Recon: Novartis Launches Eye-Disease App, Shire-Takeda Inch Closer to Takeover Deal

• Novartis re-imagines clinical studies for eye diseases with new app through Apple ResearchKit (MedCity News) (Fierce) (Reuters) (Endpoints)
• SCOTUS to biopharma: Inter partes reviews are here to stay, deal with it (Endpoints) (Reuters) (The Center for Biosimilars) (STAT-$) (Fierce)
• Arrested and charged with fraud, PixarBio CEO Frank Reynolds could face up to 20 years in prison (Endpoints) (Boston Business Journal-$) (Drug Delivery Business News) (Reuters)
• Currency and pricing squeeze GSK as new shingles vaccine shines (Reuters) (PharmaTimes) (Financial Times)
• Amgen's Key New Drug Beats Estimates After Two Quarterly Misses (Bloomberg) (Reuters)
• GSK/Innoviva’s Trelegy Ellipta wins expanded nod for COPD (PharmaTimes) (Medscape) (Drug Delivery Business News) (pharmaphorum)
• Daiichi Sankyo concedes an early setback on Duchenne MD drug, but doubles down on development (Endpoints) (Fierce)
• After mega-round investment, ADC Therapeutics cans PhI trial in HER2 (Endpoints) (Fierce)
• Celldex to ax 20% of staff after midstage glembatumumab rout (Fierce) (Endpoints)
• CMS urges hospitals to disclose prices, revamps meaningful use program (Modern Healthcare) (Healthcare IT News) (Fierce) (Medscape)

• Shire willing to back $64 billion Takeda bid, market signals doubts (Reuters) (CNN) (WSJ) (Fierce) (Bloomberg) (Endpoints) (Financial Times) (BioPharma Dive)
• Women with breast cancer risk opting out of tamoxifen therapy (PharmaTimes) (NHS) (HuffPost)
• US companies are not exempt from Europe’s new data privacy rules — and here’s what they need to do about it (CNBC)
• Pharma playing catch-up as GDPR deadline nears (pharmaphorum)
• India inks $125 million loan pact with World Bank for inclusiveness project (Times of India)

• Generic-Drug Companies to Face First Charges in U.S. Probe (Bloomberg)
• GSK boss rethinking R&D incentives, as Barron and Sin seek out early and late-stage ops (Fierce)
• With $60M and a new CEO, Corvidia Therapeutics is all systems go (Fierce)
• Express Scripts targets Amgen, Lilly migraine drugs in pricing shift (Reuters)
• GSK rules out entering Shire takeover battle (Reuters)
• Eli Lilly Lures Bain, Advent on Animal Health Sale (Bloomberg-$)
• After decades in the big leagues, Martin Mackay is going small — and he’s delighted (Endpoints)
• NicOx opens new US development office (The Pharma Letter)
• Mylan Adds to Growing Women's Healthcare Portfolio with Launch of Generic for Oral Contraceptive Yaz (Press)
• MPS to Acquire Tata Interactive Systems (Press)

• Lilly's JAK woes set the stage for AbbVie, Gilead to jump ahead (BioPharma Dive)
• In a digital first for pharma, Novartis signs on to market Pear's drug-abuse therapies (Fierce)
• Mackay’s Rallybio rare disease startup raises $37M in first funding round (Fierce)
• Cancer centers sell out science when they advertise clinical trials as treatment (STAT)
• Early trials of stem-cell therapies hint at potential to restore some vision (STAT-$)
• FDA Advisors Weigh COX-2 Inhibitor Safety (MedPage Today)
• Pfizer's Trumenba just got closer to a new FDA nod. Can it catch up to GlaxoSmithKline's Bexsero? (Fierce)
• Drug Trials Snapshot: Tavalisse (FDA)
• Alder BioPharmaceuticals New Data Demonstrated Eptinezumab Increased Migraine-Free Intervals and Improved Quality-of-Life Outcomes in Patients with Episodic Migraine (Press)
• AbbVie's Upadacitinib Meets Primary and Key Efficacy Endpoints in Phase 2b/3 Rheumatoid Arthritis Study in Japanese Patients (Press)
• AveXis Announces First Patient Dosed in Phase 3 Trial of AVXS-101 in Pre-Symptomatic SMA Types 1, 2 and 3 (Press)
• Zynerba Pharmaceuticals Announces Twelve Month ZYN002 Data from STAR 2 Study in Patients with Focal Seizures at the 2018 Annual Meeting of the American Academy of Neurology (Press)
• U.S. FDA Clears Pluristem’s Phase III Study in Treatment of Muscle Injury Following Hip Fracture Surgery (Press)

• Philips uses its intelligence for outcomes-based incomes (EP Vantage)
• Medical device maker Boston Scientific tops profit estimates, raises forecast (Reuters) (Press)
• Bard Seeks New Trial Over Vein Filters After $3.6M Verdict (Law360-$)
• FDA Plans Cybersecurity ‘Go-Team’ to Strengthen Medical Devices (WSJ)
• The Amazing Ways Infervision Uses AI To Detect Strokes (Forbes)
• Health Care Providers Can't Afford To Ignore Direct-To-Consumer Genetic Testing (Forbes)
• Hospitals and device makers still struggle to rid medical scopes of infectious bacteria (Los Angeles Times)
• 3M Healthcare’s sales, profits gain in Q1 (MassDevice) (Press)
• Edwards Lifesciences shares down on mixed-bag Q1 earnings release (MassDevice) (Press)
• Putting predictive analytics and medical device data to work reducing a common physician alert by 99% (Healthcare IT News)
• FDA Warns of Endoscope Connector Contamination Risk (AAMI)
• Saranas Submits De Novo Application to FDA for the Early Bird Bleed Monitoring System (Press)
• FDA Approval of ThinPrep Integrated Imager Expands Automated Imaging for Pap Testing to More Labs (Press)
• Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry: Letter to Health Care Providers (FDA)
• Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry (FDA)

• Maker of popular Juul e-cigarette says it wants to help stop teens from using its products (CNBC)
• Hospital profitability sinks to levels not seen since the financial crisis: Moody’s (CNBC)
• Shift From Obamacare To Medicare Advantage Boosts Anthem Profits (Forbes)
• Former CEO Of Obamacare: End To Individual Mandate Won't Be So Bad (Forbes)
• Thanks for Nothing, Supreme Court. You Left Patents a Mess. (Bloomberg)
• Healthcare experts are skeptical about Amazon, JPMorgan, and Berkshire Hathaway's new venture (Business Insider)
• Vaccines and Related Biological Products Advisory Committee; Notice of Meeting (FDA)
• Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting (FDA)

• FDA Advisory Committee Calendar

• Ten years promoting high-quality scientific research in paediatric medicines: Registration opens for workshop of the European Network of Paediatric Research at EMA (Enpr-EMA), 7–8 June 2018 (EMA)
• Pfizer’s Mylotarg wins EU approval for AML (PharmaTimes)
• Alfie Evans' parents lose legal appeal for Vatican treatment (The Guardian)
• Shockwave wins CE Mark for S4 peripheral lithotripsy catheter (MassDevice)
• Rent increase hits Europe’s drug regulator before Brexit move (Nature)
• Shire v EMA: Clarification on orphan designation for products with the same active substance (Lexology)
• Eudamed Update: Actors module testing (Emergo Group)
• European Regulators Publish UDI Guidance (Emergo Group)
• Hikma to sell biosimilar thrombosis drug in MENA region (The Pharma Letter)
• Alvogen Obtains European Approvals for Generic Lenalidomide (Press)

• Israel researchers use electronic nose, urine test to detect early breast cancer (Times of Israel)
• Biotech firms likely to apply for listing in Hong Kong soon: PwC Hong... (CNBC)
• GSK Consumer Healthcare appoints Rahul Kapoor as EVP- HR (Business Line)
• Novartis files for Japanese approval of Kymriah (The Pharma Letter)
• Entasis Therapeutics and Zai Lab Announce Exclusive License Agreement in Asia-Pacific and Global Strategic Development Collaboration for ETX2514 (Press)

• India hospital accused of misleading people in Glenmark trial without consent (Fierce)
• World Malaria Day 2018: India attempts to eliminate disease by 2030 (Hindustan Times)
• Law to punish pharma firms that bribed doctors languishing since 2015 (Times of India)

• OrthAlign, Inc. Announces First Cases Completed in Australia for Direct Anterior Hip Replacements Using HipAlign Technology (Press)

• Updated Register of Certificates of Supplementary Protection and Applications (Health Canada)
• Academics call for probe of opioid manufacturers’ marketing tactics (The Toronto Star)
• Cerus Announces Health Canada Approval of the INTERCEPT Blood System for Platelets (Press)
• CDI Receives MDEL in Canada for Non-Invasive Diagnostic Breath Tests for Patients with Small Intestinal Bacterial Overgrowth and Other Functional Gastrointestinal Disorders (Press)

• What Lyft and Uber are really bringing to hospitals (Healthcare IT News)
• A new way to ease the organ shortage: ‘Regifting’ kidneys used in previous transplants (STAT)
• Video consultation service Doctor on Demand raised $74 million  so everyone can see a doctor anytime (TechCrunch)
• Harnessing The Power Of Data For An Aging Population (Forbes)