products
FDA: Getting tough with everyone
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.
Is Transgene closing in on a major collaboration?
Analysts are eager to see France’s Transgene nail down a licensing pact for the promising lung cancer vaccine TG4010.
Dutch biotech Merus lands $30.7M in Series B
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
DDMAC Warning and NOV Letter Summary, Third and Fourth Quarters, Part 3
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.
Dominoes from FDA advisory panel on Amgen’s Demonsaub starting to fall?
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
Socialized medicine: Do a law professors arguments make sense? No ! We’re already there
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
The FDA is doing little to inform and educate for Rx and OTC products alike
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.
Read the full storySandoz
Half-page 1: [visual: Top 25 molécules génériques] Le top 25, la top priorité. Half-page 2: [visual: Produits de source unique] Produits de source uniqueun seul appel suffit. Full single-page ad: [visual: Formulations et présentations complexes
Millennium CEO hunts for deals among "delusional" execs
Millennium Pharmaceuticals CEO Deborah Dunsire showed up at ASCO’s annual meeting in Orlando intent on finding mid- and late-stage cancer therapies
CSL to fight FTC on Talecris merger
Blood plasma company CSL










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