Regulatory Focus™ > News Articles > 2020 > 6 > Recon: Vertex, NHS reach deal for CF drugs; Canadian court dismisses drugmakers’ challenge to drug p

Recon: Vertex, NHS reach deal for CF drugs; Canadian court dismisses drugmakers’ challenge to drug price rules

Posted 30 June 2020 | By Michael Mezher 

Recon: Vertex, NHS reach deal for CF drugs; Canadian court dismisses drugmakers’ challenge to drug price rules

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • After pandemic, US senators want review of drug supply chain (Reuters) (The Hill)
  • Inovio claims positive results on Covid-19 vaccine but critical data are missing (STAT)
  • Companies have raised prices on 245 drugs during pandemic, advocacy group says (The Hill)
  • Gilead’s pricing for remdesivir raises questions about the drug’s long-term prospects (STAT)
  • On a roll, Merck blazes through a new segment of the biomarker trail (Endpoints) (FDA)
  • Pandemic unleashes a spike in overdose deaths (Politico)
  • House Votes to Limit Health Costs as Drug Maker Adds Price Tag to Virus Treatment (NYTimes) (Politico)
In Focus: International
  • China Imports Stuck at India Ports Show Standoff Casualties (Bloomberg)
  • Vertex and the UK government reach deal over cystic fibrosis medicines (STAT)
  • Canada federal court dismisses drugmakers' plea challenging drug price rules (Reuters)
  • The CEO of Novartis on Developing Drugs During a Pandemic (Wired)
  • Pharma trade group scolds AstraZeneca for bad behavior over an advisory board (STAT)
  • HIV treatment found to have no benefit for hospitalised COVID-19 patients in trial (Reuters)
  • Coronavirus: Hydroxychloroquine trial to restart (BBC)
  • Flu virus with 'pandemic potential' found in China (BBC) (NYTimes)
Coronavirus Pandemic
  • Trial of T-cell coronavirus therapy approved in Scotland (Financial Times)
  • South Korea Holds Onto Patient Data From Prior Coronavirus, Worrying Privacy Groups (NPR)
  • Coronavirus (COVID-19) Update: Daily Roundup June 29, 2020 (FDA)
  • HHS will renew public health emergency (Modern Healthcare)
Pharma & Biotech
  • What to expect from ‘Modernizing the FDA’s Data Strategy’ meeting (STAT)
  • A new FDA tool aims to inform cancer care, but experts say it has a glaring gap (STAT)
  • The biotech scorecard for the third quarter: 14 stock-moving events to watch (STAT)
  • The hedge fund manager behind a long-shot coronavirus pill (Financial Times)
  • Opioid shortages open up a world of pain (Financial Times)
  • With calls for American-made drugs on the rise, a Michigan CDMO is scaling up to meet demand (Fierce)
  • Novavax hires new manufacturing chief to take COVID-19, flu vaccine hopefuls across the finish line (Fierce)
  • US FDA, Industry Share Early Lessons From Complex Innovative Trial Designs Program (Pink Sheet)
  • EU Remote Trials Project Gets Moving (Pink Sheet)
  • Successful Elocta bid should widen access to the drug in the UK (PharmaTimes)
  • Alnylam's RNAi therapy Givlaari shows lasting effect one year into treatment, new data show (Fierce)
  • Takeda maps out a discovery alliance aimed at breaking through the safety and efficacy boundaries that limit the first-gen gene therapies (Endpoints) (Fierce)
  • Elias Zerhouni discusses ‘amateur hour’ in DC, the destruction of infectious disease R&D and how we need to prep for the next time (Endpoints)
  • Freeline nabs $120M, eyes IPO as its gene therapy comes into focus (Endpoints)
  • Genmab, Seattle Genetics eye FDA filing for new cancer med after latest data drop (Fierce)
  • Seattle Genetics, Genmab turn on TV for a highlight reel in cervical cancer — but a rival biotech promises a better show (Endpoints)
  • Gilead-partnered Goldfinch Bio lands $100M as it pivots to clinical stage biotech (Endpoints)
  • Zynerba flunks another PhII trial, all but ending Fragile X hopes (Endpoints)
  • Menten AI Adds Quantum Computing to Develop New Drugs (WSJ)
  • Rubius marks milestone in PhI/II as CFO departs; Owkin closes $70M Series A; The Carlyle Group bets on Indian CDMO (Endpoints)
  • WHO urges countries to expand access to rapid molecular tests for the detection of TB and drug-resistant TBc (WHO)
  • Q&A: New NESTcc chief on the real-world evidence group's 'pivot point' and COVID-19 (MedtechDive)
  • What Next For Standards As CEN/CENELEC Reject MDR/IVDR Commission Request? (MedtechInsight)
  • Brainlab picks up Level Ex, maker of video games for surgeons (Fierce)
  • FDA nod to Boston Scientific cardiac monitor clears challenge to Abbott, Medtronic (MedtechDive)
  • Masimo announces device designed to reduce opioid withdrawal symptoms (MobiHealthNews)
  • Medtronic delivers real-world renal denervation data showing better blood pressure after 3 years (Fierce)
Government & Regulatory
  • How would a Biden White House handle drug prices? Depends on congressional races, analysts say (Fierce)
  • New BPCIA Complaint: Genentech Seeks to Block Samsung Bioepis’s Proposed AVASTIN Biosimilar (Big Molecule Watch)
  • AmerisourceBergen CEO Must Testify In Opioid Bellwether (Law360)
  • Justices Told PTAB Appointments Are Not Unconstitutional (Law360)
  • Bayer, GE Must Face Suit Over Woman's Chemical Sickness (Law360)
  • Fortress Drops Ex-Theranos IP Suit To Let Test Co. Fight Virus (Law360)
  • FDA Ducks Suit Challenging Stimulant Crackdown (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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