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Regulatory Focus™ > News Articles > 2020 > 1 > Recon: Horizon Prices Newly Approved Tepezza at $14,900 per Vial; GSK Pay-for-Delay Appeal Faces EU

Recon: Horizon Prices Newly Approved Tepezza at $14,900 per Vial; GSK Pay-for-Delay Appeal Faces EU Rebuke

Posted 22 January 2020 | By Michael Mezher 

Recon: Horizon Prices Newly Approved Tepezza at $14,900 per Vial; GSK Pay-for-Delay Appeal Faces EU Rebuke

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Horizon prices newly approved thyroid eye disease therapy at $14,900 per vial (Reuters) (Endpoints) (FDA) (Press)
  • Johnson & Johnson beats Wall Street expectations on profit, misses on revenue (CNBC)
  • California considers declaring common pain killer carcinogen (AP)
  • Ex-drug execs get over 2 years in prison for bribery scheme (AP) (Law360-$)
  • Sunscreen ingredients really do seep into the blood. Is that bad? (Reuters) (JAMA)
  • How Much Should The Public Be Told About Research Into Risky Viruses? (NPR)
  • Medline temporarily halts sterilization as Illinois ethylene oxide regs take force (MedtechDive)
  • Moderna, Novavax among biotechs working on Wuhan virus – but vaccine at least a year out (BioCentury) (CNBC) (Benzinga)
  • First Patient With Wuhan Coronavirus Is Identified in the US (NYTimes) (Reuters)
  • CDC expects more US cases of China coronavirus (Reuters)
In Focus: International
  • China Virus Death Toll Jumps to 17 as Authorities Work to Understand Illness (WSJ) (Reuters)
  • WHO weighs response to deadly Chinese virus (Politico) (CNBC) (Reuters)
  • GlaxoSmithKline censured by EU over pay-for-delay deals (Financial Times) (Reuters)
  • EU group calls for 'targeted actions' to mitigate impact of Brexit (PMLive)
  • A Hallucinogenic Root Is Pitched to Davos Set as Treatment for Opioid Addiction (Bloomberg)
  • Cutting-edge drugs must be affordable, Nobel laureate tells Davos (Nikkei)
  • Brexit, Woodford woes overshadowed UK biotech & cut 2019 financing by almost half (Endpoints)
  • AstraZeneca plans to spend $535M-plus to expand its R&D network and manufacturing ops in France (Endpoints)
  • Wuhan virus outbreak triggers inevitable small-biotech rally (Endpoints)
  • China says new virus adapting and mutating (Reuters)
Pharmaceuticals & Biotechnology
  • Artificial Intelligence In Health Care: Benefits and Challenges of Machine Learning in Drug Development (GAO)
  • 5 biopharmas to watch as the decade's last earnings kick off (BioPharmaDive)
  • Amid a competitor’s struggles, a startup with a fraction of its funding takes on ‘digital pills’ (STAT)
  • As prescribing for ADHD stimulants rose, so did industry payments to doctors (STAT)
  • Pharma is making some effort to fight superbugs, but progress is ‘patchy’ (STAT)
  • Lonza's next CEO to be pharma or biotech vet, chairman says (Fierce)
  • After Ending Cancer Drug Program, Halozyme Predicts Profits in 2020 (Xconomy)
  • Emendo Eyes the Clinic for CRISPR Therapy That Makes Single-Gene Edits (Xconomy)
  • Blueprint Medicines potentially delays Ayvakit decision; Control beats treatment in mesothelioma trial (Endpoints)
  • Eli Lilly reserves $470M for new manufacturing plant — and North Carolina is more than pleased (Endpoints) (Fierce)
  • Verrica Ready To Target Pediatric Dermatologists With First Molluscum Therapy (Scrip-$)
  • ASPI: a public–private partnership to develop treatments for autism (Nature)
  • Neutrophils as emerging therapeutic targets (Nature)
  • Product-Specific Guidance for Levonorgestrel; Intrauterine Device; Revised Draft Guidance for Industry; Availability (FDA)
  • Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Blood Products Advisory Committee (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Ionis, Akcea boosted by a positive PhII for their Novartis castoff cardio drug — and they plan to push ahead into pivotals (Endpoints) (Press)
  • Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy (Press)
  • Cyclerion drug's 4-pronged cracking of neurodegenerative diseases passes early test (Fierce)
