Recon: CNDA Says Chinese Vaccine Maker Sold 250,000 Substandard Baby Vaccines

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

In Focus: US

• Regulatory eyes on Regeneron: US FDA issues CRL for Eylea (BioPharmaReporter)
• ​Andrew Cheng to quit Gilead 6 months after taking CMO post (Fierce)
• Google Bets $375M On Medicare Advantage With Oscar Health Stake (Forbes) (MedCity) 
• Orchard Therapeutics closes $150 million Series C round (MedCity) 
• Long-acting injection a shot in the arm for GSK's HIV business (Reuters) (Endpoints) 
• Express Scripts staking out million-dollar gene therapies (Reuters) (CNBC) 
• Does Tiny Iovance Deserve To Ride The T-Cell Wave? (Forbes) 
• FDA Advances Efficient Approaches to Designing and Conducting Cancer Clinical Trials (FDA Voice) 
• New Estimates Show Overdose Deaths Surpassed 72,000, a New High, in 2017 (NYTimes) 
• Walden and Burgess on President Trump Signing Bipartisan Bill Reauthorizing Animal Drug & Animal Generic Drug User Fee Programs (E&C) 

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In Focus: International 

• China biotech looks to make leap from ‘fast followers’ (Financial Times)
• ​Chinese vaccine maker made 500,000 substandard baby vaccines: Xinhua (Reuters) 
• The biotech mood at the halfway mark of 2018? Boisterous, focusing more attention on China and looking for accelerated progress (Endpoints) 
• FDA recalls are a reminder that China controls much of world's drug supply (NBC) 
• WHO: Current Ebola Outbreak Poses New Problems (Medpage) 
• Role of Established Conditions Drawing Attention in Global Dialogue on ICH Q12’S Potential (IPQ) 
• Rotavirus vaccine cuts infant diarrhoea deaths in Malawi (EPR) 

Pharmaceuticals & Biotechnology 

• Real-World Evidence Challenges: Death Among Toughest Data Points To Measure (Pink Sheet-$) 
• Back in business after a spell in limbo, Ironshore says it has raised $143M for ADHD drug rollout (Endpoints) 
• Loncar China BioPharma ETF (Nasdaq: CHNA) Launches on Nasdaq (Loncar) 
• Bioverativ executive Rogerio Vivaldi to helm cell therapy producer Sigilon (Fierce) 
• As Alzheimer’s drug developers give up on today’s patients, where is the outrage? (STAT) 
• Not all women eligible for breast cancer gene tests are getting them (Reuters) 
• Poppy seed wash is really a drug, FDA says (NBC) 
• People taking HIV-prevention pill may get more primary care (Reuters) 
• Batycky exits Acorda to head up new biotech (Fierce) 
• How data is changing the pharma operations world (McKinsey) 
• CVS to Launch ICER-Restricted Formulary (BioCentury) 
• Insilico, Juvenescence and the Buck Institute form AI-based venture to tackle metabolism and aging-related diseases (Fierce) 
• New drug manufacturing tools change pharma chemistry (Novartis) 
• Mustang Licenses Immunodeficiency Gene Therapy from St. Jude (BioCentury) 
• Mylan launches generic of United Therapeutics' Adcirca (BioPharmaDive) 
• Cetuximab with radiation found to be inferior to standard treatment in HPV-positive oropharyngeal cancer (NIH) 
• 21st Century Citizen Pharma: The FDA & Patient-Focused Product Development (ASLME) 
• Real-World Data Analytics Fit for Regulatory Decision-Making (ASLME) 
• The Evolution of Federal Regulation of Human Drugs in the United States: An Historical Essay (ASLME) 
• Agency Information Collection Activities; Proposed Collection; Comment Request; Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act (Federal Register) 

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations 

• Janssen Reports Positive Topline Results for ATLAS Phase III Study of a Novel, Long Acting Injectable Two-Drug Regimen for the Treatment of HIV-1 (Press) 
• ​Oragenics, Inc. Resumes Phase 2 Clinical Trial of AG013 in Oral Mucositis Following Positive Routine Safety Review (Press) 
• Martin Pharmaceuticals’ LIVANTRA™ Receives FDA Orphan Drug Designation in Second Indication (Press) 
• FDA Grants Orphan Drug Designation to Onspira Therapeutics' Investigational Interleukin-1 Receptor Antagonist for the Treatment of Bronchiolitis Obliterans (Press) 

Medical Devices 

• Report: Med device recalls in Q2 highest since 2005 (MassDevice) 
• Creating New Compounds For 3D Printed Medical Devices (MDDI) 
• BARDA, J&J launch ‘reimagined’ emergency respiratory device challenge (MassDevice) 
• In midst of Epipen shortage, Kaleo confirms ‘sufficient supply’ of Auvi-Q auto-injectors (Drug Delivery) 
• 7D Surgical wins FDA nod for MvIGS nav system Cranial Module (MassDevice) 
• Actisound Intense Therapeutic Ultrasound Device Cleared in Europe (MedGadget) 

US: Assorted & Government 

• Pfizer joins DOJ probe into claims pharma bribes funded Iraqi terrorists (Fierce)
• ​Texas Officials Were 'In Over Their Heads' When They Struck Deals With Opioid Lawyers (Forbes) 
• Monsanto Roundup appeal has uphill climb on 'junk science' grounds: legal experts (Reuters) 
• Speaker Program Payments Weren't Kickbacks, Teva Says (Law360-$) 
• USPTO Issues Updated PTAB Practice Guide for Post-grant Review Proceedings (Patent Docs) 
• Its Getting Bulkier Every Day for This Section 503B Facility: Athenex Announces a Product Launch, Moves to Intervene in the Endo/Par Bulks Lawsuit Against FDA, and Files a Declaratory Judgment Complaint (FDA Law Blog) 

Upcoming Meetings & Events 

• FDA Advisory Committee Calendar 
• Vaccines and Related Biological Products Advisory Committee – 3 October 2018 

Europe 

• Charity steps in to fund PrEP access in England and NI (Pharmaceutical Journal) 
• Guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) (EMA) 
• Buying medical devices for personal use (MHRA) 

Asia 

• Trade War Spreads: Trump Rains On China Biotech Investment Parade (Pink Sheet-$) 
• Malaysia takes the lead on a public health approach to hepatitis C with new initiative to enhance diagnosis & treatment (DNDi) 

India 

• Government extends caps price of knee implants for one more year (Economic Times) 

Australia 

• Report: Women in Australia to pursue class action over Bayer’s Essure (MassDevice) 

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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