Regulatory Recon: Sanofi's Adlyxin Approved for Type 2 Diabetes PhRMA, BIO Release Off-Label Communications Principles (28 July 2016)

Posted 28 July 2016 | By Michael Mezher 

Regulatory Recon: Sanofi's Adlyxin Approved for Type 2 Diabetes PhRMA, BIO Release Off-Label Communications Principles (28 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA approves Sanofi's Adlyxin to treat type 2 diabetes (FDA) (Press)
  • Stem Cell Therapies Are Still Mostly Theory, Yet Clinics Are Flourishing (NYTimes)
  • BioMarin Gene Therapy Stops Yields Dramatic Results In Hemophilia (Forbes) (The Street)
  • Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017 (Focus) (Pink Sheet-$)
  • BIO, PhRMA lay out principles for off-label communications (BioCentury) (Pink Sheet-$) (BIO)
  • Influenza Virus Vaccine for the 2016-2017 Season (FDA)
  • Boston Scientific's sales beat on demand for heart devices (Reuters)
  • Rough public start for biotech founded by ex-con, as CEO fumes at 'vicious' press (STAT)
  • Celgene raises forecast as profit beats Street (Reuters)
  • Teva to Divest 79 Generic Drugs to Settle FTC Concerns With Allergan Generics Acquisition (Focus) (WSJ-$) (Reuters)
  • Critics of weight-loss device urge US regulator to reverse approval (Reuters)
  • Alere Faces Criminal Probe Over Medicare, Medicaid Billing (WSJ-$) (CNBC)
  • Bristol-Myers Squibb Reports Second Quarter Financial Results, Raises Guidance (Press)
  • LabCorp takes Sequenom for $300m (EP Vantage) (MassDevice)
  • Anavex Alzheimer's Drug Plays Losing Game Against Placebo Effect (The Street)
  • AstraZeneca helped by new drugs as cholesterol pill fades (Reuters) (Fierce)
  • Vertex stands by Orkambi, Kalydeco guidance (BioCentury)

In Focus: International

  • UK health service under fire over access to hepatitis C drugs (Reuters)
  • Will the UK ever produce a world-class biotech company? (PharmaPhorum)
  • EMA Adds Four New Drugs to PRIME Scheme (Focus)
  • Oxford BioMedica receives MHRA GMP manufacturing approvals (Manufacturing Chemist Pharma)
  • First patient dosed in Ph I Zika vaccine clinical trial (Outsourcing-Pharma)
  • Competent Authorities on Substances of Human Origin Expert Group (CASoHO E01718) – 12th Meeting on Organ Donation and transplantation (European Commission)
  • NICE issues decisions on leukemia, melanoma and cystic fibrosis drugs (PharmaLetter-$)
  • NICE finalises record-breaking Opdivo/Yervoy appraisal (PMLive) (BioCentury)
  • German Scientists find new antibiotic in the human nose (Washington Post) (Reuters)
  • GlaxoSmithKline Helped and Hurt by Sterling's Post-Brexit Fall (WSJ-$)

US: Pharmaceuticals & Biotechnology

  • Gilead lives and dies by hep C (EP Vantage)
  • Merck calls time on US allergy market (EP Vantage)
  • Amgen Profit Rises 13%, 2016 Outlook Raised (WSJ-$)
  • UniQure yo-yos as data raise questions about its place in hemB gene therapy race (Fierce)
  • Exclusive: Advent, CVC bid for inVentiv ahead of IPO: sources (Reuters)
  • Give Thanks for Your Compliance Officers – Reviewing Public Citizen's Study of Pharmaceutical Settlements (Policy and Medicine)
  • CDC funding accelerates antibiotic resistance efforts (CDC)
  • New medication shows promise against liver fibrosis in animal studies (NIH)
  • After Zafgen Abandons Prader-Willi Drug, Could Rhythm Offer Hope? (Xconomy)
  • Biotech startup challenges Bayer's Stivarga patent (PharmaLetter-$)
  • Clinical trial homogeny: 'pressing need' to create diversity (Oursourcing-Pharma)
  • Alzheimer's Maverick TauRx Tries To Weave Success From Failed Trial (Forbes)
  • When Drug Therapy Fails: A Case of Refractory Hyperglycemia (MPR)
  • Modular production facilities 'the future of all biologics,' says GE (BioPharmaReporter)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Baxter Presents New Evidence Demonstrating REVACLEAR Dialyzer Associated with Lower Drug Use During Hemodialysis (Press)
  • New Studies Suggest Relationship between Tau Pathology and Progression of Alzheimer's Disease (Press)
  • FluGen Initiates a Phase 1 Clinical Trial of the RedeeFlu™ Universal Influenza Vaccine in Healthy Subjects (Press)
  • vTv Therapeutics Announces Presentation of Phase 2b Azeliragon Results at the 2016 Alzheimer's Association International Conference (AAIC) (Press)
  • Millendo Therapeutics Announces Publication of Positive Phase 2a Data for MLE4901 for the Treatment of Polycystic Ovary Syndrome (Press)
  • CSL Behring Presents Pivotal Efficacy Data for AFSTYLA® In Adolescents and Children with Hemophilia A at the World Federation of Hemophilia 2016 World Congress (Press)
  • Chase Pharmaceuticals Presents Phase 2 Results for CPC-201 at 2016 Alzheimer's Association International Conference (Press)

US: Medical Devices

  • Hologic posts beat-and-raise 3rd quarter earnings (MassDevice)
  • US Regulators Recommend "Codevelopment" Approach for IVD Companion Dx Products (Emergo)
  • Boston Scientific acquires RFA manufacturer Cosman Medical (MassDevice) (MedCityNews)
  • Temporary Tattoo Keeps Tabs On Alcohol Intake(IEEE Spectrum)
  • Rapid Infectious Disease Testing Picks Up Speed (In Vivo-$)
  • REALITY Trial Enrolls First Patient in Study Evaluating Medtronic Directional Atherectomy and Drug-Coated Balloon in PAD Treatment (Press)
  • Companion Medical wins FDA nod for InPen insulin pen (MassDevice)(Press)
  • FDA Clears Expanded Indication for Itamar Medical's WatchPAT™ Sleep Apnea Diagnostic Device for Adolescents (Press)
  • Orthofix touts high fusion rates in Trinity Evolution study (MassDevice)

US: Assorted & Government

  • The Court in the Fluoroquinolone MDL Orders That Defendants Do Not Have to Produce Sales Rep Custodial Files (Not Yet) (Drug and Device Law)
  • "ACE" Is Here. Are You Ready? How FDA Intends to Help (FDA Law Blog)
  • HHS, CMS: Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System (GAO)

Upcoming Meetings & Events



  • Astellas boosts funding, involvement in updated Cytokinetics collab (Fierce) (Press)
  • Singapore research teams to work with Merck on peptide therapeutics (Fierce)


  • Sun Pharma signs licening pact with spanish firm Almirall for psoriasis drug (Economic Times)


  • Paraguay reports first cases of microcephaly linked to Zika (Reuters)
  • Advice to Blood Collection Establishments on Non-Travel Related Cases of Zika Virus in Florida (FDA)

General Health & Other Interesting Articles

  • Fighting the Next Pandemic: Airline Vaccine Screens (Harvard Bill of Health)
  • Lack of exercise costs world $67.5 billion and 5 million lives a year (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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles