Regulatory Recon: FDA to Slow Reviews for Orphan Designation Public Weighs in on Faster FDA Reviews (11 May 2016)

Posted 11 May 2016 | By Michael Mezher 

Regulatory Recon: FDA to Slow Reviews for Orphan Designation Public Weighs in on Faster FDA Reviews (11 May 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 Warns of Skin Reaction With Olanzapine (Medpage) (FDA)
  • Health Insurers Push to Tie Drug Prices to Outcomes (WSJ-$)
  • The Imprinter of All Maladies (Michael Eisen)
  • US Investigates Drugmaker Contracts With Pharmacy-Benefit Managers (WSJ-$) (Reuters)
  • Completely automated robotic surgery: on the horizon? (Reuters)
  • Public wary of faster approvals of new drugs, STAT-Harvard poll finds (STAT) (Report)
  • Big Drug Maker presses for money-back guarantee that its science will work (STAT)
  • FDA expands Imbruvica label with new survival data (Pharmafile)
  • FDA Considers New User Fee Program for OTC Drugs (Focus) (FDA Law Blog)
  • NIH's Exclusive Licenses to Biotech, Pharma Start-Ups: Lots of Secrecy, Few Successes (Focus)
  • Orphan Designation Requests To Get Slower Reviews (Pink Sheet-$)
  • Doctor-Device Deals Need Scrutiny, Report Says (WSJ-$) (MassDevice)
  • CDC labs repeatedly faced secret sanctions for mishandling bioterror germs (USA Today)

In Focus: International

  • Johnson & Johnson opens first international JLABs site in Canada (Fierce)
  • Supporting innovative SMEs as major drivers of new pharmaceutical developments (EMA)
  • IPEC-Americas Publishes Quality by Design Sampling Guide for Excipient Makers, Users, and Distributors (IPEC)
  • IVDs To Be Key Focus Of Penultimate, Three-Hour EU Reg Trilogue; Time For Progress? (Clinica-$)
  • Allergan Realigns Executive Team, Outlines $10 Billion Stock Buyback (WSJ)
  • Asia Regulatory Roundup: India Calls for Local Trials Ahead of Dengue Vaccine Launch (Focus)
  • Health Service Plans Poorly, Raising Costs, U.K. Lawmakers Say (Bloomberg)
  • Anne Deborah Atai-Omoruto, Who Helped Lead Ebola Fight in Liberia, Dies at 59 (NYTimes)
  • Russia postpones compulsory licensing of imported drugs until December (PharmaLetter-$)
  • UK cost body finally approves limited use of GSK's lupus drug (Reuters) (PharmaTimes)
  • Biosimilars In EU Seeing Reduced Clinical Data Requirements (Pink Sheet-$)
  • India seeks IMS Health guidance on PIC/S membership costs (Fierce)
  • Vaccines put brakes on yellow fever outbreaks, more may pop up: WHO (Reuters)

US: Pharmaceuticals & Biotechnology

  • Turning FDA's 'Clunky' Drug Database Into A Useable Goldmine (SCRIP-$)
  • Biologics CDMO opens new facility in Research Triangle (Outsourcing-Pharma)
  • New Bill Would Speed FDA Review of OTC Contraceptives (Focus)
  • Fighting Depression: Ketamine Metabolite May Offer Benefits Without the Risks (NIH)
  • New Bill Submitted to Promote Development of Safe Drugs for Neonates (Congress)
  • Speed And Safety At The FDA: Generic Drug Approvals Reach Record Highs (Forbes)
  • 'Good enough' digital marketing not an option for pharma (PharmaPhorum)
  • Bill Ackman Selling Zoetis, But Other Firms Jumping In (Forbes)
  • Expected Growth in PBM Exclusion Lists Poses a Challenge to Drug Developers (Tufts CSDD)
  • CytRx Bear Thesis Explained: Why Sarcoma Drug Trial Will Fail (The Street)
  • Biosimilar Blocking Strategies: Janssen Gets Day In Court, Amgen Seeks FDA Docs (Pink Sheet-$)
  • Let's Put Opioids For Treating Addiction On Equal Footing With Prescribing Opioids For Pain (Health Affairs Blog)
  • New Approach to Genetic Analysis Yields Markers to Complex Diseases (DD&D)
  • F-Star: Growing interest in bispecific antibodies drove facility upgrade (BioPharma-Reporter)
  • A New Type of Investor Relations for Biopharma (RPM Report-$)
  • Repligen to expand chromatography column production capacity in US and Europe (BioPharma-Reporter)
  • Here are the major roadblocks between us and faster cures (Faster Cures)

