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February 15, 2022
by Joanne S. Eglovitch

Recon: FDA places Legend Biotech’s early-stage CAR-T on hold; Lilly reunites with Immunogen with ADC deal

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer Sues Teva, Slayback to Block Copies of Two Xeljanz Doses (Bloomberg)
  • Legend’s early-stage CAR-T on FDA hold after single patient dosed (Fierce) (Endpoints)
  • Larimar kept in limbo as FDA maintains clinical hold on leading candidate (Fierce)
  • J&J Starts Trial on Bankruptcy Case Under Attack by Congress (Bloomberg)
  • Lilly reunites with Immunogen to expand into ADCs, paying $13M upfront and $1.7B on the back end (Fierce)
  • FTC To Study Impact Of PBM Practices On Drug Prices, Pharmacies (Inside Health Policy)
  • With $1.7T in the coffers, biopharma M&A expected to be ‘a different animal’ in 2022 (Fierce)
In Focus: International
  • EU Reveals Plans For Unitary SPC & Review Of Compulsory Licensing (The Pink Sheet)
  • EMA follows FDA in scrutinizing safety of certain immune drugs (BioPharma Dive)
  • Lynparza On Track For Broad Frontline Use In Prostate Cancer (Scrip)
  • Israel to offer AstraZeneca's Evusheld to immunocompromised people (Reuters)
  • No more waffling: Belgium discloses penalties for failing to report clinical trial results (STAT)
  • Biden’s Global Vaccine Push Falters, Echoing U.S. Struggles (Bloomberg)
  • Canadian HTA Announces New Program To Generate Real World Evidence (The Pink Sheet)
Coronavirus Pandemic
  • Omicron threat remains high in east Europe – WHO (Reuters)
  • China's potential mRNA COVID vaccine weaker against Omicron-study (Reuters)
  • Vaccine scientists have been chasing variants. Now, they’re seeking a universal coronavirus vaccine. (Washington Post)
Pharma & Biotech
  • Small pain drug player gets snapped up in $604M buyout — and the axe will soon fall (Endpoints)
  • Novartis is chopping 400 jobs in India after striking new distribution pact (Endpoints)
  • The top 10 M&A targets in biotech for 2022 (Fierce)
  • Cipla Founding Family Pares Stake But Third Generation Affirms Continuity (Scrip)
  • Pharma companies rarely default on debt, but it remains a risk factor for investors (STAT)
  • AC Immune’s Janssen-partnered Alzheimer’s vaccine spurs tau-attacking antibodies in early-stage trial (Fierce)
  • Amgen sees potential for KRAS drug in treating pancreatic cancer (BioPharma Dive)
  • Pharma Supply Chain Disruptions Increased Another 74% in 2021, Resilinc Says (The Pink Sheet)
  • Intellia-ONK ink up to $920M pact for 5 CRISPR-edited cancer cell therapies (Fierce)
  • Kallyope, with ex-Merck exec at helm, skirts ‘less desirable’ public markets with $236M series D (Fierce)
  • Cytokinetics' latest PhIII study of omecamtiv flops — kicking out another leg from under the market case it was building (Endpoints)
  • AI startup grabs $60M, unveils platform aimed at drug discovery's 'data problem' (Endpoints)
  • NMD pulls in $40M from Jeito-led, Roche-backed syndicate. Gaining financial muscle to crack myasthenia gravis market (Fierce) (Endpoints)
Medtech
  • Latest Essure data show more patients had device removed (MedTech Dive)
  • Inflationary risk 'manageable' for medtechs but impact will vary: RBC (MedTech Dive)
  • Senseonics Projects Slow Growth In 2022 Despite FDA Approval Of Eversense E3 CGM (MedTech Insight)
Government, Regulatory & Legal
  • GSK joins a crowd of pharma companies restricting sales under federal program (Endpoints)
  • Endo Opioid Saga 'Like A John Grisham Movie,' Judge Says (Law360)
  • Henrietta Lacks’ Heir Fights Firm’s Bid to End Compensation Case (Bloomberg)
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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