Regulatory Recon: Brexit Fallout: How Will MHRA and EMA Handle the Split? (24 June 2016)

Posted 24 June 2016 | By Michael Mezher 

Regulatory Recon: Brexit Fallout: How Will MHRA and EMA Handle the Split? (24 June 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

  • Medivation slams Sanofi's 'misleading' claims as merger saga continues (Fierce) (Medivation)
  • Why American Consumers Are Of Two Minds When It Comes To Drug Companies (Forbes)
  • FDA defends response to late Medtronic Infuse data (MassDevice)
  • FDA panel to vote whether diabetes drug cuts cardiac death (Reuters)
  • White House threatens to veto Republicans' Zika funding plan (Reuters) (STAT)
  • New Report Calls on FDA to Clarify Use of Real-World Evidence (Focus)
  • What Is The Private Sector Doing To Help Fight Zika? (Health Affairs Blog)
  • Senate 'Cures' Vote in July Possible, HELP Chairman Says (Bloomberg)
  • Senator Renews Scrutiny of Pharma Ties on Federal Panel (ABC)
  • Faulty Filter Prompts Recall of Leukocyte Reduction Device (Focus)
  • Why Do We Inherit Mitochondrial DNA Only From Our Mothers? (NYTimes)
  • Do scientific fraudsters deserve a second chance? (STAT)
  • PwC Medical Cost Trend: Behind the Numbers 2017 (PwC)
  • Four Ways To Address The Ethical Tensions Around Expedited Approval Of New Prescription Drugs (Health Affairs Blog)

In Focus: International

  • Brexit Conundrum: How Does MHRA Work With EMA Moving Forward (Focus) (Reuters) (Fierce) (Politico)
  • Statements on Brexit (EFPIA) (ABPI) (EU Leaders' Statements) (EP Vantage)
  • General Coverage of EU Referendum (The Telegraph) (BBC)
  • EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable (EMA)
  • Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia (EMA)
  • EMA Recommends Six New Drugs, Including One Cell Therapy for Approval (EMA)
  • Gavi Commits $27.5m to WHO Malaria Vaccine Candidate's Pilot Program as More Funds Needed (Focus)
  • Pharma sector gets new ISO tool for drug identification (ISO)
  • Regulator Reforms Coming Soon In Thailand? (PharmAsiaNews-$)

US: Pharmaceuticals & Biotechnology

  • Biogen in negotiations to sell 2,000L stainless steel plant in MA (BioPharma-Reporter)
  • BIO Opposes House Bill to Reduce Biologics Exclusivity From 12 to 7 Years (Focus)
  • Filling A Prescription? You Might Be Better Off Paying Cash (KHN)
  • FDA Extends Comment Period for Hep C Development Guidance (FDA)
  • FDA Extends Comment Period for Special Protocol Assessment Guidance (FDA)
  • FDA Warning Letters: Alerting Signs are Always There (Pharmaceutical Compliance Monitor)
  • AstraZeneca Hopes To Save FluMist In US With Foreign Data (Pink Sheet-$)
  • Valuable late-stage pipeline sets 2017 up for some big events (EP Vantage)
  • CBER's "Boutique" Role: Fitting In Oncology Center of Excellence (RPM Report-$)
  • ICER report finds Ocaliva an important advance, but too expensive (PharmaLetter-$)
  • Bye, Bye Byetta: Teva To Take AstraZeneca's GLP-1 Agonist Generic Two Years Early (Pink Sheet-$)
  • FDA extends shelf life of Flublok influenza vaccine (DSN)
  • Why Biotechnology Goliath Amgen Is a Solid Long-Term Investment (The Street)
  • Are Expensive Diabetes Drugs Worth It? (Medpage)
  • U.S. FDA Approves Changes to the SABRIL® (vigabatrin) REMS Program (Press)
  • Wilmington NC's Vibrant And Burgeoning Life Sciences Startup Ecosystem (Forbes)
  • Therapy focus – Amyloidosis pipeline still looks to Alnylam for answers (EP Vantage)
  • Deal To Fight Zika Virus Boosts NIH, CDC Efforts, But Offers No FDA Review Dollars (Gray Sheet-$)
  • Epizyme nabs combo trial deal with Genentech for NHL candidate (Fierce)
  • Biosimilar rituximab in biological naïve rheumatoid arthritis patients (GaBI)
  • ​Q&A with rare disease mom and biotech CEO Karen Aiach (Boston Biz Journal)
  • Pharma, Data Veteran Stephen Friend Bites At Apple's Health Offer (Xconomy)

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

  • FDA approves expanded label for Allergan's Avycaz (Pharmafile)
  • New Baxter Study Demonstrates Perceived Value of Telemedicine to Increase Access to Care and Reduce Hospitalizations (Press)

US: Medical Devices

  • GI Dynamics reveals final data from terminated EndoBarrier trial (Fierce)
  • FDA Returns To MDUFA Table With High, Low Proposals (Gray Sheet-$)
  • Rheumatoid Arthritis Testing Market to Approach $400m by 2022 (BioSpectrum)
  • New blood test from Epic Sciences matches patients with PARP inhibitors (MedCityNews)
  • The Future of Devices is NOT in Devices (as we know them today) (MassDevice)
  • Smells are smart sensors' last frontier (MassDevice)
  • Evaluation of commercially sold rapid rabies tests reveals serious problems with accuracy (MNT)
  • The First Step To Navigating Your Combination Product's Regulatory Pathway: PMOA (GxP Lifeline)
  • Roche receives FDA clearance for its Procalcitonin (PCT) assay to help clinicians effectively assess sepsis risk and manage sepsis patients (Press)

US: Assorted & Government

  • Appeals court upholds Thermomedic win over Exergen (MassDevice)
  • Apotex Drops Sham Litigation Counterclaims in Neupogen and Neulasta Biosimilar Litigation (Biologics Blog)
  • With Experts Barred, Bayer Says IUD Patients Have No Case (Law360-$)
  • Florida Doctor Pleads Guilty to Fraud — Years After Complaints About His Prescribing (ProPublica)
  • Janssen accuses Celltrion's media supplier HyClone of patent infringement (BioPharma-Reporter)
  • Trial slated in wrongful death suit over Norian XR bone cement (MassDevice)
  • Pharma accuses payers of using cash to sway U.S. cost watchdog (Fierce)

Upcoming Meetings & Events


  • France Plans to Invest €670M in Genomics, Personalized Medicine (GenomeWeb)
  • Genmab's CLL drug gets negative opinion from EMA committee (Pharmafile)
  • Astellas UK suspended from ABPI for "deception" and other cultural failings (Pharmafile)
  • Nice rejects Celgene's drug to treat blood cancer (Pharmafile)
  • EC grants marketing authorisation to Odefsey in HIV (EPR)
  • Nice rejects AstraZeneca's Tagrisso for lung cancer in preliminary recommendation (Pharmafile)
  • Most Borderline/Combo Products To Escape High-Risk Classification In EU (Gray Sheet-$)
  • St. Jude wins CE Mark, launches SyncAV CRT algorithm (MassDevice)
  • Trulicity gets seal of approval for Welsh NHS (PharmaTimes)


  • Takeda (TKPYY) Returns Certain Molecules, Products to Amgen (AMGN) (Biospace)
  • Zhejiang Hisun to market Fujifilm's anti-influenza drug in China (PharmaLetter-$)
  • Turkey Price Pressure Hits Profits And Market Growth (PharmAsiaNews-$)


  • Glenmark bags FDA approval for new generic  (BioSpectrum)
  • Ranbaxy whistle blower Dinesh Thakur suggests strict prosecution laws to fix drug industry (Economic Times)
  • FDI in pharma: Supply of NLEM drugs to be maintained for 5 years (Economic Times)
  • Pharma sector to grow by 20 per cent on relaxed FDI norms: Ananth Kumar (Economic Times)


  • Centinel Spine wins Australian clearance for Stalif L implant (MassDevice)


  • Without federal funding, counties brace to confront Zika on their own (Washington Post)

Other International

  • Reasons for the success of a generics company in the Sudan market (GaBI)

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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