Regulatory Focus™ > News Articles > 4 > Recon: Novartis Launches Eye-Disease App, Shire-Takeda Inch Closer to Takeover Deal

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

Posted 25 April 2018 | By Ana Mulero 

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

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In Focus: International Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
General Health & Other Interesting Articles
  • 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)
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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