False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Jublia® (efinaconazole) - Case Name: Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc.,978 F.3d 1374 (Fed. Cir. Nov. 5, 2020)(Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by O’Malley, J.) (Appeal from D.N.J.,...more
The Federal Circuit has spoken. In a per curiam opinion, it denied Valeant’s petition for rehearing by the panel and rehearing en banc. A case watched closely by the biotechnology and pharmaceutical industries, the Federal...more
2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more
Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s...more
For the first time since the U.S. Supreme Court’s TC Heartland decision, the U.S. Court of Appeals for the Federal Circuit addressed the issue of venue specific to Hatch-Waxman litigation, pursuant to which branded...more
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent...more
On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where...more
Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. Last Thursday, a Federal Circuit panel issued a decision applying a narrow reading of the patent venue statute, 28 U.S.C. § 1400(b), in a Hatch-Waxman...more
This week, the Federal Circuit issued an order finding that in cases brought under 35 U.S.C. § 271(e)(2)(A), infringement occurs for venue purposes only in districts where actions related to the submission of an Abbreviated...more
BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...more
Bausch Health agreed to pay the SEC $45 million to settle Valeant Pharmaceuticals (former name) accounting fraud schemes. Three former executives, former CEO Michael Pearson, CFO Howard Schiller and Controller Tanya Carro...more
BECAUSE PLAINTIFFS FAILED TO SHOW SPECIFICALLY HOW DEFENDANTS COMMITTED ANY ACT OF INFRINGEMENT IN NEW JERSEY—PARTICULARLY BY FILING AN ANDA IN WEST VIRGINIA WITH THE FDA IN MARYLAND—OR THAT ANY FUTURE, INTENDED ACTS WERE A...more
More on yesterday’s news of a split power-generation division at GE, including why fixing the ailing business is such an important task for new CEO Larry Culp and what federal criminal and civil accounting probes mean for the...more
Case Name: Valeant Pharms. Int’l v. Mylan Pharms., Civ. No. 15-8180 (SRC), 2018 U.S. Dist. LEXIS 73069 (D.N.J. May 1, 2018) (Chesler, J.)....more
The US House included the revised Volcker Rule that we’ve discussed in a broader package of Dodd-Frank reforms that it passed with bipartisan support last night. The bill—ostensibly aimed at easing restrictions on small to...more
In naming Gregory Abel and Ajit Jain vice chairs, Berkshire Hathaway took another big step this week in laying out LAWB (Life After Warren Buffet)....more
Barclays and a group of its former execs are facing charges of fraud by false representation by Britain’s Serious Fraud Office over deals they struck with Qatar in 2008 to avoid a government bailout....more
A group of current and former Citizen Bank branch employees from five states has admitted to fabricating information about the results of the Bank’s much-touted “Citizens Checkup” program (in which real customers are invited...more
White Collar Watch dates itself considerably with its Perry Mason allusion, but its bigger point is an interesting one–good luck finding a true “gotcha” moment when dealing with what are “quintessentially offenses of the...more
Following up on news last week that Bill Ackman was finally done with his grand Valeant experiment, the Times gives us a deeper look at what was really going on with the activist investor’s bet and ultimate $4 billion loss....more
Bill Ackman, not known for giving up easily, is finally throwing in the towel on Valeant (even after taking a board seat at the company) and cutting his losses after a failed “two-year bet that lost about $4 billion for his...more
The SEC announced that Allergan Inc. had agreed to admit securities law violations and pay a $15 million penalty for disclosure failures in the wake of a hostile takeover bid. The SEC’s order finds that Allergan failed...more
The December 22 announcement that Deutsche Bank had settled with the DOJ over long-standing RMBS-related claims and investigations for a reported $7.2 billion prompted this Times long-read that traced the Icarus-like rise and...more
Even as auto lending continues at near break-neck pace, regulators are expressing concerns about the rise (again) of subprime delinquencies from borrowers. The trend, at a time when the US economy is doing relatively well,...more
Two executives were charged last week with criminal violations in the Southern District of New York relating to Valeant Pharmaceuticals activities. These charges are the first of more to come in an ongoing investigation...more