Recon: Akcea to Cut 10% of Workforce; Hospitals Form Generic Drug Company

• Trump health chief meets with GOP lawmakers on lowering drug prices (The Hill)
• Akcea reducing workforce 10% following Waylivra rejection (BioPharma Dive) (Reuters) (Fierce)
• A Superstar Team of Hospitals Is Sick of High Drug Prices—And Launching a Nonprofit Drug Company to Fight Them (Fortune) (AP News) (Forbes) (NPR) (BioPharma Dive)
• Boston Scientific acquires prostate spacer developer Augmenix in $600M deal (Fierce)
• Maryland charges Insys with engaging in deceptive opioid scheme (Reuters) (Baltimore Sun)
• Opioid billionaire granted patent for addiction treatment (Financial Times-$) (STAT)
• Fed. Circ. Hands Win To Supernus Over Generic Seizure Drug (Law360-$) (Bloomberg-$)
• AstraZeneca, Amgen roll up a ‘breakthrough’ at the FDA in hot pursuit of a potential game changer in asthma (Endpoints) (PMLiVE) 
• Insulin’s High Cost Leads To Deadly Rationing (KHN)
• Rush to end drug rebates may be bad for patients, payers, and pharma (STAT)

• BTG buys Irish med device group Novate (PharmaTimes) (Reuters) (Irish Times)
• J&J to work with India on compensation for recalled hip implants (Reuters)
• French drugmakers urge Brexit negotiators to safeguard supply chain (Reuters)
• Mylan reveals its $463M mystery buy, and it's Novartis' TOBI cystic fibrosis products (Fierce)
• Authorities boost efforts to stem overseas opioid production, distribution (Modern Healthcare)
• UK Government to invest £200m in IT and technology boost for NHS (Pharmafile) (PMLiVE)
• New Drug Bonanza as Chi-Med, Eisai, Alexion Harvest Big Wins In China (Scrip-$)
• Evolution of the U.S. Overdose Crisis: Understanding China's Role in the Production and Supply of Synthetic Opioids (RAND Corporation)
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 September 2018: PRAC elects new vice-chair (EMA)

• Does a generic EpiPen mean lower prices? Don’t hold your breath (STAT)
• Endo Seeks Separate Settlement to End Opioid Lawsuits (Bloomberg)
• What’s next for CAR-T and TCR? Five biotech execs on the lofty goals, the scientific challenges, and the looming price questions (STAT-$)
• The High Cost Of Hope: When The Parallel Interests Of Pharma And Families Collide (KHN)
• Aging Parents And The Dangers Of Overmedication (Forbes)
• The Need for an Economic Bioethics (Bill of Health)
• Will Trump's Pharma Shaming Bring Down Drug Prices? Not Likely, Poll Says (Forbes)
• CRISPR genome-editing pioneer to set up lab at Gladstone (San Francisco Business Times-$)
• Colorado sues Oxycontin maker Purdue Pharma over its role in opioid crisis (The Denver Post)
• What next for the Sacklers? A pharma dynasty under siege (Financial Times-$)
• Blue Cross will stop covering OxyContin in Tennessee next year (The Tennessean)
• The Bloody Saga That Made Theranos Finally Call It Quits (Law360-$)
• Silicon Valley’s top biotech investors reveal what the crash and burn of blood-testing startup Theranos taught them (Business Insider-$)
• Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamination (FDA)
• Senate Agrees to Vote Next Week on “The Opioid Crisis Response Act of 2018” (Press)
• Twentyeight-Seven Therapeutics Launches with a $65 Million Series A Funding (Press)

• Tanezumab's Phase 3 Results: A Promising Sign For Non-Opioid Pain Treatments (Forbes)
• Which Drug for Erectile Dysfunction Is Better: Viagra or Cialis? (NYT)
• After midphase flop, Pfizer taps Cytoo for help identifying DMD targets (Fierce)
• Replimune Announces FDA Acceptance of Investigational New Drug Application for its Lead Oncolytic Immunotherapy Candidate, RP1 (Press)

• Eight IoT barriers for connected medical devices…and how to overcome them (Deloitte)
• Abiomed Seeks Quick Win In Fired Exec's $2.1M Equity Suit (Law360-$)
• Church & Dwight Wins $10M In Pregnancy Test False-Ad Suit (Law360-$)
• Liquid biopsy firm Guardant Health files for $100M IPO (MedCity News)
• SLLIP Study Meets Primary Endpoint, Finds the Guardant360 Assay Performs Similar to Standard-of-Care Tissue Testing in Advanced NSCLC, Investigators to Report at WCLC (Press)
• Surgical Innovation Associates Receives FDA 510(k) Clearance to Market Advanced Bioabsorbable Mesh for Reconstructive and Cosmetic Surgery (Press)
• Baxter Announces U.S. FDA Clearance of New Bone Graft Substitute, Actifuse Flow (Press)
• IRIDEX Announces FDA Clearance to Introduce Updated TruFocus LIO Premiere Laser Accessory to the U.S. Market (Press)

• NIH taps Bruce J. Tromberg, Ph.D., to lead the National Institute of Biomedical Imaging and Bioengineering (NIH)
• AP Exclusive: Modest premium hikes as ‘Obamacare’ stabilizes (AP News)
• Is Universal Health Care Socialism? (The Health Care Blog)
• Republicans are arguing that Medicare-for-all will undermine Medicare (Vox)
• 3rd Circ. Says 'Buyer's Remorse' Can't Revive Toxic Talc Suit (Law360-$)
• New Emails Reveal Kavanaugh As Opinionated Bush Lawyer (Law360-$)
• WellCare Ready To Buy Divested CVS-Aetna Medicare Drug Plans (Forbes)
• ‘A potent team’: What Jack Stoddard brings to the Atul Gawande-led health venture (STAT-$)
• North Dakota Drug-Pricing Law Not Barred by Federal Benefits Law (Bloomberg-$)
• Rite Aid Faces Whistleblower Lawsuit on Medicaid Drug Fraud (Bloomberg-$)

• FDA Advisory Committee Calendar

• Statins 'may not help over-75s without diabetes’ (NHS)
• Change in the classification of certain glucosamine products (MHRA)
• Non-Executive Directors to join Agency (MHRA)
• Lilly streams £5m into virtual lab pact with UCL, Imperial (PharmaTimes)
• NHS announces new Genomic Medicine Service (Healthcare IT News)

• Pfizer Korea ordered to suspend imports of 3 drugs for poor quality control (Korea Biomedical Review)
• Five Stocks to Watch as China Breaks Into Global Drug Market (Bloomberg)
• Pharma sector with improved health a big draw for investors (Economic Times)

• Public notice: Renaming of Central Drugs Standard Control Organization (CDSCO)
• Extension of last date for suggestions/comments on Draft Guidance Document for Medical Devices (Indian Pharmacopoeia Commission)
• Lax regulatory environment, not lack of laws, to be blamed for J&J hip implant imbroglio (Pharmabiz)

• Major Australian EHR rollout approaches halfway mark (Healthcare IT News)
• Modified release paracetamol (TGA) (TGA)
• Consumer story: Georgia and breast implant associated cancer (TGA)
• Philips signs two long-term strategic partnership agreements in Australia for medical imaging solutions (Press)

• Novartis receives Health Canada approval of its CAR-T cell therapy, Kymriah (tisagenlecleucel) (Press)

• IVF kids may have higher risk of high blood pressure (Reuters)
• Longer daily fasting times improve health and longevity in mice (NIH)
• Surprise Medical Bills Are What Americans Fear Most In Paying For Health Care (KHN)