Recon: US to buy $1B more of Merck's COVID-19 pill; AstraZeneca to create new division for vaccines and antibodies
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- U.S. government to buy $1 billion more worth of Merck's COVID-19 pill (Reuters)
- Inovio says the FDA lifted its 'hold' on the Phase 3 clinical trial for its COVID-19 shot (MarketWatch)
- GE Healthcare to become standalone company after conglomerate completes three-way split (Fierce) (CNBC)
- Surgical device maker Arthrex fined $16M over alleged kickback scheme (Fierce) (DOJ)
- Moderna founder unveils new drug company focused on a different kind of RNA (BioPharmaDive)
- Okla. High Court Erases J&J's $465M Opioid Defeat (Law360)
- How Pelosi almost killed drug pricing reform: A gamble that expanded Democrats’ deal (STAT)
- Biohaven, Pfizer enter up to $1.24 bln deal to market migraine drugs (Reuters) (Endpoints)
- Biogen investigates a death possibly linked to its controversial new Alzheimer's drug (Endpoints)
- AstraZeneca commits to vaccines business with new division (FT) (Reuters)
- Amid spike in cases, EU to shortly approve first COVID antibody drugs – sources (Reuters)
- Moderna seeks EU authorization for COVID-19 vaccine in young children (Reuters)
- WHO warns of shortage of 1-2 bln COVID vaccine syringes (Reuters)
- French health authority advises against Moderna COVID-19 vaccine for under 30s (Reuters)
- Canada authorizes Pfizer COVID vaccine booster for adults (Reuters)
- India could ship vaccines to COVAX in a few weeks, say sources (Reuters)
- BioNTech CEO says new COVID pills unlikely to dent vaccination uptake (Reuters 1, 2)
- Vaccine vial maker Stevanato ticks up 2021 guidance after Q3 results (Reuters)
- White House tells businesses to proceed with vaccine mandate despite court-ordered pause (CNBC)
- Biden plan to make unvaccinated workers pay for Covid testing could backfire (Politico)
- FDA reports 100+ drug shortages nationwide (KFOR)
- Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows (Endpoints)
- As Overdose Deaths Soar, DEA-Wary Pharmacies Shy From Dispensing Addiction Medication (KHN)
- J&J tries to back out of nanoparticle license agreement — but Alkermes says 'not so fast' (Endpoints)
- Novartis dumps 2nd bispecific from $2.6B Xencor pact, dealing further blow to hopes for blood cancer target (Fierce)
- A controversial drug for premature births, which FDA wants withdrawn, is tied to elevated cancer risk (STAT)
- Compass Pathways' Phase IIb psilocybin trial shows reduced depression symptoms (Endpoints)
- China's Zai Lab spins 2 more licensing deals, including a sudden dive into neuroscience (Endpoints)
- Feng Zhang’s quiet spinout snares $215M in a race for the next big CRISPR company (Endpoints)
- Immatics unveils promising, early-stage data for a top contender in the race to develop TCRs. Now it has to live up to expectations (Endpoints)
- Mirati gives first look at KRAS drug combination in lung cancer (BioPharmaDive) (STAT)
- Sanofi invests $40m in UK gene therapy company Gyroscope Therapeutics (PharmaTimes)
- BMS’ Opdivo improves survival in early-stage lung cancer (PMLive)
- Cue Health to kick off direct-to-consumer COVID test launch with new telehealth platform (Fierce)
- Senators urge CMS to develop new MCIT breakthrough device pathway (MedtechDive)
- Philips grows cardiac monitoring business with Cardiologs pickup (MedtechDive)
- Shkreli's Old Co. Fair Game For Antitrust Trial, Judge Says (Law360)
- DOJ Claims Texas Pharmacy Co. Inflated Ingredient Pricing (Law360)
- Qiagen Agrees To Pay $53M To Settle Patent Suit (Law360)
- High Court Won't Hear Breast Implant Suit Against J&J Unit (Law360)
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