was not something that we've seen in recent history."

In the report, CMS said that Medicare and Medicaid cost the federal government 8 percent more in 2008 than in 2007. The agency said that national health spending growth continues "to outpace growth in the resources available to pay for it. ... Monitoring the drivers of health-care spending growth will continue to be an important aspect of meeting the nation's health-care needs with the limited resources available in an uncertain fiscal future.

Merz Pharma to buy BioForm Medical in $253 million deal.
The American Press reported, "Merz Pharma Group of Germany said...it will buy BioForm Medical Inc. for $253 million cash, expanding its aesthetic medicine business." BioForm specializes in "products used in cosmetic medical procedures," such as "Radiesse, which is sued as a dermal filler and as a treatment for vocal fold insufficiency." The company is also responsible for Coaptite, an "injectable implant...used as a treatment for female urinary incontinence."

The deal has been approved by both companies' boards of directors and is expected to close during the first quarter of 2010. Under the agreement, the Business Journal of Milwaukee reported that Merz "will acquire all of the outstanding shares of BioForm Medical for $5.45 per share in cash under a cash tender offer followed by a second-step merger." After the completed transaction, "BioForm Medical will become a wholly owned subsidiary of Merz and will be renamed Merz Aesthetics."

Genzyme signs manufacturing deal with Hospira.
Biotechnology company Genzyme Corp. is contracting manufacturing for its key products to Hospira Inc. for an undisclosed amount, according to a Securities and Exchange Commission filing. The "'fill and finish manufacturing services' deal for the genetic disorder drugs Cerezyme [imiglucerase], Fabrazyme [agalsidase beta], Myozyme [alglucosidase alfa], and Thyrogen [thyrotropin alfa for injection]," follows "a series of manufacturing problems at the company's" Allston facility. The FDA "said it found tiny particles of trash in" certain drugs in November, and "recommended that doctors closely inspect vials of" the aforementioned drugs and Aldurazyme [laronidase].

The deal is contingent upon whether Genzyme can obtain the necessary regulatory approvals to outsource its fill and finish services to Hospira, The agreement, which is set to expire at the end of 2015, will be extended until 2017 unless terminated.

Genzyme to move operations away from contaminated manufacturing facility.
Genzyme Corp. will move all its filling, packaging, and distribution operations out of its Allston drug manufacturing facility because of the latest problems involving contamination at the plant.The company also said it will "move the bulk of the operations to its own site in Waterford, Ireland."

Disclaimer- The information posted is for knowledge purpose only and should not be considered as legal advise.

http://www.drshrutibhat.com

Three habits of job seekers who get hired fast

What do they do differently from average job seekers? Three things. Habitually.
Best part: These 3 habits are recession-proof। Here they are ...

1. Focus on results, not processes-People who struggle to find work always seem to be in the process of doing something. They can't tell friends exactly what job they seek because they're in the process of deciding. Or they can't improve their Linkedin profile because they're in the process of revising their resume. Highly successful job seekers know that results are what count. So, they just get stuff done.

A job seeker who meets 3 networking contacts with an imperfect resume will get hired faster than one who spends all week revising their resume and zapping out emails. Every time.

2. Pick up the phone and call

I have never met anyone who was hired solely on the strength of their resume or cover letter. You have to talk to and meet employers first. In other words, it takes multiple conversations to get a job. Successful job seekers know this. They stack the odds in their favor by proactively calling, talking to, and asking to meet employers they've sent resumes to.

What's the worst that can happen if you call and ask an employer to meet?

They say no.

But ... if you wait for a phone call that never comes, you're still getting a "No" from that employer, albeit a tacit one that can take weeks to play out.

Make your own luck. Call to verify that employers got the resume and cover letter you emailed.

Better: Print and mail your documents. In your cover letter, say: "I will call your office at 10:00 a.m. Tuesday to answer any questions you may have."

Two very good things can happen when you call at a specific time to follow up:

a. Your call may turn into a phone interview.

b. If you get voicemail, your message will be stamped with the time you called, which should be when you said you would in your cover letter. Congratulations -- you've proven that you're detail-oriented and keep promises. And you're not even on the payroll yet.

3. Contact employers 7 times-

In advertising, it's a rule of thumb that prospects must be exposed to your pitch at least 7 times before they buy. Successful job seekers recognize this. So, create a plan for contacting target employers 7 times in the next 3-4 weeks. Be sure to vary the means of contact and -- this is vital -- always give employers another reason to hire you with every contact.

Here's an example campaign to illustrate:

Day 1: Mail well-researched cover letter and resume to ABC Corp., promising to call in two days to follow up.

Day 3: Call, as promised. Ask for interview.

Day 5: Mail newspaper clipping of interview with company president, underlining comments about strategic plan that I can help achieve.

Day 8: Visit company office, saying I was "in the area." Ask if president got article by mail.

Day 14: Mail hiring manager a white paper, "5 Ways to Save on Purchasing at ABC Corp.," based on research done on days 1-10.

Day 16: Call hiring manager to follow up. Ask for interview.

Day 22: Email company president with 5 news items about ABC Corp. found via www.Google.com/alerts in days 1-21. Offer suggestions for how I could help with each.

Now. Is contacting one employer 7 times a lot of work?

Yes.

Do you think any other job seeker will create and follow such a detailed plan of action?

No.

So, which is better: a little work now, or no work later?

Want more great tips and advice like this?

Disclaimer- The information posted here is for information purpose only and should not be considered as legal advise.

http://www.drshrutibhat.com

Clinical research updates on new drugs

FDA does not approve Ofirmev due to manufacturing site issues.
Reuter’s reported, "A pain and fever drug," called Ofirmev (intravenous acetaminophen), "being developed by Cadence Pharmaceuticals was not approved by federal regulators because of manufacturing problems at a facility where the drug is made, the company said Thursday." The FDA said it will not approve the drug until the issues are resolved. "Cadence said the FDA inspected a third party manufacturing facility on Friday," and the company "plans to meet with the FDA to make sure the problems have been addressed." It is stated further that, the FDA did not cite any safety or efficacy issues for the drug or require any additional studies to be conducted prior to approval.


FDA approves heat-stable version of Norvir.
Abbott Laboratories reported that it received Food and Drug Administration approval for a heat-stable version of the HIV treatment Norvir [ritonavir]." The approval is for a new formulation of the drug that "allows it to be stored at room temperature rather than in a refrigerator."


Taspoglutide may reduce sugar levels when compared with or added to other treatments.
Roche Holding AG declared results from five late-stage clinical trials show that its experimental diabetes drug taspoglutide reduced blood sugar levels when compared with or added to widely prescribed treatments." Roche said in a statement that the drug met the main goal of studies comparing it to Lantus (insulin glargine injection), Byetta (exenatide injection) and Januvia (sitagliptin), as well as trials where it was combined with metformin and against placebo. Additionally, taspoglutide was found to be generally well tolerated in all five trials, and the most frequently reported side effects were nausea and vomiting.


Few women taking tamoxifen for breast cancer prevention.
A study, appearing in the February 2010 edition of Cancer Epidemiology, Biomarkers & Prevention,Gardner) reported that, "despite the fact that experts have known since 1998 that tamoxifen can cut the risk of developing breast cancer by almost 50 percent," a recent study found that "only a tiny fraction of women at high risk of developing breast cancer take tamoxifen to prevent the disease." Looking at data on about 10,000 women from 2000 and 2005,. Researchers found that "only about 0.2 percent of US women aged 40 to 79 took tamoxifen to prevent breast cancer" in 2000. "In 2005, the prevalence was even lower -- only 0.08 percent." Researchers "did not say specifically how many of the women taking tamoxifen were at high risk for breast tumors."


Tamoxifen use linked to lower cognitive test scores.
According to a study appearing in the February Journal of Clinical Oncology, tamoxifen appears to affect cognitive abilities, including some types of memory. After a year of taking tamoxifen (Nolvadex), women in the study scored lower on tests of verbal memory functioning and other cognitive skills than did women taking another breast cancer drug, exemestane (Aromasin). Still, researchers "emphasized that it's important to keep the study results in perspective, noting the life-saving benefits of tamoxifen.


