AstraZeneca filed suit against generic manufacturer Accord Pharmaceuticals for alleged infringement upon four patents for AstraZeneca’s breast cancer drug Faslodex (fulvestrant). Source: Drug Industry Daily
CDER Director Janet Woodcock Friday announced details of two new voluntary programs designed to support improvements in product and process quality and to enhance the agency’s use of quality metrics.…
The FDA released a draft guidance Thursday recommending ways to demonstrate if new drugs or drug uses are effective for certain low-prevalence rare diseases caused by single enzyme defects. Source:…
The FDA on Thursday released its GDUFA II user fees for fiscal 2019 — including a significant hike for generic drug applicants. Source: Drug Industry Daily
An FDA advisory committee agreed Thursday that 60 Degrees Pharmaceuticals proved the safety and efficacy of its NDA for tafenoquine indicated for the prevention of malaria in adults. Source: Drug…
The FDA on Thursday issued final guidance closing a loophole under which drug sponsors could avoid their obligation to study drugs in pediatric indications. Source: Drug Industry Daily
The FDA on Wednesday published a list for drug sponsors of surrogate endpoints they may consider in trials to support drug approvals or licensures. Source: Drug Industry Daily
Two drugmakers targeted in a lawsuit over Tennessee’s opioid epidemic filed a third-party complaint against online “black market” drug distributors, alleging they’re responsible for the state’s opioid crisis. Source: Drug…
An advisory panel Wednesday recommended that the FDA collect more data before signing off on use of GlaxoSmithKline’s asthma drug mepolizumab for treating chronic obstructive pulmonary disease (COPD). Source: Drug…
The Senate Health Committee unanimously approved a bipartisan bill on Wednesday that would outlaw “gag clauses” that prevent pharmacists from telling patients a drug would be cheaper if they paid…