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

  • Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial (PLOS)
  • H3 Biomedicine Receives FDA Acceptance for Investigational New Drug Application (Press)
  • WuXi Biologics Congratulates TESARO for Anti-TIM-3 Antibody IND Submission in the U.S. (Press)
  • Medivir Announces That Janssen Decided to Start a Phase IIb Study of Combinations of Simeprevir, Odalasvir and AL-335 for the Treatment of Hepatitis C (Press)
  • Camurus AB: Braeburn Pharmaceuticals and Camurus Announce Positive Results from Phase 2 Opioid Challenge Study with CAM2038 in Subjects with Opioid Use Disorder (Press)
  • Osel, Inc.'s Lead Product LACTIN-V Enters Phase 2b Study to Prevent Recurrence of Bacterial Vaginosis (Press)

US: Medical Devices

  • J&J's DePuy buys shape-changing, minimally invasive small bone fixation tech startup (Fierce)
  • As Good As New: Latest Industry Standard Seeks To Demystify Device Refurbishment (SCRIP             -$)
  • Lungpacer Medical, Inc. Receives Expedited Access Pathway Designation from FDA for the Lungpacer Diaphragm Pacing System (Press)
  • TransEnterix shelves SurgiBot after FDA denial, turns to ALF-X  (MassDevice)             
  • Negotiating Prices For Real-World Data Can Lower FDA Submission Costs, Shuren Says (Gray Sheet-$)
  • Breast cancer detection rates of mammogram readers don't decline over time (MNT)
  • Researchers Hope This Invention Could Wave Away Medical Data Hacks (NPR)
  • Clinical trial underway for treatment of sleep apnea in adolescents with Down syndrome (MNT)
  • Layoffs ahead as Haemonetics restructures, names new CEO (MassDevice)

US: Assorted & Government

  • FDA Seeks to Redefine 'Healthy' (WSJ-$)
  • Olympus pays $306m to settle kickbacks case (MassDevice)
  • BIO Submits Comments Re: Medicare Program; Part B Drug Payment Model  (BIO)
  • As time runs out, the Obama administration races to reshape health care (STAT)
  • House Passes Five Bills To Curb Opioid Abuse (Law360-$)
  • Hillary Clinton Takes a Step to the Left on Health Care (NYTimes)
  • Failure to Train Preempted in California (Drug and Device  Law)
  • Genentech Facing Class Action Over Cancer Drug Skimping (Law360-$)
  • Zofran MDL Jurisdictional Analysis Bounces Non-Missouri Plaintiffs (Drug and Device Law)
  • Noted Skeptic Calls For More Randomized Nutrition Trials (CardioBrief)
  • FDA's Final Deeming Regulations Covers all "Tobacco Products" (FDA Law Blog)

Upcoming Meetings & Events


  • MHRA Drug Safety Update - May (MHRA)
  • EDQM Symposium on Challenges of Quality Requirements for Fish Vaccines (EDQM)
  • Evaluation of the 2nd Health Programme 2008-2013 published today! (EC)
  • Nice recommends two blood tests to rule out pre-eclampsia in pregnant women (Pharmafile)


  • Illumina Registers MiSeqDx for Clinical Use in South Korea (GenomeWeb)
  • Staff at Baidu cancer death scandal hospital in China disciplined: China Daily (Reuters)
  • Huya Bridges China's Novel Drugs With Overseas Markets (Forbes)


  • Government fixes ceiling price of 54 drug formulations (Economic Times)
  • UPFDA to recruit 100 lab staff for testing upgradation soon (PharmaBiz)
  • Health Ministry Responds To Parliament Inquiry On ADR, Prescribing Information (24 Insight)
  • Boehringer Seeks Approval Of Additional Strengths Of Synjardy In India? (24 Insight)
  • WHO Adds Macleods' Capreomycin (As Sulfate) To Prequalified List (24 Insight)
  • Par Lands USFDA Approval For Generic Buphenyl (24 Insight)
  • Indicus Scores USFDA Approval Of Norpramin Anda (24 Insight)
  • Zydus Cadila gets USFDA nod to sell generic diabetes drug (Economic Times)


  • Summary Safety Review - EYLEA (aflibercept) - Assessing the Risk of Side Effects Outside the Eye (systemic side effects) (Health Canada)
  • Dear Health Care Professional Letter – PRAXBIND (Health Canada)

General Health & Other Interesting Articles

  • The Plan to Rescue Hawaii's Birds with Genetic Engineering (MIT Technology Review)
  • Folic acid still important for all women of childbearing age (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