Regulatory Focus™ > News Articles > 7 > Recon: Sanofi Plans $76M R&D Center in China

Recon: Sanofi Plans $76M R&D Center in China

Posted 02 July 2018 | By Ana Mulero 

Recon: Sanofi Plans $76M R&D Center in China

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Novartis Injects Itself Into Planned Rollout of EpiPen Competitor (WSJ-$) (DDBN)
  • US drugmaker Pfizer lifts price of Viagra and 100 other products (Financial Times)
  • Liquidia files for IPO to challenge United Therapeutics in PAH (Fierce) (Endpoints)
  • No Assurance About Insurance Under Experimental Drug Law (Bloomberg)
  • Medicare spent $2 billion for one drug as the manufacturer paid doctors millions (CNN) (STAT-$) (Washington Examiner) (Law360-$) (CMS)
  • Nevada Addresses SB 539’s Most Significant Flaws (PhRMA) (STAT-$)
In Focus: International Pharmaceuticals & Biotechnology
  • Emergency Rooms Run Out of Vital Drugs, and Patients Are Feeling It (NYT)
  • MiMedx top brass resign amid internal accounting investigation (DDBN)
  • Newly prequalified Active Pharmaceutical Ingredients (APIs) (WHO)
  • PillPack Aside, Amazon's Far From Catching CVS And Walgreens (Forbes)
  • FDA advises health care professionals not to use MedGyn Products’ Monsel’s Solution (FDA)
  • Drug development gets big data analytics boost: With Nerve Live, Novartis is harnessing the power of data for the benefit of patients. (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Roche gearing up to file Tecentriq for breast cancer (PharmaTimes) (Reuters) (Endpoints)
  • FDA Approves ARISTADA INITIO for the Initiation of ARISTADA for Schizophrenia (Press)
  • Merck to Present New Data from Studies of Investigational HIV Therapy Doravirine, Including Pivotal DRIVE-FORWARD Trial, at AIDS 2018 (Press)
  • FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) in Combination with Chemotherapy as First-Line Treatment for Metastatic Squamous Non-Small Cell Lung Cancer (Press)
  • NewLink Genetics Announces Positive Updated Phase 1 Data with Indoximod Plus Radio-Immunotherapy for Pediatric Patients with DIPG Presented at ISPNO 2018 (Press)
  • Compugen Welcomes FDA Clearance of Bayer’s IND Application for BAY 1905254 (Press)
  • NewLink Genetics Announces Positive Updated Phase 1 Data with Indoximod Plus Radio-Immunotherapy for Pediatric Patients with DIPG Presented at ISPNO 2018 (Press)
Medical Devices
  • July vote to repeal medical device tax may bolster vulnerable GOP lawmaker (The Hill)
  • Blind Voting and PMA Advisory Panels: “Do Great Minds Think Alike?” (FDA Law Blog)
  • FDA Clears Zephyr Endobronchial Valve to Treat Severe Emphysema (Medscape)
  • IBM, Aramark team up to support connected medical devices
  • Arthrosurface receives FDA Clearance of Patellofemoral WaveKahuna Arthroplasty System (Press)
  • TransEnterix Provides Corporate Update (Press)
US: Assorted & Government
  • Tell world leaders: We need a global action plan for R&D to fight deadly epidemics (GHTC)
  • Criminal prosecution for violating HIPAA: an emerging threat to health care professionals (STAT)
  • Signaling concern over industry funding, Congress presses for transparency at groups supporting NIH, CDC (STAT)
  • Missouri appeals court tosses $55 million J&J talc-powder verdict (Reuters)
  • Trump Says Abortion Rights Could Be Decided by States (WSJ)
  • Judge Strikes Down Kentucky’s Medicaid Work Rules (NYT)
  • States act on their own to fill holes Washington is knocking in Affordable Care Act (The Washington Post)
  • CMS to test Medicare Advantage as alternative payment model under MACRA (Modern Healthcare)
  • Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments (FDA)
  • Puerto Rico introduces bill to become 51st US state (AP News)
Upcoming Meetings & Events Europe
  • PredictImmune names Paul Kinnon as CEO (Fierce)
  • NHS To Launch New GP Mobile App, But Will It Really Make A Difference? (Forbes)
  • NHS Digital inks deal with Privitar to protect patient info in the NHS system (Fierce)
  • Insulet assumes direct commercial operations in Europe (DDBN)
  • NHS ‘Vanguards’ failing to reach potential, finds NAO (PharmaTimes)
  • CVC Will Buy Control of Recordati for 3 Billion Euros (Bloomberg)
  • AMR: How pharma is leading the charge against superbugs (pharmaphorum)
  • Wave Life Sciences Receives Positive Opinion for Orphan Drug Designation in the European Union for WVE-210201 (Press)
  • CHMP issues positive opinion to expand Jardiance, Synjardy and Glyxambi labels to include positive effects on cardiovascular and renal outcomes (Press)
  • Insulet Assumes Direct Operations of its Omnipod Insulin Management System Product Line in Europe (Press)
  • Update: Advertising investigations by MHRA (MHRA)
  • £215 million research fund to tackle the next generation of health challenges (UK Department of Health and Social Care)
  • AstraZeneca wins speedy approvals for cancer drugs in Japan (Reuters)
  • Athenex Scores $100 Million in Financing, Kicks off Joint Venture in China for Development of TCR T Cells (BioSpace) (Endpoints)
  • Takeda’s diabetes therapy to see 10 generics soon (Korea Biomedical Review)
  • Alexion Pharma Korea’s aHUS therapy Soliris gains coverage (Korea Biomedical Review)
  • Health Care in Asia Outpaces Inflation (Asia Sentinel)
  • China’s MOJ Solicits Comments on Amendment to Medical Device Regulations (Lexology-$)
  • Essex healthcare firm to double overseas exports (UK Department for International Trade)
  • Takeda Global Headquarters Grand Opening (Press)
  • New Study Investigates the Utility of Masimo ORi (Oxygen Reserve Index) in Providing Early Detection of Blood Oxygenation Decrease During One-Lung Ventilation (Press)
  • PMDA updates (June, 2018) posted (PMDA)
India Australia
  • Changeover to Therapeutic Goods Advertising Code 2018 (TGA)
  • Statutory advisory committee vacancies (TGA)
  • Annual Charge Exemption (ACE) scheme forms (TGA)
  • Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG) (TGA)
Canada General Health & Other Interesting Articles
  • Electronic Health Records a Weapon in Opioid Abuse Fight (Bloomberg)
  • Why telemedicine has been such a bust so far (CNBC)
  • Opioid addiction and overdoses in children devastate their parents (The Washington Post)
  • A Baby Was Treated With A Nap And A Bottle Of Formula. The Bill Was $18,000. (KHN)
  • Where Childhood Cancer Hits Hardest (US News & World Report)
  • Editorial: The malaria fight stalls as children die by the hundreds of thousands (The Washington Post)
  • A daredevil researcher’s latest quest: to restore sight lost to glaucoma using virtual reality (STAT)
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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