Recon: AbbVie, Boehringer Settle Humira Patent Dispute

• 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)

• 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)

• 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)

• 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 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Israel regulator warns of medical cannabis bubble, eyes Australia pact (Reuters)
• ‘Huge growth’ in Middle East manufacturing forecast (PharmaLetter-$)

• The Intersection of Race and Blood (NYTimes)