Drugs

Allarity Refocuses in Response to FDA Comments

Allarity Therapeutics says its board has ordered a refocus of the company’s oncology drug pipeline away from monotherapies and toward combination drugs. One reason for the shift, it says, is information from a meeting with FDA on a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for metastatic renal cell carcinoma.

At the meeting, the company says, FDA indicated Allarity would likely have to conduct a new dovitinib dosing study before doing any future Phase 3 studies that could enable the submission of a new NDA. “In view of these delays and increased costs/risks, the company has determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable…,” Allarity says.

The company says its board determined that the change in focus will:

align with the ongoing shift in cancer therapy standard-of-care toward combination therapies;
strengthen the company’s ability to attract additional funding;
significantly broaden the company’s possibilities for future commercial partnering; and
improve the likelihood of clinical and commercial success of the company’s pipeline assets.

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