Statin users may continue to suffer muscle pains long after stopping the drugs.
According to a study published in the New England Journal of Medicine. Researchers found that patients experiencing muscle pain and weakness as a result of statin treatment may continue to suffer symptoms long after stopping the drugs. Nearly a third of patients who stopped statin treatment because of neuromuscular symptoms still showed myalgia six months later, and creatine kinase levels above 200 units/L persisted in 17%. The researchers suggested that creatine kinase measurements at the start of statin therapy could help identify patients with underlying neuromuscular diseases."


Twice weekly etanercept may provide benefits for skin but not joints.
According to a study published Feb. 2 in the BMJ, "twice weekly treatment with 50 mg of etanercept appears to be superior to once weekly treatment for the clearance of skin lesions in patients with psoriasis and psoriatic arthritis," but "there was no significant difference between the two etanercept regimens in the treatment of joint symptoms." Researchers arrived at those conclusions after studying "752 patients with both psoriasis and psoriatic arthritis who were randomly assigned to receive etanercept 50 mg twice weekly (n=379) or 50 mg once weekly (n=373) for 12 weeks by subcutaneous injection."

Disclaimer - The information posted here is for knowledge purposes only and should not be considered as medical advise. Expert opinion should be sought for individual case matter.

Study: Generic nifedipine product not bioequivalent to Adalat XL

A report stated by Bayer Inc in The Medical News on 4th Feb 2010, mentions that an extended release generic nifedipine product (Mylan-Nifedipine extended release 60 mg formerly Gen-Nifedipine extended release 60mg, Genpharm ULC) is not bioequivalent to the Canadian originator product, Adalat(R) XL(R), according to the results of a study recently published in the International Journal of Clinical Pharmacology and Therapeutics.

Based on the study results from in vitro and in vivo tests, the generic extended release nifedipine product has a delayed onset of drug release compared to the originator which is especially noticeable in the fed state. When the tablet is taken after a standard high fat meal, the total exposure to the generic nifedipine is almost 20 per cent lower than with Adalat(R) XL(R).

"With drugs like nifedipine, we see a close relationship between plasma concentration and efficacy. A change in bioavailability could impact blood pressure," said principal investigator Dr. Frank Donath from SocraTec R&D, Oberursel, Germany. "Since it is widely accepted that small reductions in blood pressure can reduce long-term mortality, these findings may be relevant to physicians treating hypertensive patients."

The single centre, open-label, randomized phase I study was carried out with 26 healthy male subjects. Using a 4-period crossover study design, the participants were given 60 mg of either a Canadian marketed batch of the generic product (Mylan-Nifedipine extended release 60 mg formerly Gen-Nifedipine extended release 60mg, Genpharm ULC) or Bayer's once-daily nifedipine product (marketed in Canada as Adalat(R) XL(R)) either in a fed or a fasting state. Blood sampling was conducted regularly throughout the study to determine the plasma concentration of nifedipine.

An in vitro dissolution test was carried out prior to the study. The in vitro dissolution curves show a later onset and considerably lower quantity of nifedipine release from the generic nifedipine compared to Bayer's once-daily nifedipine product. These differences in the completeness of drug release were also observed in the pharmacokinetic study. The total exposure of the generic nifedipine was nearly 20 per cent lower than with Bayer's once-daily nifedipine product in the fed state and almost 10 per cent lower in the fasting state.

"It is fairly common to assume that prescription medicines that become available on a generic basis can automatically be used in place of the original product," said Shurjeel Choudhri, Head, Medical and Scientific Affairs, Bayer Inc. "These study results indicate that the generic version does not match the unique pharmacokinetic properties of Adalat(R) XL(R). As a company, we encourage health care providers to carefully evaluate their patients who switch to this generic medication to determine if optimal results are being achieved."

While a number of previous studies have shown that several generic nifedipine products are not bioequivalent to Adalat(R) XL(R), this study is the first and only published one to compare the originator head to head with a generic nifedipine formulation based on the gastro intestinal intestinal therapeutic system (GITS) principle.

Disclaimer - This information is for knowledge purposes only and should not be considered as medical or legal advise.

