Drugs

High Pace of Biotech Approvals Seen to Continue

The Tufts Center for the Study of Drug Development says that FDA approved more than 300 biotech products covering 267 indications from 1980 through 2016, or about 35% of all new drug approvals. The center’s latest Impact Report (subscription or purchase required) says that given the historically high Phase 3-to-approval success rate of biologicals in late-stage development (74%), the extensive biotech product pipeline of 429 candidates in Phase 3 trials at the end of 2016 suggests that the high pace of biotech product approvals will continue through the next decade.

In the period 2000-2016, the report says, FDA approved 225 new biotech products, compared to 304 small-molecule drug approvals in the same period. New oncology products accounted for 20% of that total.

Monoclonal antibodies were the largest product category in Phase 3 trials, the report says, accounting for 34.5% of 429 biotech products. Development of biosimilars also expanded rapidly, accounting for more than 60 products in Phase 3 in 2016. Tufts says that biosimilars are being developed for 19 different marketed products, nine of which focus on monoclonal antibodies.

Products being developed to treat oncology indications accounted for 34% of all biotech products in Phase 3 trials in 2016, the report says. Seven other disease areas — rheumatology, infectious diseases, endocrinology, ophthalmology, neurology, and dermatology — each with 20 or more products in development, accounted for 47% of all biotech products in Phase 3 trials in 2016.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome