Recon: Spectrum cuts 75% of staff following FDA rejection; WHO to rename monkeypox as ‘mpox’
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA Accepts BLA for Roche & Sarepta’s DMD Gene Therapy (Biospace) (Pharma Letter) (Endpoints)
- FDA won't hold adcomm for BioMarin's hemophilia gene therapy after all (Endpoints)
- FDA pushes back Gamida Cell’s PDUFA date by three months (Endpoints)
- FDA preps for DMD drug generics as Sarepta has yet to finish its confirmatory trial (Endpoints)
- Industry groups, CVS pick apart FDA's proposed pathway for generics to carve out OTC indications (Endpoints)
- Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come? (Pink Sheet)
- Suspended California cell therapy manufacturing site hit with FDA warning letter over major quality concerns (Endpoints)
- Standardization Of Patient-Focused Core Clinical Outcomes Could Enable Labeling Comparisons (Pink Sheet)
- US Bill Seeks To Eliminate Biosimilar Interchangeability Trial Burden (Pink Sheet)
- ‘Skinny labels’ on biosimilar medicines saved Medicare $1.5 billion over a recent five-year period (STAT)
- Former Merck CEO: Democracy and the drug industry are both in danger (STAT)
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- Researchers test mRNA technology for universal flu vaccine (Reuters)
- Addiction Treatment Record-Sharing Overhauled in HHS Proposal (Bloomberg)
- EU Finalizes Option To Omit Expiry Date On Inner Labeling Of Investigational Drugs (Pink Sheet)
- EMA Launches First RWE Studies Under Big Data Project (Pink Sheet)
- Pfizer’s CEO rapped by regulator for making ‘misleading’ statements about children’s vaccines (The Telegraph) (Fierce)
- Roche Wants EU Pharma Legislative Revision To ‘Dare Something New’ (Pink Sheet)
- Risk of More Dangerous Covid Strain Seen in South African Lab (Bloomberg)
- UK To Use Vaccine Taskforce Model For ‘Cutting-Edge’ R&D Funding Program (Pink Sheet)
- Switzerland experiencing medicine shortages says pharmacists association (Reuters)
- Germany working to ensure continued cooperation between BioNTech, Chinese partner (Reuters)
- WHO to phase out the name ‘monkeypox’ for ‘mpox’ (STAT) (Reuters) (Bloomberg) (NYT)
- China eases Covid rules after wide protests of lockdowns (STAT)
- Uganda's president extends Ebola epicentre's quarantine for 21 days (Reuters)
- Spectrum Cuts NSCLC Program and 75% of Staff on Heels of CRL (Biospace) (Fierce) (Endpoints)
- AbbVie links up with London VC firm to map out new anti-inflammatory companies (Fierce)
- AstraZeneca beefs up COPD pipeline with $400M biobuck bet on C4X program (Fierce) (Reuters)
- Racing rising resistance, Novartis marches malaria therapy into phase 3 (Fierce)
- Axsome Headed to FDA after Phase III Alzheimer’s Agitation Win (Biospace)
- US Partial Clinical Hold on Diamyd Phase III Trial Lifted by the FDA (Biospace)
- Genentech starts phase 2 trial to optimize delivery of eye disease cell therapy (Fierce)
- In new deal, AstraZeneca places small bet on 'critical but challenging' target (Endpoints)
- Spying new horizons, Xeris starts work on subcutaneous version of rare disease drug (Fierce)
- It’s A Class I Recall For Baxter’s WatchCare Device (MedTech Dive) (MedTech Insight)
- CAMD Says ‘Critical Appraisal’ Needed On EU MDR Capacity Bottlenecks (MedTech Insight)
- Europe faces 2024 bottleneck in device reapprovals as submissions slow (MedTech Dive)
- Payment Schemes For Innovative Medtech Exist In Just 8 European Countries – Report (MedTech Insight)
- German Digital Health Strategy And EPR Project Get A Reboot (MedTech Insight)
- Aidoc nets FDA clearances for AI detection of aortic tears, medium-vessel strokes (Fierce)
- Philips respirator recall reaches 260 reported deaths, FDA says (MedTech Dive) (Fierce)
- Everstone Said to Weigh Sale of $1 Billion Medical Device Firm (Bloomberg)
- Takeda, Generic Drug Makers Escape Class Antitrust Claims (Bloomberg)
- Bayer Mostly Avoids Lawsuit Over Mirena IUD Cancer Risk, For Now (Bloomberg)
- Drug Research Tech Patents Targeted in ITC Import Probe (Bloomberg)
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