Drugs

Pfizer, Wave Collaborate on Nucleic Acid Therapies

Wave Life Sciences has entered into a research, license and option agreement with Pfizer to investigate developing nucleic acid therapies aimed at silencing the underlying causes of debilitating metabolic diseases. “The collaboration will focus on genetically defined targets and bring together Wave’s proprietary stereopure drug development platform, across antisense and RNAi modalities, along with GalNAc and Pfizer’s hepatic targeting technology for enhanced delivery to the liver,” the companies say.

Under the agreement, Wave will advance up to five programs from discovery through to the selection of clinical candidates, at which point Pfizer may elect to exclusively license the programs and undertake further development and potential commercialization. One target program has already been selected — Wave’s Apolipoprotein C-III program. In addition, Wave has received rights to Pfizer's hepatic targeting technology, which Wave may elect to use for hepatic programs beyond the collaboration. Should Wave use this technology, Pfizer is eligible to receive potential development and commercial milestone payments.

“Wave’s platform enables the design and development of stereopure nucleic acid therapeutics, which are optimized across multiple dimensions of pharmacology, including efficacy, stability, specificity and safety,” they say. “Wave’s platform offers the flexibility to design therapeutics across multiple modalities, including antisense, RNAi and exon-skipping.”

Additionally, the agreement has Pfizer paying $40 million upfront. Also, assuming five potential products are successfully developed and commercialized, Wave may earn up to $871 million in potential research, development and commercial milestone payments from Pfizer.

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