iPhone in India on Aug 22, or sooner

August 6, 2008

Apple iPhone, the touchscreen handset that seems to have acquired a cult status in the US and other western countries, is finally hitting Indian shores this month.

While Bharti Airtel has announced that it will launch iPhone on August 22, Vodafone may steal its arch rival’s thunder by launching the eagerly-awaited phone a few days earlier on August 18. In fact, Indiatimes Infotech was the first to report that Vodafone will launch iPhone in India in August.

In a statement, Bharti said that millions of Airtel subscribers will be able to purchase the iPhone at Airtel’s Relationship Centres from August 22.

“iPhone has been an iconic technological revelation of this year and Airtel has been at the forefront of innovation and customer delight in the Indian telecom sector,” Sanjay Kapoor, President, Bharti Airtel mobile services, said.

iPhone is embedded with all 3G features and is twice as fast as the existing mobile phones. The phone also has in-built GPS system, which facilitates as navigation and positioning tool.

“Introducing iPhone in India further underscores Bharti’s commitment to enrich the communication experience of Airtel users,” Kapoor said.

Leading cell phone makers like Nokia, Motorola and Samsung have stepped up their R&D efforts to bring feature-rich phones in India to compete iPhone.


About FISMA?

August 6, 2008

The Federal Information Security Management Act of 2002 (FISMA), FISMA imposes a mandatory set of processes that must be followed for all information systems used or operated by a U.S. federal government agency or by a contractor or other organization on behalf of a federal agency. These processes must follow a combination of Federal Information Processing Standards (FIPS) documents, the special publications SP-800 series issued by NIST, and other legislation pertinent to federal information systems, such as the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act. However, following these mandates only results in “compliance” and not “security”.[citation needed]


Career MISTAKES you should avoid

August 6, 2008

Whether it is a candidate with good work experience or one who has just passed out of college and begun his career, everyone aspires for a career. In order to reach their goals fast many candidates do such mistakes which leave a mark on their career forever.

1. Switching jobs frequently
Switching jobs frequently reflects badly on your CV. While looking for suitable candidates, companies refrain from hiring professionals who frequently switch jobs understanding the constant job switches means

  • Lack of commitment
  • Inability to stick to one role for long
  • Being unreliable
  • Being money-minded
  • Inability to get along with people
  • Lack of clarity in job profile

When you take up a job, try to ensure that you are getting into something which you will enjoy doing. Don’t get into a job just for the sake of picking up one. You will land up into frustration and will try to switch soon.

2. Jumping Industry
Don’t get into an industry just because it looks lucrative or glamorous from outside. Research the industry properly and get into one which really fits into your interest and skills. If you get into an industry just because your friend is into and earning well, you may again land up switching the job and industry as you discover that it doesn’t suit your interest.

3. Running after money
Don’t choose a job just because it earns you a couple of thousand rupees more. Take up a job which will give you a chance to grow and use your skills in the right way. Money always follows a good career. For e.g. you may choose to get in to a BPO job today because it pays you well and early but tomorrow you might lose interest as you won’t have much to do there and the chances to grow are also minimal.

4. Lies about your candidature
Don’t tell lies about your skills, qualifications or achievements which might have an impact on the selection process. They might get you a job initially but you may lose it anytime they are discovered.

5. Taking work for granted
Ensure that you perform your job with full commitment and responsibility. If you try to shirk away your responsibilities, the chances of you losing the job get higher. This attitude will not let you grow in your career and you will always find yourself looking out for a new job.

6. Dishonesty
Always keep an element of honesty with every job you do. Even if you are leaving the job don’t handicap the company by taking away the confidential information or destroying the important data.

7. Punctuality
All your hard work will be wasted if you are not punctual and regular at work. If you need to be away from work for any reason, keep your superior and the team informed.

8. Choosing a career for money
It is difficult to get away from the charm that money offers but don’t take up a career just because it pays more. In a very short time you will realize that the charm of money has faded and you don’t want to continue the job.

