Recon: Recursion to buy Exscientia for $688M; FDA approves Citius rare blood cancer treatment
Recon | 08 August 2024 |
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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)
- 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)
- 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)
- 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)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
© 2025 Regulatory Affairs Professionals Society.
