Recon: Oxford Study Finds Half of EU Clinical Trial Results are Unreported; Boehringer Acquires ViraTherapeutics

• Global Blood’s FDA filing plan for a sickle cell drug is riskier than you think (STAT)
• Takeda Is Said to Weigh Sale of Shire Eye Drug to Cut Debt (Bloomberg) (Endpoints)
• Acorda’s awful, no good, just plain bad week gets worse as FDA hands execs another delay on Inbrija (Endpoints) (Xconomy) (Press)
• Genentech team does some cutting-edge work on a new class of antibiotics — here’s why that’s important (Endpoints) (BioCentury)
• FDA wants to study whether doctors understand drug ads (Modern Healthcare)
• Can A Cancer Drug Originated in China Be A Success in the US? (Forbes)
• FDA Approves New Drug For Hepatitis A And Measles Exposure (Forbes)
• Beleaguered price-hiking drug CEO says he wasn't defending Shkreli, he was condemning FDA (CNBC)
• Biotech unicorn Moderna prepares for sector’s biggest-ever IPO (STAT)
• A Setback For Massachusetts In States' Drive To Contain Medicaid Drug Spending (NPR)
• Limiting State Flexibility in Drug Pricing (NEJM)
• Trump Eyeing ‘Disruptive’ Changes to Drug Pricing, Health Secretary Says (Bloomberg)
• Never mind the rhetoric. Most Americans think Trump is choking on drug prices (STAT)
• Insurer To Purdue Pharma: We Won’t Pay For OxyContin Anymore (KHN)
• A heart doctor explains four things she'd need to see before trusting the Apple Watch to monitor heart conditions (CNBC)

• Half of Europe's clinical trials fail to report results despite EU rule (Reuters) (Endpoints) (BMJ)
• Boehringer Ingelheim joins the crowd and goes all-in on oncolytic viruses, buying ViraTherapeutics in $244M deal (Endpoints) (PharmaTimes)
• Cancer deaths rise to 9.6 million as populations grow and age (Reuters) (WHO)
• EU officials clash with Chinese firm on drug factory inspection (Reuters)
• Sofosbuvir Patent Challenge Could Highlight Weaknesses In IP Systems (Pink Sheet-$)
• Update on review of valsartan medicines (EMA)
• Ending tuberculosis will take lower drug prices and a new, improved innovation ecosystem (STAT)
• Sanofi swaps top execs with Bayer, triggering a reorganization that puts China in the headlights (Endpoints)
• India bans 328 combination drugs in setback for pharma companies (Reuters)
• Scouting early-stage oncology plays, biopharma vets Detlev Biniszkiewicz, Scott Chappel make VC debut at MPM (Endpoints)
• China Biopharma Stocks Fall After Centralized Tendering Talks (BioCentury)

• Woodcock Hopes I-SPY 2 Trial Is 'Blazing The Trail' For Future Adaptive Design Uptake (Pink Sheet-$)
• Pfizer, Merck and Novartis to shut manufacturing sites as hurricane looms (InPharmaTechnologist)
• Novartis doubles down on Cosentyx's efficacy in psoriasis with extensive real-world data (Pharmafile)
• Study cracks open the secrets of the cancer-causing BRCA1 gene (STAT)
• Many Americans continue to misuse prescription drugs, but patterns of abuse are ‘changing’ (STAT)
• Celgene's Otezla produces "meaningful benefits" beyond traditional metrics in plaque psoriasis (Pharmafile)
• Teva names new President, TAPI and Biologics Operations (Pharmafile)
• Medicare's CAR-T Panel Underscores Hurdles For PROs – And FDA/CMS Collaboration (Pink Sheet-$)
• REPAIR Is Trying To Fix The Antibiotic Gap Left By Industry (SCRIP-$)
• SEC charges that hedge fund manager (and priest) relied on false claims to promote a Ligand short attack (Endpoints)
• Proposal Seeks FDA Center For Rare Diseases (BioCentury)
• US perspective on the impact of Brexit on the pharmaceutical sector (EPR)
• Celltrion’s Biosimilar Rituximab Brings Indication Carve Outs To US FDA Panel Review (Pink Sheet-$)
• Pharmaceutical pollution linked to rise in superbugs (The Telegraph)
• Swedish biotech targets baldness with ‘serendipitous’ R&D (BioPharmaReporter)
• Morphogenesis initiates first in-human clinical trial after working with companion animals (BioPharmaReporter)
• Roche ranked the most sustainable healthcare company in the Dow Jones Sustainability Indices for the tenth year running (Press)
• MPM, Versant Launch Gene Therapy Play Coda (BioCentury)

