Regulatory Focus™ > News Articles > 2021 > 1 > Recon: US overhauls vaccine rollout plans; Novartis, BeiGene partner on tislelizumab

Recon: US overhauls vaccine rollout plans; Novartis, BeiGene partner on tislelizumab

Posted 12 January 2021 | By Michael Mezher 

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.

Tags: US, worldwide

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe