Regulatory Focus™ > News Articles > Regulatory Recon: PDUFA Negotiations End With Differences, Industry Scrambles to Develop Zika Vaccin

Regulatory Recon: PDUFA Negotiations End With Differences, Industry Scrambles to Develop Zika Vaccine (7 March 2016)

Posted 07 March 2016 | By Michael Mezher 

Regulatory Recon: PDUFA Negotiations End With Differences, Industry Scrambles to Develop Zika Vaccine (7 March 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

  • Franken Introduces Bill To End Tax Breaks For Drug Ads (Law360-$) (STAT)
  • PDUFA Negotiations End With Differences To Resolve In Commitment Letter (Tan Sheet-$)
  • FDA Approves Ibrutinib for First Line CLL Treatment (Medscape) (BioCentury) (Press)
  • FDA Approves CSL Behring's IDELVION for Hemophilia B Therapy (Medscape) (FDA) (Approval Letter) (Press)
  • Califf On Capitol Hill: Rally Friends, Repair Relationships (Pink Sheet-$)
  • Clinicians, Patients Discuss Best Ways to Return Complex Genetic Test Results at FDA Workshop(GenomeWeb)
  • Top Line Results Favor Victoza In Large Cardiovascular Outcomes Trial (CardioBrief)
  • Getting It Done Here – Or Not (In the Pipeline)
  • Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations? (JAMA)

In Focus: International

  • Foreign drugmakers may be refused registration of drugs in Russia (PharmaLetter-$)
  • Drugmakers Scramble to Find Zika Vaccine (WSJ-$)
  • We're Losing the Race Against Antibiotic Resistance, but There's Also Reason for Hope (NYTimes)
  • Revised Japan Prices Include Big Cuts For Gilead HCV Drugs (PharmAsiaNews-$)
  • Venezuela uses distressed bonds to settle debts with drugmakers (Reuters)
  • GSK asthma drug Nucala's long-term study supports safety profile (Reuters)
  • The Chinese and European Pharmacopoeias – The new editions (EDQM)

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US: Pharmaceuticals & Biotechnology

  • Ain't no Sunshine: second halt of heart pump trial sends shares crashing (EP Vantage)
  • Safety of Fluticasone plus Salmeterol in Asthma — Reassuring Data, but No Final Answer (NEJM, Study)
  • All Foam, No Beer: Broad Uptake of Value-Based Pricing for Prescription Drugs Unlikely Without Serious Legislative Change (Bloomberg BNA)
  • Entresto: A Case Study in Value-Based Pricing? (Medpage Today)
  • FDA: Accept human-focused preclinical tests to improve drug safety (The Hill)
  • AbbVie to Pay $595 Million for Boehringer Immunology Treatments (Bloomberg)
  • CVS Indication-Based Pricing For Cancer Drugs May Roll Out Later In 2016 (Pink Sheet-$)
  • FDA's Smart Growth Strategy: More Room At White Oak, Less In Budget (Pink Sheet-$)
  • PhRMA: Easing Speech Limits Could Reduce Need For Subgroups In Trials (InsideHealthPolicy)
  • Drug Trials 'Snapshots' Could Get Photoshopped, CDER Says (Pink Sheet-$)
  • Experimental Drug Shows Early Promise In Treating Male Baldness (Forbes)
  • Fertility treatment may not work as well for women with asthma (Reuters)
  • Bigger discounts will boost biosimilar prescribing say US physicians (BioPharma-Reporter)
  • Clinical Trial Diversity: FDA Rejects Calls For Enrollment Mandates (Pink Sheet-$)
  • Women Need More of the HIV Drug Truvada Than Men to Prevent Infection (ICT)
  • Drugmakers relieved FDA has determined this year's flu vaccine formula (Modern Healthcare)
  • Celldex's Brain Cancer Vaccine Fails Key Phase 3 Test, Shares Fall (Xconomy)
  • New paper on stem cell patenting (Harvard Bill of Health)
  • Medical Ads Here, There, Everywhere (NYTimes)
  • NIH to fund trial of pill to treat lupus owned by Norwood's Corbus Pharmaceuticals (Boston Business Journal)
  • Pharma's Space Frontier: Come On And Take A Free Ride (SCRIP-$)
  • Robert Johnson, pharmacy innovator and industry staple, dies (DSN)
  • Survey reveals significant need for increased consumer education on clinical trials (MNT)
  • Fluconazole Injection, USP, (in 0.9 Percent Sodium Chloride) 200mg per 100ml: Recall - Elevated Impurity (FDA)

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

  • FDA grants Fast Track designation for MEDI8852 (EPR)
  • FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer (Press)
  • Antibe Therapeutics' ATB-346 Receives Approval for Phase 2 Clinical Trial in Osteoarthritis Patients (Press)
  • Ixekizumab Demonstrates Rapid, Clinically Meaningful Improvements as Early as One Week among Patients with Moderate-to-Severe Plaque Psoriasis (Press)
  • Baxalta dumps Onconova's cancer drug in the midst of Phase III (Fierce)
  • Spectrum Pharmaceuticals Initiates Phase 2 Breast Cancer Trial for Poziotinib, a Novel Pan-HER Inhibitor (Press)
  • Aimmune Therapeutics Announces Phase 2 Follow-On Study of AR101 for the Treatment of Peanut Allergy Demonstrated Increased Desensitization and Improved Tolerability with Low-Dose Maintenance (Press)
  • Chugai Announces Phase II Global Study Results of Nemolizumab (CIM331) in Late-breaking Research Forums at AAD (Press)

