Regulatory Focus™ > News Articles > 2019 > 5 > Recon: AbbVie, Boehringer Settle Humira Patent Dispute

Recon: AbbVie, Boehringer Settle Humira Patent Dispute

Posted 14 May 2019 | By Michael Mezher 

Recon: AbbVie, Boehringer Settle Humira Patent Dispute

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • AbbVie, Boehringer Settle US Patent Dispute Over Drug Humira (WSJ) (BioPharmaDive) (Center for Biosimilars) (BI) (AbbVie)
  • Gilead Sciences Statement On Inaccurate Reporting On Truvada (Press)
  • How to jump-start a fledgling class of new, cheaper drugs (Axios)
  • Trump touts Democratic playbook in crackdown on drug costs (Politico)
  • Dems tee up new document fight with DOJ over Obamacare (Politico) (E&C)
  • The House’s big bill to lower drug prices and shore up Obamacare, explained (Vox)
  • Is pharma’s R&D spending a mark of shame or a point of pride? (STAT)
  • A new study sparks a war of words over the drug industry’s commitment to research (STAT)
  • FDA expands indication for Eylea to cover all stages of diabetic retinopathy (Pharmafile) (Press)
  • New Jersey amends rules on pharma gifts to doctors and eases restrictions on meals (STAT)
  • What’s taking the FTC so long? Roche won’t say, but insists it will bag Spark on time despite third delay (Endpoints) (Press)
  • Stem Cell Treatments Flourish With Little Evidence That They Work (NYTimes)
  • Bayer nears seven-year low after $2 billion award in Roundup trial (Reuters)
  • Drugmaker Insys shares tank after saying opioid lawsuits may force it into bankruptcy (CNBC)
  • A Million Americans Need This Drug. Trump’s Deal Won’t Help Enough of Them. (NYTimes)
In Focus: International
  • Takeda forecasts operating loss as Shire integration costs mount (Financial Times)
  • Pfizer’s alliance with Sosei Heptares bears first fruit (PMLive)
  • Chinese pharmaceuticals will not be subject to tariffs, US Trade Representative says (Pharmafile) (USTR)
  • SMC approves new cancer drugs, among others (PharmaTimes) (Pharmafile)
  • Canada To Open Up Priority Review To More New Drugs (Pink Sheet-$)
  • France Steps Up Scrutiny Of Epilepsy Drug Risks In Pregnancy (Pink Sheet-$)
  • With cancer rates rising worldwide, oncologist shortage predicted (Reuters)
  • Political games hinder efforts to end Ebola outbreak in Congo: WHO (Reuters)
  • WHO issues first advice on dementia: exercise and don't smoke (Reuters)
  • Could an emergency declaration over Ebola make a bad situation worse? (STAT)
  • Rejigging Merck KGaA partnership, Eliot Forster gains full control of the alpha in F-star’s constellation (Endpoints) (Fierce)
  • Teva Pharmaceutical drops 16% after 44 states accuse drugmaker of conspiring to hike generic drug prices (CNBC)
  • Sun, Dr Reddy's among 7 Indian pharma majors sued in US for price rigging (Economic Times)
Pharmaceuticals & Biotechnology
  • An Intro to Deep Learning (In The Pipeline)
  • Alzheimer’s R&D projects sidelined as Biogen’s aducanumab shock shakes researchers to the core of their beliefs (Endpoints)
  • How a biotech executive seizes on big ideas, from anti-aging therapies to antibiotics (STAT)
  • Novartis recalls liquid version of anemia drug Promacta over risk of contamination from peanut flour (Fierce)
  • Direct-to-consumer Drug Ads: Are They Doing More Harm than Good? (Forbes)
  • Brave New Real World: FDA Draft Guidance Takes First Steps to Move RWE from Dystopia (FDA Law Blog)
  • FDA Issues Another Draft Guidance Regarding Biosimilar Interchangeability (Patent Docs)
  • Ex-GSK, Novartis exec named as Mundipharma's Head of Access (Pharmafile)
  • Generic Drug Industry Rankled by Price Fixing Lawsuit, Quality Concerns (Focus)
  • Study Finds Few Voluntary Postapproval Trials for First Approved Indication (Focus)
