Regulatory Focus™ > News Articles > 8 > Recon: China Targets 48 Drugs for Priority Approval; Astellas Expands Eye Disorder Pipeline

Recon: China Targets 48 Drugs for Priority Approval; Astellas Expands Eye Disorder Pipeline

Posted 10 August 2018 | By Ana Mulero 

Recon: China Targets 48 Drugs for Priority Approval; Astellas Expands Eye Disorder Pipeline

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

In Focus: US
  • FDA approves first targeted RNA-based therapy (FDA) (Endpoints) (Stat) (WSJ)
  • Nebraska Plans First Execution in 21 Years. Not So Fast, Drug Company Says. (NYT)
  • Former Drug Company Official Pleads Guilty In Fraud and Kickback Scheme That Cost Medicare Millions (Hartford Courant) (
  • Walden Holds Roundtable on Opioid Crisis with FDA Commissioner Gottlieb (E&C)
  • Generic Drugmakers Struggle Despite U.S. Push for Copycats (Bloomberg)
  • Trump Administration Sinks Teeth Into Paring Down Drug Prices, On 5 Key Points (KHN)
  • Opioid Addiction Among Pregnant Women Has Quadrupled (Mother Jones) (CNN) (Roll Call)
  • Hackable implanted medical devices could cause deaths, researchers say (The Guardian) (Wired)
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In Focus: International
  • China’s Drugs Problem Spells Opportunity for Pharma Giants (WSJ)
  • Better U.S. Patient Access To Cancer Drugs Comes At A Price (Forbes)
  • In clash over pricing, Vertex won’t give U.K. data needed to review a new cystic fibrosis drug (STAT-$) (Fierce)
  • Pfizer, Novartis jump into an $84M development round for UK cancer drug stars at Artios (Endpoints) (Scrip-$) (PMLiVE)
  • China targets Cosentyx, Shingrix and Luxturna and 45 other drugs for priority approval (Fierce) (Endpoints)
  • Astellas Expands Its Eye Disorder Pipeline with Quethera Purchase (GEN) (Endpoints) (Fierce)
  • Novo powers rare disease startup Therachon to $60M round (Fierce) (MedCity News)
  • Rajasthan drug regulator: Brands of 4 firms substandard (Indian Express) (Pharmabiz)
  • Pharma exports up 3 pc to $17.3 billion in 2017-18 (Economic Times)
  • Australians urged to get tested for syphilis after unborn baby dies  (CNN)
  • Saudi-Canada Crisis Will Damage People’s Health (The Atlantic)
  • Korean version of ‘Watson’ unveiled at hospital meet (Korea Biomedical Review)
Pharmaceuticals & Biotechnology
  • Pharma critics turn their fire on a Democrat (Axios)
  • Why Mylan, Not Tesla, Is the Buyout to Bet On (WSJ)
  • ISS recommends shareholders vote for Cigna's acquisition of Express Scripts as Carl Icahn rails against deal (CNBC)
  • Step therapy changes at Medicare Part B to hit Amgen, Regeneron particularly hard: analysts (Fierce)
  • Clinicians were told their patient had died of an overdose. Then opioid prescribing dropped (STAT) (NIH)
  • HHS takes aim at drug companies for an ‘abusive behavior’ in Medicaid (STAT-$)
  • Lawmakers urge Trump to ensure access to TB drugs as UN meeting nears (STAT-$)
  • Manufacturing problems leave Jazz with 'extremely limited' Erwinaze supply (BioPharma Dive)
  • Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination (FDA)
  • Elite Pharmaceuticals, Inc. Reports Financial Results for the First Quarter of Fiscal Year 2019 Ended June 30, 2018 and Provides Conference Call Information (Press)
  • Puma Biotechnology Reports Second Quarter 2018 Financial Results (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications (FDA)
  • Cancer Discovery Highlights Potent Effects of TP Therapeutics’ Novel, Lead Investigational Compound Repotrectinib in Tumors Harboring ROS1, TRK or ALK Fusions with Solvent Front Mutations (Press)
  • InDex Pharmaceuticals Updates Timeline for Top Line Results from the CONDUCT Study to First Half of 2019 (Press)
  • Celltrion Begins Global Phase 3 Clinical Trial for Its Bevacizumab Biosimilar 'CT-P16' (Press)
Medical Devices
  • AngioDynamics wins early battle in antitrust case against C.R. Bard (Albany Business Review-$)
  • How Insulet’s CEO plans to create a billion-dollar business (DDBN)
  • FDA GUDID Update: Combination product deadline extension, database records reach 1.8 million (Emergo Group)
  • Senseonics debuts its 90-day Eversense CGM (Fierce)
  • NuVasive, Siemens Healthineers pair up on spine surgery tech (Fierce)
  • Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery (FDA)
US: Assorted & Government
  • Can this man bring science back to the White House? (STAT)
  • Trump Administration To Overhaul A Program Designed To Save Medicare Money (NPR)
  • U.S. appeals court orders EPA to ban pesticide said to harm children (Reuters)
  • Trump admin urges states to cooperate on expansion of non-ObamaCare plans (The Hill)
Upcoming Meetings & Events Europe
  • Big Pharma scathing on failure to endorse new cancer medicines (The Irish Times)
  • ABPI hits out at ‘punitive’ UK medicines cost controls (PMLiVE)
  • Confidence in UK’s post-Brexit healthcare sector on the wane (PMLiVE)
  • Biotech firm Novozymes sinks 3% after earnings miss (CNBC)
  • JHL Biotech Receives Positive CHMP Scientific Advice for Global Phase III Clinical Trial of Proposed Bevacizumab Biosimilar to Treat Lung Cancer (Press)
  • QUANTM Irradiation System Earns CE Mark Approval (Press)
  • Frontier, Kintor Are Said to Join Hong Kong Biotech Listing Wave (Bloomberg)
  • Pfizer Vitals suffers double-whammy from poor performance, valsartan recall (Korea Biomedical Review)
  • Janssen Korea to observe 120 for post-marketing survey of ulcerative colitis treatment (Korea Biomedical Review)
  • True North in talks to buy into Glenmark’s API biz for Rs 1500 cr (Economic Times)
  • S3V Vascular invests Rs. 70 crore for new plant, introduces Nextgen Hydrophilic Coated PTCA Balloon Catheter (Pharmabiz)
  • Consultation: Boxed Warning guidance (TGA)
  • Medical devices post-market vigilance - statistics for 2017 (TGA)
  • Medicines and vaccines post-market vigilance - statistics for 2017 (TGA)
  • My Health Record opt-out period extended (The Sydney Morning Herald)
General Health & Other Interesting Articles
  • AI can spot the pain from a disease some doctors still think is fake (Quartz)
  • Amazon has plans to open its own health clinics for Seattle employees  (CNBC)
  • Families Choose Empathy Over 'Tough Love' To Rescue Loved Ones From Opioids (NPR)
  • The maker of the Impossible Burger tested its secret sauce in rats. Then PETA went on the attack (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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