Source: Careerride


Daiichi Wins Approval to Buy Ranbaxy After Hurdles

August 6, 2008

Daiichi Sankyo Co., Japan’s third- largest drugmaker, won approval from the Indian government to buy Ranbaxy Laboratories Ltd. for as much as $4.7 billion after overcoming regulatory hurdles that delayed the takeover.

Daiichi Sankyo was cleared to acquire 34.8 percent of Ranbaxy from Chief Executive Officer Malvinder Singh and his family, said Yasuki Minobe, a spokesman for the Tokyo-based company. It will also offer to buy a further 20 percent from investors between Aug. 16 and Sept. 4, ICICI Securities Ltd., which is managing the tender, said in a statement.

The Japanese drugmaker agreed to the acquisition on June 11 to enter the generic-drug market, where sales are rising twice as fast as for branded medicines. Daiichi Sankyo said July 31 it was delaying the offer that had been scheduled to start Aug. 8.

Ranbaxy fell 1.9 percent to 512.65 rupees at 12:25 p.m. in Mumbai, reversing an earlier gain of as much as 3.8 percent. Daiichi gained 3.5 percent to 3,250 yen at the close in Tokyo.

The 737 rupee-a-share offer is still 41 percent more than Ranbaxy’s closing price yesterday. Daiichi Sankyo, which will also buy a portion of about $1 billion of preferential stock, will pay as much as 198 billion rupees ($4.7 billion), the company said in a presentation on June 12.

The Japanese drugmaker got approval from the Indian government yesterday to purchase shares of Ranbaxy and its unit Zenotech Laboratories Ltd., paving the way for the transaction process to proceed.

Ranbaxy agreed in October 2007 to buy 45 percent of Hyderabad-based Zenotech to gain access to the $65 billion market for biotechnology treatments. Daiichi plans to spend 850 million rupees to buy 20 percent of Zenotech from the public, as required by Indian takeover rules. The shares rose 1.3 percent to 113 rupees today.

To contact the reporters on this story: Saikat Chatterjee in New Delhi at schatterjee4@bloomberg.net.


FDA Fails To Pursue Off-Label Violations: Report

August 6, 2008

The FDA takes an average of seven months to issue warnings to drugmakers for off-label marketing, and the drugmakers take an average of four months to address violations, according to the Associated Press, citing a report compiled by the Government Accountability Office. Here it is.

The report also found the FDA has no one assigned to specifically monitor off-label violations. The agency’s Division of Drug Marketing, Advertising and Communications, which has 44 employees reviewing DTC ads, monitors off-label marketing.

The division examined about 68,000 ads last year, but lacks the resources to review all info received by the FDA, according to the report. The agency uses a prioritization system to select which ads should be reviewed, but the GAO found no evidence the FDA “systematically prioritizes all the submissions it receives.” In other words, the agency isn’t applying its own criteria to most submissions. (see page 40).

From 2003 to 2007, DDMAC issued 42 notices of potential violations related to off-label use, most of which prompted drugmakers to end misrepresentations in their ads. Another 11 cases involving off-label promotion were pursued by the Justice Department during the same period.

Chuck Grassley, the Republican Senator from Iowa, who requested the report, issued a statement saying the FDA “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law As a result, drugmakers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”

UPDATE: An astute reader reminds us that, earlier this year, drugmakers began lobbying Washington to push for looser government restrictions on off-label promotion. Ten drugmakers, including Pfizer, Bayer, AstraZeneca and Johnson & Johnson, formed a coalition to push for looser off-label restrictions with an eye toward submitting comments to the FDA, which has been soliciting comments on its proposed off-label promotion guidelines. 

Source: Pharmalot


FDA Issues New Rules For Advisory Committees

August 6, 2008

The changes involve conflicts of interest and waivers for panel members; advisory committee voting procedures; the timing of committee briefing materials to be released and the procedures for deciding when an advisory committee meeting should be held. The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. Here is a summary, and you can look here to read the individual guidances.