  • Interchangeable Insulins: FDA Holds Public Meeting (Focus)
  • Easier Access to Naloxone Linked to Fewer Opioid Deaths (NIH)
  • Antibiotics after assisted births could stop thousands of infections (Reuters)
  • Cholesterol-lowering drugs tied to reduced glaucoma risk (Washington Post)
  • Biopharma BD teams are speeding into the fast lane — cash in hand — as dealmaking continues to heat up in Q1 offensive (Endpoints)
  • Stroke drug cocktail normalizes brain fluids, restores movement in mice (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Myovant Sciences' uterine fibroids combo therapy meets main goal in study (Reuters) (STAT) (Endpoints)
  • Melior hits positive notes in diabetes test, but a strange error blurs the picture (Fierce) (Press)
  • Solid Bio’s higher gene therapy dose for Duchenne MD runs smack into a fresh set of safety issues — shares tumble (Endpoints)
  • VALBIOTIS Will Present the Results of the International Phase IIA Clinical Study of VALEDIA® before 31 July 2019 (Press)
  • Theravance Biopharma Announces Data from Phase 1b Study of TD-1473 to be Featured in Oral Presentation at Digestive Disease Week (DDW) 2019 (Press)
  • ‘Breakthrough’ designation for Pomalyst in HIV-positive and negative Kaposi sarcoma (PharmaLetter-$)
Medical Devices
  • Medical Device Makers May Risk Liability Following FDA Effort (Bloomberg)
  • Roche Gets CE-IVD Mark for Test That Detects Antibiotic Resistance in TB DNA (GenomeWeb)
  • FDA Warns of Battery Depletion in Medtronic Pacemakers (Focus)
  • Murray Questions Olympus on Contaminated Duodenoscopes (Focus)
  • OpGen Submits Antibiotic Resistance Test to FDA (GenomeWeb)
  • Regulatory challenges and involving clinicians in the health tech industry (mobihealthnews)
  • Apple acquires patent rights for in-bed health sensor system (mobihealthnews)
  • New Roche test aids clinicians in accelerating tuberculosis diagnosis and treatment by detecting antimicrobial resistance within the world’s leading cause of infectious disease deaths (Press)
  • Haemonetics Receives FDA Clearance For Expanded Use Of TEG® 6s Hemostasis Analyzer System In Adult Trauma Settings (Press)
US: Assorted & Government
  • Grassley, Durbin Introduce Legislation to Codify HHS Rule to Require Disclosure of Prescription Drug Prices in TV Ads (Grassley)
  • EXCLUSIVE: 340B Program Purchases Reach $24.3 Billion—7%+ of the Pharma Market—As Hospitals’ Charity Care Flatlines (Drug Channels)
  • FDA Update on Permitted Antiseptic Hand Wash Ingredients Took 45 Years (Pew)
  • Amgen Resolves Repatha Access Kerfuffle With Express Scripts (Pink Sheet-$)
  • J&J, Teva Lose Last-Ditch Bids To Avoid Okla. Opioid Trial (Law360-$)
  • Allergan Says Asacol Buyers' Generic-Delay Suit Defective (Law360-$)
  • Statute of Limitations – Not Just Pretty Words (Drug & Device Law)
Upcoming Meetings & Events Europe
  • Advertising investigations: April 2019 (MHRA)
  • Beiersdorf to acquire iconic Coppertone™ brand from Bayer (Press)
  • Is Your Testing Program Ready for the EU MDRs? (MDDI)
  • Asia Regulatory Roundup: Indian High Court Stays Profiteering Proceedings Against Abbott (Focus)
  • DCGI asks medical device & IVD manufacturing associations to give feedback on new online portal (PharmaBiz)
  • Health Canada Drafts Policies for Special Access to Medicines Program (Focus)
  • Delegate-only final decisions and reasons: Agricultural and veterinary chemicals (TGA)
Other International
  • Israel regulator warns of medical cannabis bubble, eyes Australia pact (Reuters)
  • ‘Huge growth’ in Middle East manufacturing forecast (PharmaLetter-$)
General Health & Other Interesting Articles
  • The Intersection of Race and Blood (NYTimes)
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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