Drugs

FDA is Being Flexible in Fast Track Approvals: Post

Two Hyman, Phelps & McNamara attorneys say that the recent FDA approval of Chemo Research’s NDA for benznidazole to treat children with Chagas disease, that included giving the sponsor a tropical disease priority review voucher, is the latest approval demonstrating how flexible the agency has become in applying evidence needed for accelerated approval. Writing in their firm’s FDA Law Blog, the two say the benznidazole approval brings to 25 the number of FDA accelerated approvals. It was the sixth accelerated approval in the last 30 months, they say, compared with 19 such approvals in over 30 years before 3/2015.

The attorneys also note that Chagas was added to the list of tropical diseases eligible for a voucher after FDA held a Patient-Focused Drug Development meeting on the disease to hear from patients and advocates.

They also point out that a patient organization in Argentina spoke at the drug development meeting and partnered with Chemo Research in developing benznidazole, along with support from the Drugs for Neglected Diseases initiative. In response, the company said that a “substantial portion of any revenue derived from the future sale of the priority review voucher will be directed towards enhancing access to treatment of Chagas patients and improving patient health in other disease areas.”

The attorneys say that given the scrutiny that priority review voucher programs have received, redistributing funds from the sale of vouchers to patients in need, especially in tropical diseases that are endemic in lower income regions of the world, “may help to maintain this incentive so that it can continue to encourage development of drugs.”

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

Read more

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