Tag Archives: drug markets

Drug Markets – USA Regulators Go After Deals That Slow Generic Competition

Posted on July 21, 2009 by admin| Leave a comment

Drug Markets, Out of Court Settlements for Generics in Firing Line

This issue of settling Generic Drug Patent issues out of court was on the site last week, and this week more activity in generic drug deals slowing competition, an article on Frist Word, this time its more obviously illegal but watch this space.

The appeals court had invited the DOJ to submit comments on such deals as the court considers whether to allow a challenge to a $398-million patent settlement between Bayer and Teva’s Barr unit over the antibiotic Cipro (ciprofloxacin).

The head of the department’s antitrust division, Christine Varney, stated in the brief that agreements involving payments by the drug manufacturer to the patent challenger to delay a generic launch “requires the defendant to offer justifications in order to avoid antitrust liability.” In addition, the DOJ remarked that the resulting decrease in drug costs after a generic product is introduced, as well as the terms of federal drug law, “create unique incentives and opportunities for settlements that threaten the public interest, incentives and opportunities apparently not found elsewhere.” The DOJ declined to take a position on the litigation launched by drug purchasers against Bayer and Barr over the drugmakers’ 1997 settlement to delay the introduction of a generic version of Cipro

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drugmakers reach deal to reduce US Medicare coverage gap

Posted on June 24, 2009 by admin| 1 Comment

I have just read an interesting article on www.firstwordpluss.com that I wanted to share with you.

“The pharmaceutical industry agreed to a proposal to provide drug discounts to US Medicare beneficiaries that could be worth up to $80 billion over the next ten years. The proposal, which is part of a health-care bill drafted by US lawmakers on June 19, aims to reduce the coverage gap that affects recipients once their drug costs reach a certain level”

Its part of the sign that the USA is moving away from being the golden goose drug market that many have known for years and is moving to a more European model for health markets, this was inevitable and matches some of the predictions previously published on this site (see here). Its inevitable that as health care budgets become a larger part of national spending this kind of trend is only going to become more apparent.

More on the article

“As part of the deal that was negotiated between PhRMA and lawmakers, drugmakers would “provide a 50-percent discount to most beneficiaries on brand-name medicines covered by a patient’s Part D plan when purchased in the coverage gap,” according to industry representatives. In addition, the entire cost of the medicine purchased in the coverage gap will count towards the Medicare recipient’s out-of-pocket expenses.”

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

ida consultants freestrategyconsultation 515x64 Drugmakers reach deal to reduce US Medicare coverage gap

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As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

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