• Miransertib (ARQ 092) Granted Fast Track Designation for the Treatment of PIK3CA-Related Overgrowth Spectrum (PROS) (Press)
• Ironwood Pharmaceuticals Announces FDA Fast Track Designation for Praliciguat for the Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF) (Press)
• Syntimmune Announces FDA Orphan Drug Designation for SYNT001 in Treatment of Pemphigus (Press)
• AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis (Press)
• Incyte Announces Positive Data from Phase 2b Trial of Ruxolitinib Cream in Patients with Atopic Dermatitis (Press)
• Millendo Therapeutics Announces Initiation of Phase 2b Clinical Trial of Nevanimibe in Patients with Classic Congenital Adrenal Hyperplasia (Press)
• Verseon Commences Phase I Trial for Precision Oral Anticoagulant VE-1902 (Press)

• FDA awards five grants to advance the development of pediatric medical devices (FDA)
• FDA roundup: The major device, app, and algorithm approvals of 2018 (so far) (mobihealthnews)
• Motus GI Receives FDA Clearance to Market Pure-Vu® Slim Sleeve for Use with Slim Colonoscopes (Press)
• Zimmer Biomet to open location near CEO’s CT home base (MassDevice)
• Guardant Exposed to Cybersecurity Threat from Phishing Scheme (MDDI)
• FDA grants breakthrough designation to AliveCor’s KardiaK hyperkalemia software (MassDevice)
• J&J acquires 3D-printed spinal implant maker EIT (MassDevice) (MDDI)
• One Drop wirelessly connects to Apple Watch (Drug Delivery)
• FDA warns Medtronic on CRM plants in Minnesota, Puerto Rico (MassDevice)
• FDA clears Masimo’s Rainbow acoustic monitors for infants, neonates (MassDevice)

• Israel-based Teva faces age and 'anti-American' bias claims from former US staffer (Fierce)
• Doctor claims hospital fired him for complaining about ‘unethical’ ties to Allergan (STAT)
• Health care activists’ last stand against Kavanaugh (Politico)
• If It Wanted To, The FDA Could Destroy E-Cigarette Makers (Forbes)
• F.D.A. Targets Vaping, Alarmed by Teenage Use (NYTimes)
• Walsh administration to target pharmaceutical companies in lawsuit over opioid epidemic (Boston Globe)
• Money for Nothing? No Standing This Time in the Third Circuit (Drug & Device Law)
• Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2018) (Patent Docs)
• Fred's May Sell More Pharmacies Amid Turnaround (Forbes)

• FDA Advisory Committee Calendar

• Quality of Care in the United Kingdom after Removal of Financial Incentives (NEJM)
• Oxford Biomedica to expand with fourth site, creating 100 jobs (Pharmafile)
• The State Of European Healthcare By The Numbers [Infographic] (Forbes)
• Improving understanding of biosimilars in the EU (EMA)

• Updated Schedule for 23rd AHWP Annual Meeting (AHWP)
• Zai Lab Gets Chinese Rights To Novocure's Oncology Tech (BioCentury)
• Poxel snags Janssen exec to head new Japanese subsidiary (PharmaLetter-$)
• BIOCAD and Shanghai Pharmaceuticals to build China-based plant (PharmaLetter)

• How clerk-turned-billionaire Ramprasad Reddy made Aurobindo a giant pharma company (Economic Times)
• Indian drugmakers under FDA radar as the US regulator approves more ANDAs (PharmaLetter-$)

• Voluntary Euthanasia — Implications for Organ Donation (NEJM)
• Lou Gehrig's disease may affect the mind (Reuters)