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Reforms to the US 180-day exclusivity incentive included in the Blocking Act that is part of the Lower Health Care Costs Act could cost the US healthcare system approximately $1.7bn, the AAM has warned.
China’s Bio-Thera Solutions has received approval from the country’s NMPA to launch a Phase I clinical study comparing the pharmacokinetics and safety of its proposed ustekinumab biosimilar to Johnson & Johnson’s blockbuster psoriasis drug Stelara, the latest in a string of the biotech company’s products to advance into clinical development.
Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions without written record; negotiations for BsUFA III may be opportunity to create such a process.
A new work sharing pilot has been launched to evaluate jointly generic drugs intended for launch in Singapore and Malaysia.
Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.
EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.
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