Regulatory Focus™ > News Articles > 2019 > 1 > Recon: NICE Rejects Novartis' Migraine Drug Aimovig

Recon: NICE Rejects Novartis' Migraine Drug Aimovig

Posted 10 January 2019 | By Michael Mezher 

Recon: NICE Rejects Novartis' Migraine Drug Aimovig

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Trump-Inspired Tweets Signal More Drug-Price Pressure (Bloomberg)
  • Health-Care CEOs Outline Strategies at JP Morgan Conference (WSJ)
  • JP Morgan's Dimon hosted a private dinner for pharma executives, and a major topic was Amazon (CNBC)
  • For tiny biotechs, JP Morgan is a big opportunity — and a big cost (STAT)
  • Big Pharma’s Cancer Race (WSJ)
  • Former Insys CEO pleads guilty to bribery scheme (Boston Globe)
  • A Drug That Eases Miscarriages Is Difficult For Women To Get (NPR)
  • Merck: There’s more to us than Keytruda. Really (STAT)
  • Office of Prescription Drug Promotion (OPDP) FDA-Track Metrics (FDA)
  • Senior FDA Official To Head Government Affairs At CRISPR Therapeutics (BioCentury)
  • AstraZeneca to shut down twin Colorado manufacturing sites, impacting over 200 jobs (Pharmafile) (Endpoints)
  • As pharmas revert to regular price hikes, Azar threatens action with 'fighting words' (BioPharmaDive)
  • ‘Marketers are having a field day’: Patients stuck in corporate fight against generic drugs (Washington Post)
  • Amgen's Repatha hits wall at SCOTUS but presses ahead—new price breaks included (Fierce)
In Focus: International
  • Novartis migraine drug not cost effective - UK price watchdog (Reuters) (PMLive) (Endpoints) (NICE)
  • EU Medicines Agency picks up its roots, embracing Amsterdam (STAT)
  • Chinese biotech was big at JPM. Attendees were enthusiastic — and wary (STAT)
  • China’s Junshi Prices Domestic Anti-PD-1 mAb At Deep Discount (BioCentury)
  • Sanofi and Novo Nordisk press ahead with US insulin prices rises (Financial Times)
  • Oncology Dominates As China Approves Record 48 New Drugs In 2018 (Pink Sheet-$)
  • Monumental Year Ahead For Korean Pharmas As New US Approvals Eyed (Scrip-$)
  • EU Proposes New Guidance On Allergen Products With Small Study Populations (Pink Sheet-$)
Pharmaceuticals & Biotechnology
  • HIV Viral Load and Transmissibility of HIV Infection (JAMA)
  • The NIH is thwarting research on a poorly understood yet serious condition (STAT)
  • Foundation medicine name Roche SVP as new CEO (Pharmafile)
  • FDA approves record breaking 971 generic drugs in 2018 (Pharmafile)
  • 2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections (Pink Sheet-$)
  • J&J still sees plenty of opportunity in crowded immunology markets—starting with psoriasis (Fierce)
  • JP Morgan Notebook Day 3: Biotech Feeling Government Shutdown, AstraZeneca, Denali, Allergan, Aptinyx, Sangamo (Pink Sheet-$)
  • JP Morgan 2019: Industry Throws A Bonanza, With An Elephant In The Room (Scrip-$)
  • US FDA Advertising Citations Remain Rare In 2018 (Pink Sheet-$)
  • What They Said – A Review of FDA Press Statements for 2018 (Eye on FDA)
  • Betting on allosteric mutations driving cancer, Black Diamond raises $85M in fresh round (Endpoints)
  • Smartphones Could Boost OTC Drug Utilization And Numbers Of Rx-To-OTC Switches, Too (Forbes)
  • Roche exec Pearl Huang rejoins biotech as CEO of Cygnal — Flagship’s bet on ‘exoneural biology’ (Endpoints)
  • Novartis puts AI on the job to help reps say the right things to the right doctors (Fierce)
  • Takeda’s Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options (Pink Sheet-$)
  • Orange Book Policing May Increase, US FDA's Gottlieb Says (Pink Sheet-$)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Cablivi gets positive results for rare blood clotting disorder (PharmaTimes) (Press)
  • OncoImmune Announces Completion of Phase II Trial (Press)
  • Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent TP-1287 in Phase 1 Study in Patients with Advanced Solid Tumors (Press)
  • Acceleron Announces Publication of Luspatercept Phase 2 Beta-Thalassemia Study Results in Blood (Press)
  • ChemomAb Doses First Patient in Phase 1b Clinical trial of CM-101 in Patients With Non-Alcoholic Fatty Liver Disease (Press)
Medical Devices
  • FDA: Medtronic select recall of Synergy, Stealth Station S7 cranial software is Class 1 (MassDevice)
  • Intuitive Surgical rises on Q4, 2018 prelim beats (MassDevice)
  • Philips rejiggers, promotes image-guided therapies head van Meurs (MassDevice)
  • Empatica’s pediatric seizure-predicting smartband wins FDA nod (Medical Design & Outsourcing)
  • Beta Bionics raises $63m for bionic pancreas (Drug Delivery)
US: Assorted & Government
  • FDA looks to restart safety inspections for risky foods amid shutdown (Politico)
  • Government Shutdown Curtails F.D.A. Food Inspections (NYTimes)
  • Courts again wrestle with birth control rules (Politico)
  • Guest Post -- Linking It Up: Antibody-Drug Conjugates (Patent Docs)
  • A Pair of FDC Act-Related Convictions Upheld on Appeal in the Eighth and Eleventh Circuits (FDA Law Blog)
  • Albrecht Oral Argument – Better Us Than Them (Drug & Device Law)
  • Conn. Judge Tosses Cities' Suits Against Opioid Makers (Law360-$)
Upcoming Meetings & Events Europe
  • NHS facing early exodus of skilled consultants (PMlive)
  • UK MHRA’s “No Deal” Brexit Preparations Include Role for “Responsible Person – Import” (IPQ)
  • Daiichi Sankyo collaborates on iPS cell-derived insulin producing cells in Japan (PharmaLetter-$)
  • China’s NMPA Launches Voluntary Device Master File Process (Emergo)
  • Patient advocacy groups rap one-time assistance plan for rare disease sufferers, seek govt help to get pricey SMA drug (PharmaBiz)
  • Patent experts welcome DoP's decision to deregulate prices of patented orphan and innovative drugs (PharmaBiz)
  • Upgraded drug testing lab at Vadodara in Gujarat with five times capacity to become operational from Feb 2019 (PharmaBiz)
  • Government revises MAI scheme related to reimbursement of expenditure for pharma exporters (PharmaBiz)
  • Consultation: Proposed amendments to the Poisons Standard - ACCS meeting, March 2019 (TGA)
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.
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