  • Targovax plans checkpoint combo trial after posting early data on oncolytic virus (Fierce)
  • LB Pharmaceuticals Announces the Initiation of Patient Dosing in a First-in-Human Phase 1 Study of LB-102, a Novel Benzamide for the Treatment of Schizophrenia (Press)
  • Ocuphire Pharma Announces In-License of Phase 2 Oral Small Molecule Drug Candidate for Diabetic Retinopathy and Diabetic Macular Edema from Apexian Pharmaceuticals (Press)
  • INHIBITOR Therapeutics Receives prostate cancer IND Clearance from FDA (Press)
Medical Devices
  • Abbott’s Diabetes Device Dominates As CEO White Hands Over Reigns (Forbes)
  • Study of Abbott's HeartMate 3 points to single treatment indication for LVADs (MedtechDive)
  • Medtronic wins FDA approval for Micra AV (MassDevice)
  • Myriad Genetics Files for FDA Approval of BRACAnalysis CDx for Lynparza in Prostate Cancer (GenomeWeb)
US: Assorted & Government
  • Hospira Asks Federal Circuit to Take Fresh Look at Safe Harbor Ruling in Epoetin Biosimilar Dispute (Big Molecule Watch)
  • Amazon just filed a bunch of international trademarks for ‘Amazon Pharmacy’ (CNBC)
  • Patient Services Inc. Agrees to Pay $3 Million for Allegedly Serving as a Conduit for Pharmaceutical Companies to Illegally Pay Patient Copayments (DOJ)
  • Pennsylvania Doctor Pleads Guilty to Unlawfully Distributing Oxycodone to His Patients (DOJ)
  • How Fast Can A New Internet Standard For Sharing Patient Data Catch Fire? (KHN)
  • Why Part D Plans Prefer High List Price Drugs That Raise Costs for Seniors (Drug Channels)
  • HHS price transparency efforts may decode only sliver of total spending (MedtechDive)
  • FDA Focus: What Ropes & Gray's Practice Chair Is Watching (Law360-$)
  • ITC Decision Shows Importance Of Public Interest For Biotech (Law360-$)
  • The Defense Strikes Back – with a RICO Suit (Drug & Device Law)
  • Offense May Not Be the Best Defense: Court Dismisses Lawsuit by Raw Pet Food Company Seeking to Invalidate CPG (FDA Law Blog)
  • 'Pharmaceutical dystopia': Former Insys exec decries sexist hiring in sentencing memo (Fierce)
  • JUUL use more than doubled among US teens, young adults in one year (Reuters)
Upcoming Meetings & Events Europe
  • NICE rejects Janssen’s Stelara on cost efficiency grounds (PharmaTimes)
  • NICE stays sour on AstraZeneca's Tagrisso (Endpoints)
  • England’s NICE Future Proofs Approach To Using Data (Pink Sheet-$)
  • Chicago investor devises £250M deal as real estate grows with UK's biotech sector (Endpoints)
  • French-Belgian biotech banks €20M to break ground in blood-splattered field of therapeutic cancer vaccines (Endpoints)
  • European Commission issues new guidance on Eudamed medical device database nomenclature (Emergo)
  • Korean VCs pile into PDC*line to bankroll NSCLC vaccine trial (Fierce)
  • "Record year" for clinical studies in Asia-Pacific region (PharmaLetter-$)
  • 18% of Indian pharma launches to be delayed in US, says Crisil (Economic Times)
  • Govt likely to impose anti-dumping duty on Chinese API ciprofloxacin hydrochloride (Pharmabiz)
  • First Indian company gets nod for newly-discovered antibiotic (PharmaLetter-$)
  • Glenmark sells gynac business for Rs 115 crore (Economic Times)
  • Measles vaccines available in Australia continue to meet quality standards (TGA)
Coronavirus Outbreak
  • Macau confirms first Wuhan virus case, tightens screening in casinos (Reuters)
  • Mexico says possible case of coronavirus under investigation (Reuters)
  • Thailand finds fourth coronavirus ahead of Lunar New Year (Reuters)
  • Singapore starts screening all China flights, warns against Wuhan travel to deter coronavirus (Reuters)
  • UK to tackle coronavirus threat with enhanced monitoring at Heathrow (Reuters)
  • Turkey takes steps against new coronavirus, no cases reported (Reuters)
  • Russia strengthens sanitary controls at borders over virus fears: Ifax cites watchdog (Reuters)
Other International
  • Saudi FDA extends GHAD deadlines, issues guidance documents (Emergo)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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