BioPharma Today

Latest News From "The Pink Sheet" DAILY - FDA's Hamburg Describes GDUFA Accounting Challenge

BioMarin: A Rare Disease Specialist With An Eye On The Long-Term BioMarin is in the midst of a pivotal year, with several near-term data catalysts, the most important of which will be Phase III data on GALNS for the rare disease MPS IV.

Coming In Wednesday's "The Pink Sheet" DAILY - FDA Acts To Bolster Supply of Cancer Drugs, Issues Guidance On Drug Shortages

FDA releases a draft guidance on requirements for notifying the agency of issues that could result in drug shortages. FDA also holds a news conference on steps it has taken to increase the supply of critically needed cancer drugs.

Latest News From "The Pink Sheet" DAILY - Qnexa Weight Loss Drug Requires CV Outcome Trial

NICE Doubtful On Cost-Effectiveness Of Tarceva The U.K.'s National Institute for Health and Clinical Excellence is asking for a further cost-effectiveness analysis of Roche's Tarceva to weigh against the cost effectiveness of AstraZeneca's Iressa.

Coming In Tuesday's "The Pink Sheet" DAILY - Gilead Reports Negative Trials Results Of Its Hepatits C Candidate

In the first blemish for Gilead’s previously spotless hepatitis C candidate, GS-7977, the company unveiled data showing that six of eight “null responders” experience viral relapse four weeks after ending treatment with the drug. The news sent Gilead’s share price tumbling. The compound had a 100% cure rare in a small Phase II trial last year, leading Gilead to pay almost $11 billion to buy out its developer, Pharmasset.

Coming In Wednesday's "The Pink Sheet" DAILY - Biogen Idec To Acquire Stromedix

Roughly five years after out-licensing stalled anti-fibrosis candidate STX100 to Stromedix, Biogen Idec will bring that compound, now about to enter Phase II in idiopathic pulmonary fibrosis, back in house with the $75 million buyout of Stromedix. The privately held biotech’s CEO, Michael Gilman, who headed R&D at Biogen from 2000 to 2005, will return to his former company to spearhead development of STX100.

Latest News From "The Pink Sheet" DAILY - FDA To Add 68 Staffers With 2013 Biosimilar User Fees

Valeant Adds Eyetech's Macugen To Ophthalmic Portfolio The acquisitive Canadian specialty pharma's latest deal is a relatively small one, giving it a wet AMD treatment that lags behind Lucentis and other newcomers.

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

Article preview from "The Pink Sheet"-  February 13, 2012

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 - 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 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.

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

"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