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Recon: PBMs Blame Drugmakers for High Prices at Senate Hearing

Posted 09 April 2019 | By Michael Mezher 

Recon: PBMs Blame Drugmakers for High Prices at Senate Hearing

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pharmacy benefit managers in the spotlight (Politico)
  • CVS, Cigna, Humana at Senate hearing blame Big Pharma for high drug prices (CNBC, Video)
  • These Senators Received The Biggest Checks From CVS, Humana And Other Pharmacy Benefit Managers Testifying Tuesday (Forbes)
  • Democrats to push DOJ on Obamacare stance (Politico)
  • Zogenix's seizure drug filing fails to pass FDA scrutiny (Reuters) (Endpoints)
  • GSK wins US nod for two-drug HIV combination (Reuters) (Endpoints) (FDA)
  • Cancer 'vaccine' shows promise in human trial of lymphoma patients (CNBC)
  • Health care is one of Apple's most lucrative opportunities: Morgan Stanley (CNBC)
  • Who's partisan? Republicans urge drug CEOs to ignore pricing probe started by Democrat (Fierce) (Endpoints)
  • NYC mayor orders mandatory measles vaccinations after Brooklyn outbreak (Reuters)
  • UniQure gets speedy US review for Huntington’s gene therapy (PMLive)
  • TV biz fights Trump drug pricing rule (The Hill)
  • Opioid Evangelist Switches Sides in Case Alleging Pharma Abuse (Bloomberg)
  • A troubled drug maker attempts to compensate for its problems by taking huge price hikes (STAT)
  • After three years of controversy, CDC clarifies its opioid prescribing guidelines (STAT)
  • Consumers Rejected Drug Plan That Mirrors Trump Administration Proposal (KHN)
In Focus: International
  • European Union files complaint against Turkey for ‘discriminating’ against foreign drug makers (STAT)
  • Novartis to limit M&A spend to 5% of market value (Financial Times) (Endpoints)
  • China's Draft Cell Therapy Guidelines Draws Concern From Industry (Pink Sheet-$)
  • Novartis bribery investigation craters after Greek prosecutors clear 4 officials (Fierce)
  • Manufacturing problems persist for Aurobindo, US' second-largest generics producer (Fierce)
  • Epilepsy Society calls for review of UK supply chain following "steep rise" in access issues (Pharmafile)
  • BeiGene lines up a next-gen CTLA-4 to complement its PD-1 pillar in new deal worth up to $270M (Endpoints)
  • Another EU patent for Verona in COPD drug (PharmaTimes)
  • Japan increases medical device registration fees (MassDevice)
  • In Need Of Blankets, Pain Killers, Pill Refills: Life After Cyclone Idai (NPR)
Pharmaceuticals & Biotechnology
  • Merck KGaA exec takes top job at UK biotech Kymab (PMLive)
  • ‘We owe much to the Sackler family’: How gifts to a top medical school advanced the interests of Purdue Pharma (STAT)
  • Cats And The Future Of Machine Learning In Drug Discovery (Life Sci VC)
  • CDER Develops New Method to Evaluate an Opioid’s Safety Risk (Focus)
  • FDA Warns Chinese OTC Drugmaker (Focus)
  • Centene Commits $100M To Personalized Medicine Research (Forbes)
  • Alkermes says long-acting drugs could help schizophrenics stay on medication longer (Reuters)
  • New Target for Cancer Immunotherapy: Exosomes (NIH)
  • Bayer cuts with one hand, adds cancer R&D jobs in Kendall Square with the other (Fierce) (Endpoints)
  • Drugs Are Keeping Seniors Healthy, And Hurting Them (Forbes)
  • Creating new antimicrobial drugs will require governments working with industry (STAT)
  • PhaseBio touts ‘breakthrough’ badge for bloodthinner reversal agent licensed from AstraZeneca, shares leap (Endpoints)
  • Finance Watch: Q1 Biopharma Venture Capital Dips From All-Time High, But Numbers Still Impress (Scrip-$)
  • Peter Hecht recruits Bayer/Shire vet Andreas Busch for a top R&D post at his $175M biotech spinout (Endpoints)
  • Drugmakers Push Back Against Proposed Exclusion Criteria for Rare Esophageal Disease Trial (FDANews-$)
  • Patient Engagement In Clinical Trials Needs More FDA Guidance, Stakeholders Say (Pink Sheet-$)
