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

• 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-$) (CMS)
• Nevada Addresses SB 539’s Most Significant Flaws (PhRMA) (STAT-$)

• I-Mab closes one of China’s biggest-ever biotech fundraisings (Fierce) (Endpoints)
• Chinese investment into US biotech start-ups soars (Financial Times)
• Sanofi gets serious in China with plans to hire 300 for $76M R&D site in Chengdu (Endpoints) (Press)
• Lundbeck looks to boost drug range with new CEO (Reuters) (Endpoints) (BioSpace)
• Roche drug too pricey in progressive MS, says NICE (pharmaphorum) (PharmaTimes) (Fierce)
• NHS preparing for disruption to supplies from no-deal Brexit (The Guardian) (Business Insider)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Govt aims to boost small pharma firms with 6% interest relief on loans (Livemint)
• Ferring Pharma to set up $250m R&D, manufacturing facility in city (Times of India)
• Dr. Reddy’s Recalls 2.36 Lakh Bottles Of Cholesterol Lowering Tablets From U.S. (Bloomberg Quint) (Economic Times) (Business Standard)
• Natco Pharma launches Hepatitis C drug in India (Economic Times)
• Government plans to cap drug prices at first point of sale (Economic Times)
• Aurobindo gets USFDA nod to manufacture Ibuprofen capsules (Business Line)
• Vaccine-preventable rabies is India’s most fatal infection (Hindu Times)

• 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’s health ministers talk pharmacare, rising costs of services (The Canadian Press)
• All Canadians deserve access to precious emergency care (The Globe and Mail)

• 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)