Products | Pharma Marketer

FDA: Getting tough with everyone

Thursday, March 4th, 2010

For well too long food manufacturers like POM Wonderful have been trying to con the American public with unsubstantiated claims. In the case of POM pomegranate juice, the agency said that the company’s Web site, which is listed on its bottles, carried misleading claims that the juice could prevent or cure diseases like hypertension, diabetes and cancer.

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Is Transgene closing in on a major collaboration?

Friday, February 26th, 2010

Analysts are eager to see France’s Transgene nail down a licensing pact for the promising lung cancer vaccine TG4010.

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Dutch biotech Merus lands $30.7M in Series B

Friday, January 29th, 2010

Netherlands-based Merus has raised $30.7 million (€21.7 million) Series B financing. Merus says the funding will help it produce potent human antibody-based drugs. These drugs will either be

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DDMAC Warning and NOV Letter Summary, Third and Fourth Quarters, Part 3

Thursday, January 7th, 2010

Two days ago, we examined the number of enforcement actions by DDMAC and yesterday we looked at what tripped regulatory wires to result in a Notice of Violation (NOV) letter.

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Dominoes from FDA advisory panel on Amgen’s Demonsaub starting to fall?

Wednesday, August 19th, 2009

One has to wonder if the products really failed to meet endpoints or whether the data that was going to be submitted with the NDA could have led to too many restrictions being placed on the product to make it markable or profitable. The FDA took an overly harsh look at the data for Amgen’s Denosumab and as a result Amgen did not get all of what they had hoped for which in turn might lead to smaller sales. It’s interesting to note that the FDA is receiving a lot of pressure on the approval of Gardasil as more and more people decide against vaccinations for their children

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Socialized medicine: Do a law professors arguments make sense? No ! We’re already there

Monday, July 13th, 2009

Let’s look at Mr Reynolds argument one at a time: Claim: But under a national healthcare plan, the “market” will consist of whatever the bureaucrats are willing to buy. Reality: Insurers today are the one who determines what the market will buy

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The FDA is doing little to inform and educate for Rx and OTC products alike

Thursday, July 2nd, 2009

Just look at some of the stories this week when it comes to OTC or Rx products: -Possible links between Lantus and cancer. -Acetaminophen products can cause liver damage or death if not used correctly.

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Sandoz

Friday, June 26th, 2009

Half-page 1: [visual: Top 25 molÃ©cules gÃ©nÃ©riques] Le top 25, la top prioritÃ©. Half-page 2: [visual: Produits de source unique] Produits de source uniqueun seul appel suffit. Full single-page ad: [visual: Formulations et prÃ©sentations complexes

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