BioPharma Today

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

Wendy Diller — Mon, 13 Feb 2012 10:46:57 PST

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

FDA’s Biosimilar Guidances Win Praise For High Hurdles, Flexibility

Josh — Mon, 13 Feb 2012 09:14:51 PST

Merck Bioventures and Hospira execs say the draft guidances are consistent with their approach to biosimilars development. One attorney says FDA’s broad and flexible approach will require the agency to be careful to ensure a level playing field for sponsors.

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

Wendy Diller — Mon, 13 Feb 2012 06:51:16 PST

Vernalis Raises $100 million To Support Push Into U.S. Rx Cough/Cold Market

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

Wendy Diller — Fri, 10 Feb 2012 10:12:11 PST

Financings of the fortnight looks at insider participation in biotech IPOs - Alexion posts a strong fourth quarter with higher than expected sales of Soliris - Vernalis and Tris Pharma team up to enter U.S. Rx long-acting cough/cold market

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

Wendy Diller — Fri, 10 Feb 2012 09:29:00 PST

FDA's draft guidances on biosimilar development addresses immunogencity studies, European bridge data, analytics - Shire expects gradual competitive pressure from Genzyme's resumption of Fabrazyme manufacturing - FDA panel says totality of data weighs against leukemia indicaiton for Eisai's Dacogen - Generic industry's self regulation proposal for drug shortages is questioned at House hearing - FDA advisory committee unanimously rejects NeuorgesX's Qutenza patch for HIV neuropathy pain

Editors' Picks From The World Press

Wendy Diller — Fri, 10 Feb 2012 09:16:08 PST

Business & Finance Execs, regulators, pioneers on biotech most-influential list FierceBiotech Feb. 7, 2012 Generic-drug makers build branded business Bloomberg Feb. 9, 2012 Government & Legal News FDA releases draft guidelines for biosimilars Reuters Feb. 9, 2012, Bloomberg Businessweek Feb....

Coming in Friday's "The Pink Sheet" DAILY

Wendy Diller — Thu, 09 Feb 2012 10:41:34 PST

FDA has released three biosimilars guidance documents.

Breaking through the Fog: How NOT to Kill your Presentation with your Slides

Josh — Thu, 09 Feb 2012 10:19:48 PST

PowerPoint presentations have become a vital part of both internal and external communications at pharmaceutical and medical device companies. Whether you are from regulatory affairs, charged with presenting information on how to comply with new requirements to the manufacturing team or you are from a small medical device company presenting your product to possible investors, your presentation could mean the lifeblood of your organization.

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

Wendy Diller — Thu, 09 Feb 2012 05:58:19 PST

Sanofi Targets 18 Drug Launches From 2012 To 2015

Editor's Picks from the World Press

Wendy Diller — Thu, 09 Feb 2012 05:46:06 PST

Alexion finalizes acquisition of Enobia for $1.1 billion

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

Wendy Diller — Wed, 08 Feb 2012 12:42:20 PST

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.

Trial Management Challenges at Academic Medical Centers: Why and How Can Sponsors Help?

Josh — Wed, 08 Feb 2012 08:22:44 PST

Continuously increasing regulatory requirements, operational needs and financial pressures are forcing the Academic Medical Centers (AMCs) to re-evaluate and transform the way clinical research is managed. Many pharmaceutical and medical device companies are cutting back on their R&D budgets and industry has begun to look for new and hopefully less expensive sources of innovation. AMCs seem to be a perfect fit and they are quickly becoming a deal-making hot spot.

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

Wendy Diller — Wed, 08 Feb 2012 06:23:37 PST

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

Editor's Picks From The World Press

Wendy Diller — Wed, 08 Feb 2012 06:15:36 PST

Survey: Biopharma execs are concerned with the "value challenge"

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

Wendy Diller — Tue, 07 Feb 2012 09:56:58 PST

Court dismisses Sanofi's suit challenging FDA's approval of generic Lovenox - Germany's health ministry continuses the 16% rebate and price moratorium for another year - FDA panel to review NeuorgesX's Qutenza for treatment of pain associated with HIV neuropathy

Developing a Compliant Data Trending System: FDA Demands & Quality Issues

Josh — Tue, 07 Feb 2012 09:55:14 PST

"You need to develop a strategy for trending and monitoring that is aligned with your goal. We cannot tell you what is appropriate. You need to get the expertise and if you don't have this in-house you need to hire it or contract for it." - Grace McNally of the Office of Compliance in FDA's CDER

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

Wendy Diller — Tue, 07 Feb 2012 07:32:59 PST

Xgeva prostate cancer claim may not go beyond existing cancer indication - Industry groups sponsor contests to improve tools for disease management - Final rule allows FDA to control labelilng changes for products in strategic national stockpile - Orexigen to begin CV outcomes study for its obesity drug candidate Contrave - Merck is on track to file novel sleep aid Suvorexant this year

Editors' Picks From The World Press

Wendy Diller — Tue, 07 Feb 2012 07:19:17 PST

Business & Finance Genoscience and RFS license hepatitis C candidate to BioLineRx Genetic Engineering & Biotechnology News Feb. 6, 2012 Mylan obtains generic rights to 2 Valeant skin drugs Drug Store News Feb. 6, 2012 Cadence pulls one batch of...