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ODAC has whole-heartedly backed FDA's call to raise the hurdle for cancer compounds to receive accelerated approval, specifically backing mandates for randomized trials and two confirmatory studies.
Published on 2/14/2011
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Where Glaxo's Votrient and Pfizer's Sutent appear to have cleared NICE's hurdles in first line renal cell carcinoma.
Published on 1/31/2011
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MEDCAC's meeting on use of ESAs in renal transplant graft patients points to further efforts by CMS to cut use of agents in ESRD, although physicians warned it would turn back the clock on patient care.
Published on 1/24/2011
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Lilly's Amyvid to image beta amyloid in the brain received a negative vote from an FDA advisory committee, but the panel and FDA drew up the path for approval.
Published on 1/24/2011
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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
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Describing the Inevitable Potential biosimilar mAbs in Europe Innovative medicinal products are entitled to 10 years of market protection in the EU. At least 11 mAbs representing more than $40 billion in global …
Published on 12/20/2010
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A European approval notwithstanding, AstraZeneca still has to provide FDA with a satisfactory explanation for the lower efficacy of Brilinta in the U.S. subgroup of the global PLATO study.
Published on 12/20/2010
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EMA's step-wise approach to developing biosimilar mAbs reflects the science and regulatory experience in characterizing complex biologics, paving the way for market entry as innovator patents expire.
Published on 12/20/2010
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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
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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
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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
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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
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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
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EMA's decision to expand public access to drug dossiers provides some contrasts to approaches being discussed at FDA.
Published on 12/6/2010
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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
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An FDA panel has clarified the path forward to develop products for post-exposure Anthrax prophylaxis under the animal rule. But uncertainty remains for other indications like smallpox.
Published on 11/22/2010
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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
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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
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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
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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
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Regulation: Biosimilar Fault Lines Litigation pathway Biosimilars manufacturers and innovators have had six months to ponder the biosimilars pathway created in the Patient Protection and Affordable Care Act. …
Published on 11/1/2010
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FDA hasn't determined how it will implement its biosimilars pathway, but companies on both sides of the innovator/biosimilars divide aren't waiting. At least one has started a trial.
Published on 11/1/2010
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FDA is set to hear stakeholders argue over how the biosimilars pathway should operate, including what defines similarity, substitutability, requirements for multiple indications, and even if the pathway can be avoided …
Published on 11/1/2010
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Instead of doing a relatively small QTc study of once-weekly Bydureon, Amylin and Lilly obtained FDA's blessing to take a different approach. It might have worked had not a separate study of the twice-daily Byetta …
Published on 10/25/2010
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Novo Nordisk did a tQT study of Victoza but did not have to test supratherapeutic concentrations because, unlike Bydureon, its route of excretion does not create a risk of buildup in renally impaired patients.
Published on 10/25/2010