Regulatory Focus™ > News Articles > Regulatory Recon: Addressing Generic Drug Affordability, French Regulators Investigate Epilepsy Drug

Regulatory Recon: Addressing Generic Drug Affordability, French Regulators Investigate Epilepsy Drug Tied to Birth Defects (24 February 2016)

Posted 24 February 2016 | By Michael Mezher 

Regulatory Recon: Addressing Generic Drug Affordability, French Regulators Investigate Epilepsy Drug Tied to Birth Defects (24 February 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

  • Why Pharma Faces so Many Corruption Allegations (Forbes)
  • Most Drug Makers Report Incomplete Side Effects to the FDA (STAT) (Study)
  • PTC Receives Refuse to File From FDA for Duchenne NDA (Xconomy) (BioCentury) (Reuters) (SCRIP-$) (Press)
  • FDA: Out-of-Spec Components May be Used in Finished Devices – But Beware (Gray Sheet-$)
  • Biosimilars Education Needs to Come From Industry, Not FDA, NACDS Says (Pink Sheet-$)
  • Addressing Generic Drug Unaffordability and Shortages by Globalizing the Market for Old Drugs (Health Affairs Blog)

In Focus: International

  • Indian Regulators Launching Mandatory Online Medical Device Registration Platform (Emergo)
  • First EU Trilogue Delay Drags Second Reg Meeting Into Mid-March (Clinica-$)
  • US and EU Regulators Urge Indian Drug Companies to Step up Standards (Reuters) (Economic Times)
  • Sanofi's Dengue Vaccine Made Widely Available for First Time (WSJ-$)
  • Common Epilepsy Drug Investigated in 450 Cases of Birth Defects in France (The Guardian) (Report - French)
  • Brexit Would Threaten Two Key Pillars of Health-Care Industry (Bloomberg)

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US: Pharmaceuticals & Biotechnology

  • Valeant Accounting Error Sparks Divergent Reactions (WSJ-$)
  • KaloBios Seeks Speedy Approval To Buy Chagas Drug Rights (Law360-$)
  • Sanofi abandoning Auvi-Q after dosage problems led to total recall (In-PharmaTechnologist)
  • Notable Life Sciences Merger & Acquisitions in Q4 of 2015 (Thomson Reuters)
  • Can the ventilation of GMP clean rooms be switched off overnight? (ECA)
  • FDA will reject noncompliant DMF submissions, says agency during webcast (Packaging Digest)
  • Intercept Using NDA Extension To Prep For AdComm Review And Launch (Pink Sheet-$)

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

  • Phase 2 Clinical Trial to Treat Rare Hereditary Muscle Disease Shows Promise (DD&D)
  • GSK Subsidiary Starts Phase 2 Study Results of Long-Acting HIV-1 Therapy (DD&D)
  • FDA Accepts and Grants Priority Review for AVYCAZ (ceftazidime and avibactam) Supplemental New Drug Application (sNDA) (Press)
  • Gilead announces results from study evaluating switching to F/TAF-based regimens from Truvada (EPR) (Press)
  • Once-daily Isentress formulation meets endpoints in Phase III trial (EPR)
  • Symplmed Pharmaceuticals Announces FDA Orange Book Listing for Two Prestalia Patents (Press)
  • ANI Pharmaceuticals and Dexcel Announce FDA Approval of Donepezil Hydrochloride 23mg Tablets (Press)
  • Asterias Biotherapeutics Announces Successful End-of-Phase 2 Meeting with FDA for AST-VAC1 (Press)
  • FDA Concurs on Clinical Dose for SIGA's Tecovirimat Antiviral (Press)
  • Janssen says cabotegravir/rilpivirine combo matches three-drug HIV maintenance therapy (Pharmafile)

US: Medical Devices

  • FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings (Gray Sheet-$) (Focus)
  • Final Device Human Factors Guidance - Ch-Ch-Ch-Ch-Changes? (FDA Law Blog) (Focus)
  • UK Company Banned From Shipping Medical Devices to US (Focus)
  • FMC aims for 110,000 U.S. patients to be on Mircera in first-quarter (Reuters)
  • Medtronic claims title to world's 1st app-based remote monitoring for pacemakers (MassDevice)
  • Video: Whole Genome Sequencing In 25 Minutes With Edico Genome (Pink Sheet-$)
  • FTC Approves Final Order Prohibiting "Ultimeyes" Manufacturer from Making Deceptive Claims that the App Can Improve Users' Vision (FTC)
  • More PET scans may not help lung, esophageal cancer survivors (Reuters)
  • Hologic touts 3D mammography study data (MassDevice)
  • FDA approves Boston Scientific's Acuity X4 quad leads (MassDevice)
  • TransMedics launches pivotal trial for OCS liver transplant system (MassDevice)
  • InVivo Therapeutics enrolls 6th patient in spinal scaffold trial (MassDevice)
  • 'Stentrode' could revolutionize thought-control tech (MassDevice)

