Recon: US overhauls vaccine rollout plans; Novartis, BeiGene partner on tislelizumab
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
HHS 'unleashed' in string of last-minute policies (Politico )
In a last-minute, intra-agency scuffle, HHS overrules FDA pick for a key position (STAT ) (Politico )
Pfizer has produced more than 70 million COVID-19 vaccine doses: CEO (Reuters )
US shifts to speed vaccinations; won’t hold back 2nd doses (AP ) (Reuters ) (Bloomberg )
Democrats demand plan from Trump to fix ‘failed’ vaccine rollout (Politico )
Biden to unveil vaccination plan this week (Politico )
Biden team gets access to Warp Speed-related meetings (Politico )
Governors’ red tape blamed as vaccine doses pile up (Politico )
Moderna doesn’t expect Covid vaccine data for young children until 2022, CEO says (CNBC )
Middlemen sue to block a signature Trump drug pricing proposal (STAT )
Ex-FDA Chief Getting Biden Admin. Post, Opioid Atty Says (Law360 )
HHS Secretary Azar is mum on 25th Amendment discussions (Axios )
In Focus: International
EU wraps preliminary talks to buy 60 million Valneva COVID vaccines (Reuters )
EU’s Covid vaccine chief defends procurement scheme (FT )
Canada orders 20 million more doses of Pfizer/BioNTech COVID-19 vaccine: PM (Reuters )
Swiss drugs regulator approves Moderna’s COVID-19 vaccine (Reuters )
EU watchdog to review AstraZenenca-Oxford vaccine this month (Reuters )
Brazil researchers report more modest 50.4% efficacy for China's CoronaVac (Reuters )
Pfizer could pitch its COVID-19 vaccine to Russian regulators: TASS (Reuters )
Sanofi's standalone drug ingredients business to be called EUROAPI (Reuters )
Sanofi, Israel's Biond Biologics to collaborate on new cancer drug (Reuters )
GSK, Vir to test antibody for COVID-19 treatment (Reuters )
Roche says updated data shows Tecentriq cocktail gives longer liver cancer survival (Reuters )
BeiGene, Novartis partner to develop cancer drug tislelizumab (Reuters )
Report: The Impact of Biosimilar Competition in Europe (EC )
Coronavirus Pandemic
Bangladesh's Beximco could start private sales of AstraZeneca vaccine next month (Reuters )
Abbott Labs rolls out its BinaxNOW rapid Covid-19 test to schools and workplaces nationwide (CNBC )
Japan’s Chugai soars nearly 6% after UK says its drug reduces hospital time for Covid patients (CNBC )
Thailand receives requests to register AstraZeneca, Sinovac vaccines (Reuters )
Mexico to conclude Sputnik vaccine authorization process quickly (Reuters )
Mexico could buy 24 million doses of Russia's Sputnik COVID-19 vaccine (Reuters )
India's Bharat Biotech to supply its COVID-19 vaccine to Brazil (Reuters )
Malaysia's Pharmaniaga buys 14 million doses of China's Sinovac COVID vaccine (Reuters )
Ukraine pharma group to supply 5 million doses of Sinovac COVID-19 vaccine in first-half (Reuters )
Pharma & Biotech
Gilead’s remdesivir sales are surging, but investors aren’t impressed (STAT )
EY Firepower Report: Biopharma M&A Poised to Rebound in 2021 (GEN )
The prices of 7 drugs were hiked without proof of new benefits, costing the U.S. $1.2 billion in 2019 (STAT )
After repeated FDA rejections, key investor writes down stake in former diabetes unicorn Intarcia Therapeutics (STAT )
With durable monkey data, Verve selects its first CRISPR base editing treatment for human trials (STAT )
Spark co-founder Kathy High joins a longtime collaborator at AskBio, helping steer Bayer's gene therapy push (Endpoints )
After pandemic-related disruptions, will 2021 bring about a renewed spotlight on R&D? A CFO survey says yes (Endpoints )
News briefing: AbbVie selects first target for Dragonfly partnership; Cognito nets BDD for Alzheimer's treatment device (Endpoints )
Boehringer Ingelheim enlists a UK startup in a milestone-heavy quest for 'dark antigens' (Endpoints )
Merck snags priority review for Prevnar 13 rival — just one month after Pfizer sent its follow-on to the FDA (Endpoints )
Abzena plots 6th biologics plant as demand for mammalian cell-line production continues to grow (Endpoints )
Looking to leapfrog antibodies and RNAi, Sekar Kathiresan says gene editing approach to cut PCSK9 looks durable (Endpoints )
DHSC publishes ‘UK Rare Disease Framework’ (PharmaTimes )
Medtech
In medtech win, MDR-IVDR remote audits OK'd amid pandemic pressures (MedtechDive ) (MedtechInsight )
FDA clears Abbott's hand-held blood test for TBIs, concussions (Fierce )
Medtech M&A to take off after pandemic slowed deals in 2020: EY (MedtechDive )
JPM: Illumina inks multiple cancer diagnostic partnerships to complement upcoming Grail acquisition (Fierce )
A Colonoscopy Alternative Comes Home (NYTimes )
Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation (FDA )
Government, Regulatory & Legal
Commerce Department agency proposes eliminating ‘march-in rights’ as a tool to lower drug prices (STAT ) (Law360 )
The Top 10 Non-COVID Legal Developments of 2020 (Pink Sheet )
Humana Sues Teva Over Alleged Copay Fraud Scheme (Law360 )
Fed. Circ. Patent Decisions In 2020: An Empirical Review (Law360 )
GoodRx IPO Timed To Beat Amazon's Rival Launch, Suit Says (Law360 )
Mylan, Pfizer Fight Remote Testimony In EpiPen Trial (Law360 )
3rd Circ. Revives Fresenius Generic Drug Suit (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.