Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more
In a decision rendered on August 17, 2022, the Federal Court granted Sandoz Canada Inc (Sandoz) leave to amend its Statement of Defence to add new allegations, contingent on an adjournment of the trial and an extension of a...more
Case Name: Bayer Intellectual Prop. GmbH v. Aurobindo Pharma Ltd., No. 15-902, 2018 U.S. Dist. LEXIS 116931 (D. Del. July 13, 2018) (Stengel, C.J.)....more
Case Name: Bayer Pharma AG v. Watson Labs., Inc., 874 F.3d 1316, No. 2016-2169, 2017 U.S. App. LEXIS 21705 (Fed. Cir. Nov. 1, 2017) (Circuit Judges Lourie, Moore, and O’Malley presiding; Opinion by Moore, J.) (Appeal from D....more
Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more
On February 8, 2017, the PTAB denied Fustibal LLC’s (“Fustibal”) petition to institute inter partes review of U.S. Patent 8,637,553 B2 (“the ’553 patent”) owned by Bayer HealthCare LLC (“Bayer”) (IPR2016-01490). The 553...more
Case Name: Bayer Pharma AG v. Watson Labs., Inc., 12-1726-LPS, 2016 U.S. Dist. LEXIS 179103 (D. Del. Dec. 28, 2016) (Stark, J.). Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate/estradiol...more
By decision of December 2nd, 2016, No 24658, Industriale Chimica S.r.l. vs Bayer Pharma AG, the Italian Supreme Court ruled on the infringement by equivalence and on the patentability of intermediates. ...more
On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more
Case Name: Bayer Pharma AG v. Watson Labs., Inc., Case No. 12-1726-LPS, 2016 U.S. Dist. LEXIS 96267 (D. Del. July 18, 2016) - Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate / dienogest); U.S. Patent No....more
Case Name: Bayer Pharma AG v. Watson Labs., Inc., Civ. No. 12-cv-517 (GMS), 2016 U.S. Dist. LEXIS 55752 (D. Del. Apr. 27, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Staxyn® (vardenafil hydrochloride...more
Case Name: Bayer Pharma AG v. Watson Labs., Inc., Civ. No. 12-cv-517 (GMS), 2016 U.S. Dist. LEXIS 57888 (D. Del. May 2, 2016) (Sleet, J.) - Drug Product and U.S. Patent(s)-in-Suit: Staxyn® and Levitra® (vardenafil...more
Case Name: Intendis GMBH et al. v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. May 16, 2016) (Circuit Judges Prost, Moore, and Taranto presiding; Opinion by Moore, J.) (Appeal from D. Del., Robinson, J.) - Drug...more
In today’s increasingly global economy, trademark owners are more frequently butting up against the territorial limitations of trademark law. It has long been a matter of black letter law that trademark rights are...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Lupin Atlantis Holdings SA et al. 1:15-cv-00904; filed October 9, 2015 in the...more
Case Name: Bayer Intellectual Property GmbH v. Warner Chilcott Co., LLC, 12-1032-GMS, 2015 U.S. Dist. LEXIS 52061 (D. Del. Apr. 21, 2015) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Lo Loestrin® Fe (norethindrone...more
In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for...more
On May 7, 2015, the California Supreme Court issued its long-awaited decision in In re Cipro Cases I & II, Case No. S198616 (May 7, 2015) (Cipro). Cipro holds that reverse payment settlements can be challenged under...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc. 1:15-cv-00128; filed February 5, 2015 in the District...more