US: Assorted & Government

  • Personal Jurisdiction and Choice of Law (Drug and Device Law)
  • Stryker, Zimmer Get Day In Supreme Court For Questions On Enhanced Patent Damages (Gray Sheet-$)
  • Trade Judge OKs Hearing In Hemophilia Drug Import Dispute (Law360-$)
  • Senators push protections for opioid-dependent parents, infants (Reuters)
  • J&J must pay $72 million for cancer death linked to talcum powder: lawyers (Reuters) (The Guardian)
  • Virginia: The Latest (Failed) Attempt at Mandating Drug Pricing Transparency (Policy and Medicine)
  • Cajun TwIqbal Kiss-off (Drug and Device Law)
  • Supreme Court Tangles With 'Enhanced' Patent Damages (SCRIP-$)
  • Ohio: No Drugs Found as Execution List Grows (NYTimes)
  • HQ Settles Baxter's Dispute Over Arrhythmia Drug Generic (Law360-$)
  • Oklahoma Supreme Court upholds state law on limiting abortion drugs (Reuters)
  • Shortage Of Addiction Counselors Further Strained By Opioid Epidemic (NPR)
  • Data Mining and Pregnancy Prediction (Harvard Bill of Health)
  • A Closer Look at Tea and Rice: FDA Brings FSMA Outreach to Japan (FDA Voice)
  • CHPA, PCPC Urge 'Modern' Evaluations Of Sunscreen Ingredients (Tan Sheet-$)
  • FDA Targets CBD Products, Claims Made in Social Media (Lexology)

Upcoming Meetings & Events


  • EUnetHTA Evidence Submission Template – a practical tool for technology developers and assessors (EUnetHTA)
  • European Commission: Cranberry-Derived Products are not Medical Devices (Clinica-$) (Focus)
  • European Commission approves Lilly's Portrazza for NSCLC (Pharmafile)
  • CPhI Russia 2016 opens as the country is seeking rapid upgrades to GMP standards (EPR)
  • What You Need To Know About The Meningitis B Vaccine (Buzzfeed)
  • Brexit is the wrong prescription, says European pharma industry (Reuters)
  • Cancer research UK launches trial for potential new drug that could help immune system fight cancer (MNT)
  • Coll Plant jumps on CE Mark win for wound filler (MassDevice)
  • Euformatics Receives CE Mark for OmnomicsNGS Clinical Decision Support Tool (GenomeWeb)
  • The Past, Present and Future of CAPA (GxP Lifeline)
  • Doctors warn of demand for 'vaginal seeding' despite thin evidence (Reuters)
  • LFB's FibCLOT human fibrinogen gets approvals in Europe (PharmaLetter-$)
  • NICE final nod for MSD's cholesterol buster Ezetrol (PharmaTimes)


  • Astellas Submits New Drug Application for Linaclotide, Treatment for Irritable Bowel Syndrome with Constipation, in Japan (Press)
  • Tokyo team developing stroke vaccine (BioPharmaReporter)
  • Otsuka commits to increasing access to TB drug delamanid (PharmaLetter-$)
  • OBI Pharma To Forge Ahead With Cancer Vaccine In Face Of Study Failure (SCRIP-$)


  • Glenmark gets USFDA nod for contraceptive tablets (Economic Times)
  • New Indian Medical Device Certification Scheme To Fill Regulatory Vacuum (SCRIP-$)
  • Bodily resistance to anti-microbes major health challenge: J P Nadda (Economic Times)
  • Anadys Pharma (Roche) Obtains Indian Patent For Hepatitis C Treatment (24 Insight)
  • IPC to start strengthening, expansion of regional training centres to enhance ADR reporting (PharmaBiz)
  • NIPER Ahmedabad to set up centre of excellence to boost skill development in devices sector (PharmaBiz)
  • Poor land availability, water shortage in Goa for pharma cos to be addressed soon: Goa IDC (PharmaBiz)
  • SRP recommends label change for intravenous ranitidine due to ADR (PharmaBiz)


  • Australian Parliament passes historic medicinal cannabis legislation (PharmaLetter-$)
  • PharmAbcine Seeks Australian Fast Track For Glioblastoma Candidate (PharmAsiaNews-$)

Zika Virus

  • Proving Zika guilty: A long and painstaking task (Reuters)
  • Zika may have been sexually transmitted in 14 cases: CDC (Reuters)
  • Texas hospitals say they have developed rapid test for Zika (Reuters)
  • After the Ebola crisis, can the WHO rise to the challenge of Zika? (STAT)
  • Brazil health service cracking under strain of microcephaly (Reuters)
  • CDC adds 2 destinations to interim travel guidance related to Zika virus (CDC)
  • Zika Shows It's Time For The Catholic Church To Rethink It's Stance On Birth Control (Forbes)
  • Brazil Confirms 75 More Microcephaly Births Amid Zika Outbreak (WSJ-$)
  • CDC encourages following guidance to prevent sexual transmission of Zika virus (CDC)
  • Brazil will make Olympics safe from Zika virus: WHO official (Reuters)
  • Logistics Cause Delays on First Day of Brazil Zika Study (DD&D)
  • Venezuela Won't Talk To Colombia About Zika — And That's A Problem (NPR)
  • US President calls on Congress for $1.9 billion to fight Zika virus crisis (PharmaLetter-$)

Other International

  • Celebrating in Africa: the end of the reign of meningitis (PATH Blog)
  • MSF bemoans the fact that the issue of high vaccine prices is not on the agenda of key Africa conference (PharmaLetter-$)
  • 2015 Turkish Pharma Growth Driven Mainly By Volume (PharmAsiaNews-$)

General Health & Other Interesting Articles

  • How Exercise May Lower Cancer Risk (NYTimes)
  • Best practice for monitoring medication errors (PharmaPhorum)
  • Four Ways To Save $1,000 On Your Next Surgery (Forbes)
  • Lyme Disease: Gene Signatures May Catch the Infection Sooner (NIH)
  • We Might Soon Have A New Way To Combat Antibiotic Resistance (BuzzFeed)

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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