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July 22, 2024
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • ‘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)
Government, Regulatory & Legal
  • 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)
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.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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