Regulatory Recon: NICE Rejects Opdivo, FDA Approves Merck Drug After 7 Years (16 December 2015)

Posted 16 December 2015 | By Michael Mezher 

Regulatory Recon: NICE Rejects Opdivo, FDA Approves Merck Drug After 7 Years (16 December 2015)

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

  • Republicans Scrutinize FDA's Vouchers, Generic Drug Approvals (Bloomberg) (Letter)
  • Valeant gets boost from new distribution deal with Walgreens (Reuters) (Bloomberg) (WSJ-$)
  • Congress ready to give NIH its biggest increase in 12 years (STAT)
  • NIH-funded trials dip, industry trials on the rise (Reuters)
  • FDA approves Merck drug to reverse effects of muscle relaxants (Reuters) (FDA)
  • Genetic Testing May Be Coming to Your Office (WSJ-$)

In Focus: International

  • Curing Hepatitis C, in an Experiment the Size of Egypt (NYTimes)
  • More systems training needed to help inspectors spot data falsification say PIC/S experts (In-Pharma Technologist)
  • News from Europe: Trilogues, medical devices and IVD regulations carry on in 2016 (MassDevice)
  • Bristol's drug pricing under fire as UK agency rejects Opdivo (Reuters)
  • Indian pharma market crosses Rs 1,00,000 crore mark (Economic Times)
  • New Zealanders now waiting over 3 years for many new drugs (PharmaLetter-$)
  • Russian government to start inspections of foreign drug manufacturers (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology

  • Biosimilar Pre-Marketing Notice Always Required (National Law Review)
  • Pacira Settles and Heralds Changes to How FDA Will Regulate Off-Label Promotion in the New Year (FDA Law Blog)
  • Merck's IMPROVE-IT Study Epitomizes Inherent Risks Of Major Clinical Trials (Forbes)
  • Cancer Drug for Dogs No Longer Conditionally Approved (FDA)
  • Neulasta Biosimilar Approval 'Within Next Several Months,' Apotex Says (Pink Sheet-$)
  • 83% of patients willing to donate leftover blood samples to research (MedCityNews)
  • FDA: Review of Advisory Committees 2008-2012, Fewer Meetings and More Approvals (Policy and Medicine)
  • FDA Field Office Will Have Three Device Management Teams After Program Alignment
  •  (Gray Sheet-$)
  • FDA Approves Expanded Age Indication for GARDASIL 9 in Males (Press)
  • The right dose for every patient: a key step for precision medicine (Nature)
  • New Nonclinical Guidance for 505(b)(2) Products: No Cause for Alarm (The 505(b)(2) Blog)
  • Increasing REMS Program Awareness, One Alliance at a Time (Cutting Edge Info)
  • Expensive, exploratory research biopsies overused in early studies of new cancer drugs (MNT)
  • Novartis hires Harvard star to plug gaps in cancer drug arsenal (Reuters)
  • Lack Of Diversity In Clinical Trials Presents Possible Health Consequences (NRP)

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

  • Array BioPharma cancer drug succeeds in late-stage study (Reuters)
  • Tris Pharma Announces First Ever FDA-Approved Extended-Release Chewable Tablet (Press)
  • KemPharm Submits NDA for Immediate Release Hydrocodone Combination and Requests Priority Review From the FDA (Press)
  • FDA Accepts Biologics License Application for PaxVax's Single-Dose Oral Cholera Vaccine Vaxchora (Press)
  • Zavante Announces FDA Endorsed ZTI-01 Development Plan to Include a Single Pivotal Trial (Press)
  • Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Registrational Trial of SPI-2012, a Novel, Long Acting G-CSF in Patients with Breast Cancer (Press)
  • Kitov Pharmaceuticals' Pivotal Phase III Trial Successfully Meets Primary Efficacy Endpoint (Press)
  • REMD Biotherapeutics to Begin Phase 1B Clinical Study of REMD-477 for Patients with Type 1 Diabetes (Press)

US: Medical Devices

  • Digital diagnostics face development hurdles (Financial Times)
  • Burn Treatment Wins Expedited Access Designation (MDDI)
  • Variety of NGS Testing Stakeholders Join PrecisionFDA Community at Beta Release (GenomeWeb) (Focus)
  • Viatom gets FDA clearance for Checkme vitals monitoring device (mobihealthnews)
  • Should the FDA Regulate Laboratory Developed Tests? (imarc)
  • Illumina, bioMérieux launch first genomic sequencing service for bacterial infections (FierceMedicalDevices)
  • Study shows test aids physicians in Tamoxifen drug monitoring, including non-compliance due to side effects (MNT)

US: Assorted and Government

  • Tale of Two Pages: WSJ Coverage of Drug Pricing (DrugWonks)
  • House Panel Calls on GAO to Study FDA's Approval Pathway for Complex Generics (Focus)
  • Why Martin Shkreli's Price Hike May Hurt Everyone...Including You And The Pharmaceutical Industry (Forbes)
  • Plaintiff Seeking to Remake Sprint Fidelis Gets Shut Down (Drug and Device Law)
  • Funding pact includes pause for medical device tax (MassDevice)
  • Patent watch: Migraine therapies targeting the CGRP pathway: intellectual property landscape (Nature)
  • New PhRMA CEO: Drug Costs Must Be Viewed In Context (SCRIP-$)
  • FTC To Get Its Mitts On AbbVie Docs In Pay-For-Delay Suit (Law360-$)

Upcoming Meetings and Events              


  • Lack Of Year-End Conclusion To EU Trilogues Means More Timetable Shifts Likely (Clinica-$)
  • With EU Unitary Patent Sealed, All Eyes Are On New Patent Court (SCRIP-$)
  • 'Different Animals With Different Purposes': Putting PRIME And Adaptive Pathways In Context (SCRIP-$)
  • New IMS Report Highlights the Importance of Biosimilar Competition on Patient Access and Treatment Cost of Biological Medicines (EFPIA)
  • Leading Russian drugmakers plan expansion into EU and US markets (PharmaLetter-$)
  • Lenvima® (lenvatinib) Now Reimbursed for Advanced Thyroid Cancer in Sweden (Press)
  • Svelte Medical granted CE Mark for Slender IDS drug-eluting stent catheter (MassDevice)
  • Samsung Bioepis selects UK as EU biosimilar base; no comment on IPO plan (BioPharma-Reporter)
  • HiberGene Garners CE Mark for MDx System (Press)


  • Gujarat may get India's first medical device park (Economic Times)
  • No Room To Increase Medical Spending: Indian Govt (PharmAsiaNews-$)
  • Health ministry contemplating waiver of brand approval of notified medical devices for export (PharmaBiz)
  • Only Rajasthan, UP, Kerala and Karnataka take steps to have drug price monitoring cells so far (PharmaBiz)
  • IDMA urges inclusion of clause xiii in rule 96 of D&C Rules 1945 with more clarity (PharmaBiz)
  • Mylan Seeks Compensation from Agila for Three Plants Warned by FDA (Pharmaceutical Manufacturing)
  • National Filaria Week: Campaign to treat lymphatic filariasis may be one of India's last (End the Neglect)
  • One doctor available for every 1,681 persons in country: Government (Economic Times)
  • FDA Approves OCs Blisovi Fe 1/20, Blisovi 1.5/30 (MPR)


  • Deal-Making Darling Among Latest To Retract China NDAs (PharmAsiaNews-$)
  • China to adopt credit ratings for food, drug producers (Xinhua)
  • Pharmaron Receives a CFDA GLP Certificate for its Safety Assessment Facility (Press)


  • Half yearly performance report - January to June 2015 (TGA)
  • Medicines and Medical Devices Regulation – current developments and future options (TGA)
  • Pre-submission Pilot Evaluation Plan Estimator (TGA)

Other International

  • Experimental Ebola vaccine could tamp out last embers of outbreak (STAT)
  • Rapid 'Dipstick' Test Developed to Diagnose Human African Trypanosomiasis (ICT)
  • Brazil reports 1,761 microcephaly cases as mosquito virus spreads (Reuters)
  • NZ Keytruda Funding Knockback Sparks Drug Cost Row (SCRIP-$)

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