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A European Parliament committee is proposing that the European Commission promote transparency in private research to foster better access to medicines across the EU. Read More
A joint meeting of three FDA advisory committees tackled the issue of prescribing opioid painkillers in pediatrics and came up with a constant refrain: We need more data. Read More
Diabetes drugs carry special development challenges and can be the riskiest sector in pharmaceuticals, with one in 13 investigational drugs achieving U.S. approval, according to a report from the Tufts Center for the Study of Drug Development. Read More
Spectrum Pharmaceuticals failed to impress an FDA advisory committee, which unanimously voted against recommending approval of the company’s treatment to prevent recurrence of low-grade non-muscle invasive bladder cancer. Read More
The FDA confirmed the use of total kidney volume measurements in selecting patients for clinical trials in autosomal dominant polycystic kidney disease. Read More
Kite Pharma announced positive interim results from a Phase II clinical trial of its immunotherapy in patients with aggressive non-Hodgkin’s lymphomas and said the study would form the basis of its marketing submissions to the FDA. Read More
Three pharmaceutical companies announced Phase III trial results from their injectable psoriasis treatments — with one delivering better head-to-head clinical results than international top-selling drug Humira, which reached over $14 billion in sales in 2015. Read More
To achieve the national cancer moonshot’s goal of accelerating cancer research, the FDA is planning to encourage more seamless, adaptive clinical trial designs for oncologic drugs. Read More
The expanded HHS mandate that clinical trial investigators publish their full results on ClinicalTrials.gov is backed up with strong consequences for non-compliance that will be enforced by the FDA and the National Institutes of Health. Read More
Next month, voters in California will decide on Proposition 61, which is intended to lower prescription drug prices, but veterans organizations oppose the initiative, saying it will raise drug prices for veterans. Read More
The UK Court of Appeal affirmed an earlier ruling that invalidates Pfizer’s patent claims for Lyrica, saying generic versions will not lead to any infringement. Read More