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