US: Medical Devices

  • For Real: Medical Devices Vulnerable to Hacking (MedpageToday)
  • Neurological Device Trials: FDA Offers Draft Guidance (Focus)
  • Many lens implant patients may develop cataracts within 10 years (Reuters)
  • FDA permits marketing of device that senses optimal time to check patient's eye pressure (FDA)
  • For $999, Veritas Genetics Will Put Your Genome on a Smartphone App (MIT Technology Review)
  • BD Receives FDA Approval for New Automated Cervical Cancer Screening System (Press)

US: Assorted & Government

  • Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge (Focus)
  • Tips For Protecting Hatch-Waxman Stay After Lilly, Alcon (Law360-$)
  • Blind Pfizer sales rep battles for a car and driver to visit doctors (STAT)
  • Jimmy Carter says he no longer needs cancer treatment (STAT)
  • A Plaintiff Needs More Than a Broken Device To Win (Drug and Device Law)
  • Coming Soon to a Pharma Inspection Near You: The Program Alignment Group (PAG) Plan (FDA Law Blog)
  • Senate HELP Committee Schedules Second Markup of 21st Century Cures (FDANews-$)
  • 21st Century Oncology says investigating cyber breach (Reuters)
  • Sequenom vs. Ariosa and international approaches to the patent eligibility of biomedical innovation (Harvard Bill of Health)
  • Rumors Of The Obamacare Death Spiral Have Been Greatly Exaggerated (Forbes)

Upcoming Meetings & Events


  • Philips Beats JNJ, Medtronic In 2015 EU Patent Rankings (Clinica)
  • Thalidomide 'caused up to 10,000 miscarriages and infant deaths in UK' (The Guardian)
  • Whitepaper: Navigating Labeling and Symbol Requirements in the European Medical Device Market (Emergo)
  • EMA Seeks Input on First Guidance for Autism Treatments (Focus)
  • UK slower to diagnose child cancer than Germany (OnMedica)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2016 (EMA)
  • EUnetHTA JA3 kick-off meeting was held in Amsterdam, Netherlands, on March 3, 2016 (EUnetHTA)
  • EMA Pilots Reduced Parallel Trade Fee To Improve Availability Of Medicines In Malta (SCRIP-$)
  • Ukraine Health Ministry signs MoU with insulin makers (PharmaLetter-$)


  • Fujifilm, Canon Are Front-Runners in Bidding for Toshiba Medical Business (WSJ-$)
  • 3SBio's PEG-irinotecan Wins IND Approval From China FDA (Press)
  • China requires generics to obtain brand-name drug quality (PharmaLetter-$)
  • PharmaEngine Announces Taiwan FDA Granting the Product License of ONIVYDE (Irinotecan Liposome Injection) for the Treatment of Metastatic Pancreatic Cancer (Press)


  • Union Budget 2016-17 Provides Few Benefits to Indian Life Sciences Industry (24 Insight)
  • How Windlas Healthcare studied FDA rulings and tweaked systems to come up trumps at inspection (Economic Times)
  • Govt to soon amend clause limiting clinical trials per investigator under clinical trial rules (PharmaBiz)
  • Kerala govt plans action against doctors for not prescribing generic names of medicines in capital letters (PharmaBiz)
  • DCGI directs pharma cos to print red line on packs of antibiotics to differentiate it from other drugs (PharmaBiz)
  • Siemens India to hive off healthcare arm for Rs 3,050 crore (Economic Times)
  • DCGI to appoint more experts for classifying products as 'nutraceutical' or 'drug' (PharmaBiz)
  • Alkem's Mandva plant gets establishment nod from USFDA (Economic Times)
  • Ajanta Pharma gets USFDA nod for migraine pain relief drug (Economic Times)
  • Zydus Pharma Inc recalls 9,504 bottles of Risperidone tablets (Economic Times)
  • NIB, DBT organise training on quality control of biologicals (PharmaBiz)
  • Gujarat's pharma exports to Africa decline (PharmaAfrica)


  • IRIS inSite Program (TGA)

Zika Virus

  • BioCryst's Zika drug shows promise in mice (Reuters)
  • CDC Director Travels to Puerto Rico to Assess Zika Response (ICT)
  • New range of serious fetal abnormalities linked to Zika: study (Reuters)
  • Zika Vaccines Would Pose Special Risks to Pregnant Women (WSJ-$)
  • As Olympics Near and Zika Spreads, No Talk of a Plan B (NYTimes)
  • Fetus of Venezuelan woman who likely had Zika dies; had microcephaly: doctors (Reuters)
  • Colombia doctor reports first case of Zika-linked microcephaly (Reuters)
  • Evidence Grows Linking Zika Virus to Birth Defect, Paralysis (WSJ-$)

Other International

  • UN Panel To Hear Stakeholder Ideas On IP, Innovation And Access (SCRIP-$)
  • Zika Isn't The Only Outbreak; Nigeria Struggles To Rein In Lassa Fever (NPR)
  • Shortages threaten patients in Libya's Benghazi: minister (Reuters)

General Health & Other Interesting Articles

  • When baby is due, genetic counselors seen downplaying false alarms (NECIR)
  • How Can We Prevent The Next Global Health Epidemic? (NPR)
  • Is it a drug or is it a Pokemon? A new quiz for the 20th anniversary (Boston Business Journal) (Editor's note: I got nine out of 12)

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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