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  • Lysing what it sees

    Amgen buying BioVex for OncoVEX immunotherapy based on Phase II melanoma data

    Amgen's acquisition of oncolytic vaccine company BioVex demonstrates that strategic buyers and investors are now looking beyond the science of immunotherapy to focus on what happens in the clinic.

    Published on 1/31/2011
  • Table: Oncolytic virus therapies

    Lysing what it sees Oncolytic virus therapies At least 17 oncolytic virus therapies are in development for various cancers. (A) Received rights to oncolytic virus programs from MediGene AG (Xetra:MDG); (B) Received …

    Published on 1/31/2011
  • The Low Road

    BioCentury Commentary says House GOP takes low road on Avastin in breast cancer

    The House GOP could shine a productive light into FDA, but if the response to Avastin is any indication, so far it's off on the wrong track.

    Published on 1/24/2011
  • Arguing for Avastin

    Why Genentech says FDA moved the goalposts for Avastin in breast cancer

    If FDA grants Genentech a public hearing on Avastin to treat breast cancer, the company will argue the agency moved the goalposts for approval and that it now has the necessary information to run the correct …

    Published on 1/24/2011
  • Jockeying with JAKs

    Incyte sets high hurdle for JAK-2 inhibitors for myelofibrosis

    Comparing data from trials of competing JAK-2 inhibitors for myelofibrosis, it's clear Incyte is not only ahead in its development timeline, but also has Phase III results that set a high hurdle for others to beat.

    Published on 1/17/2011
  • Commercial Risk

    Buysiders pin demand for biotech on commercial launches in 2011

    BioCentury's 19th Annual Buyside View of investor sentiment finds asset managers wanting better biotech performance on commercial launches, and hoping that the appetite for beta goes up as the economy turns.

    Published on 1/10/2011
  • Table: 2011 Milestones

    Buyside View XIX: Commercial Risk 2011 milestones Selected products with Phase III or regulatory milestones expected in 2011. Company Product Indication Event Milestone Accentia Biopharmaceuticals Inc. (OTCQB:…

    Published on 1/10/2011
  • Table: Approval Watch

    Buyside View XIX: Commercial Risk Approval watch Selected products up for approval in 2011. Company Product Indication Event Milestone Adventrx Pharmaceuticals Inc. (NYSE-A:ANX) Exelbine vinorelbine emulsion…

    Published on 1/10/2011
  • Table: Post-Launch Report

    Buyside View XIX: Commercial Risk Post-launch report Sales through 3Q10 of selected drugs approved in 2009 and for which the company discloses sales. Product sales figures reported by listed companies below unless …

    Published on 1/10/2011
  • Table: Top Biotech Products

    Buyside View XIX: Commercial Risk Top biotech products At least 29 drugs developed and marketed by biotech companies are expected to have more than $500 million in annual sales in 2010. Product sales as reported by …

    Published on 1/10/2011
  • Table: New Products to Watch

    Buyside View XIX: Commercial Risk New products to watch Selected drugs that received regulatory approval in 2010. Company Product Indication 2010 approval Acorda Therapeutics Inc. (NASDAQ:ACOR) Ampyra …

    Published on 1/10/2011
  • Label: No; Access: Yes

    NCCN guidelines likely to preserve access to Avastin breast cancer despite FDA

    FDA wants to remove metastatic breast cancer from Avastin's label, but U.S. payers are signaling they will cover the drug while it remains in the NCCN's guidelines. And NCCN hasn't changed its mind.

    Published on 12/20/2010
  • It Pays to Weight

    FDA panel backing for Orexigen: a boost for Qnexa, but not lorcaserin?

    Contrave apparently was helped by being the fourth obesity drug to undergo FDA panel scrutiny, and the panel's body language suggests the door now could reopen for Vivus' Qnexa, but perhaps not Arena's lorcaserin.

    Published on 12/13/2010
  • Table: Interpreting Obesity Votes

    Regulation: It Pays to Weight Interpreting obesity votes FDA's Endocrinologic and Metabolic Drugs Advisory Committee reviewed four obesity treatments in 2010, with panel members casting apparently inconsistent votes…

    Published on 12/13/2010
  • Table: Sibutramine Comparisons

    Regulation: It Pays to Weight Sibutramine comparisons FDA's Endocrinologic and Metabolic Drugs Advisory Committee was concerned that increases in systolic blood pressure (SBP) seen in Phase III trials of Contrave …

    Published on 12/13/2010
  • New Diagnostics Pathway

    Details emerge of Sen. Hatch plan for new regulatory pathway for diagnostics

    Sen. Orrin Hatch's plan to create a new regulatory pathway for diagnostics is taking form. But unless reimbursement is also revamped, the new pathway for high-value added diagnostics will be incomplete.

    Published on 12/6/2010
  • Table: BETTER at a glance

    New diagnostics pathway BETTER at a glance Highlights of the Better Evaluation and Treatment Through Essential Regulatory Reform ("BETTER") for Patient Care Act, being drafted by the staff of Sen. Orrin Hatch (R-…

    Published on 12/6/2010
  • Mild Was Enough

    Final FDA backing for Benlysta may not provide roadmap for other lupus drugs

    While an FDA panel backed approval of Benlysta as the first new treatment for lupus in more than 50 years, it's not clear the clinical program Human Genome Sciences used is a formula other companies could follow.

    Published on 11/22/2010
  • Table: Benlysta Efficacy

    Mild Was Enough Benlysta efficacy At the 10 mg/kg dose, Benlysta belimumab met the primary endpoint of a higher proportion of responders based on the SLE responder index (SRI) compared with placebo in both Phase III…

    Published on 11/22/2010
  • Table: Lupus Pipeline

    Mild Was Enough Lupus pipeline Despite a 13-2 vote in favor of approvalof Benlysta belimumab, questions raised by FDA's Arthritis Advisory Committee make it doubtful the BLISS trials run by Human Genome Sciences Inc…

    Published on 11/22/2010
  • The Provenge Message

    Provenge-Medicare points to routine challenges of FDA-approved uses of new drugs

    The MEDCAC meeting on Dendreon's Provenge makes it clear Medicare is on course to routinely question labeled uses of expensive therapies and deny coverage of off-label uses for new drugs.

    Published on 11/22/2010
  • Innovators pick China

    BeiGene teams Americans, Chinese returnees to develop cancer drugs in China

    American entrepreneur John Oyler is making his second start-up bid in China, but this time aiming to do novel oncology drug development with a team that not only includes a prestigious Chinese returnee, but also two …

    Published on 11/15/2010
  • Wanted: Less Dilution

    1B in therapeutic discovery tax credit awards spread among 3,000 biotechs

    After seeing $1 billion in therapeutic discovery project money spread out among 3,000 companies, biotech CEOs and BIO are already looking at ways to make a hoped-for version 2.0 more meaningful.

    Published on 11/8/2010
  • Table: R&D reviewer's checklist

    Wanted: Less dilution R&D reviewer's checklist For an applicant to have received a tax credit or grant, the reviewer must have concluded the project passed three hurdles. First, it must have met at least one of the …

    Published on 11/8/2010
  • Table: Stacking up awards

    Wanted: Less dilution Stacking up awards BioCentury estimates the $1 billion in grants and credits under the Qualifying Therapeutic Discovery Project program went to about 2,914 companies, after consolidating …

    Published on 11/8/2010

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