President Obama sends $4.5 billion FDA budget request to Capitol Hill; proposed and existing user fees would provide $2 billion of the funds, with $2.5 billion to come from the Treasury.
Continue reading "Coming In Tuesday's "The Pink Sheet" DAILY - FDA Budget Request: $4.5 Billion" »
Financings of the fortnight considers the value of insider participation in biotech IPOs. Plus news on recent financings by Radius Health, Cempra, Ironwood and Acetylon.
Continue reading "Coming In Monday's "The Pink Sheet" DAILY - Alexion To Boost Its R&D Spending" »
FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics The agency's first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.
Continue reading "Latest News From "The Pink Sheet" DAILY - FDA's Biosimilars Draft Guidances Describe Analytics, Immunogenicty, European Data" »
FDA has released three biosimilars guidance documents. One describes the "totality of the evidence" approach FDA will use in evaluating whether a proposed product is biosimilar to the reference product. Another provides an overview of analytical factors to consider when assessing biosimilarity for the purpose of submitting an application under the biosimilars 351 (k) pathway. And the third guidance provides answers to common questions, such as whether an applicant can obtain approval for fewer than all the conditions of uses, routes of administrations and presentations than the reference product.
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Sanofi Targets 18 Drug Launches From 2012 To 2015 Management highlighted several near-term product launch opportunities during a year-end sales and earnings call in an attempt to assure investors business goes on after Plavix, Avapro patent expirations.
Continue reading "Latest News From "The Pink Sheet" DAILY - FDA Panel Nixes Prostate Cancer Claim For Amgen's Xgeva" »
GSK To Downplay Europe Because of Poor Innovation Support, Focuses On U.S. and Japan Instead GSK CEO Andrew Witty is scathing about the lack of support in Europe for innovation, and the company will now prioritize the U.S., Japan and emerging markets for the development of new products
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A court dismisses Sanofi’s suit against FDA finding that the agency acted properly in approving Sandoz’s ANDA for generic Lovenox (enoxaparin). The court says it was reasonable for the agency to require Sandoz to submit immunogenicity studies, to approve a generic before the brand had been fully characterized, and to find that the active ingredient in the generic was the same as the active ingredient in Lovenox.
Continue reading "Coming In Wednesday's "The Pink Sheet" DAILY - Court Upholds FDA's Approval Of Generic Lovenox" »
Xgeva Prostate Cancer Claim May Not Benefit Beyond Existing Cancer Indication, FDA Says The agency will ask the Oncologic Drugs Advisory Committee whether delaying bone metastases in high-risk castrate-resistant prostate cancer patients provides benefit above that obtained with current use of t drug to delay skeletal-related events and is worth a potentially higher risk for osteonecrosis of the jaw.
Continue reading "Latest News From "The Pink Sheet" DAILY - Orexigen Expects To Refile NDA For Contrave Diet Pill By 2014 " »