Biogen gets much-needed pipeline lift with speedy ALS drug review
amyotrophic lateral sclerosis, antisense oligonucleotides, Biogen, neurology, regulatory, tofersen
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regulatory
Pfizer, Flynn fined £70m in resurrected epilepsy drug pricing probe
competition law, Drug pricing, epilepsy, Financial, Flynn Pharma, Pfizer, regulatory, UK
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EMA pilot will see if clinical trial data should be digested ‘raw’
clinical research, clinical trials, data, ema, regulatory
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HRA Pharma bids to bring first OTC contraceptive pill to US
contraception, HRA Pharma, OTC, Perrigo, regulatory, women's health
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Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan
Aduhelm, Alzheimer's disease, Biogen, Eisai, fda, lecanemab, neurology, regulatory
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FDA rejection of Spero’s tebipenem ‘raises resistance threat’
antibiotic, antimicrobial resistance, fda, regulatory, Spero Therapeutics, tebipenem
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US panel backs Omicron-targeting vaccines for booster campaigns
BioNTech, coronavirus, COVID-19, COVID-19 vaccine, fda, GlaxoSmithKline, Moderna, Novavax, Omicron, Pfizer, regulatory, variant
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Sarepta shares yo-yo as FDA places hold on Duchenne trial
Duchenne muscular dystrophy, Exondys 51, fda, rare disease, regulatory, safety, Sarepta, vesleteplirsen
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