Recon: FDA flagged sterility issues at plant that fills Novo’s Wegovy; WHO adds MS, Ebola drugs to essential medicines list
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Lapses at Catalent plant filling Novo’s Wegovy forced 2 prior shutdowns: report (Fierce) (Reuters)
- Octapharma wins FDA approval for drug to urgently reverse effects of blood thinners (Endpoints)
- Merck’s next-gen pneumococcal vaccine strides forward after two phase 3 wins (Fierce) (BioSpace)
- Further blow for Biohaven as FDA refuses to consider failed rare disease drug for approval (Fierce)
- Another dosage of Eli Lilly’s Mounjaro is in shortage (Endpoints) (Fierce)
- Biden announces an advanced cancer research initiative as part of the bipartisan ‘moonshot’ effort (STAT)
- Cancer Trials: Patient-Reported, Overall Side Effect Impacts Should Be Measured, US FDA Says (Pink Sheet)
- FDA inspection underscores problem at major U.S. compounder behind hospital drug recalls (STAT)
- US Officials Weigh Deeming a Syphilis Emergency as Drugs Run Low (Bloomberg)
- Biosimilars Could Give Brands the Boot Mid-Year Under Amendment Added to Senate PBM Reform Bill (Pink Sheet) (Bloomberg) (Endpoints)
- Medicare to Hike Pay by $70 Million for Psychiatric Facilities (Bloomberg)
- European Commission accelerates phasing out animal testing, but stops short of a ban (STAT)
- UK probes Novo's Ozempic, weight-loss drug Saxenda over suicidal, self-harming thoughts (Reuters) (Bloomberg)
- WHO Essential Medicines List Adds Three MS Drugs But Excludes Expensive Cancer Products (Pink Sheet) (Reuters)
- EU Country Coalition Wants New Unmet Needs System To Incentivize The Right Innovation (Pink Sheet)
- New EU Filings (Pink Sheet)
- New Zealand Passes Bill To Overhaul Drug And Device Regulation (Pink Sheet)
- Pfizer Announces Executive Leadership to Advance Oncology Research and Development Strategy (BioSpace) (Endpoints)
- FDA Grants Breakthrough Therapy Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy (BioSpace)
- Private Equity Backers of Plan B Morning-After Pill Weigh $4 Billion Sale of Company (Bloomberg)
- ‘That’s certainly on our minds:’ Novartis, GSK mull impact of IRA on R&D, M&A strategies (Fierce)
- GSK Raises Outlook, Looks to New Medicines to Fuel Growth (Bloomberg) (Endpoints) (Fierce)
- Moderna/Merck begins late-stage study of skin cancer vaccine combination (Reuters)
- Roche loses spark for gene therapy, axing hemophilia A candidate from pipeline (Fierce) (BioSpace) (Endpoints)
- Roche CFO flags need to bolster late-stage drug development (Reuters)
- Eye drug success mitigates Roche's earnings decline (Reuters)
- Finnish CDMO Biovian earmarks €50M to expand advanced therapy production sites (Fierce)
- Bristol Myers sales fall, cuts 2023 forecast as drugs face competition (Reuters)
- Fortrea inks deal with Australia’s Incannex for sleep apnea drug trial (Fierce)
- Takeda suffers setback as promising neuroscience prospect flunks phase 2 (Endpoints) (Fierce)
- 'An unholy union': Stanford scientists create a drug that flips cancer driver into killer (Endpoints)
- Thermo Fisher's revenue falls in Q2 amid 'challenging' climate for biotechs and in China (Endpoints)
- Lilly's obesity drug leads to about 26% weight loss in new studies (Reuters)
- The Once-Hot Market for Biotech Jobs and Lab Space Has Cooled: What Now? (Boston Globe)
- FDA Takes Steps to Facilitate Innovation for Devices Intended to Treat Opioid Use Disorder (BioSpace)
- FDA Grants Clearance for UltraSight's AI-Powered Cardiac Ultrasound Technology (BioSpace)
- New Zealand Passes Bill To Overhaul Drug and Device Regulation (MedTech Insight)
- Expert: Boost Compliance By Monitoring Social Media (MedTech Insight)
- AbbVie raises profit forecast as Humira stays strong, new drugs impress (Reuters)
- Teleflex to expand urology portfolio with $600M acquisition (MedTech Dive)
- Boston Scientific lifts annual profit forecast on heart devices strength (Reuters)
- Glucotrack’s two-year CGM implant passes first feasibility study (Fierce)
- Quest maps out base business boost despite COVID test crunch, high worker turnover (Fierce)
- Labcorp cuts 2023 profit forecast on drug development spin-off (Reuters)
- Merck's $1.4B cyberattack suit goes to New Jersey Supreme Court (Endpoints)
- British billionaire Joe Lewis indicted for alleged insider trading scheme involving Mirati, Solid Bio shares (Endpoints) (Fierce) (Reuters)
- Ipsen ends neurotoxin pact with Galderma after arbitration cases filed in international court (Endpoints)
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