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 - AstraZeneca To Cut 12% Of Its Workforce

AstraZeneca Goes Virtual In Neuroscience R&D As Part Of Workforce Reduction AstraZeneca is to slash 12% of its workforce in the next three years, as the company forecasts declining revenues in 2012 because of its steep patent cliff, government pricing interventions and R&D pipeline failures.

Diabetes Franchise May Help Merck Offset Loss Of Singulair The Januvia/Janumet franchise posted sales growth of 40% both in the fourth quarter and over the full year for Merck, while Isentress and Gardasil also posted strong growth rates.

Amitiza Hits Mark In Confirmatory Opioid-Induced Bowel Dysfunction Study Sucampo/Takeda's constipation treatment Amitiza meets primary endpoint in Phase III study of OBD, with a clean safety profile. Sucampo now sets its sights on a supplemental NDA for a third indication.

Abraxane White Paper Distribution At ASCO Draws FDA Advertising Letter Celgene says the white paper - which FDA says promotes Abaxane as effective for unapproved uses and superior to Bristol-Myers Squibb's Taxol - was intended solely for potential business partners interested in nab technology.

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Coming In Wednesday's "The Pink Sheet" DAILY - Vertex's Kalydeco Cystic Fibrosis Drug Speeds Through FDA

FDA announced the approval of Vertex’s Kalydeco for cystic fibrosis on Jan. 31, after just three months’ review and no advisory committee evaluation. It is thought to be the second-quickest FDA approval of a drug, trailing only Novartis’ leukemia drug Gleevec.

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 Monday's "The Pink Sheet" DAILY - Pfizer's Kidney Cancer Drug Inlyta Clears FDA

Verastem completed an intial public offering at $10 per share on Jan. 26, despite only having preclinical assets in its pipeline. Strong interest from large companies for cancer stem cell therapies helped contribute to the price.

Coming In Wednesday's "The Pink Sheet" DAILY - FDA Approves New Formulation Of Takeda's Velcade

FDA approved a subcutaneous formulation of Velcade (bortezomib) Jan. 23, immediately conferring upon the market-leading proteasome inhibitor an improved adverse event profile that will help fend off competition in an increasingly crowded multiple myeloma market.

Latest News From "The Pink Sheet" DAILY - BIO Seeks Expanded Accelerated Approval In PDUFA

ClinicalTrials.gov: NIH Busy Educating Sponsors On Mandates While Regs Remain In The Works Draft rules are still being developed to fully implement ClinicalTrials.gov, but the law has been in effect for some time and officials say they are making a consistent effort to ensure study sponsors are educated on their new responsibilities.