The most contentious issue has to do with concern over conflicts involving committee members, a hot-button topic that regularly embroils the FDA (see this item earlier today). The FDA has long argued finding experts without financial conflicts is arduous, if not impossible, because many top-flight physicians and academics serve as industry consultants.

To answer the criticism, the FDA has these new rules: For starters, if an individual, his or her spouse, or minor child has potentially conflicting financial interests totaling more than $50,000, he or she would not be allowed to participate in that meeting.

Second, the guidance specifies four scenarios where a conflict is significant and FDA does not intend to issue a waiver, even if the potential personal conflict is below $50,000. (For example, if the advisor is the principal investigator of a clinical trial of a product about which the committee will be providing advice, the advisor will not be allowed to participate in that meeting.) Third, before a waiver is issued, the FDA will require a showing that the waiver is necessary to ensure the committee has “essential expertise.” Fourth, as now required by law, the FDA will limit the number of waivers granted.

[Our thought: $50,000 is still a lot of money. Disagree? Ask someone who thinks $4 for a gallon of gas is too much. We recognize there is no perfect situation, but the threshhold remains stubbornly high.]

Source: Pharmalot


FDA builds higher walls between advisors, industry

August 6, 2008

Panellists serving on the FDA’s advisory committees will have stricter limits on their financial ties to industry under a raft of reforms announced by the agency yesterday.

The guidance, which is expected to come into effect within 120 days and formalises a draft policy drawn up in 2007, would set a cap of $50,000 “as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting,” such as a company or competitor whose product is under review.

The aim is to reduce any real or perceived risk that the objectivity of an advisory committee could be compromised by a panellist with a conflict of interest, according to the agency.

The FDA relies on external experts to help it make decisions on complex medical and scientific issues, so aside from what will doubtless be endless debate about the appropriateness of the $50,000 threshold itself, the big question is whether this new will prevent impropriety among panellists but still allow the best expertise to be included.

Recognising this, the guidance also includes a waiver system. This means that FDA staffers can elect to allow a panel member with a smaller financial stake to take part, provided FDA officials “determine that there is an essential need for the advisor’s particular expertise.” There are still exclusion criteria however – for example the principal investigator in a sponsor clinical trial would be barred.

The waivers would also be posted on the FDA’s website ahead of the meeting and include a description of the panellist’s interest and why his or her attendance was deemed necessary. It will also impose a limit on the number of waivers issued.

Critics have suggested that the agency should have stuck to original proposals to allow panellists with a lesser financial stake to attend but not to vote.

Conflict of interest has been a central part of the FDA reform process in recent years, with accusations often levelled that current waivers and notification procedures are simply not working.

There is some evidence to back that up. In 2006, for example, the Journal of the American Medical Association published a study which analysed 221 meetings and found that “conflicts of interest at drug advisory committee meetings are common, often of considerable monetary value, and rarely result in recusal of advisory committee members.”

However, that study also concluded that there was only a weak effect on the outcome of meetings. In other words, the conflicts of interest did not appear to be swaying the votes cast.

There have been suggestions that the funding for the FDA should be hiked to remove its reliance on external advisors entirely, but many observers believe this is simply not a workable solution as it is very likely that the best experts in any field will not be employed by the regulatory body.

What is clear is that for now the agency cannot do without its advisors. Last year alone it relied on their input for 48 advisory committee meetings, on topics ranging from the safety of diabetes medications to the evaluation of new anticancer drugs for use in children.

Other reforms include the publication of FDA briefing documents at least 48 hours in advance of the meetings, and a ban on sequential voting. Now all panellists will vote simultaneously to avoid any risk of ‘voting momentum’, in which some voters may be influenced, even subconsciously, by the votes of those who precede them.

Source: in-Pharma