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Biodefense report card U.S. bioterror stockpile The U.S. government has invested more than $3 billion to stockpile medical countermeasures against bioterrorism since 2001. The largest single acquisition has been of …
Published on 9/12/2011
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An HHS report concludes CMS would save billions if it reimburses only Avastin and not Lucentis for wet AMD. But given its makeup, Congress looks unlikely to give Medicare the legal authority to do so.
Published on 9/12/2011
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Ten years and $20 billion after 9/11 and the anthrax attacks, the U.S. has created a few new biodefense countermeasures, but nothing for most of the pathogens that top the government's threat lists.
Published on 9/12/2011
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Diagnostic companies will have to write narrower claims following CAFC's ruling that Myriad's methods patents for analyzing BRCA genes are invalid, leaving MDx patents more vulnerable to competition.
Published on 8/8/2011
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Novartis used a Priority Review voucher from malaria drug Coartem to speed up FDA review of Ilaris for gouty arthritis, providing some clarity on how the process will work. But the value of PRVs remains unclear.
Published on 8/8/2011
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BIO, the National Venture Capital Association and patient groups are angling to get sweeping proposals for regulatory innovation at FDA included in PDUFA V
Published on 6/27/2011
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Alongside its proposals for regulatory reform, BIO is rolling out a series of proposals for tax and financial legislation to boost investment in biotech.
Published on 6/27/2011
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Progressive thinking for FDA Regulatory innovation proposals The Biotechnology Industry Organization, the National Venture Capital Association, and patient advocacy group the National Health Council are making the …
Published on 6/27/2011
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Talking capital in the Capitol BIO's capital formation proposals Key elements of the Biotechnology Industry Organization's legislative proposal to improve capital formation. • Expand eligibility for preferential …
Published on 6/27/2011
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A Microsoft victory at the U.S. Supreme Court would make it easier to invalidate patents, make it harder to value IP protection, and probably send biotech and other innovator industries to Congress for help.
Published on 4/25/2011
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Orphan Drug prices flew under the radar for years, but now are under increased scrutiny from payers and legislators worried that the system will collapse under their weight.
Published on 4/18/2011
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KV at the Brink Makena by the numbers Even with the price reduction it announced last Friday, KV Pharmaceutical Co. is asking the U.S. healthcare system, including cash-strapped Medicaid programs, to pay a …
Published on 4/4/2011
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KV Pharma's decision to slash the price of Makena may be a case of too little, too late. The company says its ability to stay in business depends on the pregnancy drug, but doctors and Medicaid payers say they still can…
Published on 4/4/2011
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KV Pharmaceutical has drawn congressional attention over the $1,500 per dose price for Makena. The drug has long been used to prevent preterm birth and was available from compounding pharmacies for $10-$20 a dose.
Published on 3/21/2011
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Only the pricing is new Legal issues The high price of Makena 17 alpha-hydroxyprogesterone caproate isn't the only reason KV Pharmaceutical Co. has been in the news recently. On March 10, the U.S. Attorney for the …
Published on 3/21/2011
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The U.K. government is moving to the next step in its initiative to create value-based pricing for drugs by 2014. The goal is to balance cost control with improved access to medicine, but the abundance of unanswered …
Published on 3/21/2011
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Value-based complexity Ramping up staff A value-based pricing scheme undoubtedly will require more civil servants in the U.K. Assuming the National Institute for Health and Clinical Excellence is now working at full…
Published on 3/21/2011
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President Obama's proposal to lop five years off the exclusivity period for biologics is unlikely to be enacted, but it underlines the tenuous nature of PhRMA's deal with Congress and the White House.
Published on 2/21/2011
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Lost in translation Sliver of the NIH pie The Small Business Innovation Research grant program is a sliver of NIH's budget pie. In fiscal 2010, NIH allocated about $654 million to SBIR program grants, or about 3.1% …
Published on 2/14/2011
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The biomedical research community has geared up to fight cuts to the NIH budget. But behind the scenes a more fundamental debate is being waged over how life sciences budgets, regardless of their size, should be divvied…
Published on 2/14/2011
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BIO is moving to create a comprehensive legislative package to address biotech's economic and regulatory challenges, building on a report commissioned from former NIH Director Elias Zerhouni.
Published on 2/14/2011
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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
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Body language from U.S. Supreme Court justices suggest drug and device companies will have to disclose more information about adverse events.
Published on 1/17/2011
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The Principal Deputy Commissioner's exit from FDA is setting off a 60-day organizational review at the agency; drug developers will want to see whether Commissioner Hamburg is really going to tackle the hard issues.
Published on 1/10/2011
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The new House will be far more challenging for FDA than the last Congress, but pro-business instincts and deep industry ties will make it friendlier to drug developers.
Published on 1/10/2011