Recon: Novo Nordisk Acquires Diabetes Firm Ziylo for $800M

• Just a few days after a stumble, FDA OKs 12-week dose for Eylea as Regeneron braces for Novartis attack (Endpoints) (Press)
• Trump pushes U.S. lawsuit against drug companies over opioids (Reuters)
• Exclusive: OxyContin maker Purdue taps financial restructuring adviser (Reuters)
• Purdue Pharma’s Sales Pitch Downplayed Risks Of Opioid Addiction (KHN)
• FDA green-lights Bristol-Myers’ Opdivo for a niche group of metastatic lung cancer patients (Endpoints) (Xconomy) (Press)
• FDA Approves First Generic Versions of EpiPen (Focus)
• BPCIA Litigation Updates: Bevacizumab, Trastuzumab, Filgrastim (Big Molecule Watch)
• Senators challenge Azar over his comments about PBMs and price cuts (STAT)
• Eisai sets price tag of about $16,000 on liver cancer drug (Reuters) (Press)
• Genentech to axe 223 staff from San Francisco HQ (Pharmafile)
• CVS Health program takes aim at ‘me-too’ drugs it deems not cost-effective (MedCity)
• Hospitals Battle For Control Over Fast-Growing Heart-Valve Procedure (KHN)

• Novo buys UK group Ziylo (PharmaTimes) (Forbes) (PMLive) (Press)
• WHO Expects Ebola To Spread In Congo In Areas Too Dangerous To Send Workers (NPR) (Reuters)
• GSK announces closure of Sligo, Ireland facilties (Pharmafile) (Fierce)
• Turnaround believer Buffett's big Teva investment sends shares soaring (Fierce)
• No handshakes, no helmets in eastern Congo city preparing for Ebola (Reuters)
• China sacks top official over vaccine scandal, firm may de-list (Reuters) (BioCentury)
• Bayer: Conditions for beginning Monsanto integration fulfilled (Bayer)
• Samsung looks to expand CDMO biz with $22bn investment (BioPharmaReporter)
• Biosimilar Infliximab Success Paves The Way For Adalimumab In Europe (SCRIP-$)
• Japan Approves Nesp “Biosame,” Eyes Riveted on December Listing (PharmaJapan)
• NICE sticks with ‘no’ for use of Perjeta after breast cancer surgery (PharmaTimes)

• Preparing for the big biologic switch (Pharmaceutical Journal)
• The Agonizingly Slow Progress Against The Cancer That Killed Aretha Franklin (Forbes)
• Most Americans Accept Genetic Engineering of Animals That Benefits Human Health, but Many Oppose Other Uses (Pew)
• PhRMA Hits Governors’ Ideas for Drug Price Cuts (FDANews-$)
• After a hiring blitz, where is Mustang's CAR-T manufacturing headed? (BioPharmaDive)
• Duke antidepressant startup Evecxia brings on ex-Cerecor chief as CEO (Fierce)
• FDA Exploring Data-Driven Quality Reviews To Speed Generic Approvals (Pink Sheet-$)
• Too scared to speak in public? Biohaven says it has a drug that can help (Fierce)
• John Kaiser finds next CEO role at Duke spinout Evecxia; Immunocore vet Namir Hassan moves to I/O biotech Zelluna (Endpoints)
• Hubert Chen resigns as Pfenex CMO ahead of NDA (Fierce)
• FDA Commissioner Gottlieb Issues Statement On Advancing the Science and Regulation of Live Microbiome-Based Products (National Law Review) (FDA)
• "Triple pill" blood pressure combo proves more effective, safe than standard care (Pharmafile)
• Gene therapy: Gene therapy before the cradle (Nature)
• Regenerative medicine: Stem cell-derived cardiomyocytes heal a broken heart (Nature)
• Promoting the clearance of neurotoxic proteins in neurodegenerative disorders of ageing (Nature)
• ICER Weekly View 08-17-18 (ICER)

• NIH begins clinical trial of live, attenuated Zika vaccine (NIH)

• Sirnaomics Oncology IND Receives Green Light from US FDA to Initiate Study for Treatment of Cholangiocarcinoma (Press)

• FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder (FDA)
• Blood test may identify gestational diabetes risk in first trimester (NIH)
• SPR Therapeutics gains FDA clearance for update to its percutaneous, wearable pain relief platform (mobihealthnews)
• Highly compensated doctors often fail to disclose relationships with medical device companies (mobihealthnews)
• Treatment with ITB Therapy vs. Oral Medication Shows Quality of Life Improvement, Reduction in Spasticity-Related Pain (Press)

• Thousands of Medicaid enrollees could lose coverage in Arkansas (Politico)
• Novo Nordisk Can't Dodge Shareholder Suit In NJ (Law360-$)
• 8th Circ. Voids Tax Court Ruling In $1.36B Medtronic Case (Law360-$)
• 3rd Circ. Won't Revive Allergan Medicaid Rebate Suit (Law360-$)
• Back to the Well with Pre-Service Removal (Drug & Device Law)
• Teva scoffs at whistleblowers' evidence in bid to dismiss kickbacks case (Fierce)
• Louisiana seeking comments on 'Netflix' model for hepatitis C drugs (Fierce)

• FDA Advisory Committee Calendar
• Neurological Devices Panel Advisory Committee; Notice of Meeting – 27 September 2018
• Pediatric Advisory Committee; Notice of Meeting – 20 September 2018
• IMDRF Management Committee meeting, Beijing, China – 18-20 September 2018
• Science and Regulation of Live Microbiome-Based Products Used To Prevent, Treat, or Cure Diseases in Humans; Public Workshop – 17 September 2018

• Brexit Update: New UK MHRA Guidance for Medical Device Companies (Emergo)
• Concordia Names Six Drugs Targeted By UK Competition Inquiry (Pink Sheet-$)

• PMDA-ATC GMP Inspection Seminar 2018 (PMDA)
• Japanese scientists conduct first clinical trial for Parkinson’s using iPS cells (BioPharmaReporter)
• Jiao Hong meets with the Former Prime Minister of Czech,Bohuslav Sobotka (CFDA)

• Apotex plant in India hit with third warning letter in 4 years (Fierce)
• Oxytocin curbs unite activist groups and drug companies in court (Economic Times)
• Key diabetes, anti-cancer drugs among 92 in price-ceiling list (Economic Times)
• India looks beyond US markets for its pharma exports, achieves positive growth despite 8% decline in US sales (PharmaBiz)
• Maha FDA, CDSCO start risk-based inspections of Sch M units for compliance to norms (PharmaBiz)