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Recon: Drugmakers Kick Off 2019 With Hundreds of Price Increases

Posted 02 January 2019 | By Michael Mezher 

Recon: Drugmakers Kick Off 2019 With Hundreds of Price Increases

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Drugmakers Raise Prices on Hundreds of Medicines (WSJ) (NBC)
  • Upcoming market catalysts in Q1 2019 (Nature)
  • How PhRMA finally lost: the inside story of the group’s biggest lobbying failure in years (STAT)
  • On the cusp of the ‘JPM,’ here’s a cheat sheet for what to watch in biotech in 2019 (STAT)
  • What's ahead in health policy in 2019 (Politico)
  • The 2018 breakdown on a chart-topping set of new drug approvals — and the 5 big things we learned from it (Endpoints)
  • Pharma's 2019 Prognosis Hinges on These Key Themes (Bloomberg)
  • How Sen. Orrin Hatch Changed America’s Health Care (KHN)
  • House Democrats set up framework to intervene in federal court case striking down Obamacare (CNBC)
  • Portola boosted by FDA nod for new Andexxa manufacturing (BioPharmaDive)
  • BioWorld’s Top 10: Biggest newsmakers and trending stories of 2018 (BioWorld)
  • Memorial Sloan Kettering’s Season of Turmoil (NYTimes)
  • Pfizer, Merck shares smoking hot in 2018 despite doldrums for overall biopharma sector (Fierce)
  • Pharma finds its feet in fight against climate change (Financial Times)
  • At the end of a bumper year for approvals, FDA hit by government shutdown (Fierce)
  • Sanofi's pediatric hexavalent vaccine approved by U.S. FDA (Reuters) (Press)
  • U.S. medic quarantined in Nebraska for possible Ebola exposure (Reuters)
In Focus: International
  • Selling Drugs Is No Longer a Free Lunch in China (Bloomberg)
  • Pharma firms face shake-up with China’s plan to bulk-buy drugs (SCMP)
  • Celgene invests in Chinese biotech Antengene again (Fierce)
  • Chinese Gene-Editing Experiment Loses Track of Patients, Alarming Technology’s Inventors (WSJ)
  • China's Innovent Biologics Emerges As Immuno-Oncology Competitor With Sintilimab Approval (Scrip-$)
  • After 4 years, it’s a no from Sanofi as it punts MyoKardia drug program deal (Fierce)
  • Falling vaccination rates pose a global health risk (Financial Times)
  • Longevity drugs: about time (Financial Times)
  • Pharma’s confidence in Brexit deal falls as vote looms (PMLive)
  • NHS to fund Afinitor for TSC-related epilepsy (PharmaTimes)
  • NHS England to fund Actelion's Uptravi (PharmaTimes)
  • Ebola outbreak in Congo surpasses 600 cases amid more violence (CNN) (Reuters)
Pharmaceuticals & Biotechnology
  • Did Moderna break the biotech IPO market? (Endpoints)
  • Biomedical Research Highlighted in Science’s 2018 Breakthroughs (NIH)
  • Orphan drugs dominate FDA's record-breaking year (PMLive)
  • U.S. drug developer Capricor places Duchenne drug trial on hold (Reuters)
  • Atlas Venture raises $250M for later-stage investments (Fierce)
  • Boom: 2018's biotech IPOs (Nature)
  • Targeting transcription factors (Nature)
  • Harpoon files $86M IPO to help fund its T-cell engager platform (Fierce)
  • Deciphera expands cancer trial after seeing early data (Fierce)
  • The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table (Harvard Bill of Health)
  • Rapidly taking patients off opioids might not be a good idea, experts say (Reuters)
  • FDA: Immune Tx Monotherapy in Bladder Ca May Worsen Survival (Medpage)
  • Impact of FDA's Warning on Immunotherapy in Urothelial Ca (Medpage)
  • Cipla recalls 4,800 bottles of anti-HIV tablets from US (Economic Times)
  • Doctors still prescribing testosterone to men with heart disease, despite risks (Reuters)
  • Federal proposal to force drug prices in TV ads draws big response from pharma, others (Fierce)
  • Battered Acorda pulls off delayed Parkinson’s approval for Inbrija (Fierce)
  • Pfizer, Merck KGaA's Bavencio takes a hit with second ovarian cancer failure (Fierce)
