Kite and Oxford BioTherapeutics sign oncology research pact (PMLive)
NICE recommends AstraZeneca's FORXIGA for heart failure (Pharmafile)
Scorpion Therapeutics strikes major $162M funding round for 'precision oncology 2.0' (Fierce)
Indian Pharma exports get a boost as nations depend less on China (Economic Times)
Fujifilm's CDMO arm plots massive $2B plant in the US for broad range of therapeutics (Endpoints)
Dermira vets license back candidates from Eli Lilly to launch their own upstart (Endpoints)
EXCLUSIVE: Zai Lab’s Samantha Du scoops up China rights to an autoimmune drug with a hefty $175M licensing deal — heavily fronted with cash and stock (Endpoints)
Alnylam nears FDA filing for 4th RNAi therapy vutrisiran after late-stage data back use in protein misfolding disorder (Endpoints)
With decades in gene therapy under his belt, Ronald Crystal launches new venture with up to 18 candidates in the pipe (Endpoints)
Bristol Myers Squibb ices licensing pact with ArsenalBio to draft its designer T cells into the solid tumor fight (Endpoints)
Kira and its complement-target inhibitors plot run to the clinic with new investor cash just months after uncloaking (Endpoints)
Rick Klausner fronts cash for his fungus outfit LifeMine and brings on Nobel Laureate to further push cancer discovery (Endpoints)
Looking to solve the solid tumor puzzle box, Carisma aims to take 'CAR-M' groundbreaker into early-stage trial (Endpoints)
Abcuro will take an anti-KLRG1 antibody into the clinic with new funding, and has big plans for another (Endpoints)
Gary Glick, Keith Flaherty now have $270M to realize their vision for Precision Oncology 2.0 — we'll just have to wait for the details (Endpoints)
Werewolf prepares to bare its teeth in 1st trial for targeted cytokine tumor fighters with new round of investor cash (Endpoints)
Factor Bioscience spins out a new cell therapy player with eyes on the clinic within 2 years (Endpoints)
Medtech
Trump Signs Bill Allowing FDA Seizure Of Counterfeits (Law360)
MDIC Announces Pathology ‘Collaborative Community’ With FDA Involvement (MedtechInsight)
UK All-Party Report Assesses Brexit Medtech Impact While Germany Worries Over Border Delays (MedtechInsight)
French medtechs Carmat, CorWave advance heart failure device plans (MedtechDive)
New Mexico sues device sterilizer Sterigenics over ethylene oxide emissions (MedtechDive)
Medtronic’s ICM Proves Cost-Effective In Preventing Recurrent Stroke (MedtechInsight)
MTI’s Top 20 Of ’20: Medtech Industry Laser-Focused On FDA’s Quality System Reg Rewrite, Facility Inspections, And More (MedtechInsight)
Government, Regulatory & Legal
Biden’s FDA Commissioner Playbook: Build On COVID Innovations To Modernize Agency (Pink Sheet)
Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc. (Fed. Cir. 2021) (Patent Docs)
Strike Three. Southern District of New York Joins Other Federal Courts In Blocking Trump Administration’s Most Favored Nation Drug Pricing Rule on Procedural Grounds (FDA Law Blog)
Allergan Says Federal Law Preempts Breast Implant Claims (Law360)
Hatch-Waxman Venue Issue Still Live After Fed. Circ. Ruling (Law360)
Gov't Pandemic Response Will Boost Life Sciences In 2021 (Law360)
Feds Want In On Allergan Collusion Suit Amid Criminal Probe (Law360)
4th Circ. Undoes $1.25M Verdict In Pradaxa Suit (Law360)
W.Va. Opioid Distributor Bellwether Trial Set For May (Law360)
Fed. Circ. Won't Revive Axed Horizon Pain Drug Patents (Law360)
DOJ Misled Court About Planned Opioid Suit, Walmart Says (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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