Regulatory Recon: FDA Approves Expanded Use for Alexion's Soliris Novartis Preparing for 2019 Sale of Alcon Unit (24 October 2017)

Posted 24 October 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Expanded Use for Alexion's Soliris Novartis Preparing for 2019 Sale of Alcon Unit (24 October 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Trump confounds Senate on whether he wants health care deal (politico)
  • Going all in: Biogen commits an extra $500M to Alzheimer's blockbuster hopeful aducanumab (Endpoints) (Bloomberg)
  • AbbVie antes up $225M in cash to buy into the Alzheimer's platform at Alector (Endpoints) (Financial Times) (Reuters) (Fierce)
  • Alexion wins approval for expanded use of its ultra-expensive drug for ultra-rare disease (STAT) (Endpoints) (Press)
  • Gottlieb Defends Accelerated Approval, Scorns Access Limits By Payors (Pink Sheet-$)
  • FDA chief supports opioid prescription limits, regrets agency's prior inaction (USA Today)
  • FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options (FDA Voice)
  • How drug manufacturers are fighting to push their drugs for unapproved purposes (Salon)
  • Lilly mulls sale, IPO of animal health business, hikes full-year forecast (CNBC) (Financial Times) (The Street) (Press)
  • How complicated is it to declare opioids a national emergency? (CBS)
  • Actually, Many New Cancer Drugs May Be Helpful And Worth Trying (Forbes)
  • Can cancer charity efforts from Roche, Bristol, AbbVie and more boost pharma's reputation? (Fierce)
  • US Hospitals Wrestle With Shortages of Drug Supplies Made in Puerto Rico (NYTimes)

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In Focus: International

  • ANVISA Provides More Details on New Brazilian GMP Inspection Regime (Emergo)
  • Novartis boosts third-quarter profit, pushes Alcon decision to 2019 (CNBC) (WSJ) (Financial Times)
  • Indian Pharma industry seeks extension as skill certification cut-off looms (LiveMint)
  • ISO: Identification of Medicinal Products Standards Revised (Focus)
  • UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments (Focus)
  • Asia Regulatory Roundup: CFDA Posts Draft Guidance on Postapproval Manufacturing Changes (Focus)
  • Industry Welcomes EU Action Plan To Boost ATMP Development (Pink Sheet-$)
  • ICH Expansion To Bring New Challenges For Global Consensus On Pediatric Extrapolation (Pink Sheet-$)
  • ABPI responds to publication of 'Pills and profits' report (ABPI)
  • Nurofen Plus rebellion: Liberal MPs resist plans to restrict codeine sales (The Guardian)
  • AZ tops annual R&D spend in UK, Roche is greatest pharma spender worldwide (Pharmafile)
  • Clinigen buys Japan's largest supplier of unlicensed medicines (PharmaLetter) (Press)
  • EMA's PRAC Recommends New Safety Warnings and Side Effect Labeling (FDANews-$)
  • Reckitt Benckiser Gives Consumer Health Portfolio Its Own Home – What's Next? (Pink Sheet-$)
  • VBL opens Israel's first commercial-scale gene therapy manufacturing unit (PharmaLetter)

Pharmaceuticals & Biotechnology

  • FDA's Office of Pharmaceutical Quality Continues to Advance Review/Inspection Integration (IPQ)
  • FDA Releases 2015 NARMS Integrated Report (FDA)
  • Stockpiling Biologics Under Hatch-Waxman Protection (Law360-$)
  • Discussing the Hepatitis Epidemic? Invite the Drug Rep (Medpage)
  • FDA Issues CRL For Antares' Hypogonadism Candidate (BioCentury)
  • Eyeing a big heart failure market, scPharmaceuticals aims for $100M IPO (Endpoints)
  • Global Blood Therapeutics ditches IPF attempt after weak data (Fierce)
  • Imprimis spins out dry eye disease drugs to create biotech (Fierce)
  • Five Prime founder Williams makes way for new CEO (Fierce)
  • Reality Check: New Prime Therapeutics Data Show Very Low Drug Spending Growth in 2017 (Drug Channels)
  • Gilead promotes Alessandro Riva to Senior VP, Hematology and Oncology Therapeutic Area Head (Pharmafile)
  • Tiny hep B drug combo study touts potential of a 'functional cure' at little-known Replicor (Endpoints)
  • Genmab vets at low-profile Y-mAbs steer two MSK cancer drugs to the FDA after landing $50M from HBM (Endpoints)
  • Arsanis Eyes IPO to Support Clinical Testing of Pneumonia Drug (Xconomy)
  • Valeant's Salix hooks up with Lifetime Channel to talk IBS-D (Fierce)
  • Charity slams UK government's lack of response to access issues (PharmaTimes)
  • Cancer Vanguard, Amgen develop commissioning toolkit (PharmaTimes)
  • Akorn sterile plant in Illinois smacked again by the FDA (Fierce)
  • Alibaba collaboration will give Bayer access to valuable customer data (PharmaLetter-$)
  • FDA Announces ADUFA/AGDUFA Reauthorization Draft Recommendations and Extension of Comment Period (FDA)
  • Trand Doan Nguyen; Denial of Hearing; Final Debarment Order (FDA)
  • Electronic Study Data Submission; Data Standards; Support for Version Update of World Health Organization Drug Global (FDA)
  • Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • In an update, Gilead spotlights top-line hits amid a mixed set of PhII data for its $600M NASH drug (Endpoints) (Fierce) (Press)
  • Alzheon's Alzheimer's asset boards FDA fast track ahead of second swing at phase 3 (Fierce) (Press)
  • TiGenix's Crohn's fistulas treatment wins orphan drug status (PMLive)
  • Neurocrine Granted FDA Orphan Drug Designation for Valbenazine for the Treatment of Pediatric Patients With Tourette Syndrome (Press)
  • Denovo Biopharma Receives FDA's Permission to Proceed a Phase 3 Clinical Trial with DB102 (Enzastaurin) In the First Line Treatment of High Risk DLBCL (Press)
  • Minneamrita Announces FDA Clearance of Investigational New Drug (IND) Application and Initiation of a Phase I Clinical Trial of an Oral Formulation of Minnelide in Patients with Advanced Cancer (Press)
  • FzioMed Receives FDA Approval for Small Confirmatory Study of Oxiplex® in Patients Undergoing Lumbar Surgery for Disc Herniation (Press)
  • Brickell Biotech Announces Positive Phase 2b Study Results for BBI-4000 (Sofpironium Bromide) in Subjects with Primary Axillary Hyperhidrosis (Press)
  • Synlogic Receives Orphan Drug Designation for SYNB1618, a Synthetic BioticTM Medicine for the Treatment of Phenylketonuria (Press)
  • Perrigo Announces Tentative FDA Approval For A First-To-File Generic Version Of Picato Gel .015% (Press)
  • Impax Announces FDA Approval and Launch of Generic Renvela® (Sevelamer Carbonate) Tablets, 800 mg (Press)

