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PCORI says it will issue new conflict of interest standards before it begins to award contracts for primary research into comparative effectiveness this month.
Published on 5/7/2012
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Biopharma companies have been making business plans on the presumption that the Affordable Care Act would survive. But the Supreme Court's review leaves the future of biosimilars, Part D drugs and IPAB up in the air.
Published on 4/2/2012
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The Supreme Court ruling in Prometheus did little to remove uncertainty about MDx patents, and raised worries the decision could be extended to drugs. The next shoe will drop when PTO issues guidance.
Published on 3/26/2012
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FDA officials are supporting the principle behind IDSA's proposal for a staged approval pathway to shorten development of therapies for well-defined populations with serious unmet medical need.
Published on 3/19/2012
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Both the House and Senate have drafted PDUFA legislation that includes the GAIN Act, which would add market exclusivity and other incentives for developing antibiotics.
Published on 3/19/2012
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Oral arguments before the U.S. Supreme Court suggest MDx companies may not get the guidance they were hoping for from the high court's decision in Mayo v. Prometheus.
Published on 12/12/2011
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The scientific complexity of hESC-derived products should provide a high barrier to entry despite a European Court of Justice ruling that deems such products unpatentable.
Published on 10/31/2011
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Biodefense report card BARDA bioterror pipeline The Biomedical Advanced Research and Development Authority (BARDA) is responsible for the U.S. government's procurement and advanced development of medical …
Published on 9/12/2011
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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