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May 22, 2023
by Michael Mezher

Recon: Ironwood to buy VectivBio for $1B; FDA panel votes against recommending Intercept NASH drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Intercept tumbles on concerns over prospects of fatty liver disease drug (Reuters 1, 2)
  • Ironwood bulks up on digestive therapies with $1.15 bln VectivBio buy (Reuters) (BioPharmaDive) (Endpoints)
  • U.S. FDA approves Genmab-AbbVie's blood cancer therapy (Reuters)
  • U.S. FDA approves Krystal Biotech's skin-disorder gene therapy (Reuters) (STAT)
  • Amgen agrees not to seek quick close to Horizon acquisition (Reuters)
  • A More Aggressive FTC Is Starting to Target Drug Mergers and Industry Middlemen (KFF)
  • Here’s what Pfizer and Moderna say is next for their Covid vaccines (CNBC)
  • Pear Therapeutics sold for parts at $6 million auction (STAT)
In Focus: International
  • WHO recommends new COVID shots should target only XBB variants (Reuters)
  • Sanofi: smoker's lung drug benefit was swift and sustained in trial (Reuters)
  • Novo Nordisk says trial of oral weight-loss drug shows significant result (Reuters)
  • Novo Nordisk pauses ads for weight loss drug Wegovy as it struggles to meet demand (STAT)
  • Novartis beefs up gene therapy pipeline, spending $87.5M on an Avrobio therapy (Endpoints)
  • Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cancer (PMLive)
  • Novo Nordisk’s Obesity Drug Activities Break UK Rules Again (Scrip)
  • India's Glenmark Pharma reports lower Q4 profit as domestic sales weaken (Reuters)
  • Don't delay reforms to prepare for next pandemic, WHO chief says (Reuters)
  • WHO launches global network to detect and prevent infectious disease threats (WHO)
  • Cholera vaccine shortage to last until 2025 as cases surge, Gavi says (Reuters)
Pharma & Biotech
  • Catalent cuts forecast, delays results again as challenges mount (Reuters)
  • Opinion: The FDA’s Birth Control Decision and Breaking the Medical Monopoly Over Health (NYTimes)
  • Pfizer oral weight loss drug may be as effective as Ozempic injection by Novo Nordisk, study says (CNBC)
  • Drug price caps in Inflation Reduction Act exacerbating shortages, Gottlieb says (The Hill)
  • CBER chief Peter Marks to consider 'alternatives' to clinical holds as they 'put shudders down investors' spines' (Endpoints)
  • In early trial, drug appears to reduce harmful protein buildup in heart (STAT)
  • Gene therapy death not caused by CRISPR, investigators confirm (STAT)
  • Alnylam updates its pitch for expanded Onpattro label with 18-month PhIII data (Endpoints)
  • EMA Looks For Efficiencies For Companies Ahead Of Relaunching Clinical Data Transparency Policy (Pink Sheet)
  • Oculis' eye drug meets main goal in study (Reuters)
  • Hepion's NASH drug meets main goal in mid-stage trial (Reuters)
  • UK's Dechra slumps after profit warning (Reuters)
  • Q&A with FDA: Drug Shortages with CDR Emily Thakur (FDA)
  • G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging (FDA)
Medtech
  • Thermo Fisher's test to detect pregnancy-related complication gets FDA nod (Reuters) (MedtechDive)
  • Abbott, Boston Scientific, Medtronic share data on heart rhythm devices at conference (MedtechDive)
  • FDA clears Beta Bionics’ insulin pump and automated dosing software to create artificial pancreas (Fierce) (MedtechDive)
  • Paradromics reels in $33M, FDA breakthrough tag for mind-reading brain implant (Fierce)
  • Swing Therapeutics receives FDA authorisation for digital therapeutic for fibromyalgia (Pharmafile)
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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