Regulatory Focus™ > News Articles > 2019 > 3 > Recon: Senate Committee Calls on PBMs to Testify at Next Drug Pricing Hearing; FDA Approves New Gene

Recon: Senate Committee Calls on PBMs to Testify at Next Drug Pricing Hearing; FDA Approves New Generic Valsartan Amid Shortage

Posted 13 March 2019 | By Michael Mezher 

Recon: Senate Committee Calls on PBMs to Testify at Next Drug Pricing Hearing; FDA Approves New Generic Valsartan Amid Shortage

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Senate committee invites PBMs to third drug pricing hearing (Reuters) (STAT) (Endpoints)
  • Wyden probes a patient advocacy group over its ties to opioid makers (STAT)
  • FDA approves generic valsartan amid drug shortage (Reuters) (NBC) (NYTimes) (FDA)
  • Key Republican says Dems left him out of process on drug pricing bills (The Hill)
  • Hedge fund investing $100 million in Harvard drug research (STAT)
  • Purdue CEO says bankruptcy is ‘an option’ as company faces opioid lawsuits (Washington Post)
  • Purdue gets fast track designation for opioid overdose drug (Financial Times) (Press)
  • Aerie scores new glaucoma drug approval (Endpoints) (Xconomy) (Press)
  • One of the top late-stage drugs Bristol-Myers wants in its $74B Celgene deal faces a ‘roadblock’ — analyst (Endpoints)
  • Drug-Price Watchdog ICER Dives into Trump-Fueled Pharma Rebate Debate (Xconomy) (Pink Sheet-$)
  • Bristol-Myers CEO Caforio wants M&A dissidents to know there’s been no ‘high level’ overtures about buying the company since ’17 (Endpoints)
  • BioNTech hires banks for IPO worth up to $800 million: sources (Reuters) (Fierce) (Endpoints)
  • Opioid Litigation Brings Company Secrets Into The Public Eye (NPR)
  • CDC reports 228 measles cases in 12 states (The Hill)
In Focus: International
  • Why the Italian health minister is pushing for global transparency on drug pricing (STAT)
  • Brexit Deal Rejection Sounds Alarm Bells For Pharma Industry (Pink Sheet-$)
  • UK will be ‘less attractive’ for clinical research post Brexit (PharmaTimes)
  • EU Calls For Action To Reduce Environmental Impact Of Pharmaceuticals (Pink Sheet-$)
  • MSF Access Campaign analysis of the MPP Licence Agreement with AbbVie for glecaprevir/pibrentasvir (MSF)
  • GSK's Emma Walmsley becomes highest-paid female FTSE 100 chief (The Guardian) (Endpoints)
  • What to expect for 2019 with MDR and IVDR implementation? (MedicalDevicesLegal)
  • Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR) (Emergo)
  • NICE partially clears Darzalex combo in blood cancer (PMLive)
  • New Manufacturing Technologies And Regulatory Convergence Expected To Improve Access In Developing Countries (Pink Sheet-$)
  • Japan's Fujifilm buys biologics unit from Biogen to boost healthcare business (Reuters) (Law360-$)
  • India Cuts Prices Of 463 Anticancers But Loose Ends Remain (Scrip-$)
Pharmaceuticals & Biotechnology
  • Endpoints News poll: Industry insiders offer a big thumbs up for Ned Sharpless (Endpoints)
  • Unblinded: Scott Gottlieb on biosimilars' precarious moment and the gene therapy boom (BioPharmaDive)
  • Making Markets Work For Pharmaceuticals (Forbes)
  • Exercise vs. Drugs to Treat High Blood Pressure and Reduce Fat (NYTimes)
  • AstraZeneca taps microbiome specialist Seres for I-O support (Fierce)
  • Karuna hires another ex-Lilly scientist in quest to resurrect Alzheimer’s drug (Fierce)
  • Genes may explain why some women on the Pill still get pregnant (Reuters)
  • Manufacturers, Compounders Clash As FDA Prepares Final Offer On Office Compounding (Pink Sheet-$)
  • Cipla, Piramal Launch Sensipar Generics Amid Growing Antitrust Challenges to Amgen/Teva Settlement (Pink Sheet-$)
  • Innate Pharma hires Jennifer Butlers to lead commercialisation of leukaemia drug Lumoxiti (Pharmafile)
  • Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Lilly’s Cyramza hits first-line NSCLC trial targets (PharmaTimes)
  • Celgene’s chemotherapy Abraxane stumbles in pivotal pancreatic cancer study (Endpoints)
  • Janssen Submits Application to FDA Seeking Approval of DARZALEX (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible (Press)
  • Alvotech Enrolls First Patient in Clinical Phase III Study Involving Biosimilar Version of HUMIRA (Press)
  • Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant (Press)
  • Neurotrope Completes Enrollment Of Confirmatory Phase 2 Study of Bryostatin-1 in Moderate to Severe Alzheimer's Disease (Press)
Medical Devices
  • Medtronic’s Covidien to pay $20m to settle ClosureFast kickback allegations (MassDevice)
  • FDA issues ‘leap-frog’ guidance on brain/computer interfaces (MassDevice) (FDA Law Blog)
  • Smith & Nephew acquires Brainlab assets, teases next-gen robotic surgical platform (MassDevice)
  • Boston Scientific wins CE Mark for Watchman FLX anti-stroke implant (MassDevice)
  • Admedus wins CE Mark for CardioCel 3D, VascuCel products (MassDevice)
  • FDA grants de novo for the HemoSonics' Quantra® QPlus System; This Revolutionary Diagnostic Provides Unique Information for Accessing Coagulation at the Point of Care; Now Commercially Available in US (Press)
US: Assorted & Government
  • CRISPR Patent Watch (Patent Docs)
  • Medicare cuts are less than meets the eye (Politico)
  • Generic-Drug Exclusivity 'Squatting' Draws Bipartisan Heat (Law360-$)
  • FDA proposes stricter compliance policy for e-cigarettes (Reuters)
  • The Company Accused Of Blinding Dozens Will Be Allowed To Stay Open, Judge Rules (BuzzFeed)
  • Special 301 submission calls for a level playing field for American innovators (PhRMA)
  • Synergy Pharma Gets OK For Ch. 11 Plan Releases (Law360-$)
  • More Adventures in Personal Jurisdiction – Has Pennsylvania Fire Already Been Extinguished? (Drug & Device Law)
Upcoming Meetings & Events Europe
  • Early access to medicines scheme (EAMS) scientific opinion: Atezolizumab as 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% (MHRA)
India
  • Unichem Labs gets USFDA nod to market Allopurinol tablets (Economic Times)
  • NGOs ask govt to withdraw amendment to Para 32 of DPCO as it seriously undermines access to medicines for treating rare diseases (PharmaBiz)
  • Domestic API makers to face stringent quality checks as poorly bio-available products enter drug supply chain (PharmaBiz)
Australia
  • Updated GMP licence application e-forms (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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