Study Links Paxil to Breast Cancer Patient Deaths

February 10, 2010 news room bring Bad news for GSK and generics manufacturers of Paxil !

A report appeared of a new study published in BMJ (the British Medical Journal) linking antidepressant paroxetine (marketed by GSK as Paxil) with increased mortality rates in breast cancer patients over the age of 66.

The observational study, conducted by a team at the Sunnybrook Health Sciences Centre in Toronto, looked at data on 2,430 patients treated with tamoxifen for breast cancer along with a single SSRI (selective serotonin reuptake inhibitor) for depression. The women were all 66 or older, and all were from the province of Ontario. Those taking paroxetine for 25 percent of the duration of their tamoxifen treatment had a 24 percent increase in risk of death from breast cancer. Patients taking paroxetine for 75 percent of the duration saw their risk jump to 91 percent.

The researchers report that these percentages were confined to paroxetine; other SSRIs, like fluoxetine (Prozac) and sertraline (Zoloft) had no effect on mortality rate.

David Juurlink, a member of the research team, explained that the discrepancy comes from paroxetine’s method of reuptake inhibition. While the other SSRIs settle for temporarily inhibiting a particular enzyme (CYP2D6), paroxetine’s effect is not reversible. Unfortunately, CYP2D6 is essential for metabolizing tamoxifen, so with paroxetine permanently inactivating this enzyme, the cancer-fighting drug is essentially neutralized.

“There’s been a suspicion for years about possible negative effects of paroxetine on drugs like these,” Juurlink said. “This is the first study to actually quantify it.”

The data excluded women younger than 66 for the simple reason that data sets are much less complete—or nonexistent—for those populations in Canada. However, Juurlink believes physicians will (and should) discontinue using paroxetine for all patients being treated with tamoxifen, and is confident that further studies on younger populations will yield similar results.

“You’ll soon see warnings from the FDA and Health Canada, which have already been sniffing around this for a while,” he predicted.

Disclaimer – This information is for knowledge purposes only and should not be considered as medical or legal advise. Expert consultation should be sought for your individual query related to this topic.

Ablynx says first nanobody drug may hit market by 2013

* Ablynx-Pfizer rheumatoid arthritis drug in Phase II

Belgium's Ablynx (ABLX.BR), which specialises in ultra-small drugs derived from llamas, could see its first product on the market in 2013, its chief executive said in an interview.

Ablynx specialises in nanobodies -- touted as the next generation in antibody treatment -- which are developed from the antibodies in llamas. They have the potential to enable drugs to get to diseases that are too small for traditional antibodies to reach.

One of its lead drugs, being developed in partnership with U.S. drugs giant Pfizer (PFE.N), which inherited it when it took over Wyeth last year, is currently in Phase II trials and could become its first commercialised product.

"The earliest we think it could be on the market is 2013, that's a tangible distance away," Chief Executive Edwin Moses told Reuters in an interview late on Thursday at the company's headquarters in Ghent.

Pfizer is hoping it will be able to use the new nanobody drug to replace its arthritis medicine Enbrel -- which made almost $1 billion in the third quarter of 2008 [ID:nN21437632] -- Moses said.

The company also has partnerships with Merck (MRCG.DE), Boehringer Ingelheim and Novartis (NOVN.VX).

In a twist of nature, llamas have evolved to produce extra small antibodies, which are in turn used to make nanobodies. They are stable enough to be inhaled or inserted under the skin, setting Ablynx' technology apart from rivals like GlaxoSmithKline's (GSK.L) Domantis, Moses said.

Nanobodies are being tested on animals for Alzheimer's disease and they are currently in mid-size human trials for arthritis and thrombosis.

They also cost about a third of the price of developing traditional antibodies, Moses said.

"We take two or three llamas, give them an injection and go away on holiday (and create) what might have taken 20 medical chemists a year to come up with," said Moses. ($1=.7040 Euro) (Editing by Karen Foster).

Reference-

http://www.reuters.com/article/idUSLDE60O0DM20100125

Disclaimer- This posting is for information purposes only and sould not be considered as medical advise.