Recon: Illumina to Buy Pac Bio for $1.2B; FDA Panel Turns Down Alkermes' Depression Drug

• DNA sequencing giant Illumina just bought rival Pac Bio for $1.2 billion (CNBC) (Endpoints) (Xconomy) (Forbes)
• Voters don’t like ‘Big Pharma.’ But they could soon elect a Senate that includes two pharma lobbyists and a CEO (STAT)
• Pfizer Is Weighing Sale of $2 Billion-Women's Health Portfolio (Bloomberg) (Fierce)
• Alkermes' depression treatment fails to get FDA panel backing (Reuters) (Endpoints) (Press)
• Experts question Amarin’s early touting of Vascepa data ahead of detailed results (Endpoints) (KHN)
• What Exactly Does ‘Medicare for All’ Mean? (NYTimes)
• Tale of 2 CEOs: Merck chief treads carefully on pricing, while Pfizer's Read predicts more hikes (Fierce)
• How to Turbocharge Flu Protection (Llamas Required) (NYTimes)
• Dan Best, HHS drug pricing adviser, dies (STAT) (The Hill)

• J&J dumps PhII-ready CD28 autoimmune asset, returns rights to French partner (Endpoints)
• Merck's rolling with RotaTeq in China while phasing out a discounted Africa supply deal (Fierce)
• Novo Nordisk cuts 1300 jobs in the midst of Trump's pricing pressures and depreciation of US dollar (Pharmafile)
• PIC/S To Guide Member Inspectorates On Harmonizing GMP Deficiency Classifications (Pink Sheet-$)
• Long-term data backs safety and efficacy of GSK’s Nucala (PharmaTimes)
• No-Deal Brexit: UK Can Wave Goodbye To Savings From Parallel Imports (Pink Sheet-$)
• Brexit – will all the medicines get to the patients? (EPR)The Brexit debate: As the U.K. prepares to leave the EU, what will happen to research? (Fierce)
• Uganda begins Ebola vaccinations amid Congo transmission fears (Reuters)
• India's NPPA fixes retail price of 68 drug formulations (Economic Times)
• 'Very few people' likely to get prescription for medical cannabis as it becomes legal in the UK (Pharmaceutical Journal)

• 2018 ASH meeting to feature new CAR-T therapies for myeloma (MedCity)
• Genetic testing: Opportunities to unlock value in precision medicine (McKinsey)
• Tuning in: Intensity’s immune-based chemo delivery tech attracts backing of British billionaire Jim Mellon (Endpoints)
• Pfizer-to-Bicycle migration continues with Phil Jeffrey appointment (Fierce)
• When it comes to vaccines, celebrities often call the shots (NBC)
• Magenta stem cell transplant drug seems to work, but is it safe? (Fierce)
• US FDA Mulling Core Criteria For Patient-Reported Outcomes (Pink Sheet-$)
• Assessing The Impact Of State Policies For Prescription Drug Monitoring Programs On High-Risk Opioid Prescriptions (Health Affairs)
• Chutes & Ladders—Intellia’s clinical head moves to Casebia to be its first CMO (Fierce)
• Shire's Takhzyro gets off to hot start, boosting immunology sales ahead of Takeda buyout (Fierce)
• Editorial: Drug price controls? A good idea, but don't bet on it (Modern Healthcare)
• Celgene lines up for $600M Revlimid boost as Rituxan combo scores in lymphoma (Fierce)
• Prostate cancer surgery and radiation tied to antidepressant use (Reuters)
• Omeicos scores $19.5M in Series C to take its omega-3 drug to the next round (Endpoints)
• Gilead investors spooked by UnitedHealthcare push to cut HIV drug costs (Fierce)

• GSK's anti-seizure drug shows promise in early depression study (Pharmafile)
• Genentech to Present New Data from Its Industry-Leading Hematology Portfolio at the American Society of Hematology (ASH) 2018 Annual Meeting (Press)
• Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Approval for SYMPAZAN™ (clobazam) Oral Film (Press)
• Catabasis Pharmaceuticals and Parent Project Muscular Dystrophy to Host a Webinar on PolarisDMD: Phase 3 Clinical Trial of Edasalonexent (CAT-1004) in Duchenne Muscular Dystrophy (Press)
• MaaT Pharma to Present Positive Results from Phase 1b/2a Clinical Trial at 60th American Society of Hematology (ASH) Annual Meeting (Press)
• BerGenBio to Present Late-breaking Abstract on Phase II Trial of Bemcentinib in Combination With KEYTRUDA® in Advanced NSCLC at SITC (Press)

• Apple Watch study enrolls 400k participants (MassDevice)
• FDA warns of battery shutdown issues with Getinge’s Maquet/Datascope IABPs (MassDevice)
• Hill-Rom’s Q4, 2018 beat estimates (MassDevice)
• Endologix posts Street-beating Q3 (MassDevice)
• Tandem Diabetes Q3 sales top The Street (Drug Delivery)
• Insulet Q3 beats The Street (Drug Delivery)
• RTI Surgical puts $300m on the table for Paradigm Spine (MassDevice)
• Class 1 Device Recall SpF PLUSMini (60 A/W) Implantable Spinal Fusion Stimulator (FDA)
• Class 1 Device Recall EBI Osteogen Implantable Bone Growth Stimulator (FDA)

• PhRMA submission to the 2019 National Trade Estimate Report urges action to protect U.S. biopharmaceutical innovation (PhRMA)
• Inside the White House plan to target 'Medicare for All' (Politico)
• HP&M Weighs in on FDA’s “Technical Assistance” to Proposed IVD Legislation (FDA Law Blog)
• A Twist On The Old One-Two Punch (Drug & Device Law)
• Medicaid Expenditures Among Children With Noncomplex Chronic Diseases (Pediatrics)
• AbbVie Looks To Ditch FCA Suit Alleging Humira Kickbacks (Law360-$)
• PTAB Says Rituxan Patent Challenged By Pfizer Is Obvious (Law360-$)
• Celgene's Bid To Trim Drug Monopoly Suit Denied (Law360-$)
• Supreme Court Docket Includes Four Cases Impacting Pharma Industry (Pink Sheet-$)

• FDA Advisory Committee Calendar
• Product Development in Hemophilia; Public Workshop – 6 December 2018

• ‘Alarming’ percentage of families share leftover antibiotics (EPR)
• Breast implants and Anaplastic Large Cell Lymphoma (ALCL) (MHRA)

• Asia Deal Watch: FujiFilm, Hisun Team To Develop Flu Drug For Chinese Market (SCRIP-$)

• Implementation date for track and trace system for exports of drug formulations extended (Economic Times)
• Weak rupee likely to help pharma companies post double-digit growth (Economic Times)
• GSK India Narrows Focus, May Take Foot Off Pedal In CNS (SCRIP-$)
• Lupin Paints Better Second Half Riding On Solosec, New US Launch Hopes (SCRIP-$)

• Comparable Overseas Reports (COR-A) pathway - First registration decision (TGA)
• How to determine if your product should be included in the ARTG (TGA)