Recon: Agilent to acquire Biovectra for $925M; China OKs Eli Lilly’s tirzepatide for weight loss
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Kamala Harris, endorsed by Biden to replace him, is left of the president on health care (STAT)
- Harris health care agenda swiftly hailed by progressives and reproductive rights groups (STAT)
- SEC staff recommends enforcement action against Allarity over potential federal securities laws violations (Endpoints)
- Vermont attorney general sues two major PBMs for allegedly driving up costs (Endpoints)
- Clinical Trial Diversity Action Plans Will Take 100 Hours To Prepare, US FDA Predicts (Pink Sheet)
- Judge refuses to disqualify leading opponents of J&J's talc bankruptcy plan (Reuters)
- Pharma companies report various levels of exposure to IT outage caused by CrowdStrike, Microsoft (Fierce Pharma)
- Regulatory tracker: J&J seeks monotherapy FDA approval for depression nasal spray (Fierce Pharma)
- Agilent to buy contract drug manufacturer Biovectra for $925 million (Reuters)
- IQVIA raises annual profit forecast on improving demand for analytics services (Reuters)
- European Commission reaches deal with Vifor for ‘disparaging’ its only rival in iron deficiency market (STAT) (Reuters)
- China approves Eli Lilly's weight loss drug as country launches obesity awareness campaign (Endpoints)
- EMA reasserts differences with FDA for Covid vaccine strain selection (Endpoints)
- OrbiMed forms biotech with assets from China-based Keymed, enlists former Biohaven exec as CEO (Endpoints)
- EMA Backs New Method For Measuring Alzheimer’s Disease In Trials (Pink Sheet)
- FDA sends 2 warning letters after inspecting Chinese syringe manufacturers (MedTech Dive)
- Trunzo: ’We’ve Come A Long Way To Get To Regulatory Reliance’ (MedTech Insight)
- Roche looks to have a competitive GLP-1 drug (STAT)
- Ionis flashes new Angelman syndrome data, will pursue Phase 3 trial next year (Endpoints)
- Chinese biotech boasts competitive Phase 2b weight loss data for GLP-1 drug (Endpoints)
- Grünenthal inks a deal with Valinor; Valneva gets $41M from CEPI (Endpoints)
- A rare disease first; Lilly’s Alzheimer’s push; Argenx’s next act; Novartis' obesity approach; and more (Endpoints)
- US inks $113M deal with Siga to bolster smallpox, mpox reserves (Endpoints)
- Layoffs at Rapt Therapeutics after winding down mid-stage trials of lead drug (Endpoints)
- Nadir Mahmood returns to Nkarta a year after leaving; BeiGene picks longtime Merck exec for CFO post (Endpoints)
- Docs embrace Takeda’s Eohilia, creating competition for Sanofi, Regeneron's blockbuster Dupixent (Fierce Pharma)
- Abbott CEO eyes ‘guerilla marketing’ to get Lingo CGM to people without diabetes (Fierce Pharma)
- Novartis CEO sees IRA impact ‘manageable’ in short run, maintains midterm growth goal (Fierce Pharma)
- ‘Our next frontier is prediction’: Medtronic on AI and heart disease (MedTech Dive)
- Intuitive’s da Vinci 5 robot launch ‘well ahead’ of Wall Street expectations (MedTech Dive)
- GE Healthcare to buy AI software from Intelligent Ultrasound for $51M (MedTech Dive)
- Dental implant maker Osstem in talks to acquire Zimvie: report (MedTech Dive)
- Why And How Last-Option, Essential Devices Must Now Be Identified As A Matter Of Urgency (MedTech Insight)
- Court weighs what US must prove in Regeneron kickback case (Reuters)
- NIDA should beware of funding companies that violate people’s privacy (STAT)
- The newest tool to prevent STIs is not available to everyone: A call for participatory and inclusive research (STAT)
- At a Mass General perfusion lab, a push to make more and more hearts viable for transplant (STAT)
- Express Scripts overcharged postal workers by $45 million, audit says (STAT)
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