Recon: FDA Approves AAA's Lutathera for Certain Digestive Tract Cancers

Posted 26 January 2018 | By Michael Mezher 

Recon: FDA Approves AAA's Lutathera for Certain Digestive Tract Cancers

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

In Focus: US

  • FDA Approves Advanced Accelerator Applications' Lutathera for  Digestive Tract Cancers (FDA)
  • Everything That Could Go Wrong for This Drugmaker Did (Bloomberg)
  • The drug development process gets faster and, scientists hope, better (STAT)
  • Pharma gets a seat at the table at private dinner with Trump at Davos (STAT)
  • Everyone seems to want lower drug prices. 5 reasons why that hasn't happened (STAT)
  • Treating and Preventing HIV with Generic Drugs — Barriers in the United States (NEJM)
  • US panel deals blow to Philip Morris tobacco device (Reuters) (NPR) (NYTimes)
  • Roche chairman sees opportunities for drugmakers under Trump (Reuters)
  • Illumina wins $26.7 million in patent fight with Roche unit Ariosa (Reuters)
  • Abbott's Acquisitive CEO Turns To Paying Debt, Boosting Research (Forbes)
  • Drug companies flex lobbying muscle in fight against state opioid lawsuits (CBS)
  • Meet Alex Azar's new chief of staff (Politico)
  • FTC Approves Final Order Requiring Divestiture of 2 Medical Device Product Lines as Condition of Becton, Dickinson and Company Acquiring C. R. Bard, Inc. (FTC)
  • AstraZeneca's three-in-one inhaler helps COPD patients in trial (Reuters) (Fierce) (Endpoints)
  • Biogen buys a brain disorder drug for $217 million, but needs to go bigger, analyst says (CNBC)
  • Biogen: Where Is That Blockbuster Acquisition? (Forbes) (Endpoints)
  • Behind the deal spree, Celgene continues to cautiously explore neurosciences (Endpoints) (BioCentury)

In Focus: International

  • Groups warn against NAFTA moves that could keep drugs out of reach (STAT)
  • India's Largest Drugmaker Says Slump in Generics Won't Last Long (Bloomberg)
  • WHO Officials On The Trouble With Value-Based Pricing (Pink Sheet-$)
  • Lancet-published data show potential of GW's Epidiolex (PharmaTimes)
  • Fast-growing Shanghai Pharma to plant foot in San Diego, hunting deals in US and Europe (Endpoints)
  • Korea To Introduce Fast-Track Review For Cutting-Edge Biologics, Devices (Pink Sheet-$)
  • Meeting highlights from the Committee for Medicinal Products for Human Use – January (EMA)
  • GSK's shingles vaccine gets green light from EMA panel (Reuters)
  • EMA panel recommends Merck, Pfizer's diabetes drug (Reuters)
  • Roche wins EU panel's recommendation for hemophilia drug (Reuters) (Press) (EMA)
  • New enzyme replacement therapy to treat rare genetic disorder alpha-mannosidosis in children and adults (EMA)
  • Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation (EMA)
  • Companies Reluctant To Put Combo Drugs Through NICE, UK Breast Cancer Charity Warns (Pink Sheet-$)
  • Merck & Co eyes vaccines production in Russia (PharmaLetter-$)

Pharmaceuticals & Biotechnology

  • Flu deaths may be less likely with annual vaccination (Reuters)
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA's strengthened commitments to humane and judicious animal research and the termination of a nicotine study (FDA)
  • Duchenne MD dad pivots from last-minute alert on FDA's partial hold to $125M IPO for Solid Bio (Endpoints) (EP Vantage) (Xconomy)
  • Patients seeking "death with dignity" face drug price-gouging (CBS)
  • Under pressure to perform, Woodford counterattacks against Sahm Adrangi's latest short assault (Endpoints)
  • Ex-Merrimack CEO Mulroy launches oncology startup Partner Therapeutics (Endpoints)
  • Heptares co-founder Fiona Marshall to lead Merck's London research hub; Ablynx appoints Robert Friesen as new CFO (Endpoints)
  • The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium (Harvard Bill of Health)
  • Interview: Sandoz CEO On Biosimilars And Reshaping US Business (SCRIP-$)
  • Takeda Utilizes Social Media Analysis and Survey in a Study to Better Understand Patient Preferences When Seeking Treatment for Inflammatory Bowel Disease (Press)
  • British newco KaNDy Therapeutics said to be in Allergan M&A crosshairs (Fierce)
  • FDA Warns Australian Firm for GMP Violations (FDANews-$)
  • ICER Panel Says Luxturna Has An Intermediate Value, Discusses Pricing Models (BioCentury)
  • Data integrity: sharing results regulators can trust (PharmaLetter-$)
  • Biogen's MS drug Tecfidera could make cancer-killing viruses more potent: study (Fierce)
  • Switching to biosimilars in rheumatology (GaBI)
  • Biopharma veterans go in on oncology company that will tackle treatment gaps (Fierce)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Summit's Ezutromid Reduces Muscle Damage In DMD (BioCentury)
  • Accelerated EMA assessment for patisiran in hereditary ATTR amyloidosis (PharmaLetter-$)

Medical Devices

  • Philips IntelliSpace Cardiovascular System Vulnerability (ICS-CERT)
  • Nothing Appealing in Proposed Device Appeal Regulations: They are Identical to Existing Guidance (FDA Law Blog)
  • Armune Bio's Cancer Detection Tech Finds New Home with Exact Sciences (Xconomy)
  • FDA Grants Approval for Hologic Hepatitis B Viral Load Assay (GenomeWeb)
  • Hitachi wins FDA nod for proton beam therapy real time image gating system (MassDevice)
  • Tryton Medical launches post-approval study of Side Branch Stent system (MassDevice)

US: Assorted & Government

  • HHS Touts 2017 Accomplishments in New Report (HHS)
  • Few Children Take Free Lead Tests Offered by New York City (WSJ)
  • More on BMS & Nationwide Class Actions (Drug & Device Law)
  • FDA, Endo Pause Bulk Compounding Lawsuit Pending FDA Guidance (FDANews-$)
  • FDA Lawfully Denied Exclusivity For Namenda Generic: Judge (Law360-$)
  • Medicis Falls Short In Bid To Escape Pay-For-Delay Suit (Law360-$)

Upcoming Meetings & Events


  • First Takes From Medicines for Europe Event (Pink Sheet-$)
  • NICE urges curbing the use of antibiotics for sore throats (Pharmafile)
  • List of centrally authorised products requiring a notification of a change for update of annexes (EMA)
  • EMA accepts application for pegfilgrastim biosimilar from USV (GaBI)
  • Russia's Geropharm to invest $60 million in insulin production in Russia (PharmaLetter-$)


  • FiercePharmaAsia—Takeda's Alzheimer's flop, Shanghai Pharma's US plan, NextCODE talk (Fierce)
  • Shanghai Pharma seeking deals to drive overseas expansion (Fierce)


General Health & Other Interesting Articles

  • More birth defects in US areas with Zika: US health officials (Reuters)

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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