Regulatory Focus™ > News Articles > 11 > Recon: Illumina to Buy Pac Bio for $1.2B; FDA Panel Turns Down Alkermes' Depression Drug

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

Posted 02 November 2018 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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 $2 Billion-Women's Health Portfolio (Bloomberg) (Fierce)
  • Alkermes' depression treatment fails to get FDA panel backing (Reuters) (Endpoints) (Press)
  • Experts question Amarin’s early touting of Vascepa data ahead of detailed results (Endpoints) (KHN)
  • What Exactly Does ‘Medicare for All’ Mean? (NYTimes)
  • Tale of 2 CEOs: Merck chief treads carefully on pricing, while Pfizer's Read predicts more hikes (Fierce)
  • How to Turbocharge Flu Protection (Llamas Required) (NYTimes)
  • Dan Best, HHS drug pricing adviser, dies (STAT) (The Hill)
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In Focus: International
  • J&J dumps PhII-ready CD28 autoimmune asset, returns rights to French partner (Endpoints)
  • Merck's rolling with RotaTeq in China while phasing out a discounted Africa supply deal (Fierce)
  • Novo Nordisk cuts 1300 jobs in the midst of Trump's pricing pressures and depreciation of US dollar (Pharmafile)
  • PIC/S To Guide Member Inspectorates On Harmonizing GMP Deficiency Classifications (Pink Sheet-$)
  • 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-$)
  • Brexit – will all the medicines get to the patients? (EPR)The Brexit debate: As the U.K. prepares to leave the EU, what will happen to research? (Fierce)
  • Uganda begins Ebola vaccinations amid Congo transmission fears (Reuters)
  • India's NPPA fixes retail price of 68 drug formulations (Economic Times)
  • 'Very few people' likely to get prescription for medical cannabis as it becomes legal in the UK (Pharmaceutical Journal)
Pharmaceuticals & Biotechnology
  • 2018 ASH meeting to feature new CAR-T therapies for myeloma (MedCity)
  • Genetic testing: Opportunities to unlock value in precision medicine (McKinsey)
  • Tuning in: Intensity’s immune-based chemo delivery tech attracts backing of British billionaire Jim Mellon (Endpoints)
  • Pfizer-to-Bicycle migration continues with Phil Jeffrey appointment (Fierce)
  • When it comes to vaccines, celebrities often call the shots (NBC)
  • Magenta stem cell transplant drug seems to work, but is it safe? (Fierce)
  • US FDA Mulling Core Criteria For Patient-Reported Outcomes (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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 $300m on the table for Paradigm Spine (MassDevice)
  • Class 1 Device Recall SpF PLUSMini (60 A/W) Implantable Spinal Fusion Stimulator (FDA)
  • Class 1 Device Recall EBI Osteogen Implantable Bone Growth Stimulator (FDA)
US: Assorted & Government
  • PhRMA submission to the 2019 National Trade Estimate Report urges action to protect U.S. biopharmaceutical innovation (PhRMA)
  • Inside the White House plan to target 'Medicare for All' (Politico)
  • HP&M Weighs in on FDA’s “Technical Assistance” to Proposed IVD Legislation (FDA Law Blog)
  • A Twist On The Old One-Two Punch (Drug & Device Law)
  • Medicaid Expenditures Among Children With Noncomplex Chronic Diseases (Pediatrics)
  • AbbVie Looks To Ditch FCA Suit Alleging Humira Kickbacks (Law360-$)
  • 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-$)
Upcoming Meetings & Events Europe
  • ‘Alarming’ percentage of families share leftover antibiotics (EPR)
  • Breast implants and Anaplastic Large Cell Lymphoma (ALCL) (MHRA)
  • Asia Deal Watch: FujiFilm, Hisun Team To Develop Flu Drug For Chinese Market (SCRIP-$)
  • 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)
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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