BioPharma Today

Coming In Tuesday's "The Pink Sheet" DAILY - FDA Budget Request: $4.5 Billion

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.

Latest News From "The Pink Sheet" DAILY - Vernalis Moves Into Rx Cough/Cold Market

Vernalis Raises $100 million To Support Push Into U.S. Rx Cough/Cold Market Vernalis reveals new strategy to market long-acting prescription cough/cold preparations in the US, supported by Tris Pharma's technology and a $104 million fundraising

Coming In Monday's "The Pink Sheet" DAILY - Alexion To Boost Its R&D Spending

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.

Latest News From "The Pink Sheet" DAILY - FDA's Biosimilars Draft Guidances Describe Analytics, Immunogenicty, European Data

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.

Coming in Friday's "The Pink Sheet" DAILY

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.

Latest News From "The Pink Sheet" DAILY - FDA Panel Nixes Prostate Cancer Claim For Amgen's Xgeva

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.

Coming In Thursday's "The Pink Sheet" DAILY - Sanofi Talks Silver Lining

The year 2012 is a transitional one for Sanofi SA, which is facing the loss of exclusivity for blockbuster drugs Plavix (clopidogrel) and Avapro (losartan), losses that alone will drag net income down €1.4 billion ($1.86 billion). But management highlighted the silver lining during a year-end sales and earnings call Feb. 8: the acquisition of Genzyme, which will mitigate damage, and that the company’s pipeline, which could yield 18 product launches from 2012 through 2015.

Elan reported unremarkable fourth quarter results, but highlighted the growth of MS drug Tysabri despite the loss of patients due to a new assay that shows which patients are susceptible to a rare brain disease.

Latest News From "The Pink Sheet" DAILY - GSK Shifts Focus To U.S. And Japan

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

Coming In Wednesday's "The Pink Sheet" DAILY - Court Upholds FDA's Approval Of Generic Lovenox

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.

Latest News From "The Pink Sheet" DAILY - Orexigen Expects To Refile NDA For Contrave Diet Pill By 2014

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.