Recon: AstraZeneca Spins Out $250M Biotech Company

• AstraZeneca spins out new firm Viela Bio (The Pharma Letter) (Reuters) (Press)
• Amid PBM Market Concerns, Express Scripts Sets High Retention Goal (Forbes) (Press)
• Justice Department sides with states in nationwide opioid lawsuit against distributors, manufacturers (Stat News) (DOJ) (E&C Hearing)
• Mallinckrodt subpoenaed, again, over sales of oxymorphone in growing opioid crisis (Fierce)
• NORD to Collaborate with FDA on Pilot Patient Engagement Activity (Press) (Pink Sheet-$)
• U.S. Prescription Drug Costs Are a Crime (Bloomberg)
• Going Strong! Orphan Drug Approvals and Designations Skyrocketed in 2017, While Orphan Drug Designation Requests Dipped Slightly (FDA Law Blog)
• On this Rare Disease Day, let’s all commit to helping recognize the life and work of biotech giant Henri A. Termeer (Endpoints)
• FDA research to improve technique for studying multipotent stromal cell morphology (FDA)
• NIAID Unveils Strategic Plan for Developing a Universal Influenza Vaccine (NAID)

• Bayer to win EU approval for $62.5 billion Monsanto deal (Reuters) (Fierce)
• Billionaire-Backed Cancer Testing Firm Plans Hong Kong IPO (Bloomberg)
• Novartis’ oncology research chief in China jumps to upstart EpimAb in Shanghai (Endpoints) (Fierce)
• European Commission approves Hemlibra, first new hemophilia A treatment in 20 years (The Pharma Letter) (Press)
• Nortech Systems is expanding its Mexico operations (Medical Design & Outsourcing)
• WHO cancer agency “left out key findings” in benzene review (Reuters)
• Roche out-licenses commercialization of Actemra and Avastin in India (The Pharma Letter)
• Second wave of NHS England test beds launched (MHRA)
• Nigeria battles its largest Lassa fever outbreak on record (WHO)

• Celgene stumbles again, as FDA declines to review multiple sclerosis drug critical to company future (Stat News) (Forbes) (Focus)
• This Valeant Chart Looks Great (Just Don't Try to Measure It) (Bloomberg)
• Novo Holdings ponies up $165M for superbug venture fund (Fierce)
• BeiGene Announces Approval of REVLIMID for Newly Diagnosed Multiple Myeloma in China (Press)
• Acadia Pharma raised the price of its only drug twice but quarterly sales still disappoint (Stat News)
• Speedy EU review for Shire’s lanadelumab (The Pharma Letter)
• Comment Request; Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products (FDA)
• Recap of Access! 2018 — Chip's Call to Action (Part 2) (AAM)
• Judge's ruling sets Shkreli up for possible 10 years in prison, but he seeks leniency for his good deeds (Fierce)
• Citizen Petition from Buchanan Ingersoll & Rooney PC (on behalf of Synergy Pharmaceuticals Inc.) (Petition)
• Acorda Enters Into Cooperation Agreement with Scopia (Press)
• Teva Announces Launch of Offering of Senior Notes (Press)
• Fast Pace of Drug and Device Approvals in 2017 Signals Wider Sector Health for Biopharma but Medtech Companies Struggle, Says EP Vantage (Press)
• Johnson & Johnson Human Performance Institute Invests in the Future of Wellbeing with New $18 Million Facility in Lake Nona Medical City (Press)

• What’s in the IV bag? Studies show safer option than saline (Stat News)
• GW’s cannabidiol gets EU orphan status for TS (The Pharma Letter)
• FDA solicitation for research and development to support regulatory science and innovation (FDA)
• Armed with published animal data, gene-editing pioneer Intellia maps the road to an IND (Endpoints)
• Acceleron Announces Publication of ACE-083 Phase 1 Trial Results in Muscle & Nerve (Press)
• Promising HIV vaccines could stall without coordinated research (Nature)
• Field evidence for manipulation of mosquito host selection by the human malaria parasite, Plasmodium falciparum (bioRxiv)
• This scientist is testing a marijuana ingredient as a way to prevent relapse. It’s a daunting task (Stat News)

• AI and facial diagnosis company FDNA sets up genomics coalition (Fierce)
• Medtronic and Lehigh Valley Health Network Sign Strategic Partnership Agreement Focused on Delivering Value-Based Healthcare Programs (Press)
• InterSystems and ZOLL Medical Corporation Collaborate to Integrate Emergency Medical Services into Care Continuum (Press)
• Patients would like their data, please. Will the medical device industry listen? (Stat News)
• Brain Implant for Some Blind People Shows Benefits of FDA’s Breakthrough Device Program (FDA Voice)
• Microsoft’s focus on transforming healthcare: Intelligent health through AI and the cloud (Microsoft)
• TDK to acquire Chirp Microsystems, aiming for leadership in ultrasonic sensing solutions (Press)
• Elligo Health Research and Saama Technologies Announce Strategic Partnership to Advance Clinical Research Data Management (Press)

• E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1); International Council for Harmonisation; Guidance for Industry (FDA)
• Utilization Management Strategies to Address the Opioid Crisis (CVSHealth)
• US economic growth revised down to 2.5 percent (The Hill)
• FTC Recommends Steps to Improve Mobile Device Security Update Practices (FTC)
• Under Trump, the pace of FDA regulations slowed to a trickle (Stat News)
• New opioid bill would impose sweeping limits on some prescriptions, boost funding (Stat News)
• There's a shortage of opioids where they're needed most - in hospitals (Philly.com)
• A Modest Proposal Redux (Patent Law Weblog)
• Meunerie Sawyerville, Inc.; Denial of Hearing; Final Debarment Order (FDA)
• Prescription for secrecy (Journal Sentinel)

• FDA Advisory Committee Calendar
• Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

• List of medicines under additional monitoring (EMA)
• Recommendations on eligibility to PRIME scheme (EMA)
• NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe (Press)

• Merck Invests €40 Million In Asia (Asian Scientist Magazine)

• No discrimination: on health insurance in India (The Hindu)
• Google Brings Health 'Symptom Search' Feature to India (News18)
• US pharma concerns on IP rights and compulsory licensing in India (The Pharma Letter)
• Why Indian pharma need to track Amazon's plans in health care (Business Today)

• One in six Australian women suffer physical or sexual abuse from partner (The Guardian)
• Paragon Care Ltd to acquire a surgical medical device company (Motley Fool Australia)
• MedX Health Corp. Announces Regulatory Clearance for its SIAscopy Medical Devices in New Zealand (Press)

• More than 200 Quebec doctors oppose proposed pay raise for themselves (Toronto Star)

• A Big Divergence Is Coming in Health Care Among States (NY Times)
• A Secretive Sect Opens A Debate On Female Genital Mutilation (NPR)
• Microsoft and UPMC unveil virtual AI assistant that listens in and takes notes on doctor’s visits (GeekWire)