BioPharma Today

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.

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.

Coming In Monday's "The Pink Sheet" DAILY - Gilead Cites Positive Data On Its Hepatitis C Drug

Gilead gives the market a snippet of positive data for its hepatitis C drug ‘7977 during its fourth quarter conference call, priming investors for the drug’s major blockbuster potential.

Latest News From "The Pink Sheet" DAILY - FDA Names New Head Of CDER Office Of Drug Evaluation I

Unger Takes Over ODE I As Acting Director; Temple To Focus On Clinical Science Role Ellis Unger has been promoted to run the CDER Office of Drug Evaluation I, although he will retain the acting title like his predecessor. Long-time ODE I Acting Director Robert Temple, considered among FDA's most experienced and respected regulators, will scale back his duties as part of the change.

Coming In Wednesday's "The Pink Sheet" DAILY - SFJ Pharmaceuticals To Conduct Trial Of Pfizer Cancer Compound In Asia

In another sign of Big Pharma’s growing need to curb development cost and risk, Pfizer has engaged drug development company SFJ Pharmaceuticals to fund and supervise a Phase III trial of renal cancer candidate axitinib in Asia.

Latest News From "The Pink Sheet" DAILY - Lilly Holds Guidance Call With Analysts As It Suffers Zyprexa Erosion

Boehringer, Forma Strike Discovery Deal In Oncology The German pharma pays $65 million upfront in a deal with high-ceilinged milestones, in an ambitious effort to discover cancer drugs that affect protein-protein interactions.

Latest News From "The Pink Sheet" DAILY - Baxter and Momenta Join Forces To Develop Biosimilars

Cell Therapeutics' Dual Strategy On Pixuvri Will Be Tested At Advisory Committee While appealing the "complete response" letter it got for its non-Hodgkin's lymphoma treatment Pixuvri on the basis of re-analyzed data, Cell Therapeutics also is doing the additional combination trial the agency requested.

Coming In Monday's "The Pink Sheet" DAILY - NeuorgesX's QUTENZA To Go Before FDA Panel

The Medicare Payment Advisory Commission votes to recommend that Congress increase the difference between copayments for generic and branded drugs used by low-income beneficiaries in Medicare Part D to encourage greater generic use in that population.

Coming In Wednesday's "The Pink Sheet" DAILY - Actelion Declines To Acquire Trophos SA

Actelion  passes on acquiring privately held Trophos SA after Trophos reported failed results of its olesoxime Phase III Lou Gehrig’s study.