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A MEDCAC meeting outcome suggests national coverage of beta amyloid PET imaging agents such as Lilly's Amyvid may be at least two years away.
Published on 2/4/2013
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FDA wants a public discussion on proposals to create a pathway for drugs for limited, well-defined populations with serious or life-threatening conditions. Key is finding a way to inhibit, but not prohibit, off-label …
Published on 1/28/2013
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No laws needed Antibiotic tiers Scientists from seven antibiotics developers have proposed a regulatory framework to address the unmet need for new antibacterial drugs. The framework consists of four tiers of …
Published on 1/28/2013
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Antibiotic developers have proposed a tiered-approval scheme for antibiotics and a corresponding labeling scheme to ensure appropriate use, which they say can be done without additional authorities
Published on 1/28/2013
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While an FDA panel backed approval of J&J's Invokana to be the first SGLT2 inhibitor to market in the U.S., the agency's analysis of the CV data shows it is still being very cautious with diabetes drugs.
Published on 1/21/2013
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An FDA panel's thumbs-down vote on Zohydro ER challenges the agency's classwide opioid REMS, as well as what it should do with a product that met existing safety and efficacy standards.
Published on 12/17/2012
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While industry would like EMA to restrict access to patient-level clinical data through a gatekeeping mechanism, opponents want open access to allow reproducibility of secondary analyses.
Published on 12/10/2012
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FDA's approach to its panel meeting for Theravance's Vibativ may reflect the agency's greater willingness to work with industry to overcome hurdles in antibacterial development.
Published on 12/3/2012
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GlaxoSmithKline's Q-Pan H5N1 vaccine could become the first product approved under FDA's pandemic influenza vaccine pathway. But GSK's product may have benefitted from Europe's head start.
Published on 12/3/2012
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FDA's vaccines panel meeting for GSK's Q-Pan and Dynavax's Heplisav provided three clear messages about what companies should and should not do in developing adjuvanted vaccines.
Published on 12/3/2012
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FDA's breakthrough drug pathway should get exceptional new therapies to patients faster, but key players in academia and Europe need to get on board, and manufacturing roadblocks avoided.
Published on 12/3/2012
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Antibiotics reset Less than Meets the Eye While 53 antibiotic new chemical entities in the clinic look robust, there is less there than meets the eye, particularly regarding new classes of broad-spectrum drugs that …
Published on 11/19/2012
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Antibiotics reset A class apart There are at least 53 systemic antibiotic NCEs in clinical development, of which 14 fall into innovative classes/mechanisms of action, defined as compounds that are not based on …
Published on 11/19/2012
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While the GAIN Act reflects a consensus between the U.S. government, industry and the medical community, infectious disease specialists and biopharma say much more is needed to get antibiotic development back on track.
Published on 11/19/2012
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An FDA committee backed hoFH compounds from Aegerion and Genzyme, but neither the discussion nor the companies' clinical trials give doctors a clear idea of how and when to use one over the other.
Published on 10/29/2012
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Familial competition Lomitapide vs. mipomersen Both lomitapide from Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) and Kynamro mipomersen from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) and Isis …
Published on 10/29/2012
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New PDUFA clock starts Creating hope The FDA Safety and Innovation Act incorporates the Creating Hope Act, which creates a Priority Review voucher incentive program for rare pediatric diseases. The legislation was …
Published on 10/1/2012
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New PDUFA clock starts Never mind In the FDA Amendments Act of 2007, Congress tightened conflict of interest restrictions on advisory committee members and limited FDA's ability to grant waivers for COI. Five years…
Published on 10/1/2012
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PDUFA V goes into effect Oct. 1, launching an experiment designed to test the hypothesis that a longer, more interactive review process will make drug regulation more predictable and efficient.
Published on 10/1/2012
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Stakeholders are arguing over what percentage of drugs are determined to have a benefit under Germany's AMNOG pricing law, but the real benchmark is whether patients are actually getting innovative drugs.
Published on 9/17/2012
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Optimer and BTG are the first drug developers in nearly a decade to utilize a CMS policy designed to boost reimbursement for hospitals using newly approved inpatient products that are effective but expensive.
Published on 8/20/2012
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EMA has said it will automatically make clinical trial data available after drugs are approved, but how much data it will reveal and who will get it remain uncertain.
Published on 7/30/2012
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On the fourth try, uniQure's Glybera Orphan gene therapy finally won the backing of CHMP, in part due to management's campaign to remind policymakers about Europe's commitment to rare diseases.
Published on 7/30/2012
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Persistence pays off Glybera's clinical program Lipoprotein lipase (LPL) deficiency is characterized by severe hypertriglyceridemia leading to acute pancreatitis. uniQure B.V.'s gene therapy Glybera alipogene …
Published on 7/30/2012
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ThromboGenics' bet on an erstwhile clot buster in a new ophthalmic indication has turned out to be a life-saver now that an FDA panel voted for Jetrea to treat symptomatic vitreomacular adhesion.
Published on 7/30/2012