Regulatory Focus™ > News Articles > 10 > Recon: Abbvie Settles Humira Patent Dispute With Sandoz; BMS’ Opdivo Fails in Ph. III Lung Cancer St

Recon: Abbvie Settles Humira Patent Dispute With Sandoz; BMS’ Opdivo Fails in Ph. III Lung Cancer Study

Posted 12 October 2018 | By Michael Mezher 

Recon: Abbvie Settles Humira Patent Dispute With Sandoz; BMS’ Opdivo Fails in Ph. III Lung Cancer Study

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Abbvie settles Humira patent disputes with Novartis unit (Reuters) (Fierce) (Big Molecule Watch) (Endpoints)
  • US appeals court upholds ruling that canceled Teva Copaxone patents (Reuters)
  • Feds charge 5 New York doctors with prescribing 8.5 million opioid pills (NBC) (NYTimes) (WSJ)
  • A biotech company misled investors about its dealings with FDA (STAT) (Endpoints)
  • Trevena's opioid injection fails to win over FDA committee (Pharmafile) (Medpage)
  • Bristol-Myers concedes a PhIII lung cancer flop for Opdivo as competition heats up in SCLC (Endpoints) (Reuters) (Fierce) (Press)
  • In public, lawmakers scold drug distributors. Come campaign season, they accept their cash willingly (STAT)
  • Pfizer pays $700,000 to settle charges over misleading copay coupons (STAT) (Law360-$) (Reuters)
  • AbbVie staves off another US Humira knockoff to 2023 as European launch looms
  • FDA expands Xarelto use to patients with coronary artery disease and peripheral artery disease (Press) (PharmaTimes)
  • Public seems to know value of clinical trials, but not how they work (Reuters)
  • Percentage of young US children who don’t receive any vaccines has quadrupled since 2001 (Washington Post) (NBC)
  • FDA approves new DNA-based test to determine blood compatibility (FDA)
  • Merck ditches biosimilar Lantus, but will that ease the path for Mylan’s rival insulin product? (Fierce)
  • Shire opens $1.2B Georgia plant to make rare disease drugs (Fierce)
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In Focus: International
  • Merck KGaA posts mixed data from their big PhIIb MS study on evobrutinib — spurring plenty of questions (Endpoints)
  • FDA And EU Regulators Find Data Integrity Lapses Are Still A Major GMP Problem (Pink Sheet-$)
  • No-Deal Brexit Means ‘Re-Planning A Whole Industry,’ Says ABPI Chief (Pink Sheet-$)
  • Nordic Procurement Deal Signals New Weapons In Fight For Lower Prices (Pink Sheet-$)
  • CHMP delays decision on Kiadis’ GVHD immunotherapy (PMLive)
  • UK Appeal Panel Tells NICE To Revisit Scenesse Rejection (Pink Sheet-$)
  • Samsung BioLogics opens third plant, contemplates a fourth in Korea (BioPharmaReporter)
  • Coroner calls on MHRA to take action over 'inherently unsafe' EpiPen (Pharmaceutical Journal)
  • EU validates Repligen’s marketing application for fostamatinib (PharmaTimes)
  • Indian Govt gets ready to revise Schedule M to make it on par with WHO-GMP standards (PharmaBiz)
  • Korean approval for Opdivo in RCC combination (PharmaLetter-$)
  • EMA To Discuss Reactivating Landmark Clinical Trials Transparency Policy (Pink Sheet-$)
  • Chanelle Pharma announces €86m investment over next five years (Pharmafile)
Pharmaceuticals & Biotechnology
  • Aetna, CVS, Walgreens, And Amazon May Finally Let Pharma Do What It Does Best (Forbes)
  • Fake friends at the FDA, cancer counter-narratives, and biotech’s bear turn (STAT)
  • BIO Has Big Diversity Goals. Does It Have the Means to Reach Them? (Xconomy)
  • Proposed Provisions for a Draft NIH Data Management and Sharing Policy (NIH)
  • Drug repurposing: progress, challenges and recommendations (Nature)
  • FDA approves Stiolto Respimat sNDA (PharmaLetter-$)
  • Cancer stem cell pipeline flounders (Nature)
  • Regulatory T cells in the treatment of disease (Nature)
  • Hoth Therapeutics seeks IPO cash to battle eczema (Fierce)
  • Inter Partes Review To Be More Favorable To Biotech (BioCentury)
  • Tired Of Winning? When It Comes To US FDA Appeals, “Denied” Can Still Mean Victory (Pink Sheet-$)
  • Rare HIV PrEP Failure Reported in San Francisco (Medpage)
  • Seeking cash to fund PhIII for once-failed drug, Adynxx rides Alliqua’s shell to Nasdaq (Endpoints) (Fierce)
  • Immune Design buries its PhIII work on cancer, and investors hit the panic button (Endpoints)
  • FDA draft guidance on generic-delaying citizen petitions a ‘warning shot’ to industry, lawyer says (MedCity)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Phase II Data For Merck's BTK Inhibitor Highlighted At ECTRIMS (BioCentury) (SCRIP-$)
  • MaaT Pharma Announces First Patient Dosed in Phase 2 Clinical Trial of Lead Product MaaT013, a First-in-Class Biotherapeutic to Treat Acute GvHD (Press)
  • Ipsen to present new data from its oncology portfolio at the 2018 European Society for Medical Oncology (ESMO) congress (Press)
  • Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting 2018 (Press)
  • Arrowhead to Present Late-Breaking Clinical Data on ARO-AAT and ARO-HBV at AASLD Liver Meeting 2018 (Press)
Medical Devices
  • If at First You Don’t Succeed, Try, Try, Try Again: FDA Issues Plan to Increase Efficiency of 510(k) Third Party Review Program (FDA Law Blog)
  • FDA Continues Its Press On Medical Device Cybersecurity (Drug & Device Law)
  • Boston Scientific touts 3-year Solyx stress urinary incontinence mesh trial data (MassDevice)
  • Securing legacy medical devices is daunting – but not optional (mobihealthnews)
  • FDA to revamp medtech cybersecurity — with your help (Medical Design & Outsourcing)
  • With $4.5B, Q3 2018 was digital health funding's biggest quarter yet (mobihealthnews)
US: Assorted & Government
  • Alex Azar for attorney general? HHS says no way (Politico)
  • Investor suits against AbbVie pile up in wake of Humira kickback allegations (Fierce)
  • Jury clears J&J of liability in New Jersey talc cancer case (Reuters)
  • Judge may overturn $289 million verdict in Monsanto Roundup case (CBS)
  • FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy (FDA)
Upcoming Meetings & Events Europe
  • Early access to medicines scheme applications: pending, refused, granted (MHRA)
  • Marketing authorisations granted in September 2018 (MHRA)
  • Parallel import licenses granted in September 2018 (MHRA)
  • Looming questions for Japan pharma (PharmaLetter-$)
  • AmoyDx Lung Cancer CDx Approved in South Korea (GenomeWeb)
  • Maharashtra FDA to urge Centre to bring amendments in D&C Act for better compliance (PharmaBiz)
  • Canada clears Medtronic’s MiniMed 670G insulin pump (MassDevice)
  • Submissions received and TGA response: Complaints Handling - Advertising therapeutic goods to the public (TGA)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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