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)
- 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)
- 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)
- 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)
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