5 Things Small Businesses Must Know About Google Plus

Posted by: admin  :  Category: Pharmacy news

Google+ (also known as G+, Google Plus or Plus) is the biggest trending topic online these days. So, what is it and why should you care about it? Simple – it’s a new social media site that is directly tied into the most widely-used search engine on the planet, with looming search engine optimization (SEO) implications. If you care about your company’s online reputation – what consumers are saying and where they are saying it – you need to read this post. Read more…

FDA cites “corrupt” CRO for widespread falsification

Posted by: admin  :  Category: Pharmacy news

Any drug developers which relied on Cetero Research for early-stage research or bioanalytics may have a real problem on their hands. The FDA says that two inspections of its Houston lab in 2010 revealed a “pattern of misconduct” that raised serious questions about the research work the CRO carried out between April 2005 and June 2010. And some developers may be required to pay for a do-over in order to keep the FDA’s seal of approval. Read more…

CommzDevice Introduced for Medical Device firms by MakroCare

Posted by: admin  :  Category: Pharmacy news

Specialized Commercialization and launch service program introduced by MakroCare to help assist smaller medical device firms reach emerging markets effectively

Commz, the Commercialization division of MakroCare, introduced CommzDevice which is an integrated project management program that undertakes regulatory, device import/export, distribution channel management, marketing and launch activities. For smaller device firms taking a device in to a new country can be a tiring process and getting vendors that can be integrated for a smooth launch from start to finish is a huge challenge in terms of project management. Commz helps these companies by integrating all or as many services needed under single project management scope that would minimize risk and speed up launch process. Apart from regulated markets like USA, Europe and Japan, CommzDevice has specialization in emerging markets like Brazil, India and China Read more…

FDA finds U.S. drug research firm faked documents

Posted by: admin  :  Category: Pharmacy news

(Reuters) – Drug companies that had medicines tested by contractor Cetero Research might have to reevaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples.

The Food and Drug Administration said on Tuesday two 2010 inspections, an internal company investigation and a third-party audit uncovered “significant instances of misconduct and violations” at a Cetero facility in Houston. Read more…

FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero Research May Require Reevaluation

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FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero Research May Require Reevaluation

The FDA is notifying pharmaceutical companies that bioanalytical studies conducted by Cetero Research, Houston, Texas (Cetero) between April 2005 and June 2010 in support of marketing applications may need to be repeated or confirmed. Cetero is a contract research organization (CRO) that performs bioequivalence and pharmacokinetic testing for a number of pharmaceutical companies. Read more…

Woodcock: New dhttp://pharmacy-in-jobs.pharmacy-bg.com/wp-admin/post-new.phprug approvals reach 20-year high

Posted by: admin  :  Category: Pharmacy news

Is it too soon for the FDA to call 2011 a good year for drug approvals? Maybe not. CDER director Janet Woodcock claims that new chemical and molecular entity approvals have reached a 20-year high, and that two-thirds of drug applications are reviewed in a timely manner. So far this year 20 drugs have been approved, compared to just 21 in all of 2011. Her remarks were delivered in testimony before a U.S. House of Representatives subcommittee on health. Read more…

UPDATE 2-U.S. FDA approves AstraZeneca heart drug Brilinta

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* FDA warns against use of Brilinta with high-dose aspirin

* AstraZeneca shares up as much as 2.7 pct

* Analysts peg Brilinta sales at $1.1 billion in 2015 (Adds details, shares, FDA and analyst comment)

By Anna Yukhananov

WASHINGTON, July 20 (Reuters) – AstraZeneca‘s (AZN.L) heart drug Brilinta won approval from U.S. regulators on Wednesday, opening up the world’s largest market to the company’s biggest drug hope. Read more…

Express Scripts to Buy Medco for $29.1 Billion

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Express Scripts Inc. agreed to buy Medco Health Solutions Inc. for $29.1 billion in cash and stock, a deal that combines two of the largest U.S. pharmacy-benefit managers at a time when health-care services companies are searching for new opportunities in the face of sweeping industry changes.

“The cost and quality of health care is a great concern to all Americans; this is the right deal at the right time for the right reasons,” Express Scripts Chief Executive George Paz said.

Medco holders will receive $28.80 in cash and 0.81 Express Scripts shares for each share, valuing Medco at $71.36 …


online.wsj.com

Tango raises $42 million

Posted by: admin  :  Category: Pharmacy news

In its second round of venture funding, TangoMe Inc. raised $42 million.

The Palo Alto company offers a video call service for mobile phones.

Draper Fisher Jurvetson led the round, while investors Len Blavatnik and Alex Zubillaga also gave money.

“Mobile is the new frontier,” said Timothy Draper of DFJ. “Mobile video calling is the big trend of the year.”

Uri Raz and Eric Setton, who started Tango in 2009, are CEO and chief technology officer, respectively. In the past, Raz started video streaming business Dyyno (also with Setton) and Appstream, which Symantec Corp. (NYSE: SYMC) bought in 2006. Setton has a Ph.D. in electrical engineering from Stanford University .


The company is hiring — open positions include a senior director of marketing as well as a slew of engineering jobs.

Ex-Pfizer R&D chief LaMattina criticizes short-term pharma strategy

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John LaMattina has some advice for Pfizer, where he worked for 30 years before retiring as the head of research. Once the pharma giant finishes chopping the R&D budget to around $6.5 billion, he says, Pfizer will only be committing 10% to 11% of its 2012 estimated revenue to R&D. And by shortchanging R&D now to satisfy the short-term profit demands of analysts and investors, he adds, Pfizer will likely be haunted by the anemic funding in years to come.

“This industry historically has spent anywhere from 15% to 20% of top-line sales in R&D,” LaMattina told Reuters. “It’s their lifeblood. If you don’t have new products you don’t have a business anymore.” Added LaMattina: “In the short term, I guess that’s OK in terms of delivering for shareholders. But four, five, 10 years out, I’m not sure that is going to be a very good position to be in.”

These cuts are also coming after years in which development costs spiked due to the increased demands placed on clinical trials from regulators and payers. Actual discovery work, he adds, only accounted for about 15% of the R&D budget.

LaMattina, now a senior partner at PureTech Ventures, is in closer sync with CEOs like John Lechleiter at Eli Lilly, who recently told reporters that cutting the R&D budget is “nuts.” And the big mergers of recent years haven’t helped the R&D side, he says, noting that even when cost cutting isn’t a big priority there’s still a significant amount of disruption when the pharma company has to decide which scientist will lead each of its programs.

www.fiercebiotech.com