  • FDA gifts Alexion quick OK for Soliris follow-up Ultomiris (Fierce)
  • Product-Specific Guidance for Linaclotide; Draft Guidance for Industry; Availability (FDA)
  • FDA accepts acer, kala ndas before funding lapse (BioCentury)
  • Aurobindo Pharma USA recalls 80 lots of blood pressure drug from America (Economic Times) (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; RYDAPT (FDA)
  • International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV; Draft Guidance for Industry; Availability (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Banner Receives FDA Tentative Approval for BAFIERTAM for the Treatment of Relapsing Forms of Multiple Sclerosis (Press)
  • FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management (Press)
  • Myonexus Therapeutics Receives Orphan Drug Designation for MYO-102, an Investigational Gene Therapy for Alpha-sarcoglycanopathy (LGMD2D) (Press)
  • Harpoon Therapeutics Announces Preliminary Safety and Pharmacology Data from its HPN424 Phase 1 Trial in Prostate Cancer (Press)
  • Deciphera Pharmaceuticals Announces Positive, Preliminary, Top-Line Clinical Data for the Ongoing Phase 1 Clinical Study with DCC-3014 and an Update on Future Development Plans (Press)
  • Intec Pharma Advances Medical Cannabinoid Development Program With Dosing of First Patient in a Phase 1 Pharmacokinetic Study of Accordion Pill-THC (Press)
  • Innovent Announces First Patient Dosed in a Phase III Clinical Trial of Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) as First-line Treatment for Patients with Advanced Esophageal Cancer (Press)
Medical Devices
  • FDA's Changes to Essure Postmarket Study: Too Little, Too Late? (Medpage)
  • FDA Approves Next-Gen TAVR Device (Medpage)
  • Class 1 Device Recall StealthStationTM Cranial and SynergyTM Cranial Depth Gauge (FDA)
  • Personalized Medicine 2018: More Drugs, Greater NGS Adoption, Growing Appreciation of Dx Value (GenomeWeb)
  • GenMark Fungal Blood Culture Test Clears FDA (GenomeWeb)
  • FDA approves Teva’s digital COPD, asthma inhaler (DrugDelivery)
  • BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment (Press)
US: Assorted & Government
  • Life Sciences Cases To Watch In 2019 (Law360-$)
  • Patent Cases To Watch In 2019 (Law360-$)
  • Health Care Cases To Watch In 2019 (Law360-$)
  • Opioid-Makers Face Wave of Lawsuits in 2019 (NPR)
  • Ex-CEO of Insys to plead guilty in major opioid case (NBC)
  • Sun Pharma arm gets relief from US court in patent infringement case (Economic Times)
  • Hoosier Daddy, Part 510(k): FDA Clearance is Admissible (Drug & Device Law)
  • The DOJ Lashes Out at Qui Tam Abuse (Drug & Device Law)
  • Federal Court Invalidates CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Drugs (FDA Law Blog)
Upcoming Meetings & Events Europe
  • Early access to Tecentriq combination granted through EAMS (PharmaTimes) (MHRA)
  • Conversion of existing approved Community Marketing Authorisations to UK Marketing Authorisations (MAs) – letter to industry and guidance (MHRA)
  • Foundation Medicine Cancer CDx Approved in Japan (GenomeWeb)
  • China regulator probes TCM firm after cancer case sparks online furor (Reuters)
  • Government may revise compensation formula for 'faulty' Johnson & Johnson hip implant patients (Economic Times)
  • Suven Life gets product patents from Brazil, Eurasia (Economic Times)
  • Shilpa Medicare gets USFDA nod for cancer treatment injection (Economic Times)
  • Dr Reddy's launches oral suspension drug in the US market (Economic Times)
  • French inspectors find issues at Indian plant cited earlier by Italy (Fierce)
  • CDSCO to introduce rigorous quality control measures to boost quality of generic drugs (PharmaBiz)
  • Advertising: Questions and answers on the Advertising Code (TGA)
  • Medicine shortages guidance and resources (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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