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Recon: China Pushes for Lower Cancer Drug Prices

Posted 16 July 2018 | By Zachary Brennan 

Recon: China Pushes for Lower Cancer Drug Prices

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

In Focus: US
  • Trump Fails at Lowering Drug Prices as Costs Keep Going Up (Bloomberg)
  • This Form of Ambien Now Costs Over 800% More (WSJ-$)
  • Lawmaker asks Pfizer to make recent rollback on drug prices permanent (Stat-$)
  • Drug to Treat Smallpox Approved by FDA, a Move Against Bioterrorism (NYT-$) (Endpoints) (FDA)
  • Drug industry takes center stage in Senate race, as Hugin punches back against Menendez (Stat-$) (Endpoints)
  • Following EU Recalls, FDA Announces Voluntary Recall of Drugs Containing Valsartan (Focus)
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In Focus: International
  • China vaccine producer under investigation (ECNS)
  • China pushes for lower cancer drug prices: Xinhua (Reuters) (Pharmaphorum) (ECNS)
  • Novartis is the implied villain of the most popular film in China right now (Stat-$)
  • Interview – Why Immatics could soon become the next listed cell therapy player (EP Vantage)
  • Investment in digital health and access to drugs at the core of Austrian Presidency (Euractiv)
  • Access to medical devices for Universal Health Coverage and achievement of SDGs (WHO)
  • Otsuka has high hopes for its ‘drug creation engine’ acquisition (Pharmaphorum)
  • Polio: The Odyssey of Eradication, by Thomas Abraham (FT-$)
  • NICE guideline set to address variation in provision of services for adults with cerebral palsy (NICE)
Pharmaceuticals & Biotechnology
  • Indivior's shares soar 33 percent after U.S. court blocks sale of rival generic (Reuters) (Law360-$)
  • Why Aren't Prison Inmates With Hepatitis C Being Treated? (Forbes)
  • Event – Sink or swim for fish oils, and Amarin (EP Vantage)
  • Richard Lehman’s journal review—16 July 2018 (BMJ)
  • Life Sciences Court Report (Patent Docs)
  • ICER Weekly View 07-13-18 (ICER)
  • Big Pharma & The Rise Of Gangster Capitalism (Zero Hedge)
  • PhRMA Statement on Efforts to Support Real-World Evidence (PhRMA)
  • Preserving Stewardship Of The Patient’s Story (Health Affairs)
  • Beating the Next Superbug Needs a Big Pharma Payoff (Bloomberg)
  • Could Brain Stimulation Slow Cancer? (Scientific American)
  • Job Cuts Seen At Dr Reddy’s Amid Cost Recalibration (Scrip-$)
  • Scientist searching to cure her own prion disease reveals an industry alliance (Stat-$)
  • Midyear analysis: Partnering transactions show no signs of slowing down in 2018 (BioWorld-$)
  • Irregular flow improves bioreactor platelet production (BioWorld)
  • Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients (Lachman Consultants)
  • Biotech Movers and Shakers for July 16 (BioSpace)
  • FDA AdComm backs GlaxoSmithKline’s one-shot P. vivax malaria therapy (Fierce)
  • Hemophilia, the musical: BioMarin sponsors one-of-a-kind performance created by teens (Fierce)
  • McCann Health fires chief creative officer over conduct code violation (Fierce)  
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • FDA approves enzalutamide for castration-resistant prostate cancer (FDA)
  • FDA grants accelerated approval to Yervoy for MSI-H or dMMR metastatic colorectal cancer (Cancer Letter)
  • Vant commander Ramaswamy heads back to Nasdaq with a $150M pitch — are investors ready to forgive Axovant? (Endpoints)
  • Chasing Biogen, the Pliant crew banks a $62M round to fuel their shot at fibrosis targets (Endpoints)
  • Pharma Q2 Results Preview: Johnson & Johnson And Novartis (Scrip-$)
  • Spero Awarded up to $54 Million by BARDA and DTRA to Support SPR994 Development (Press)
  • Tonix Pharmaceuticals Receives Fast Track Designation from the U.S. FDA for TNX-102 SL for Treatment of Agitation in Alzheimer’s Disease (Press)
  • Idera Pharmaceuticals provides update (Press)
  • Ironwood Pharmaceuticals Initiates Phase IIIb Study of Linaclotide in Adult Patients with Irritable Bowel Syndrome with Constipation (Press)
  • Horizon Pharma plc Announces the U.S. Patent and Trademark Office Issuance of Additional Notices of Allowance With Claims Covering Ravicti (glycerol phenylbutyrate) Oral Liquid (Press)
  • Guardian Pharmacy Services Secures $60 Million to Fuel Expansion (Press)
Medical Devices
  • Stryker wins FDA approval for Surpass Streamline brain aneurysm device (MassDevice)
  • Insulet settles shareholder suit over Omnipod Eros device (MassDevice)
  • Nevro Q2 prelims top expectations on The Street (MassDevice)
  • Kypha acquires Dublin, Ireland-based diagnostics company, Biosensia (PharmaBiz)
  • AdvaMed Statement on FDA Medical Device Communications Guidance (Press)
  • Reducing the risks of information security breaches with ISO/IEC 27005 (ISO)
US: Assorted & Government
  • AmerisourceBergen response to Sen. McCaskill (Letter)
  • Wyden Statement on Tom Price HHS Inspector General Report (Press)
  • Former HHS secretary Tom Price’s air travel wasted $341,000 in government funds, watchdog says (Washington Post-$)
  • Tepid Reactions to Medicare Fee Schedule Proposal (MedPage Today)
  • Reducing Health Care Costs: Eliminating Excess Health Care Spending and Improving Quality and Value for Patients (Senate HELP Committee)
  • Patients, Advocates To FDA: Repurpose Drugs, Waive Prescribing Restrictions (InsideHealthPolicy-$)
Upcoming Meetings & Events Europe
  • Criminal involvement in falsification of medicines: maximum prison sentence ranges from one to 15 years across EU, says report (European Commission)
  • Annual review of good clinical practice referrals (MHRA)
  • Substances that may require child-resistent packages (Swedish Medical Products Agency)
  • China expands surveillance of sewage to police illegal drug use (Nature News)
  • Lupin down despite Goa plant approval from UK regulator (PharmaLetter-$)
  • Wockhardt sets up 13-bed dialysis unit in South Mumbai with 3 extra beds for hepatitis B/C, HIV positive patients (PharmaBiz)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)
  • Australia Canada Singapore Switzerland (ACSS) Consortium – Erleada approval (Health Canada)
  • Product Monograph Brand Safety Updates (Health Canada)
General Health & Other Interesting Articles
  • William McBride, Who Warned About Thalidomide, Dies at 91 (NY Times-$)
  • Breast-Feeding or Formula? For Americans, It’s Complicated (NYT) (NPR)
  • Backers of Tesla and SpaceX fund 29-year-old Alice Zhang’s AI-powered neuroscience startup (Endpoints)
  • New Weapons Against Antibiotic-Resistant Bacteria (Bloomberg)
  • Biomarker’s Potential for Diagnosing Traumatic Brain Injury Solidified (GEN)
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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