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June 18, 2020
by Michael Mezher

Recon: EU in talks to reserve J&J COVID-19 vaccine; Pfizer gene therapy shows sustained effect in hemophilia study

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Drugmakers Have Even Less Reason to Fear Price Reform Now (Bloomberg)
  • Gilead to enroll pediatric patients for late-stage remdesivir study (Reuters)
  • Pfizer's hemophilia gene therapy shows sustained effect in early-stage study (Reuters) (Endpoints) (Press)
  • Trump pushing officials to speed up already-ambitious coronavirus vaccine timeline (Washington Post)
  • California attorney general says FTC failed to follow ‘best practices’ in approving AbbVie-Allergan deal (STAT) (Endpoints)
  • AbbVie spends $60M, with $805M in biobucks, for Alpine Immune's lupus asset (Fierce) (Endpoints)
  • A majority of Americans fear pharma will use Covid-19 as an excuse to raise prices (STAT)
  • 'Medicaid best price' changes aimed at value-based gene therapy contracts: CMS (Reuters) (STAT)
  • U.S. district court rules for Mylan in MS drug patent battle with Biogen (Reuters) (Fierce) (Endpoints)
  • Medtronic partners with Foxconn to boost ventilator production (Reuters)
In Focus: International
  • Europeans discuss deal to access potential J&J coronavirus vaccine (Financial Times) (Reuters)
  • Roche rheumatoid arthritis drug fails to help COVID-19 patients in Italian study (Reuters)
  • WHO testing interim data from COVID-19 trial on HIV drugs (Reuters)
  • WHO hopes for hundreds of millions of vaccine doses this year, 2 billion next year (Reuters)
  • International regulators stress value of safe and effective vaccines (EMA)
  • Pandemic reopens wounds on IP rights (Financial Times)
  • UK launches world's first ‘subscription-style’ payment model for antibiotics (PharmaTimes)
  • Some Covid-19 trial sponsors never posted other study results in an EU database. Will they hide data again? (STAT)
  • Chinese vaccine developers have begun to shed some secrecy around Covid-19 candidates. What do we know? (Endpoints)
  • Novacyt shares jump after launch of new COVID-19 testing products (Reuters)
Coronavirus Pandemic
  • Test maker targeted by FDA says it responded to US concerns (ABC)
  • Ginkgo Bioworks CEO on scaling up Covid-19 testing: ‘If we try, we can win’ (CNBC)
  • New study casts more doubt on Swedish coronavirus immunity hopes (Reuters)
  • UK ditches COVID-19 app model to use Google-Apple system (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup June 17, 2020 (FDA)
Pharma & Biotech
  • US FDA’s Oncology Center In The Lockdown: ‘Business As Usual’ (Pink Sheet)
  • Cures II Wish List: Reconsidering Accelerated Approval? (Pink Sheet)
  • Opinion: It’s Time to Make the FDA Independent (Politico)
  • Lilly touts Emgality's ability to reduce migraine patients' overall pain in first look at 'holistic approach' (Fierce)
  • Tecentriq passes neoadjuvant breast cancer trial as Roche looks for early start on the next big checkpoint opportunity (Endpoints) (Press)
  • Two Bay Area upstarts out to deliver on cell therapy 2.0 join forces on a quest: pursuing a Holy Grail in oncology R&D (Endpoints)
  • AbbVie’s Rinvoq passes PhIII AD test; Dicerna races Alnylam; New Sarepta gene & cell collab (Endpoints) (Press)
  • Nan Fung Life Sciences antes up $32M to fuel a neuro play as the Hong Kong conglomerate burns through $1.5B mandate (Endpoints)
Medtech
  • ‘Email Me’: FDA Director Says He’ll Cut Through Red Tape To Ensure EUAs Are Assigned Liaison (MedtechInsight)
  • US FDA clarifies adverse event reporting requirements for medical devices designated under Emergency Use Authorizations (Emergo)
Government & Regulatory
  • The Trump Administration Paid Millions for Test Tubes — and Got Unusable Mini Soda Bottles (ProPublica)
  • Shire Wants Jury Trial Over Validity Of Its Genetic Disorder IP (Law360)
  • Generic Cos. Ask Fed. Circ. To Deny Amarin's Vascepa Appeal (Law360)
  • Biotech Co. Investors' FDA Convo Suit Survives Dismissal Bid (Law360)
  • Pharmacies Want Out Of Opioid MDL 'Public Nuisance' Suits (Law360)
  • Boehringer Ingelheim Sued For €23M Over Diabetes Drug IP (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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