Recon: Medicago’s plant-based COVID vaccine secures first approval in Canada; BMS sues XSpray to block Sprycel generic
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA Approves Treatment for Wider Range of Patients with Heart Failure (FDA)
- Possible Orange Book Revisions Back In Play With US FDA Report To Congress (The Pink Sheet)
- Pfizer drops case against ex-staffer accused of stealing trade secrets — including details about Covid-19 vaccine (Endpoints)
- Unidentified witnesses accuse Bristol Myers of scuttling timely FDA move on liso-cel to avoid $6.4B payout (Endpoints)
- Bristol-Myers Sues XSpray to Block Copies of Blockbuster Sprycel (Bloomberg)
- Public Citizen picks apart Cures 2.0 draft legislation, criticizing several RWE provisions (Endpoints)
- Sanofi presses CDC experts to back its high-dose Fluzone shot for older adults (Fierce)
- Former FDA office director Unger joins law firm (Biocentury)
- EMA backs Pfizer COVID booster for teens, Moderna shot for ages 6-11 (Reuters) (Bloomberg)
- Canada approves Medicago's plant-based COVID-19 vaccine for adults (Reuters) (Fierce)
- SIFI Among EU Fast-Track Hopefuls With ‘World’s First’ Drug For Parasitic Eye Infection (The Pink Sheet)
- Moderna ties the knot with Thermo Fisher on a 15-year manufacturing alliance, gluing a global network (Endpoints)
- Orphazyme goes soul searching as EU advisers add 2nd rejection for rare disease drug (Fierce)
- Need For Skilled Workforce A Key Issue In Countries Using mRNA Tech Transfer (The Pink Sheet)
- Canada wants to clear the way for more decentralized clinical trials: Will the US follow suit? (Endpoints)
- World should send 60 mln COVID-19 vaccines to N.Korea, UN investigator says (Reuters)
- Explainer: How the World Health Organization might face future pandemics (Reuters)
- US Covid Shots Plummet to Slowest Pace Since Start of Campaign (Bloomberg)
- The CDC advises some people wait longer between the first and second dose of the Pfizer or Moderna vaccines. (NYT)
- Merck cuts ties to Moderna’s early-phase KRAS vaccine, leaving mRNA specialist to mull next steps (Fierce)
- AbbVie sees a megablockbuster in Vraylar. Could a new depression indication push peak sales past $4B? (Endpoints) (Fierce)
- Decentralized trials are staying put, but sites and sponsors aren’t quite prepared: survey (Fierce)
- Merck KGaA pledges $550M in manufacturing upgrades after closing buyout of mRNA CDMO Exelead (Fierce)
- Amgen looks to multispecifics for long-term growth (Biocentury)
- Developer of therapeutic strategies for thrombosis raises millions in Series A round (BioPharma Reporter)
- Mark Cuban’s US Pharma Ventures: Ally Or Gadfly In The Mix For Indian Firms? (Scrip)
- Regeneron, Bayer’s Eylea ‘to remain king’ as analysts see ‘tepid’ response to biosimilar threats (Fierce)
- Unraveling of Amicus spinout spells more trouble for gene therapy field (STAT)
- Gearing up for anemia market-grab against GSK – and maybe AZ-Akebia expands Vifor pact with $85M for key launch (Fierce)
- Building on CRISPR success, Intellia inks deal for new manufacturing facility in Waltham, MA (Endpoints)
- With a new startup, ARCH and Takeda wade into growing search for a Swiss Army knife RNA drug (Endpoints)
- Tillman Gerngross makes it official: He's out as CEO as troubled Adagio vows to soldier on (Endpoints)
- Spectrum's penny stock takes another hit as CFO quietly plans exit (Endpoints)
- QMSR Quick Take: QSR Author Kim Trautman (MedTech Insight)
- Viz.ai software gains FDA clearance for automatically spotting brain aneurysms (Fierce)
- FDA Grants the First Condom Approval for Anal Sex (NYT)
- Baxter Issues Spectrum Infusion Pump Safety Alert After 3 Patient Deaths (MedTech Insight)
- Baxter hit with $18M SEC penalty for accounting improprieties (MedTech Dive)
- Insulet’s Omnipod insulin pump sales send it past $1B mark for the first time (Fierce)
- Judge bars Shkreli from running another public company, fines him $1.4 million (STAT) (Law360) (Endpoints)
- White House Science Advisor Shuffle Could Affect ARPA-H – And ‘March In’ Debate (The Pink Sheet)
- DOJ scraps divisive China Initiative that swept up prominent scientists — but vows to keep guarding against academic espionage (Endpoints)
- Federal court strikes down part of HHS surprise billing rule (STAT)
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