Recon: AstraZeneca Spins Out $250M Biotech Company

Posted 28 February 2018 | By Ana Mulero 

Recon: AstraZeneca Spins Out $250M Biotech Company

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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 (
  • A Modest Proposal Redux (Patent Law Weblog)
  • Meunerie Sawyerville, Inc.; Denial of Hearing; Final Debarment Order (FDA)
  • Prescription for secrecy (Journal Sentinel)
Upcoming Meetings & Events Europe
  • 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)
Asia India
  • 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)
General Health & Other Interesting Articles
  • 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)
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