May 22, 2018| Blog
Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel Guzman v. Insys Therapeutics, Inc., filed in the U.S. District Court for the Central District of California.
Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug Prices
May 21, 2018| Blog
On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day.
May 14, 2018| Blog
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration's plan to lower drug prices and reduce out-of-pocket costs.
On Tuesday, May 8th, the House held three hearings related to combating the opioid epidemic. The first hearing came out of the Energy and Commerce (E&C) Subcommittee on Oversight and Investigations, which examined opioid distribution and diversion by the pharmaceutical industry.
Personalized Medicine Gets a Boost from Federal Circuit’s Vanda Pharma Decision – PART II: Enforcement
May 1, 2018| Advisory
The Federal Circuit’s decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2707, 2016-2708 April 13, 2018) provided some good news on the subject matter eligibility front for innovators and other stakeholders in the personalized medicine space, as discussed in a previous post.
April 25, 2018| Blog
On April 16, 2018 in a precedential opinion, the United States Court of Appeals for the Federal Circuit, Sumitomo Dainippon Pharma v. Emcure Pharms., Nos. 2017-1798, -1799, -1800, affirmed the United States District Court for the District of New Jersey by construing the claimed chemical structure diagram to encompass at least the specific enantiomer depicted, refusing to limit the claim to only cover a racemic mixture of the (+) and (–) enantiomers, absent clear indication that the depicted enantiomer should be excluded from the claim.
April 19, 2018| Advisory
The Federal Circuit provided a welcome boost for stakeholders in the field of personalized medicine with its recent decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2702, 2016-2708 April 13, 2018).
April 13, 2018| Blog
Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.
April 4, 2018| Blog
Earlier this week, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. CMS also released fact sheets for the Final Rule and the Call Letter.
March 22, 2018| Blog
Mintz and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018! This year's summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker.
March 20, 2018| Blog
Although the options for accelerated FDA pathways have recently expanded, the current political climate has increased scrutiny of expedited approvals. Next week, my colleague Bethany Hills will be moderating a panel discussion in our Boston office about the realities of pursuing an accelerated pathway.
March 15, 2018| Podcast
Ken Cohen discusses how raising money for life sciences companies is different than for technology companies and gives entrepreneurs advice on how to finance and grow their life sciences company.
February 20, 2018| Blog
As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices.
February 1, 2018| Blog
The pharmaceutical industry is facing new limits on payments to prescribers in New Jersey. Earlier this month the state's Division of Consumer Affairs finalized sweeping new rules prohibiting some types of payments and capping others. New Jersey now joins the ranks of other states, like California and Massachusetts, with specific payment prohibitions between manufacturers and prescribers.
January 18, 2018| Blog
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products.
NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book
January 18, 2018| Advisory
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.
January 2, 2018| Blog
Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement priorities for over-the-counter homeopathic drug products.
April 27, 2017| Alert
On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010.
Federal Circuit Limits Claim to Single Embodiment Because Only Enabling Description Provided in the Patent
April 12, 2017| Blog
On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for non-infringement of The Medicines Company’s (“MedCo”) patents-in-suit.
March 20, 2017| Blog
Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to commercialize a biosimilar version of Genentech’s cancer drug, Avastin®.
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