  • Rebate Reshuffle: Could Pharma Foot The Bill To Offset Higher Premiums? (Pink Sheet-$)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Roivant-backed Merck Serono spinout hits phase 3 diabetes goal; NDA on the horizon (Fierce) (Press)
  • PIXUVRI® (pixantrone) Receives Positive CHMP Opinion to Convert Conditional Approval into Standard Marketing Authorization in Patients with Aggressive non-Hodgkin B-cell Lymphoma (Press)
  • Rakuten Medical's ASP-1929 photoimmunotherapy for head and neck cancers to be designated under the Sakigake Designation System for its potential innovativeness and effectiveness (Press)
  • LSK BioPharma and Jiangsu Hengrui Medicine Announce FDA Clearance to Initiate a Phase 3 Clinical Trial in Advanced Hepatocellular Carcinoma (HCC) (Press)
  • MaaT Pharma Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD (Press)
  • NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer (Press)
  • Frequency Therapeutics Announces Positive Phase 1/2 Data for Drug Candidate for Hearing Restoration (Press)
  • Ra Pharmaceuticals Announces Completion of End-of-Phase 2 Interactions with FDA and Design of Pivotal Phase 3 gMG Study (Press)
  • Peloton Therapeutics Announces Completion of Enrollment in Phase 2 Trial of PT2977 for Treatment of Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma (Press)
  • Cerevel Therapeutics Announces Publication of Phase 2a Study Results in Neurology on Its Most Advanced Investigational Epilepsy Treatment (Press)
  • Galmed Pharmaceuticals Announces Successful Completion of End of Phase 2 Meeting With FDA and Plan for Start of Phase 3 (Press)
Medical Devices
  • FDA Warns Patients Against Using Pre-Owned and Unauthorized Diagnostic Test Strips (Focus)
  • WHO Drafts Global Strategy on Digital Health (Focus)
  • Novartis completes spinout of Alcon eye biz (MassDevice)
  • Histogenics to merge with Ocugen (MassDevice)
  • Silk Road Medical clears $109m in IPO (MassDevice)
  • J&J’s Ethicon touts economic study of magnetic Torax GERD device (MassDevice)
  • Bio-Rad Receives U.S. FDA Clearance for the IH-500, Expanding Its Offering for the Blood Testing Market (Press)
US: Assorted & Government
  • How HHS Secretary Reconciles Proposed Medicaid Cuts, Stopping The Spread Of HIV (NPR)
  • U.S. measles tally hits 465, mostly in kids (AP)
  • Culture of Secrecy Shields Hospitals With Outbreaks of Drug-Resistant Infections (NYTimes)
  • California allows aid-in-dying drugs for terminally ill, but hospitals set barriers (Reuters)
  • In New York, confusion reigns in the emerging CBD edibles business (Reuters)
  • Cardinal Health is fined by Ohio for failing to secure shipments of controlled substances (STAT)
  • Recent Developments in Opioid Litigation: A Re-Cap, Visual Aid, and Summary of Outstanding Inquiries (Harvard Bill of Health)
  • America's $103 billion home health-care system is in crisis as worker shortage worsens (CNBC)
  • Concordia Pharma Sues Over Bowel Drug Trade Secrets (Law360-$)
  • Judge Says Lack of State and Federal Plans Means That the Farm Bill’s Interstate Commerce Protections for Hemp Don’t Apply (FDA Law Blog)
  • A Generic Drug Failure to Warn Claim? (Drug & Device Law)
Upcoming Meetings & Events Europe
  • Legal requirements for children's medicines (MHRA)
  • Class 4 Medicines Defect Information: Chloramphenicol 0.5% W/V Antibiotic Eye Drops (MDR 105-03/19) (MHRA)
  • Virtual manufacturing of medical devices (MHRA)
  • Valproate use by women and girls (MHRA)
  • Bain, Piramal-led fund offers Panacea a Rs 992 crore bail-out deal (Economic Times)
  • J&J agrees to pay only Rs 25 lakh compensation for faulty hip implants (Economic Times)
  • International Work-sharing Initiative - Abemaciclib (Verzenio) (TGA)
  • Consultation of Draft Guidance Documents: Identifying and Labelling Medicinal Ingredients, Generic Drug Equivalence: Medicinal Ingredients (Canada)
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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