Recon: AbbVie Reverses $140M AndroGel Verdict, Biogen-Eisai Alzheimer’s Drug Makes a Comeback

• AbbVie wins reversal of $140 million verdict in case over AndroGel risks (Reuters) (Fierce)
• Boston Scientific buys up cardiac cryoablation device firm Cryterion for $202M upfront (Fierce) (Minneapolis Star Tribune) (Boston Business Journal-$)
• Teva moving North America headquarters from North Wales to North Jersey (Philadelphia Business Journal-$) (Endpoints) (Fierce) (BioSpace)
• Unsealed lawsuit: Opioid firm placed profits over people (AP News)
• Hidden conflicts? An investigation finds a pattern of after-the-fact compensation by pharma to those advising the U.S. government on drug approvals (Science)
• Ironwood cuts 40 jobs ahead of company split (BioPharma Dive) (Endpoints) (Fierce)

• Biogen And Eisai Say Alzheimer's Drug A Success, Reversing Earlier Result (Forbes) (Financial Times) (STAT) (Reuters) (Endpoints)
• With tech from Spinraza’s maker, French startup Dynacure gets $55M to tackle neuromuscular disease (Endpoints) (Scrip-$) (Fierce)
• Herpes virus discoveries could lead to new drugs (pharmaphorum) (The Times)
• Pfizer UK MD takes the helm at the ABPI (PharmaTimes) (PMLiVE)
• Predicine and Suzhou Kintor deepen ties over biomarker development (The Pharma Letter)
• Walgreens Completes Investment In Chinese Pharmacy Chain (Forbes) (Daily Herald)
• Low quality healthcare is increasing the burden of illness and health costs globally (WHO)

• Hitting cancer early: AstraZeneca's bid to outmaneuver rivals (Reuters)
• Drug Development For Neglected Diseases Has Stagnated (Forbes)
• Amazon undercuts drugstores on prices for most over-the-counter drugs (CNBC)
• Baxter, Hospira Freed From Saline Price-Fixing Case For Now (Law360-$)
• In shadow of Shire sale, Takeda's TiGenix takeover nears completion (The Pharma Letter-$)
• After breathing new life into old mice, senescence startup Cleara bags cash to move toward the clinic (Fierce) (Press)
• Bill signed allows women year supply of birth control pills (AP News)
• Opioid stigma is keeping many cancer patients from getting the pain control they need (STAT)
• In the age of mail-order DNA, a firm seeks to increase safety without slowing progress (STAT-$)
• Cash-rich Cambridge startup Rubius to build $155M cell therapy manufacturing site in Rhode Island (Endpoints)
• Is Gilead Poised for a Comeback? (BioSpace)

• Siga Technologies touts pivotal data for oral smallpox therapy (DDBN)
• One step closer to personalized treatments for bladder cancer (Fierce)
• Arming antibiotics with a vaccination-like immune response (Fierce)
• A case study in the fast-rising threat of antibiotic resistance (STAT-$)

• Putting AI and cloud computing to work automating hardware maintenance (Healthcare IT News)
• FDA green-lights 14 digital health products, continues to evolve regulations (MobiHealthNews)
• VA facilities across Ohio lost $1 million worth of medical equipment (10TV)
• Fireworks among the small and mid-cap device makers (EP Vantage)
• Drug-coated balloon developer Urotronic raises $6m (DDBN)
• StratoScientific raises $12m for smartphone stethoscope (MassDevice)
• Intuitive Surgical wins FDA nod for 60mm stapler (MassDevice)
• Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and Devices Not Meeting the Medicare National Coverage Determination, 2007-2015 (JAMA)
• FDA Clears The Way: Lipogems' Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body's Own Fat To Support Tissue Repair In Orthopaedic And Arthroscopic Surgeries (Press)

• FDA announces revised guidance on the testing of donated blood and blood components for Zika virus (FDA)
• Supporting the Next Generation of Biomedical Researchers (JAMA)
• Big Data and Predictive Analytics: Recalibrating Expectations (JAMA)
• To Bring Health Information Privacy Into The 21st Century, Look Beyond HIPAA (Health Affairs)
• U.S. pushes back on global declaration for TB drugs, a move advocacy groups say will restrict access (STAT-$)
• California to Pharmacies: Start Balancing your Opioid Checkbook (FDA Law Blog)
• Troublesome News: Numbers Of Uninsured On The Rise (Forbes)

• FDA Advisory Committee Calendar

• Brexit uncertainty leacescompanies ‘having to prepare for every scenario’, says BIA (BioPharma-Reporter)
• EHR Vendor Mistake Impacts 150,000 U.K. Patients (GovInfoSecurity)
• Orion takes repurposed heart failure drug into phase 3 for ALS (Fierce)
• PathoFinder Granted CE Mark For Combined Trichomonas Vaginalis, Mycoplasma Genitalium, Azithromycin-Resistance PCR Test (GenomeWeb)

• Pilot system for medical device registrant expanded to all in Shanghai (China Association for Medical Devices Industry)
• SFDA officials: There will be a large number of medical AI listing reviews next year (China Association for Medical Devices Industry)
• Science board: English translation of an outcome document (PMDA)
• Chinese film on cancer highlights need of Indian drugs (Deccan Herald)
• Seoul strengthens clinical trial regulations (Korea Biomedical Review)

• NPPA has fixed/revised ceiling prices/retail prices of 58 formulations under Drugs (Prices Control) Order, 2013 in related Notification /order dated 04.07.2018. (NPPA)
• Bihar drug makers heave sigh of relief as HC quashes ban on levofloxacin, ofloxacin formulations for paediatric use (Pharmabiz)
• Tamil Nadu to come up with new pharma policy; industry welcomes move (Business Standard)
• A shot of confidence for Indian pharma, its regulator (Hindu Business Line)
• India may formulate standards for pharma industry’s antibiotic residue (Hindustan Times)

• Profits before Patients – Insurer’s claims hide a deeper agenda (MTAA)
• Submissions received: Options for the implementation of a claimer for efficacy assessed non-prescription medicines (TGA)
• TGA presentation: National Medicines Symposium, 30 May 2018 (TGA)

• Notice: Prescription Drug List: Multiple additions (Health Canada)

• Air pollution may account for 1 in 7 new diabetes cases (Reuters)
• The Health 202: 'Gag clauses' mean you might be paying more for prescription drugs than you need to (The Washington Post)
• Listen to ‘The Daily’: How the Opioid Crisis Started (NYT)
• New approach to breast cancer screening — tailoring guidelines for each patient — may save lives and money, study says (STAT)
• He Went In for a Heart Transplant. He Suffered Severe Brain Damage. Now His Family Is Suing St. Luke’s. (ProPublica)
• How Holograms Are Helping Medical Training (WSJ)