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.
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