Recon: Teva Settles Oklahoma Opioid Suit for $85M; FDA Approves Allergan’s Vraylar for Bipolar Depression

• Teva reaches $85 million settlement on eve of opioid trial in Oklahoma (STAT) (Reuters) (CNN)
• Big drug distributor pays $22 million to settle U.S. opioid charges (Reuters)
• First Opioid Trial Takes Aim at Johnson & Johnson (NYTimes) (Reuters) (The Guardian)
• Allergan's Vraylar wins FDA approval for bipolar depression (Reuters) (Fierce) (Press)
• Novartis' breast cancer treatment wins FDA approval (Reuters) (FDA) (Press)
• Incyte's Jakafi gets FDA approval to treat Graft vs Host Disease (Reuters) (FDA) (Press)
• Newron delays schizophrenia drug trial after FDA raises concerns (Reuters) (Fierce) (Endpoints)
• Pfizer's Lyrica fails at Phase 3 in treating primary generalised tonic-clonic (PGTC) seizures (Pharmafile) (Press)
• Biomarin to seek approval for hemophilia gene therapy, but durability questions persist (STAT)
• Brad Loncar’s ASCO19 preview: 5 big ideas to watch for at the ultimate cancer show of the year (Endpoints)
• 5 cash-hungry biotechs crowd into Nasdaq in search of a $600M-plus windfall (Endpoints) (Fierce)
• TSA approves cannabis-containing epilepsy drug for flights (The Hill)
• How the anti-vaccine movement crept into the GOP mainstream (Politico)
• US measles outbreak grows with 60 new measles cases across 26 states (Reuters)

• Drug Giant AstraZeneca Tries New Tactic to Fight Cancer (WSJ) (Fierce)
• B.C. to be first Canadian province to switch patients to biosimilars (Reuters) (Globe and Mail)
• PIP breast implant scandal: Victims visited by bailiffs (BBC)
• WHO sees high risk as polio breaks out in Central African Republic (Reuters)
• WHO Adopts Weakened Resolution on Drug Price Transparency (Focus)
• World Health Assembly Update, 25 May 2019 (WHO)
• EMA closed 30-31 May 2019 (EMA)
• Pharma sector is a bigger polluter than the automotive industry (Pharmafile)
• The right way to spend $1bn on healthcare (Financial Times)

• Where Drugs Come From: A Comprehensive Look (In The Pipeline)
• Follow the money: How biopharma CEOs and workers got paid in 2018 (BioPharmaDive)
• Opinion: Don’t let the maker of a buprenorphine drug abuse the Orphan Drug Act (STAT)
• Making Orphan drug prices work for society (BioCentury)
• Tech start-ups tackle US opioid crisis (Financial Times)
• Half of H.I.V. Patients Are Women. Most Research Subjects Are Men. (NYTimes)
• FDA warns of hidden ingredients in sexual enhancement pills sold online (NBC)
• The Growing Wave of Biotech IPOs in China (BIO)
• Frances Arnold Turns Microbes Into Living Factories (NYTimes)
• Stoke Therapeutics Preps IPO to Bring Dravet Syndrome Drug to Clinic (Xconomy)
• Inhibrix Pulls In $40M to Press Ahead With Cancer Drug Clinical Trials (Xconomy)
• Tylenol For Infants And Children Is The Same. Why Does 1 Cost 3 Times More? (NPR)
• NYSE changes fee schedule in bid to woo biotech companies (MedCity)
• A bruised Eli Lilly buys rights to Centrexion’s early-stage pain drug for $47.5M upfront (Endpoints)
• Analysis shows The Medicines Company/Alnylam drug inclisiran safe for renally-impaired patients (Endpoints)
• Factor VIII levels continue to drop in BioMarin’s 3-year update on hemophilia A gene therapy — but wait… (Endpoints)
• Fred Hutchinson team uses gold nanoparticles to improve CRISPR gene editing (Fierce)
• Industry Seeks More From FDA on Natural History Study Guidance (Focus)
• FDA Issues Drug Compounding Small Entity Compliance Guide (Focus)
• ‘I was shocked’: Controversy brews at Emory after prominent Chinese neuroscientists are ousted over disclosure issues (Endpoints)
• Mallinckrodt updates spin-off plans; FDA expands Vraylar approval for Allergan; Juvenescence spawns Souvien Therapeutics (Endpoints)

• Eisai to Present Eight Lemborexant Posters at SLEEP 2019 Meeting, Including New Pooled Analyses From Phase 3 Studies and New Phase 1 Data (Press)
• UCB Initiates Phase 1b US-Based Multicenter Clinical Trial in Parkinson’s Disease Patients with UCB0599, a Compound Arising from the Neuropore-UCB Collaboration (Press)
• Last Patient Enrolled in the Phase 2 Trial with Transgene’s TG4010 + Nivolumab + Chemotherapy for the First-Line Treatment of Advanced Lung Cancer (NSCLC) (Press)

• Experts Discuss CDRH Proposals That May Require New Authorities (Focus)
• FDA: Beware of Faulty Platelet Counts From B-C Analyzers (Medpage)
• Apple bought a start-up that was working on monitoring asthma in children (CNBC)
• Boston Sci Initiates New Watchman FLX Study (MDDI)
• Review and Update of Device Establishment Inspection Processes and Standards; Extension of Comment Period (FDA)
• MiniMed(TM) 670G System Real-World Data on 8 Million Patient Days Shows 71 Percent Time in Range Across All Age Groups (Press)
• FDA Approves Qiagen's PIK3CA Test as Companion Test for Novartis Breast Cancer Drug (GenomeWeb)
• FDA Grants Theranica De Novo to Market First Smartphone-controlled Acute Migraine-relief Wearable Device (Press)
• Shape Memory Medical Receives FDA Clearance for the IMPEDE® FX Embolization Plug (Press)
• Soliton Receives FDA 510(k) Clearance of its Acoustic Shockwave RAP Device (Press)
• How Robotic Surgery is Transforming Orthopedics (iMarc)

• Trump Administration Preparing Executive Order on Health-Cost Disclosure (WSJ)
• Progressives still not satisfied with Pelosi drug plan (Politico)
• Trump officials move to roll back LGBTQ protections (Politico)
• Specialty Drug Pricing and Out-of-Pocket Spending on Orally Administered Anticancer Drugs in Medicare Part D, 2010 to 2019 (JAMA)
• Artificial Intelligence Is No Threat to PMA Preemption (Drug & Device Law)
• No Expert, No Diluted Warning, No Case (Drug & Device Law)
• Merck Sharp & Dohme Corp. v. Albrecht (2019) (Patent Docs)
• Doctor, medical funder charged in New York in transvaginal mesh fraud (Reuters)
• Scientists Wanted: Recruited by Juul, Many Researchers Say No (NYTimes)

• FDA Advisory Committee Calendar

• Brexit hard-liner, biotech booster Johnson early favorite for UK PM (BioCentury)

• Macrogen Receives South Korean Accreditation (GenomeWeb)
• TransEnterix Announces Japanese Regulatory Approval of the Senhance Surgical System (Press)

• Experts see need for India to align with global good practices to reinvogorate capability in pharma manufacture (PharmaBiz)