Regeneron shoots for longer Eylea dosing interval in diabetic retinopathy with NIH data (Fierce)
Regulators Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021 (IPQ)
Gilead expands AbCellera antibody discovery pact to access rival to Regeneron's mouse platform (Fierce)
Pfizer breaks ground on sterile injectables plant in Michigan, plans to add around 450 jobs to the region (Endpoints)
Merck KGaA lands rights to 3rd F-star oncology bispecific antibody (Fierce)
Proteomics company SomaLogic to chase $1.2B public valuation through SPAC deal (Fierce)
Alloy Therapeutics nabs a $75M series C to sow more seeds into the biotech ecosystem (Fierce)
Alcami appoints new CEO in Patrick Walsh, the executive who helped lead the CDMO's predecessor company (Endpoints)
It's time: After 19 years, legendary Koch Institute director Tyler Jacks passes the torch to Matthew Vander Heiden (Endpoints)
Stuart Lipton offers a new possible reason why all the Alzheimer's drugs have failed (Endpoints)
United Therapeutics bags a new OK on Tyvaso, with blockbuster expectations; Gilead goes back to AbCellera's well with a set of fresh targets (Endpoints)
After name change and dropped IPO, IN8bio tries again to boost its cancer pipeline (Fierce)
Medtech
FDA cites potential infection risks with reusable urological endoscopes (Fierce) (FDA)
Bluestar's blood test nets FDA breakthrough label to screen for pancreatic cancer after sudden cases of diabetes (Fierce)
Quest sells minority share of Q2 Solutions for $760M (MedtechDive)
Government, Regulatory & Legal
Bills, Bills, Bills: Congress Advances Bills to Address Drug Competition (FDA Law Blog)
Mitsubishi Tanabe Wins US Patent Suit on Canagliflozin (PharmaJapan)
Vagisil Maker Gets Rival's 'Vagisert' TM Blocked At TTAB (Law360)
Big Pharma Tells Justices To Keep Assignor Estoppel (Law360)
Illumina Agrees To Delay $8B Grail Deal During FTC Challenge (Law360)
Bristol Myers Squibb Settles Medicaid Rebate Suit For $75M (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.
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