Medical Devices

  • FDA Warns Lead-Testing Diagnostics Company (Focus)
  • NeuroPace raises $74 million to market seizure-monitoring device (Reuters)
  • 'White Hats' Face Red Tape As Data Gets Deadly (Law360-$)
  • TPG Picks Up Medical Device Maker Exactech In $625M Deal (Law360-$)
  • Sun Pharma's acne medication companion app records daily progress toward clearer skin (mobihealthnews)
  • FDA clears Acutus Medical's AcQMap cardiac mapping tech (MassDevice)
  • Ortek Therapeutics, Inc. Announces FDA Clearance For Breakthrough Electronic Cavity Detection Device (Press)
  • Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis (FDA)
  • Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms (FDA)
  • Classification of the Zinc Transporter 8 Autoantibody Immunological Test System (FDA)

US: Assorted & Government

  • Iowa pulls request to opt out of Obamacare requirements (Reuters)
  • Courts Reverse Johnson's Baby Powder Judgments for Nearly $500 Million (NYTimes)
  • Boehringer Sues Five Generics Companies to Protect its Gilotrif Lung Cancer Therapy (FDA News-$)
  • Tennessee Judge Denies Endo Request to Move Opioid Lawsuit to Federal Court (FDA News-$)
  • Judge Turns Down Abbott's Motion in Depakote Birth Defects Case (FDA News-$)
  • Post-Remand Consolidated Mesh Trial Upheld on Appeal (Drug & Device Law)
  • 15 Minutes With Teva Pharmaceuticals' General Counsel (Law360-$)
  • Court upholds $27m pelvic mesh verdict against Boston Scientific (MassDevice)
  • Renishaw wins FDA approval for neurosurgery planning software (MassDevice)
  • Abbott wins FDA nod for Confirm Rx smartphone-connected cardiac monitor (MassDevice)

Upcoming Meetings & Events


  • Medineering touts EU approval of its robotic positioning arm (MassDevice)
  • Recipharm equips Lisbon facility for US and European serialization (Pharmafile)
  • Sterling steps-up solid form services with UK facility (InPharmaTechnologist)


  • CRISPR Bacon: Chinese Scientists Create Genetically Modified Low-Fat Pigs (NPR)
  • Pfizer expands Japan contracting offering touting market knowhow (InPharmaTechnologist)
  • TBG Biotechnology Wins Chinese Approval for HLA Typing Kits (GenomeWeb)


  • Lupin gets FDA approval for drug to treat Parkinson's disease (Economic Times)
  • For the first time, ICMR issues national ethical guidelines for biomedical research involving children (PharmaBiz)
  • Fleming Lab's Nawabpet facility comes under USFDA scanner (Economic Times)
  • Glenmark launches oral drug for Psoriasis treatment in India (Economic Times)
  • Panacea Biotec gets USFDA nod to launch Prasugrel tablets(Economic Times)


  • Regulation of autologous cell and tissue products (TGA)
  • Submissions received: Regulation of autologous cell and tissue products and proposed consequential changes to the classification of biologicals (TGA)

General Health & Other Interesting Articles

  • NIH BRAIN Initiative launches cell census (NIH)
  • Screening For Diabetes Is Working Better Than Thought (NPR)
  • Cancer Is the Biggest Killer of America's Firefighters (NBC)
  • CardioBrief: Blacks Face Higher Mortality from Heart Disease, Stroke (Medpage)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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