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The FDA has distributed a revised draft guidance document titled ‘Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices’.
FDA revises forms for submission of patent information to the Orange Book: Federal Circuit decision alters patent term adjustment
Two recent developments will affect the listing of patent information with pharmaceutical products approved by the US Food and Drug Administration.
NYAG forges new ground in scrutiny of pharmaceutical agreements with first-filer exclusivity no-challenge settlement
NYAG has reached a settlement with two drug manufacturers regarding allegations that an agreement between the firms not to challenge each other’s eligibility for regulatory exclusivity was anti-competitive.
Hogan Lovells has continued the expansion of its Los Angeles office with the addition of healthcare litigation partner Michael Maddigan.
Hogan Lovells has announced the further expansion of its New York office with the addition of corporate partner Adam Golden.
Federal judge limits antitrust scrutiny of pharmaceutical reverse payments to settlements involving monetary transfers
A judge held that only patent settlements involving a reverse monetary payment will be subject to antitrust scrutiny under the framework articulated by the Supreme Court last year in FTC v Actavis.
Health, Pharmaceutical and Biotechnology Alert: HRSA issues letter discussing ADAP 340B rebates; proposed rule expected
On 3 February 2014, the Office of Pharmacy Affairs posted a letter to its 340B drug pricing program website discussing 340B rebates paid to AIDS Drug Assistance Programs.
The National Academy of Sciences is set to present its 2014 Public Welfare Medal to Hogan Lovells partner John E Porter.
Hogan Lovells has announced the promotion of 29 new partners, effective 1 January 2014.
The FTC has announced final changes to certain HSR rules regarding acquisitions of exclusive patent rights in the pharmaceutical industry.
Corporate lawyers from Hogan Lovells’ Silicon Valley office have helped Five Prime Therapeutics to finance its operations and to enter the public market.
Hogan Lovells has hired partner Eduardo Ustaran to join its global privacy and information management practice.
Hogan Lovells has announced that Michael Kasser has joined the firm as a regulatory specialist in its food, drug, medical device and agriculture group.
On 27 September, the PhRMA filed suit against the HHS challenging the 340B orphan drug final rule.
The US Food and Drug Administration (FDA) issued the final unique device identifier (UDI) rule on 24 September 2013.
On 23 September 2013, the FDA released the long-awaited mobile medical applications final guidance.
New Third Circuit decision toughens standard for class certification when information about individual consumers is lacking
A recent decision has toughened the standard for class certification when information about individual consumers is lacking.
A federal judge has largely denied a series of motions seeking dismissal of various ‘pay-for-delay’ claims brought by direct and indirect purchasers involving AstraZeneca’s Nexium drug.
The OIG has released an advisory opinion approving a proposed arrangement by a manufacturer to establish a tiered rebate programme for its customers.
On 17 June, the Supreme Court finally weighed in on the issue of pharmaceutical patent settlement agreements involving so-called ‘reverse payments’.