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4th March 2021
by Michael Mezher

Recon: Amgen buys Five Prime for $1.9B; EU investigating Teva over Copaxone practices

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Biden convenes bipartisan meeting on cancer research (The Hill) (Reuters)
  • Amgen spends $1.9 billion on Five Prime, eyeing an expansion in Asia (STAT)
  • The $14 million CEO: Drug distributor boosts executive’s pay despite historic opioid settlement (Washington Post)
  • Pfizer’s Lorbrena scores expanded FDA approval for first-line NSCLC (PMLive) (Endpoints)
  • US administers 80.5 million doses of COVID-19 vaccines: CDC (Reuters)
In Focus: International
  • EU investigating Teva for blocking rivals to multiple sclerosis drug (Reuters)
  • No need for lengthy trials of vaccine modifications, UK regulator says (FT) (Reuters) (MHRA 1, 2)
  • European Union begins review of Russia’s Sputnik Covid vaccine (CNBC) (EMA)
  • Russia expects several EU countries to approve Sputnik V vaccine this month: RDIF chief (Reuters)
  • EU says no talks under way to buy Russia's COVID-19 vaccine (Reuters)
  • Italy to give "significant" support to vaccine production hub: minister (Reuters)
  • Italy blocks shipment of Oxford/AstraZeneca vaccine to Australia (FT)
  • Pfizer/BioNTech, Astrazeneca COVID-19 vaccine data encouraging: WHO (Reuters)
  • Novartis to Help Make CureVac Covid-19 Vaccine (WSJ)
Coronavirus Pandemic
  • CDC delays guidelines for vaccinated people (Politico)
  • mRNA Covid-19 Vaccines Are Fast to Make, but Hard to Scale (WSJ)
  • Takeda to File Moderna Vaccine in Japan This Week (PharmaJapan)
  • US FDA Still Discussing Ideas For Pediatric Development Of COVID-19 Vaccines (Pink Sheet)
  • South Africa official explains why world trade rules should be waived to fight Covid-19 (STAT)
  • Choices in a Crisis — Individual Preferences among SARS-CoV-2 Vaccines (NEJM)
  • An Uncertain Public — Encouraging Acceptance of Covid-19 Vaccines (NEJM)
  • Sweden recommends AstraZeneca COVID-19 vaccine for over 65s: Health Agency (Reuters)
  • Germany approves AstraZeneca jab for over-65s (FT)
  • Italy to give just one COVID shot to some patients as EU struggles with inoculations (Reuters)
  • Czech Republic declines intermediary's offer for AstraZeneca vaccines (Reuters)
  • Germany to give single AstraZeneca vaccine dose to COVID-19 patients (Reuters)
  • Raging pandemic shuts down Sao Paulo as Brazil nears Pfizer deal (Reuters)
  • GC Pharma says picked to import and distribute 40 million doses of Moderna's vaccine in South Korea (Reuters)
  • Japan's JCR Pharma to build new plant to produce COVID-19 vaccine solution (Reuters)
  • Philippines receives its first AstraZeneca vaccines under COVAX (Reuters)
  • Sudan to start vaccine rollout next week after getting COVAX doses (Reuters)
Pharma & Biotech
  • Kronos Bio speeds development of genetically targeted leukemia drug with unique trial design (STAT) (Endpoints)
  • Amid back office consolidation, Gilead axes 179 jobs in California (Endpoints)
  • Latest MassBio report shows just how much biopharma's biggest sector boomed in 2020 (Endpoints)
  • In the latest big investment in gene therapy manufacturing, Biogen commits $200M to a major new facility in NC (Endpoints)
  • Eli Lilly’s experimental diabetes drug reduced weight and blood sugar in clinical trial (STAT)
  • CDMO Celonic to beef up cell and gene therapy work at up-and-coming Novartis hub (Fierce)
  • NICE rejects rare blood cancer treatment Poteligeo in final appraisal (PharmaTimes)
  • ConserV Bio partners with eTheRNA on mRNA vaccine development (PharmaTimes)
  • Advanced Manufacturing May Require US FDA To Think Differently About Guidance (Pink Sheet)
  • BlackRock pushes Exscientia Series C to $100M as AI biotech boom continues (Endpoints)
  • Galapagos posts a safety win for filgotinib, but is it too little, too late?; Bio-Techne inks $320M molecular diagnostics buyout (Endpoints)
  • With $117M in fresh cash, Amunix paves path to the clinic for 'universal mask' prodrug on the hunt for HER2 tumors (Endpoints)
  • Nichi-Iko Chief Apologizes for GMP Violations, but Draws Clear Distinction from Kobayashi Kako Case (PharmaJapan)
  • Sofinnova Partners stays focused on late-stage deals with a new, $540M crossover fund (Endpoints)
  • Peter Thiel-backed psychedelics player ATAI pulls in another nine-figure raise. But they're not ready to talk IPO — yet (Endpoints)
Medtech
  • Stalemate Over Virtual Audits In EU As Commission Tells TEAM-NB To Back Off (MedtechDive)
  • FDA clamps down on bogus device 'registration certificates' amid rising use during pandemic (MedtechInsight)
Government, Regulatory & Legal
  • Federal judge enters permanent injunction against New York-based dietary supplement manufacturer (FDA)
  • Becerra's HHS secretary bid moves forward on tie committee vote (MedtechDive)
  • Health care industry scores lobbying wins in Senate on drug pricing, provider funds, insurance subsidies (STAT)
  • Reckitt Benckiser Coughs Up $53M To End False Ad Suit (Law360)
  • Minnesota Bill Aimed at Expanding Access to Biosimilars (Big Molecule Watch)
  • Del. Justices Reverse GSK's $57M Lupus Drug Patent Loss (Law360)
  • CEO In $150M Opioid Scheme Hit With 15-Year Sentence (Law360)
  • Pharma Cos. Held In Contempt In Trade Secrets Case (Law360)
  • AstraZeneca Beats Mylan Challenge To Inhaler IP's Validity (Law360)
  • NY Opioid Trial Defendants Want New COVID-19 Delay (Law360)
  • Okla. Seeks 19-Year Extension To J&J $465M Opioid Judgment (Law360)
  • Hillrom's retreat from $375M Bardy Diagnostics acquisition countered in court (mobihealthnews)
  • New Jersey Rejects Bogus Exclusion of FDA Device Clearance Evidence (Drug & Device Law)
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.