Regulatory Recon: Walgreens Struggles to Distance Itself From Theranos, AstraZeneca to Sequence 2  Million Genomes (22 April 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

• A Marriage Gone Bad: Walgreens Struggles to Shake Off Theranos (NYTimes)
• Novartis muscular drug fails in Phase III trials (Pharmafile) (DD&D)
• Elizabethkingia Cases in U.S. Reported to PAHO, WHO (ICT)
• We Still Haven't Found a Fountain of Youth in Our DNA (MIT Technology Review)
• When is Adaptive Design Right for Your Clinical Trial? (Geeks Talk Clinical)
• Companies Plan To Study Diabetes Drug In Heart Failure Population (CardioBrief)
• FDA's Muscular Dystrophy Debacle Shows Trying To Speed Drug Approvals Up Can Slow Them Down (Forbes)
• Wondering What Caused the Cancer (NYTimes)
• Eric Lander talks CRISPR and the infamous Nobel 'rule of three' (Washington Post)
• Senators close to proposal on Zika funds: Republican committee chairman (Reuters)

In Focus: International

• AstraZeneca to sequence 2m genomes in hunt for new drugs (The Guardian) (On Medica) (Reuters)
• NICE wants proactive role in ensuring medicines use (PharmaPhorum)
• Imported generics as effective as branded antivirals for hepatitis C (Pharmaceutical Journal-$)
• UK agency backs cancer drug after Sanofi cuts price (Reuters) (BioCentury)
• Lawsuit in Brazil Allows Some Manufacturers to Pay Reduced ANVISA Fees Sooner (Emergo)
• India's Affordable Medicines Under Threat In Asian RCEP Talks? (PharmasiaNews-$)
• Ukraine Medical Device Industry Gets Hoped-For Transition (SCRIP-$)
• Canada Ups Pricing Pressure on Biosimilars And Originators (SCRIP-$)
• Integrating patients' views in clinical studies of anticancer medicines (EMA)
• Draft of U.N. HIV political declaration released along with calls for comments (Center for Global Health Policy)

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US: Pharmaceuticals & Biotechnology

• NIH Looks to Grant Exclusive License to Dedalus for Anti-CD70 Chimeric Antigen Receptors (CARs) for the Treatment of Chronic Myelogenous Leukemia (NIH)
• FDA Extends Comment Period on Draft Guidance: Scientific Evidence in Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval (FDA)
• IRB Faces Warning Letter Over Written Procedures (FDA News-$)
• Right-Size Risk-Based Monitoring Activities By Evaluating Individual Site Data (Cutting Edge Info)
• Benefits Of Expedited Review Of Sole-Source Drug ANDAs (Law360-$)
• Merck's Barr On Treating Neglected HCV Patients, Lowering Infection Rates (SCRIP-$)
• Tackling Tough-To-Treat Patients As HCV Cure Rates Near 100% (SCRIP-$)
• Actelion reports first Uptravi sales, raises guidance (BioCentury)
• Biogen gains as cost-cutting drives earnings (BioCentury)
• Scientists Have Discovered How to Deal With Fungal Resistance to Antimycotic Drugs (ICT)
• Quality Risk Management Adoption More Wide Than Deep – Survey (Pink Sheet-$)
• Precision medicine: is it becoming a reality for childhood cancer? (MNT)
• US FDA Centralizes Effort to Address Combination Product Issues (Emerg)

US: Medical Devices

• FDA Grants Emergency Use Authorization for Zika and Ebola Diagnostics (FDA – EbolaZika)
• Brief Summary of the Orthopaedic and Rehabilitation Devices Panel Meeting (FDA)
• Humana launches medication tracking app for Apple Watch (MobiHealthNews)
• Is Abbott Wavering On Alere Acquisition Plans? (Gray Sheet-$)
• Make Sure SOPs For FDA Inspections Are Robust, Industry Experts Say – And Don't Forget To Train The Receptionist (Gray Sheet-$)
• NEA-backed startup wins positive FDA panel vote for the first synthetic cartilage implant (Fierce)
• FujiFilm wins 510(k) for Vevo MD clinical ultrasound system (Mass Device)
• AV Medical Announces Successful Completion of 30 Patient Study with its Innovative Angioplasty Balloon Catheter, Chameleon (Press)

US: Assorted & Government

• IBio Settles Investor Suit Over Ebola Drug Plans For $1.87M (Law360-$)
• Why an obscure Supreme Court case is a big deal for prescription drugs (STAT)
• FDA Addresses "Facility Definition" For Outsourcing Facilities: Manufacturers Can Live With Outsourcing Facilities But Section 503A Compounders Cannot (FDA Law Blog)
• Podcast: A Conversation On Presidential Politics and HealthCare Impact (RPM Report-$)
• American College of Physicians Calls on Federal Government to Regulate Prescription Drug Prices (Policy and Medicine)
• FDA Issues Draft Guidance Concerning Hospital and Health System Compounding: FDA Will Permit Compounding in Advance of a Prescription for Hospital Pharmacies (FDA Law Blog)
• What the Doctor Ordered? What the Pharmacist Understood? FDA Issues Compounding Draft Guidance Addressing Compounding for Office Use under FDC Act § 503A (FDA Law Blog)
• Georgia MDL Court Muddles Utah Law (Drug and Device Law)

Upcoming Meetings & Events

• RAPS' FDA Advisory Committee Meeting Tracker

Europe

• Phase I Trials: French Body Urges Transparency, Says Don't Just Follow The Rules (SCRIP-$)
• Audio conference of the HSC on vaccine shortages and AMR (EC)
• Germany Adopts Healthcare Corruption Bill, Criminalizing Bribery (Pharmaceutical Manufacturing)
• First DNA vaccine in the EU recommended for use in salmon (EMA)
• Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (EMA)
• Boston Sci's EMBLEM Subcutaneous Defibrillator Approved in EU for MRI Scans (medGadget)

India

• NPPA shifts onus of implementing revised prices of medicines to chemists (PharmaBiz)
• Aurobindo Pharma gets USFDA nod for gastro reflux drug (Economic Times)
• Pharma industry faults NPPA's latest move to cut drug prices (Economic Times)

Other International

• Countries on verge of beating malaria face new threat, study says (Reuters)

General Health & Other Interesting Articles

• Who Approved the Genetically Engineered Foods Coming to Your Plate? No One. (MIT Technology Review)
• Massive Study Finds Genetic Links To Happiness And Depression (Forbes)
• Could Flu Have Caused Prince's Death? Yes. Here's Why (Forbes)
• Some children born with the genetic risk for schizophrenia, scientists say (Washington Post)
• Suicide Has Increased 24% In Fifteen Years, The CDC Says (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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at [email protected].

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.