FDA’s plan for approving biosimilars isn’t ‘one size fits all’ (Morning Read)

Current medical news from today, including FDA’s draft rules for approving biosimilars, mobile health’s integration into insurance, and healthcare social media makes clinical trials easier.

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CMXI’s Aldagen acquisition is no exit; stem cell payoff is still down the road

Cytomedix‘s (OTC:CMXI) Aldagen acquisition signaled the company’s intention to establish a strong presence in regenerative medicine therapies and the deal fills needs for both companies. Aldagen, who had tried twice to go public only to withdraw both times amid poor market conditions, gets a partner interested in developing its stem cell treatments. Cytomedix gains prospective [...]

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Artificial immune cell treatment for melanoma aims for human trials in 2013

A new treatment for cancer that uses artificial immune cells to trigger the body to kill cancerous cells will raise a series A round this spring and look to an investigational new drug (IND) application next year.NexImmune is an early stage biopharmaceutical company engineering artificial cells that can stimulate the immune system to treat cancer, [...]

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House GOP wants to kill medical device tax, but are their arguments tenuous?

The ongoing battle to repeal the medical device tax continues with the latest campaign being led by House GOP freshman Todd Rokita from Indiana.Rokita, along with 74 cosigners, sent a letterMonday to Speaker John Boehner that asked him to bring a bill to the floor that would essentially kill the $2.2 billion annual tax to [...]

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CWRU researchers: Drug shows promise in reducing Alzheimer’s plaque in brain

A drug that’s already approved by the FDA has shown promise in clearing away a plaque in the brain that’s associated with Alzheimer’s disease, Case Western Reserve University researchers have found.The drug, bexarotene (brand name Targretin), in mice was able to reduce levels of Beta-amyloid plaque, a protein fragment that builds up in the brains [...]

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With $6 billion allocation, Watson aspires to add branded drugs focus

Watson Pharmaceuticals (NYSE:WPI) wants to add a branded drugs focus alongside its generics business and is setting aside $6 billion for acquisitions to do it, according to a report by Bloomberg.Chief executive officer Paul Bisaro said: “Everything we need to be a branded pharma company we have, except for the sales force. … And we [...]

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Intravenous device company lands first major customer

A startup that’s developed a device to better secure intravenous lines has landed its first major customer.Linebacker said winning its first big client would help the startup build credibility for its eponymous product and expand to other healthcare systems, according to a statement from the Columbus-area company.The company didn’t have to look far for the [...]

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IA Ventures raises $105 million to invest in Big Data companies

Big Data investor IA Ventures has raised a new $105 million fund that it will funnel into two dozen or so startups over the next three years.The New York-based venture firm invests in “companies that create competitive advantage through data,” usually in pre-revenue stages. With its second fund, IA will try to balance its portfolio [...]

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N.C. CRO Clinipace names new chief medical officer for Europe

North Carolina clinical research organization Clinipace Worldwide is flexing its muscles abroad with an executive hire that boosts the CRO’s European operations.Dr. Jurgen Frisch has been named chief medical officer for Clinipace’s European operations. He will be based in the company’s offices in Zurich, Switzerland.var page_count = “off”; [...]

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University of Minnesota licenses cyanide-poisoning antidote to California startup

The University of Minnesota announced Thursday that it has granted an exclusive license to a San Francisco pharmaceutical company that will commercialize a cyanide-poisoning antidote researchers have developed.Vytacera Pharma Inc. will develop and marketSulfanegen, a compound that can be administered by first responders to victims of smoke inhalation or a large-scale terrorist attack. Current treatments [...]

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