Tocilizumab for Covid-19 — The Ongoing Search for Effective Therapies (NEJM)
HHS rolls $250M ad campaign with Fauci, science focus front and center (Fierce)
Diagnostics group Novacyt develops new tests to detect COVID-19, bird flu (Reuters)
Single-patient study adds to debate over Gilead's remdesivir for COVID-19 (Reuters)
Trump admin defends national stockpile as PPE, equipment shortages persist (MedtechDive)
WHO says authorities investigating new COVID-19 variant in England (Reuters)
Trial of azithromycin in severe COVID-19 patients finds no benefit (Reuters)
Brazil delays Chinese vaccine efficacy report, keeps rollout date (Reuters)
Brazil's top court orders government to set date for COVID-19 vaccination plan (Reuters)
Germany will get 11 million doses of BioNTech vaccine by March – ministry (Reuters)
Philippines targets deal for 25 million doses of Sinovac COVID-19 vaccine (Reuters)
Mexico says Pfizer vaccine doses could arrive in 5-8 days (Reuters)
Codagenix, Serum Institute to begin UK trials of nasal COVID-19 vaccine in January (Reuters)
Pharma & Biotech
Life Science Sector Still In The Dark As UK-EU Trade Talks Make Progress (Pink Sheet)
EU Stakeholders Want More Focus On Availability Of Medicines (Pink Sheet)
New Global Alliance To Drive Momentum On Decentralized Trials (Pink Sheet)
FDA reviewers argue for Novartis ahead of Entresto advisory panel confab (Fierce)
A new biotech tries to bridge the drug innovation gap between East and West (STAT)
Sarepta shakes up C-suite as they prepare to test FDA on Duchenne again (Endpoints)
European approval for AstraZeneca's Trixeo Aerospace in moderate to severe COPD (Pharmafile)
Novo Holdings invests in Hemab, a company going against the hemophilia gene therapy grain with a plan for bispecifics (Endpoints)
Chasing Amgen on KRAS combo, Roche dishes out $75M for Relay's SHP2 drug to pair with in-house program (Endpoints) (Biopharmadive)
CRISPR upstart ticks off another box on the IPO prep list as RA, SVB Leerink step in on a mega-raise (Endpoints)
Gene therapy player InnoSkel debuts with €20M for rare skeletal diseases (Fierce)
After scoring big Pfizer buyout, a Therachon co-founder turns once again to dwarfism with $24M Series A (Endpoints)
Amid a tough year with ransomware attacks and a CEO departure, ERT merges with Bioclinica (Fierce)
UK to Ease Rules on Blood Donations by Gay and Bisexual Men (NYTimes)
Medtech
UK shares post-Brexit device guidance as uncertainty around EU split looms (MedtechDive)
Edwards plots TAVR comeback even as COVID-19 surge hits harder (MedtechDive)
Industry Voices Growing Frustration Over Notified Body Designations Despite Latest Listing (MedtechInsight)
SoniVie, ReCor Move Forward With Ultrasound Renal Denervation Technologies (MedtechInsight)
Acutus Medical expands heart treatment portfolio in Europe with new CE marks (Fierce)
Government, Regulatory & Legal
Lauded By Industry, Loathed By FDA? New HHS ‘Good Guidance’ Rule Likely Ruffling Feathers (MedtechInsight)
Senate Passes Bills On Drug Patent Listings (Law360)
Allergan Must Face FCA Claims Over Dementia Drug Patents (Law360)
Hospital groups sue HHS for failing to stop drug makers from cutting medication discounts (STAT)
Celgene, Cipla Resolve Patent Claims Over Cancer Drug (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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