Recon: Recursion to buy Exscientia for $688M; FDA approves Citius rare blood cancer treatment

ReconRecon | 08 August 2024 | Michael Mezher

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Biotech firm Recursion to buy smaller peer Exscientia for $688 million (Reuters) (Endpoints) (STAT)
  • US FDA approves Citius' therapy for rare blood cancer (Reuters)
  • US FDA approves Novartis' kidney disease drug (Reuters)
  • US FDA approves Servier's brain tumor treatment (Reuters)
  • Viagra-maker Viatris beats Q2 estimates on branded and generic drug demand (Reuters)
  • Third trial over Zantac cancer claims ends with hung jury (Reuters)
  • Novavax cuts 2024 revenue forecast, shrinks European presence (Reuters)
  • Merck stops testing combo drug for lung cancer (Reuters)
  • FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose (FDA)
  • Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel (Pink Sheet)
  • CMS finalizes notice on Medicare coverage for breakthrough devices (MedtechDive)
In Focus: International
  • UK's NHS to roll out Vertex/CRISPR gene therapy for rare blood disorder (Reuters)
  • German panel endorses GSK, Pfizer RSV vaccines for elderly (Reuters)
  • How Little Denmark Got Homegrown Giant Novo Nordisk To Lower Ozempic Prices (KFF)
  • Roche considers options for $1.9bn cancer data start-up (FT)
  • India's Biocon posts Q1 profit rise on sale of branded formulations business (Reuters)
  • India's J B Chemicals and Pharma tops Q1 profit view on domestic business strength (Reuters)
  • Philippines seeks emergency procurement of swine fever vaccines to tackle outbreak (Reuters)
  • Africa CDC likely to declare mpox public health emergency next week (Reuters)
  • Japan Pharma Layoffs: Takeda And Others Implementing Broad Cuts (Scrip)
Pharma & Biotech
  • Aldeyra to resubmit dry eye disease drug this year following positive Phase 3 data (Endpoints)
  • Big drugmakers have cut outside R&D spending amid broad pullback, key contractor warns (Endpoints)
  • FDA grapples with its role in AI, and how to guide industry's adoption (Endpoints)
  • Lilly says to ‘take some caution’ on other companies’ early-stage obesity data, calls out compounders (Endpoints)
  • Lilly crushes expectations with GLP-1 franchise, as supply constraints ease (Endpoints)
  • WuXi Bio gains some traction in Europe in the face of Biosecure threat in the US (Endpoints)
  • Novo Pulls Wegovy Heart Failure Application, Will Resubmit To Get ‘Hard Endpoints’ In Label (Pink Sheet)
  • Lilly’s anti-tau pill for Alzheimer’s fails in Phase 2 study (Endpoints)
  • Apellis and Sobi land another late-stage win for rare kidney disease drug (Endpoints)
  • Amneal Pharma's extended-release Parkison's treatment clinches FDA approval (Endpoints)
  • Intellia’s gene editing therapy succeeds in Phase 2 genetic swelling condition study (Endpoints)
  • TIGIT drugs take another hit as Merck stops Phase 3 lung cancer trial for futility (Endpoints)
  • Entero Therapeutics turns the lights off as creditors come calling (Endpoints)
  • Sanofi’s Sarclisa scores in Phase 3 transplant-eligible multiple myeloma test (Endpoints)
Medtech
  • Zimmer to buy surgical navigation company Orthogrid (MedtechDive)
  • Big Health gets FDA nod for its digital therapy for insomnia (STAT)
  • Labcorp wins FDA OK for pan-solid tumor liquid biopsy (MedtechDive)
  • Medtronic recalls nerve monitoring system linked to 10 injuries (MedtechDive)
  • Abbott taps Medtronic to connect CGM sensors with insulin delivery systems (Fierce)
  • Diality secures FDA clearance for hemodialysis system (Fierce)
  • Bayer partners with Alara Imaging to standardize CT radiation doses (Fierce)
Government, Regulatory & Legal
  • Q&A: PhRMA CEO Stephen Ubl on the IRA, challenges to the FDA’s authority and the US-China relationship (Endpoints)
  • AI app claiming to diagnose STIs from penis pictures shut down after FTC scrutiny (STAT)
  • Another Preemption Win Involving An Economic Loss Class Action And An OTC Drug (Drug & Device Law)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
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